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Webinar on the application procedure for active substances in pesticides and maximum residue levels (MRLs)
28 October 2021
APDESK webinars
Tentative Agenda
Time Topic SpeakerSpeaker
1100-1105 Welcome and introduction Margherita Guidi
1105-1200
Lifecycle of an applicationbull Account creation and managementbull Pre-application ID Pre-submission advice
and Notification of Studiesbull IUCLID dossier submissionbull Portal updates and updates of applicationsbull Confidentiality in the context of actives substances
in pesticides and MRLsbull Public consultationbull Peer review adoption and publication
Karine LheureuxSilvia MazzegaSimone Gabbi
1200-1230 QampA session and conclusions
Stefano CappeacuteSara De BerardisAngelo ColagiorgiMatthias HaslerDimitra Kardassi
Goran KumricChiara MacchiRemigio MaranoAlessia VeraniFrancesca Volpi
Welcome and Introduction
bull What is the goal of this webinar The aim is to explain the arrangements steps and the tools of the application procedure for Active Substances in Pesticides and MRLs implemented by EFSA following the entry into application of the Transparency Regulation
bull Address questions encountered by applicants in recent months following the entry into application of the Transparency Regulation
bull Out of scope Clarifications about aspects of the authorisation process which have not been affected by the Transparency Regulation
Presenters of this webinarbull Karine Lheureuxbull Silvia Mazzegabull Simone Gabbi
Who we are
Goals
Webinar moderatorbull Margherita Guidi
QampA contributorsbull Stefano Cappeacutebull Sara De Berardisbull Angelo Colagiorgibull Matthias Haslerbull Dimitra Kardassi
bull Goran Kumricbull Chiara Macchibull Remigio Maranobull Alessia Veranibull Francesca Volpi
4
bull You are automatically connected to the audio broadcast One-way audio (listen only mode)bull You can submit questions throughout the webinar via the dedicated QampA tab on the top right
navigation barbull The webinar is in English and questions should be submitted in English through the platformbull Some questions will be answered in written and some others will be answered livebull Is some questions remain unanswered you can resubmit them via the Ask a question
ConnectEFSA tool (httpsconnectefsaeuropaeuRMsaskefsa)
bull This webinar is being recorded
Presentationwindow
QampA box For any
questions related to
the topic or unexpected
IT issues
Webinar guide for attendees
Lifecycle of an application
Transparency Regulation from 27th March 2021
Improve coordination between risk assessors and risk managers to ensure better communication to stakeholders and general public
Member States will contribute more to EFSAs governance and scientific Panels
EFSA will have more access to relevant scientific evidence in requests for authorisation
Better access to scientific studies
Effective risk communication
4 pillars
Better governanceMore reliable
independent studiesTransparency
Applicable For - New dossierapplications submitted on or after 27th March 2021
Click here to access the Factsheet rdquoA Modern and Sustainable Food Law in the EUrdquo
7
Pesticides Peer review workflow
0101
bull Pre-intake activities (NoS PSA)
bull Receipt of application dossier for approval or amendment of approval conditions
bull Withdrawal of dossier
bull Validity check during admissibility step by RMS
bull Publication of non-confidential dossier
bull Assessment of confidentiality requests on the admissible dossier
bull Consultation of the public on non-confidential dossier additional evidence
bull Receipt of DARRAR by RMS
Mandate amp Dossier intake01
bull EFSA preparatory steps
bull Consultation of the public and stakeholders on the DARRAR
Preliminary activities to Risk
Assessment02bull Preparation of the
reporting Table
bull Request for Additional Data Request (ADR)
bull Assessment of confidentiality requests on submittedADR (if applicable)
bull Preparation of the draft scientific output and subsequent finalisation (Conclusion)
bull Approval of the scientific output (Conclusion)
Peer Review
03
03
bull Notification on approvedscientific output
bull Editorial checks and corrections
bull Pre-notification of scientific output
bull Publication of scientific outputs and supporting evidence
bull Correction of a published scientific output (if applicable)
Output publication amp dissemination
04
Pesticides MRL workflow
bull Pre-intake activities (NoS PSA)
bull Receipt of Application Dossier
bull Withdrawal of application
bull Validity check during admissibility step by EMS
bull Publication of non-confidential dossier
bull Assessment of confidentiality requests on the admissible dossier
bull Consultation of the public on non-confidential dossier additional evidence
bull Receipt of Evaluation Report by EMS
Mandate amp Dossier intake
01
bull EFSA preparatory steps
Preliminary activities to Risk
Assessment02
bull Request for Additional Data Request (ADR)
bull Preparation of the firstdraft scientific output(Reasoned Opinion)
bull Finalization of the scientific output (Reasoned Opinion)
bull Approval of the scientific output (Reasoned Opinion)
bull Assessment of confidentiality requests on submitted ADR (if applicable)
Risk Assessment (RA)
03
bull Notification of the approved scientific output
bull Editorial checks and corrections
bull Publication of scientific output and supporting evidence
bull Correction of a published scientific output (if applicable)
Output publication amp
dissemination n04
New TOOLS for Business Operators
Dossier eSubmission(Pesticides PPP MRL basic substances)
Additional Data request (ADR)
Follow-up lifecycle
IUCLID
Monitoring of riskassessment flow
Disseminationportal
Proactive disclosure of information
OpenEFSA
Notification of Studies (NoS)
Pre-submission Advice (PSA)
AskAQuestion Public access to
document Public and
targeted consultation
Connect EFSA
Used by legal or natural persons for submitting confidentiality requests related to applications datasets and documents supporting the generic mandates
PORTALINO
Account creation and management
Registration Process
11sup1) Practical arrangements on pre-submission phase and public consultations
Sarah
Business OperatorPotential Applicant
Third Parties
Martin
LaboratoriesTesting facilities
John
In order to initiate a pre-submission activity a potential applicant or a laboratory or testing facility to which a study has been commissioned shall first register in the system hellipsup1 1
Third parties representing one or more entities shall also register in the Authority system supporting pre-submission activities hellipsup1 and obtain the authorization by represented entities to act on their behalf
2
Registered entities shall ensure that all information provided is reported accurately and kept up-to-datesup1 3
The public(during PC or once studies
are published)
ConnectEFSA Portal - Account Registration
The potential applicant starts the registration in
the portal
The potential applicantmust register as the
entity heshe is representing (eg a
company)Sarah
The account name will then be the entity (company) name
Click here to register
1
1
ConnectEFSA Portal - Account Registration
Information related to the contact person of the account Theinformation and the e-mail address must be person specific andlinked to the entity registered No functional and genericmailboxes (eg gmail)
Each account can register a maximum of 6 contact persons(NEW since 30 June)
Information related to the organisation (eg company) Thename inserted will be the account name
A complete billing address is essential for a clear identificationof the company
As regards multinational companies made up of several entities any of these entities may register provided that the registered entity is recognised as having a separate legal personality under the national law of the country in which it has its registered office
After the registration the account and the contact(s)
are not active yet
Upon registration EFSA performs a security check of
the account in few days
Once the account is considered valid EFSA
activate the account and the contact(s) inside
The applicant is ready to use the functionalities of the
portal
Authorisation of delegation to third parties
14
Third Parties
Martin
Sarah
Business OperatorsPotential Applicants
Database of Study Notifications
Martin send a notification on behalf of Sarah
Creates an account relationshipldquoMy Detailsrdquo page ldquoManage Relationshiprdquo button
Example A consultant creates a pre-application ID and add the business operator (the potential applicant not the consultant) in the lsquoBusiness Operatorrsquo field The consultant shares the pre-application ID with other business operator(s)
The third party must notify studies indicating as business operator the applicant they represent Additional applicants of a group of applicants can be indicated with ldquoshare withrdquo functionality
Organisations playing multiple roles
15
SarahBusiness OperatorsPotential Applicants
Third Parties
Martin
LaboratoriesTesting facilities
John
Sarah
Business Operator
Laboratory Third Party
Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
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Stay connected
Tentative Agenda
Time Topic SpeakerSpeaker
1100-1105 Welcome and introduction Margherita Guidi
1105-1200
Lifecycle of an applicationbull Account creation and managementbull Pre-application ID Pre-submission advice
and Notification of Studiesbull IUCLID dossier submissionbull Portal updates and updates of applicationsbull Confidentiality in the context of actives substances
in pesticides and MRLsbull Public consultationbull Peer review adoption and publication
Karine LheureuxSilvia MazzegaSimone Gabbi
1200-1230 QampA session and conclusions
Stefano CappeacuteSara De BerardisAngelo ColagiorgiMatthias HaslerDimitra Kardassi
Goran KumricChiara MacchiRemigio MaranoAlessia VeraniFrancesca Volpi
Welcome and Introduction
bull What is the goal of this webinar The aim is to explain the arrangements steps and the tools of the application procedure for Active Substances in Pesticides and MRLs implemented by EFSA following the entry into application of the Transparency Regulation
bull Address questions encountered by applicants in recent months following the entry into application of the Transparency Regulation
bull Out of scope Clarifications about aspects of the authorisation process which have not been affected by the Transparency Regulation
Presenters of this webinarbull Karine Lheureuxbull Silvia Mazzegabull Simone Gabbi
Who we are
Goals
Webinar moderatorbull Margherita Guidi
QampA contributorsbull Stefano Cappeacutebull Sara De Berardisbull Angelo Colagiorgibull Matthias Haslerbull Dimitra Kardassi
bull Goran Kumricbull Chiara Macchibull Remigio Maranobull Alessia Veranibull Francesca Volpi
4
bull You are automatically connected to the audio broadcast One-way audio (listen only mode)bull You can submit questions throughout the webinar via the dedicated QampA tab on the top right
navigation barbull The webinar is in English and questions should be submitted in English through the platformbull Some questions will be answered in written and some others will be answered livebull Is some questions remain unanswered you can resubmit them via the Ask a question
ConnectEFSA tool (httpsconnectefsaeuropaeuRMsaskefsa)
bull This webinar is being recorded
Presentationwindow
QampA box For any
questions related to
the topic or unexpected
IT issues
Webinar guide for attendees
Lifecycle of an application
Transparency Regulation from 27th March 2021
Improve coordination between risk assessors and risk managers to ensure better communication to stakeholders and general public
Member States will contribute more to EFSAs governance and scientific Panels
EFSA will have more access to relevant scientific evidence in requests for authorisation
Better access to scientific studies
Effective risk communication
4 pillars
Better governanceMore reliable
independent studiesTransparency
Applicable For - New dossierapplications submitted on or after 27th March 2021
Click here to access the Factsheet rdquoA Modern and Sustainable Food Law in the EUrdquo
7
Pesticides Peer review workflow
0101
bull Pre-intake activities (NoS PSA)
bull Receipt of application dossier for approval or amendment of approval conditions
bull Withdrawal of dossier
bull Validity check during admissibility step by RMS
bull Publication of non-confidential dossier
bull Assessment of confidentiality requests on the admissible dossier
bull Consultation of the public on non-confidential dossier additional evidence
bull Receipt of DARRAR by RMS
Mandate amp Dossier intake01
bull EFSA preparatory steps
bull Consultation of the public and stakeholders on the DARRAR
Preliminary activities to Risk
Assessment02bull Preparation of the
reporting Table
bull Request for Additional Data Request (ADR)
bull Assessment of confidentiality requests on submittedADR (if applicable)
bull Preparation of the draft scientific output and subsequent finalisation (Conclusion)
bull Approval of the scientific output (Conclusion)
Peer Review
03
03
bull Notification on approvedscientific output
bull Editorial checks and corrections
bull Pre-notification of scientific output
bull Publication of scientific outputs and supporting evidence
bull Correction of a published scientific output (if applicable)
Output publication amp dissemination
04
Pesticides MRL workflow
bull Pre-intake activities (NoS PSA)
bull Receipt of Application Dossier
bull Withdrawal of application
bull Validity check during admissibility step by EMS
bull Publication of non-confidential dossier
bull Assessment of confidentiality requests on the admissible dossier
bull Consultation of the public on non-confidential dossier additional evidence
bull Receipt of Evaluation Report by EMS
Mandate amp Dossier intake
01
bull EFSA preparatory steps
Preliminary activities to Risk
Assessment02
bull Request for Additional Data Request (ADR)
bull Preparation of the firstdraft scientific output(Reasoned Opinion)
bull Finalization of the scientific output (Reasoned Opinion)
bull Approval of the scientific output (Reasoned Opinion)
bull Assessment of confidentiality requests on submitted ADR (if applicable)
Risk Assessment (RA)
03
bull Notification of the approved scientific output
bull Editorial checks and corrections
bull Publication of scientific output and supporting evidence
bull Correction of a published scientific output (if applicable)
Output publication amp
dissemination n04
New TOOLS for Business Operators
Dossier eSubmission(Pesticides PPP MRL basic substances)
Additional Data request (ADR)
Follow-up lifecycle
IUCLID
Monitoring of riskassessment flow
Disseminationportal
Proactive disclosure of information
OpenEFSA
Notification of Studies (NoS)
Pre-submission Advice (PSA)
AskAQuestion Public access to
document Public and
targeted consultation
Connect EFSA
Used by legal or natural persons for submitting confidentiality requests related to applications datasets and documents supporting the generic mandates
PORTALINO
Account creation and management
Registration Process
11sup1) Practical arrangements on pre-submission phase and public consultations
Sarah
Business OperatorPotential Applicant
Third Parties
Martin
LaboratoriesTesting facilities
John
In order to initiate a pre-submission activity a potential applicant or a laboratory or testing facility to which a study has been commissioned shall first register in the system hellipsup1 1
Third parties representing one or more entities shall also register in the Authority system supporting pre-submission activities hellipsup1 and obtain the authorization by represented entities to act on their behalf
2
Registered entities shall ensure that all information provided is reported accurately and kept up-to-datesup1 3
The public(during PC or once studies
are published)
ConnectEFSA Portal - Account Registration
The potential applicant starts the registration in
the portal
The potential applicantmust register as the
entity heshe is representing (eg a
company)Sarah
The account name will then be the entity (company) name
Click here to register
1
1
ConnectEFSA Portal - Account Registration
Information related to the contact person of the account Theinformation and the e-mail address must be person specific andlinked to the entity registered No functional and genericmailboxes (eg gmail)
Each account can register a maximum of 6 contact persons(NEW since 30 June)
Information related to the organisation (eg company) Thename inserted will be the account name
A complete billing address is essential for a clear identificationof the company
As regards multinational companies made up of several entities any of these entities may register provided that the registered entity is recognised as having a separate legal personality under the national law of the country in which it has its registered office
After the registration the account and the contact(s)
are not active yet
Upon registration EFSA performs a security check of
the account in few days
Once the account is considered valid EFSA
activate the account and the contact(s) inside
The applicant is ready to use the functionalities of the
portal
Authorisation of delegation to third parties
14
Third Parties
Martin
Sarah
Business OperatorsPotential Applicants
Database of Study Notifications
Martin send a notification on behalf of Sarah
Creates an account relationshipldquoMy Detailsrdquo page ldquoManage Relationshiprdquo button
Example A consultant creates a pre-application ID and add the business operator (the potential applicant not the consultant) in the lsquoBusiness Operatorrsquo field The consultant shares the pre-application ID with other business operator(s)
The third party must notify studies indicating as business operator the applicant they represent Additional applicants of a group of applicants can be indicated with ldquoshare withrdquo functionality
Organisations playing multiple roles
15
SarahBusiness OperatorsPotential Applicants
Third Parties
Martin
LaboratoriesTesting facilities
John
Sarah
Business Operator
Laboratory Third Party
Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
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Stay connected
Welcome and Introduction
bull What is the goal of this webinar The aim is to explain the arrangements steps and the tools of the application procedure for Active Substances in Pesticides and MRLs implemented by EFSA following the entry into application of the Transparency Regulation
bull Address questions encountered by applicants in recent months following the entry into application of the Transparency Regulation
bull Out of scope Clarifications about aspects of the authorisation process which have not been affected by the Transparency Regulation
Presenters of this webinarbull Karine Lheureuxbull Silvia Mazzegabull Simone Gabbi
Who we are
Goals
Webinar moderatorbull Margherita Guidi
QampA contributorsbull Stefano Cappeacutebull Sara De Berardisbull Angelo Colagiorgibull Matthias Haslerbull Dimitra Kardassi
bull Goran Kumricbull Chiara Macchibull Remigio Maranobull Alessia Veranibull Francesca Volpi
4
bull You are automatically connected to the audio broadcast One-way audio (listen only mode)bull You can submit questions throughout the webinar via the dedicated QampA tab on the top right
navigation barbull The webinar is in English and questions should be submitted in English through the platformbull Some questions will be answered in written and some others will be answered livebull Is some questions remain unanswered you can resubmit them via the Ask a question
ConnectEFSA tool (httpsconnectefsaeuropaeuRMsaskefsa)
bull This webinar is being recorded
Presentationwindow
QampA box For any
questions related to
the topic or unexpected
IT issues
Webinar guide for attendees
Lifecycle of an application
Transparency Regulation from 27th March 2021
Improve coordination between risk assessors and risk managers to ensure better communication to stakeholders and general public
Member States will contribute more to EFSAs governance and scientific Panels
EFSA will have more access to relevant scientific evidence in requests for authorisation
Better access to scientific studies
Effective risk communication
4 pillars
Better governanceMore reliable
independent studiesTransparency
Applicable For - New dossierapplications submitted on or after 27th March 2021
Click here to access the Factsheet rdquoA Modern and Sustainable Food Law in the EUrdquo
7
Pesticides Peer review workflow
0101
bull Pre-intake activities (NoS PSA)
bull Receipt of application dossier for approval or amendment of approval conditions
bull Withdrawal of dossier
bull Validity check during admissibility step by RMS
bull Publication of non-confidential dossier
bull Assessment of confidentiality requests on the admissible dossier
bull Consultation of the public on non-confidential dossier additional evidence
bull Receipt of DARRAR by RMS
Mandate amp Dossier intake01
bull EFSA preparatory steps
bull Consultation of the public and stakeholders on the DARRAR
Preliminary activities to Risk
Assessment02bull Preparation of the
reporting Table
bull Request for Additional Data Request (ADR)
bull Assessment of confidentiality requests on submittedADR (if applicable)
bull Preparation of the draft scientific output and subsequent finalisation (Conclusion)
bull Approval of the scientific output (Conclusion)
Peer Review
03
03
bull Notification on approvedscientific output
bull Editorial checks and corrections
bull Pre-notification of scientific output
bull Publication of scientific outputs and supporting evidence
bull Correction of a published scientific output (if applicable)
Output publication amp dissemination
04
Pesticides MRL workflow
bull Pre-intake activities (NoS PSA)
bull Receipt of Application Dossier
bull Withdrawal of application
bull Validity check during admissibility step by EMS
bull Publication of non-confidential dossier
bull Assessment of confidentiality requests on the admissible dossier
bull Consultation of the public on non-confidential dossier additional evidence
bull Receipt of Evaluation Report by EMS
Mandate amp Dossier intake
01
bull EFSA preparatory steps
Preliminary activities to Risk
Assessment02
bull Request for Additional Data Request (ADR)
bull Preparation of the firstdraft scientific output(Reasoned Opinion)
bull Finalization of the scientific output (Reasoned Opinion)
bull Approval of the scientific output (Reasoned Opinion)
bull Assessment of confidentiality requests on submitted ADR (if applicable)
Risk Assessment (RA)
03
bull Notification of the approved scientific output
bull Editorial checks and corrections
bull Publication of scientific output and supporting evidence
bull Correction of a published scientific output (if applicable)
Output publication amp
dissemination n04
New TOOLS for Business Operators
Dossier eSubmission(Pesticides PPP MRL basic substances)
Additional Data request (ADR)
Follow-up lifecycle
IUCLID
Monitoring of riskassessment flow
Disseminationportal
Proactive disclosure of information
OpenEFSA
Notification of Studies (NoS)
Pre-submission Advice (PSA)
AskAQuestion Public access to
document Public and
targeted consultation
Connect EFSA
Used by legal or natural persons for submitting confidentiality requests related to applications datasets and documents supporting the generic mandates
PORTALINO
Account creation and management
Registration Process
11sup1) Practical arrangements on pre-submission phase and public consultations
Sarah
Business OperatorPotential Applicant
Third Parties
Martin
LaboratoriesTesting facilities
John
In order to initiate a pre-submission activity a potential applicant or a laboratory or testing facility to which a study has been commissioned shall first register in the system hellipsup1 1
Third parties representing one or more entities shall also register in the Authority system supporting pre-submission activities hellipsup1 and obtain the authorization by represented entities to act on their behalf
2
Registered entities shall ensure that all information provided is reported accurately and kept up-to-datesup1 3
The public(during PC or once studies
are published)
ConnectEFSA Portal - Account Registration
The potential applicant starts the registration in
the portal
The potential applicantmust register as the
entity heshe is representing (eg a
company)Sarah
The account name will then be the entity (company) name
Click here to register
1
1
ConnectEFSA Portal - Account Registration
Information related to the contact person of the account Theinformation and the e-mail address must be person specific andlinked to the entity registered No functional and genericmailboxes (eg gmail)
Each account can register a maximum of 6 contact persons(NEW since 30 June)
Information related to the organisation (eg company) Thename inserted will be the account name
A complete billing address is essential for a clear identificationof the company
As regards multinational companies made up of several entities any of these entities may register provided that the registered entity is recognised as having a separate legal personality under the national law of the country in which it has its registered office
After the registration the account and the contact(s)
are not active yet
Upon registration EFSA performs a security check of
the account in few days
Once the account is considered valid EFSA
activate the account and the contact(s) inside
The applicant is ready to use the functionalities of the
portal
Authorisation of delegation to third parties
14
Third Parties
Martin
Sarah
Business OperatorsPotential Applicants
Database of Study Notifications
Martin send a notification on behalf of Sarah
Creates an account relationshipldquoMy Detailsrdquo page ldquoManage Relationshiprdquo button
Example A consultant creates a pre-application ID and add the business operator (the potential applicant not the consultant) in the lsquoBusiness Operatorrsquo field The consultant shares the pre-application ID with other business operator(s)
The third party must notify studies indicating as business operator the applicant they represent Additional applicants of a group of applicants can be indicated with ldquoshare withrdquo functionality
Organisations playing multiple roles
15
SarahBusiness OperatorsPotential Applicants
Third Parties
Martin
LaboratoriesTesting facilities
John
Sarah
Business Operator
Laboratory Third Party
Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
4
bull You are automatically connected to the audio broadcast One-way audio (listen only mode)bull You can submit questions throughout the webinar via the dedicated QampA tab on the top right
navigation barbull The webinar is in English and questions should be submitted in English through the platformbull Some questions will be answered in written and some others will be answered livebull Is some questions remain unanswered you can resubmit them via the Ask a question
ConnectEFSA tool (httpsconnectefsaeuropaeuRMsaskefsa)
bull This webinar is being recorded
Presentationwindow
QampA box For any
questions related to
the topic or unexpected
IT issues
Webinar guide for attendees
Lifecycle of an application
Transparency Regulation from 27th March 2021
Improve coordination between risk assessors and risk managers to ensure better communication to stakeholders and general public
Member States will contribute more to EFSAs governance and scientific Panels
EFSA will have more access to relevant scientific evidence in requests for authorisation
Better access to scientific studies
Effective risk communication
4 pillars
Better governanceMore reliable
independent studiesTransparency
Applicable For - New dossierapplications submitted on or after 27th March 2021
Click here to access the Factsheet rdquoA Modern and Sustainable Food Law in the EUrdquo
7
Pesticides Peer review workflow
0101
bull Pre-intake activities (NoS PSA)
bull Receipt of application dossier for approval or amendment of approval conditions
bull Withdrawal of dossier
bull Validity check during admissibility step by RMS
bull Publication of non-confidential dossier
bull Assessment of confidentiality requests on the admissible dossier
bull Consultation of the public on non-confidential dossier additional evidence
bull Receipt of DARRAR by RMS
Mandate amp Dossier intake01
bull EFSA preparatory steps
bull Consultation of the public and stakeholders on the DARRAR
Preliminary activities to Risk
Assessment02bull Preparation of the
reporting Table
bull Request for Additional Data Request (ADR)
bull Assessment of confidentiality requests on submittedADR (if applicable)
bull Preparation of the draft scientific output and subsequent finalisation (Conclusion)
bull Approval of the scientific output (Conclusion)
Peer Review
03
03
bull Notification on approvedscientific output
bull Editorial checks and corrections
bull Pre-notification of scientific output
bull Publication of scientific outputs and supporting evidence
bull Correction of a published scientific output (if applicable)
Output publication amp dissemination
04
Pesticides MRL workflow
bull Pre-intake activities (NoS PSA)
bull Receipt of Application Dossier
bull Withdrawal of application
bull Validity check during admissibility step by EMS
bull Publication of non-confidential dossier
bull Assessment of confidentiality requests on the admissible dossier
bull Consultation of the public on non-confidential dossier additional evidence
bull Receipt of Evaluation Report by EMS
Mandate amp Dossier intake
01
bull EFSA preparatory steps
Preliminary activities to Risk
Assessment02
bull Request for Additional Data Request (ADR)
bull Preparation of the firstdraft scientific output(Reasoned Opinion)
bull Finalization of the scientific output (Reasoned Opinion)
bull Approval of the scientific output (Reasoned Opinion)
bull Assessment of confidentiality requests on submitted ADR (if applicable)
Risk Assessment (RA)
03
bull Notification of the approved scientific output
bull Editorial checks and corrections
bull Publication of scientific output and supporting evidence
bull Correction of a published scientific output (if applicable)
Output publication amp
dissemination n04
New TOOLS for Business Operators
Dossier eSubmission(Pesticides PPP MRL basic substances)
Additional Data request (ADR)
Follow-up lifecycle
IUCLID
Monitoring of riskassessment flow
Disseminationportal
Proactive disclosure of information
OpenEFSA
Notification of Studies (NoS)
Pre-submission Advice (PSA)
AskAQuestion Public access to
document Public and
targeted consultation
Connect EFSA
Used by legal or natural persons for submitting confidentiality requests related to applications datasets and documents supporting the generic mandates
PORTALINO
Account creation and management
Registration Process
11sup1) Practical arrangements on pre-submission phase and public consultations
Sarah
Business OperatorPotential Applicant
Third Parties
Martin
LaboratoriesTesting facilities
John
In order to initiate a pre-submission activity a potential applicant or a laboratory or testing facility to which a study has been commissioned shall first register in the system hellipsup1 1
Third parties representing one or more entities shall also register in the Authority system supporting pre-submission activities hellipsup1 and obtain the authorization by represented entities to act on their behalf
2
Registered entities shall ensure that all information provided is reported accurately and kept up-to-datesup1 3
The public(during PC or once studies
are published)
ConnectEFSA Portal - Account Registration
The potential applicant starts the registration in
the portal
The potential applicantmust register as the
entity heshe is representing (eg a
company)Sarah
The account name will then be the entity (company) name
Click here to register
1
1
ConnectEFSA Portal - Account Registration
Information related to the contact person of the account Theinformation and the e-mail address must be person specific andlinked to the entity registered No functional and genericmailboxes (eg gmail)
Each account can register a maximum of 6 contact persons(NEW since 30 June)
Information related to the organisation (eg company) Thename inserted will be the account name
A complete billing address is essential for a clear identificationof the company
As regards multinational companies made up of several entities any of these entities may register provided that the registered entity is recognised as having a separate legal personality under the national law of the country in which it has its registered office
After the registration the account and the contact(s)
are not active yet
Upon registration EFSA performs a security check of
the account in few days
Once the account is considered valid EFSA
activate the account and the contact(s) inside
The applicant is ready to use the functionalities of the
portal
Authorisation of delegation to third parties
14
Third Parties
Martin
Sarah
Business OperatorsPotential Applicants
Database of Study Notifications
Martin send a notification on behalf of Sarah
Creates an account relationshipldquoMy Detailsrdquo page ldquoManage Relationshiprdquo button
Example A consultant creates a pre-application ID and add the business operator (the potential applicant not the consultant) in the lsquoBusiness Operatorrsquo field The consultant shares the pre-application ID with other business operator(s)
The third party must notify studies indicating as business operator the applicant they represent Additional applicants of a group of applicants can be indicated with ldquoshare withrdquo functionality
Organisations playing multiple roles
15
SarahBusiness OperatorsPotential Applicants
Third Parties
Martin
LaboratoriesTesting facilities
John
Sarah
Business Operator
Laboratory Third Party
Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
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Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Lifecycle of an application
Transparency Regulation from 27th March 2021
Improve coordination between risk assessors and risk managers to ensure better communication to stakeholders and general public
Member States will contribute more to EFSAs governance and scientific Panels
EFSA will have more access to relevant scientific evidence in requests for authorisation
Better access to scientific studies
Effective risk communication
4 pillars
Better governanceMore reliable
independent studiesTransparency
Applicable For - New dossierapplications submitted on or after 27th March 2021
Click here to access the Factsheet rdquoA Modern and Sustainable Food Law in the EUrdquo
7
Pesticides Peer review workflow
0101
bull Pre-intake activities (NoS PSA)
bull Receipt of application dossier for approval or amendment of approval conditions
bull Withdrawal of dossier
bull Validity check during admissibility step by RMS
bull Publication of non-confidential dossier
bull Assessment of confidentiality requests on the admissible dossier
bull Consultation of the public on non-confidential dossier additional evidence
bull Receipt of DARRAR by RMS
Mandate amp Dossier intake01
bull EFSA preparatory steps
bull Consultation of the public and stakeholders on the DARRAR
Preliminary activities to Risk
Assessment02bull Preparation of the
reporting Table
bull Request for Additional Data Request (ADR)
bull Assessment of confidentiality requests on submittedADR (if applicable)
bull Preparation of the draft scientific output and subsequent finalisation (Conclusion)
bull Approval of the scientific output (Conclusion)
Peer Review
03
03
bull Notification on approvedscientific output
bull Editorial checks and corrections
bull Pre-notification of scientific output
bull Publication of scientific outputs and supporting evidence
bull Correction of a published scientific output (if applicable)
Output publication amp dissemination
04
Pesticides MRL workflow
bull Pre-intake activities (NoS PSA)
bull Receipt of Application Dossier
bull Withdrawal of application
bull Validity check during admissibility step by EMS
bull Publication of non-confidential dossier
bull Assessment of confidentiality requests on the admissible dossier
bull Consultation of the public on non-confidential dossier additional evidence
bull Receipt of Evaluation Report by EMS
Mandate amp Dossier intake
01
bull EFSA preparatory steps
Preliminary activities to Risk
Assessment02
bull Request for Additional Data Request (ADR)
bull Preparation of the firstdraft scientific output(Reasoned Opinion)
bull Finalization of the scientific output (Reasoned Opinion)
bull Approval of the scientific output (Reasoned Opinion)
bull Assessment of confidentiality requests on submitted ADR (if applicable)
Risk Assessment (RA)
03
bull Notification of the approved scientific output
bull Editorial checks and corrections
bull Publication of scientific output and supporting evidence
bull Correction of a published scientific output (if applicable)
Output publication amp
dissemination n04
New TOOLS for Business Operators
Dossier eSubmission(Pesticides PPP MRL basic substances)
Additional Data request (ADR)
Follow-up lifecycle
IUCLID
Monitoring of riskassessment flow
Disseminationportal
Proactive disclosure of information
OpenEFSA
Notification of Studies (NoS)
Pre-submission Advice (PSA)
AskAQuestion Public access to
document Public and
targeted consultation
Connect EFSA
Used by legal or natural persons for submitting confidentiality requests related to applications datasets and documents supporting the generic mandates
PORTALINO
Account creation and management
Registration Process
11sup1) Practical arrangements on pre-submission phase and public consultations
Sarah
Business OperatorPotential Applicant
Third Parties
Martin
LaboratoriesTesting facilities
John
In order to initiate a pre-submission activity a potential applicant or a laboratory or testing facility to which a study has been commissioned shall first register in the system hellipsup1 1
Third parties representing one or more entities shall also register in the Authority system supporting pre-submission activities hellipsup1 and obtain the authorization by represented entities to act on their behalf
2
Registered entities shall ensure that all information provided is reported accurately and kept up-to-datesup1 3
The public(during PC or once studies
are published)
ConnectEFSA Portal - Account Registration
The potential applicant starts the registration in
the portal
The potential applicantmust register as the
entity heshe is representing (eg a
company)Sarah
The account name will then be the entity (company) name
Click here to register
1
1
ConnectEFSA Portal - Account Registration
Information related to the contact person of the account Theinformation and the e-mail address must be person specific andlinked to the entity registered No functional and genericmailboxes (eg gmail)
Each account can register a maximum of 6 contact persons(NEW since 30 June)
Information related to the organisation (eg company) Thename inserted will be the account name
A complete billing address is essential for a clear identificationof the company
As regards multinational companies made up of several entities any of these entities may register provided that the registered entity is recognised as having a separate legal personality under the national law of the country in which it has its registered office
After the registration the account and the contact(s)
are not active yet
Upon registration EFSA performs a security check of
the account in few days
Once the account is considered valid EFSA
activate the account and the contact(s) inside
The applicant is ready to use the functionalities of the
portal
Authorisation of delegation to third parties
14
Third Parties
Martin
Sarah
Business OperatorsPotential Applicants
Database of Study Notifications
Martin send a notification on behalf of Sarah
Creates an account relationshipldquoMy Detailsrdquo page ldquoManage Relationshiprdquo button
Example A consultant creates a pre-application ID and add the business operator (the potential applicant not the consultant) in the lsquoBusiness Operatorrsquo field The consultant shares the pre-application ID with other business operator(s)
The third party must notify studies indicating as business operator the applicant they represent Additional applicants of a group of applicants can be indicated with ldquoshare withrdquo functionality
Organisations playing multiple roles
15
SarahBusiness OperatorsPotential Applicants
Third Parties
Martin
LaboratoriesTesting facilities
John
Sarah
Business Operator
Laboratory Third Party
Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Transparency Regulation from 27th March 2021
Improve coordination between risk assessors and risk managers to ensure better communication to stakeholders and general public
Member States will contribute more to EFSAs governance and scientific Panels
EFSA will have more access to relevant scientific evidence in requests for authorisation
Better access to scientific studies
Effective risk communication
4 pillars
Better governanceMore reliable
independent studiesTransparency
Applicable For - New dossierapplications submitted on or after 27th March 2021
Click here to access the Factsheet rdquoA Modern and Sustainable Food Law in the EUrdquo
7
Pesticides Peer review workflow
0101
bull Pre-intake activities (NoS PSA)
bull Receipt of application dossier for approval or amendment of approval conditions
bull Withdrawal of dossier
bull Validity check during admissibility step by RMS
bull Publication of non-confidential dossier
bull Assessment of confidentiality requests on the admissible dossier
bull Consultation of the public on non-confidential dossier additional evidence
bull Receipt of DARRAR by RMS
Mandate amp Dossier intake01
bull EFSA preparatory steps
bull Consultation of the public and stakeholders on the DARRAR
Preliminary activities to Risk
Assessment02bull Preparation of the
reporting Table
bull Request for Additional Data Request (ADR)
bull Assessment of confidentiality requests on submittedADR (if applicable)
bull Preparation of the draft scientific output and subsequent finalisation (Conclusion)
bull Approval of the scientific output (Conclusion)
Peer Review
03
03
bull Notification on approvedscientific output
bull Editorial checks and corrections
bull Pre-notification of scientific output
bull Publication of scientific outputs and supporting evidence
bull Correction of a published scientific output (if applicable)
Output publication amp dissemination
04
Pesticides MRL workflow
bull Pre-intake activities (NoS PSA)
bull Receipt of Application Dossier
bull Withdrawal of application
bull Validity check during admissibility step by EMS
bull Publication of non-confidential dossier
bull Assessment of confidentiality requests on the admissible dossier
bull Consultation of the public on non-confidential dossier additional evidence
bull Receipt of Evaluation Report by EMS
Mandate amp Dossier intake
01
bull EFSA preparatory steps
Preliminary activities to Risk
Assessment02
bull Request for Additional Data Request (ADR)
bull Preparation of the firstdraft scientific output(Reasoned Opinion)
bull Finalization of the scientific output (Reasoned Opinion)
bull Approval of the scientific output (Reasoned Opinion)
bull Assessment of confidentiality requests on submitted ADR (if applicable)
Risk Assessment (RA)
03
bull Notification of the approved scientific output
bull Editorial checks and corrections
bull Publication of scientific output and supporting evidence
bull Correction of a published scientific output (if applicable)
Output publication amp
dissemination n04
New TOOLS for Business Operators
Dossier eSubmission(Pesticides PPP MRL basic substances)
Additional Data request (ADR)
Follow-up lifecycle
IUCLID
Monitoring of riskassessment flow
Disseminationportal
Proactive disclosure of information
OpenEFSA
Notification of Studies (NoS)
Pre-submission Advice (PSA)
AskAQuestion Public access to
document Public and
targeted consultation
Connect EFSA
Used by legal or natural persons for submitting confidentiality requests related to applications datasets and documents supporting the generic mandates
PORTALINO
Account creation and management
Registration Process
11sup1) Practical arrangements on pre-submission phase and public consultations
Sarah
Business OperatorPotential Applicant
Third Parties
Martin
LaboratoriesTesting facilities
John
In order to initiate a pre-submission activity a potential applicant or a laboratory or testing facility to which a study has been commissioned shall first register in the system hellipsup1 1
Third parties representing one or more entities shall also register in the Authority system supporting pre-submission activities hellipsup1 and obtain the authorization by represented entities to act on their behalf
2
Registered entities shall ensure that all information provided is reported accurately and kept up-to-datesup1 3
The public(during PC or once studies
are published)
ConnectEFSA Portal - Account Registration
The potential applicant starts the registration in
the portal
The potential applicantmust register as the
entity heshe is representing (eg a
company)Sarah
The account name will then be the entity (company) name
Click here to register
1
1
ConnectEFSA Portal - Account Registration
Information related to the contact person of the account Theinformation and the e-mail address must be person specific andlinked to the entity registered No functional and genericmailboxes (eg gmail)
Each account can register a maximum of 6 contact persons(NEW since 30 June)
Information related to the organisation (eg company) Thename inserted will be the account name
A complete billing address is essential for a clear identificationof the company
As regards multinational companies made up of several entities any of these entities may register provided that the registered entity is recognised as having a separate legal personality under the national law of the country in which it has its registered office
After the registration the account and the contact(s)
are not active yet
Upon registration EFSA performs a security check of
the account in few days
Once the account is considered valid EFSA
activate the account and the contact(s) inside
The applicant is ready to use the functionalities of the
portal
Authorisation of delegation to third parties
14
Third Parties
Martin
Sarah
Business OperatorsPotential Applicants
Database of Study Notifications
Martin send a notification on behalf of Sarah
Creates an account relationshipldquoMy Detailsrdquo page ldquoManage Relationshiprdquo button
Example A consultant creates a pre-application ID and add the business operator (the potential applicant not the consultant) in the lsquoBusiness Operatorrsquo field The consultant shares the pre-application ID with other business operator(s)
The third party must notify studies indicating as business operator the applicant they represent Additional applicants of a group of applicants can be indicated with ldquoshare withrdquo functionality
Organisations playing multiple roles
15
SarahBusiness OperatorsPotential Applicants
Third Parties
Martin
LaboratoriesTesting facilities
John
Sarah
Business Operator
Laboratory Third Party
Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
7
Pesticides Peer review workflow
0101
bull Pre-intake activities (NoS PSA)
bull Receipt of application dossier for approval or amendment of approval conditions
bull Withdrawal of dossier
bull Validity check during admissibility step by RMS
bull Publication of non-confidential dossier
bull Assessment of confidentiality requests on the admissible dossier
bull Consultation of the public on non-confidential dossier additional evidence
bull Receipt of DARRAR by RMS
Mandate amp Dossier intake01
bull EFSA preparatory steps
bull Consultation of the public and stakeholders on the DARRAR
Preliminary activities to Risk
Assessment02bull Preparation of the
reporting Table
bull Request for Additional Data Request (ADR)
bull Assessment of confidentiality requests on submittedADR (if applicable)
bull Preparation of the draft scientific output and subsequent finalisation (Conclusion)
bull Approval of the scientific output (Conclusion)
Peer Review
03
03
bull Notification on approvedscientific output
bull Editorial checks and corrections
bull Pre-notification of scientific output
bull Publication of scientific outputs and supporting evidence
bull Correction of a published scientific output (if applicable)
Output publication amp dissemination
04
Pesticides MRL workflow
bull Pre-intake activities (NoS PSA)
bull Receipt of Application Dossier
bull Withdrawal of application
bull Validity check during admissibility step by EMS
bull Publication of non-confidential dossier
bull Assessment of confidentiality requests on the admissible dossier
bull Consultation of the public on non-confidential dossier additional evidence
bull Receipt of Evaluation Report by EMS
Mandate amp Dossier intake
01
bull EFSA preparatory steps
Preliminary activities to Risk
Assessment02
bull Request for Additional Data Request (ADR)
bull Preparation of the firstdraft scientific output(Reasoned Opinion)
bull Finalization of the scientific output (Reasoned Opinion)
bull Approval of the scientific output (Reasoned Opinion)
bull Assessment of confidentiality requests on submitted ADR (if applicable)
Risk Assessment (RA)
03
bull Notification of the approved scientific output
bull Editorial checks and corrections
bull Publication of scientific output and supporting evidence
bull Correction of a published scientific output (if applicable)
Output publication amp
dissemination n04
New TOOLS for Business Operators
Dossier eSubmission(Pesticides PPP MRL basic substances)
Additional Data request (ADR)
Follow-up lifecycle
IUCLID
Monitoring of riskassessment flow
Disseminationportal
Proactive disclosure of information
OpenEFSA
Notification of Studies (NoS)
Pre-submission Advice (PSA)
AskAQuestion Public access to
document Public and
targeted consultation
Connect EFSA
Used by legal or natural persons for submitting confidentiality requests related to applications datasets and documents supporting the generic mandates
PORTALINO
Account creation and management
Registration Process
11sup1) Practical arrangements on pre-submission phase and public consultations
Sarah
Business OperatorPotential Applicant
Third Parties
Martin
LaboratoriesTesting facilities
John
In order to initiate a pre-submission activity a potential applicant or a laboratory or testing facility to which a study has been commissioned shall first register in the system hellipsup1 1
Third parties representing one or more entities shall also register in the Authority system supporting pre-submission activities hellipsup1 and obtain the authorization by represented entities to act on their behalf
2
Registered entities shall ensure that all information provided is reported accurately and kept up-to-datesup1 3
The public(during PC or once studies
are published)
ConnectEFSA Portal - Account Registration
The potential applicant starts the registration in
the portal
The potential applicantmust register as the
entity heshe is representing (eg a
company)Sarah
The account name will then be the entity (company) name
Click here to register
1
1
ConnectEFSA Portal - Account Registration
Information related to the contact person of the account Theinformation and the e-mail address must be person specific andlinked to the entity registered No functional and genericmailboxes (eg gmail)
Each account can register a maximum of 6 contact persons(NEW since 30 June)
Information related to the organisation (eg company) Thename inserted will be the account name
A complete billing address is essential for a clear identificationof the company
As regards multinational companies made up of several entities any of these entities may register provided that the registered entity is recognised as having a separate legal personality under the national law of the country in which it has its registered office
After the registration the account and the contact(s)
are not active yet
Upon registration EFSA performs a security check of
the account in few days
Once the account is considered valid EFSA
activate the account and the contact(s) inside
The applicant is ready to use the functionalities of the
portal
Authorisation of delegation to third parties
14
Third Parties
Martin
Sarah
Business OperatorsPotential Applicants
Database of Study Notifications
Martin send a notification on behalf of Sarah
Creates an account relationshipldquoMy Detailsrdquo page ldquoManage Relationshiprdquo button
Example A consultant creates a pre-application ID and add the business operator (the potential applicant not the consultant) in the lsquoBusiness Operatorrsquo field The consultant shares the pre-application ID with other business operator(s)
The third party must notify studies indicating as business operator the applicant they represent Additional applicants of a group of applicants can be indicated with ldquoshare withrdquo functionality
Organisations playing multiple roles
15
SarahBusiness OperatorsPotential Applicants
Third Parties
Martin
LaboratoriesTesting facilities
John
Sarah
Business Operator
Laboratory Third Party
Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Pesticides MRL workflow
bull Pre-intake activities (NoS PSA)
bull Receipt of Application Dossier
bull Withdrawal of application
bull Validity check during admissibility step by EMS
bull Publication of non-confidential dossier
bull Assessment of confidentiality requests on the admissible dossier
bull Consultation of the public on non-confidential dossier additional evidence
bull Receipt of Evaluation Report by EMS
Mandate amp Dossier intake
01
bull EFSA preparatory steps
Preliminary activities to Risk
Assessment02
bull Request for Additional Data Request (ADR)
bull Preparation of the firstdraft scientific output(Reasoned Opinion)
bull Finalization of the scientific output (Reasoned Opinion)
bull Approval of the scientific output (Reasoned Opinion)
bull Assessment of confidentiality requests on submitted ADR (if applicable)
Risk Assessment (RA)
03
bull Notification of the approved scientific output
bull Editorial checks and corrections
bull Publication of scientific output and supporting evidence
bull Correction of a published scientific output (if applicable)
Output publication amp
dissemination n04
New TOOLS for Business Operators
Dossier eSubmission(Pesticides PPP MRL basic substances)
Additional Data request (ADR)
Follow-up lifecycle
IUCLID
Monitoring of riskassessment flow
Disseminationportal
Proactive disclosure of information
OpenEFSA
Notification of Studies (NoS)
Pre-submission Advice (PSA)
AskAQuestion Public access to
document Public and
targeted consultation
Connect EFSA
Used by legal or natural persons for submitting confidentiality requests related to applications datasets and documents supporting the generic mandates
PORTALINO
Account creation and management
Registration Process
11sup1) Practical arrangements on pre-submission phase and public consultations
Sarah
Business OperatorPotential Applicant
Third Parties
Martin
LaboratoriesTesting facilities
John
In order to initiate a pre-submission activity a potential applicant or a laboratory or testing facility to which a study has been commissioned shall first register in the system hellipsup1 1
Third parties representing one or more entities shall also register in the Authority system supporting pre-submission activities hellipsup1 and obtain the authorization by represented entities to act on their behalf
2
Registered entities shall ensure that all information provided is reported accurately and kept up-to-datesup1 3
The public(during PC or once studies
are published)
ConnectEFSA Portal - Account Registration
The potential applicant starts the registration in
the portal
The potential applicantmust register as the
entity heshe is representing (eg a
company)Sarah
The account name will then be the entity (company) name
Click here to register
1
1
ConnectEFSA Portal - Account Registration
Information related to the contact person of the account Theinformation and the e-mail address must be person specific andlinked to the entity registered No functional and genericmailboxes (eg gmail)
Each account can register a maximum of 6 contact persons(NEW since 30 June)
Information related to the organisation (eg company) Thename inserted will be the account name
A complete billing address is essential for a clear identificationof the company
As regards multinational companies made up of several entities any of these entities may register provided that the registered entity is recognised as having a separate legal personality under the national law of the country in which it has its registered office
After the registration the account and the contact(s)
are not active yet
Upon registration EFSA performs a security check of
the account in few days
Once the account is considered valid EFSA
activate the account and the contact(s) inside
The applicant is ready to use the functionalities of the
portal
Authorisation of delegation to third parties
14
Third Parties
Martin
Sarah
Business OperatorsPotential Applicants
Database of Study Notifications
Martin send a notification on behalf of Sarah
Creates an account relationshipldquoMy Detailsrdquo page ldquoManage Relationshiprdquo button
Example A consultant creates a pre-application ID and add the business operator (the potential applicant not the consultant) in the lsquoBusiness Operatorrsquo field The consultant shares the pre-application ID with other business operator(s)
The third party must notify studies indicating as business operator the applicant they represent Additional applicants of a group of applicants can be indicated with ldquoshare withrdquo functionality
Organisations playing multiple roles
15
SarahBusiness OperatorsPotential Applicants
Third Parties
Martin
LaboratoriesTesting facilities
John
Sarah
Business Operator
Laboratory Third Party
Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
New TOOLS for Business Operators
Dossier eSubmission(Pesticides PPP MRL basic substances)
Additional Data request (ADR)
Follow-up lifecycle
IUCLID
Monitoring of riskassessment flow
Disseminationportal
Proactive disclosure of information
OpenEFSA
Notification of Studies (NoS)
Pre-submission Advice (PSA)
AskAQuestion Public access to
document Public and
targeted consultation
Connect EFSA
Used by legal or natural persons for submitting confidentiality requests related to applications datasets and documents supporting the generic mandates
PORTALINO
Account creation and management
Registration Process
11sup1) Practical arrangements on pre-submission phase and public consultations
Sarah
Business OperatorPotential Applicant
Third Parties
Martin
LaboratoriesTesting facilities
John
In order to initiate a pre-submission activity a potential applicant or a laboratory or testing facility to which a study has been commissioned shall first register in the system hellipsup1 1
Third parties representing one or more entities shall also register in the Authority system supporting pre-submission activities hellipsup1 and obtain the authorization by represented entities to act on their behalf
2
Registered entities shall ensure that all information provided is reported accurately and kept up-to-datesup1 3
The public(during PC or once studies
are published)
ConnectEFSA Portal - Account Registration
The potential applicant starts the registration in
the portal
The potential applicantmust register as the
entity heshe is representing (eg a
company)Sarah
The account name will then be the entity (company) name
Click here to register
1
1
ConnectEFSA Portal - Account Registration
Information related to the contact person of the account Theinformation and the e-mail address must be person specific andlinked to the entity registered No functional and genericmailboxes (eg gmail)
Each account can register a maximum of 6 contact persons(NEW since 30 June)
Information related to the organisation (eg company) Thename inserted will be the account name
A complete billing address is essential for a clear identificationof the company
As regards multinational companies made up of several entities any of these entities may register provided that the registered entity is recognised as having a separate legal personality under the national law of the country in which it has its registered office
After the registration the account and the contact(s)
are not active yet
Upon registration EFSA performs a security check of
the account in few days
Once the account is considered valid EFSA
activate the account and the contact(s) inside
The applicant is ready to use the functionalities of the
portal
Authorisation of delegation to third parties
14
Third Parties
Martin
Sarah
Business OperatorsPotential Applicants
Database of Study Notifications
Martin send a notification on behalf of Sarah
Creates an account relationshipldquoMy Detailsrdquo page ldquoManage Relationshiprdquo button
Example A consultant creates a pre-application ID and add the business operator (the potential applicant not the consultant) in the lsquoBusiness Operatorrsquo field The consultant shares the pre-application ID with other business operator(s)
The third party must notify studies indicating as business operator the applicant they represent Additional applicants of a group of applicants can be indicated with ldquoshare withrdquo functionality
Organisations playing multiple roles
15
SarahBusiness OperatorsPotential Applicants
Third Parties
Martin
LaboratoriesTesting facilities
John
Sarah
Business Operator
Laboratory Third Party
Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
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Receive job alerts
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Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Account creation and management
Registration Process
11sup1) Practical arrangements on pre-submission phase and public consultations
Sarah
Business OperatorPotential Applicant
Third Parties
Martin
LaboratoriesTesting facilities
John
In order to initiate a pre-submission activity a potential applicant or a laboratory or testing facility to which a study has been commissioned shall first register in the system hellipsup1 1
Third parties representing one or more entities shall also register in the Authority system supporting pre-submission activities hellipsup1 and obtain the authorization by represented entities to act on their behalf
2
Registered entities shall ensure that all information provided is reported accurately and kept up-to-datesup1 3
The public(during PC or once studies
are published)
ConnectEFSA Portal - Account Registration
The potential applicant starts the registration in
the portal
The potential applicantmust register as the
entity heshe is representing (eg a
company)Sarah
The account name will then be the entity (company) name
Click here to register
1
1
ConnectEFSA Portal - Account Registration
Information related to the contact person of the account Theinformation and the e-mail address must be person specific andlinked to the entity registered No functional and genericmailboxes (eg gmail)
Each account can register a maximum of 6 contact persons(NEW since 30 June)
Information related to the organisation (eg company) Thename inserted will be the account name
A complete billing address is essential for a clear identificationof the company
As regards multinational companies made up of several entities any of these entities may register provided that the registered entity is recognised as having a separate legal personality under the national law of the country in which it has its registered office
After the registration the account and the contact(s)
are not active yet
Upon registration EFSA performs a security check of
the account in few days
Once the account is considered valid EFSA
activate the account and the contact(s) inside
The applicant is ready to use the functionalities of the
portal
Authorisation of delegation to third parties
14
Third Parties
Martin
Sarah
Business OperatorsPotential Applicants
Database of Study Notifications
Martin send a notification on behalf of Sarah
Creates an account relationshipldquoMy Detailsrdquo page ldquoManage Relationshiprdquo button
Example A consultant creates a pre-application ID and add the business operator (the potential applicant not the consultant) in the lsquoBusiness Operatorrsquo field The consultant shares the pre-application ID with other business operator(s)
The third party must notify studies indicating as business operator the applicant they represent Additional applicants of a group of applicants can be indicated with ldquoshare withrdquo functionality
Organisations playing multiple roles
15
SarahBusiness OperatorsPotential Applicants
Third Parties
Martin
LaboratoriesTesting facilities
John
Sarah
Business Operator
Laboratory Third Party
Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Registration Process
11sup1) Practical arrangements on pre-submission phase and public consultations
Sarah
Business OperatorPotential Applicant
Third Parties
Martin
LaboratoriesTesting facilities
John
In order to initiate a pre-submission activity a potential applicant or a laboratory or testing facility to which a study has been commissioned shall first register in the system hellipsup1 1
Third parties representing one or more entities shall also register in the Authority system supporting pre-submission activities hellipsup1 and obtain the authorization by represented entities to act on their behalf
2
Registered entities shall ensure that all information provided is reported accurately and kept up-to-datesup1 3
The public(during PC or once studies
are published)
ConnectEFSA Portal - Account Registration
The potential applicant starts the registration in
the portal
The potential applicantmust register as the
entity heshe is representing (eg a
company)Sarah
The account name will then be the entity (company) name
Click here to register
1
1
ConnectEFSA Portal - Account Registration
Information related to the contact person of the account Theinformation and the e-mail address must be person specific andlinked to the entity registered No functional and genericmailboxes (eg gmail)
Each account can register a maximum of 6 contact persons(NEW since 30 June)
Information related to the organisation (eg company) Thename inserted will be the account name
A complete billing address is essential for a clear identificationof the company
As regards multinational companies made up of several entities any of these entities may register provided that the registered entity is recognised as having a separate legal personality under the national law of the country in which it has its registered office
After the registration the account and the contact(s)
are not active yet
Upon registration EFSA performs a security check of
the account in few days
Once the account is considered valid EFSA
activate the account and the contact(s) inside
The applicant is ready to use the functionalities of the
portal
Authorisation of delegation to third parties
14
Third Parties
Martin
Sarah
Business OperatorsPotential Applicants
Database of Study Notifications
Martin send a notification on behalf of Sarah
Creates an account relationshipldquoMy Detailsrdquo page ldquoManage Relationshiprdquo button
Example A consultant creates a pre-application ID and add the business operator (the potential applicant not the consultant) in the lsquoBusiness Operatorrsquo field The consultant shares the pre-application ID with other business operator(s)
The third party must notify studies indicating as business operator the applicant they represent Additional applicants of a group of applicants can be indicated with ldquoshare withrdquo functionality
Organisations playing multiple roles
15
SarahBusiness OperatorsPotential Applicants
Third Parties
Martin
LaboratoriesTesting facilities
John
Sarah
Business Operator
Laboratory Third Party
Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
ConnectEFSA Portal - Account Registration
The potential applicant starts the registration in
the portal
The potential applicantmust register as the
entity heshe is representing (eg a
company)Sarah
The account name will then be the entity (company) name
Click here to register
1
1
ConnectEFSA Portal - Account Registration
Information related to the contact person of the account Theinformation and the e-mail address must be person specific andlinked to the entity registered No functional and genericmailboxes (eg gmail)
Each account can register a maximum of 6 contact persons(NEW since 30 June)
Information related to the organisation (eg company) Thename inserted will be the account name
A complete billing address is essential for a clear identificationof the company
As regards multinational companies made up of several entities any of these entities may register provided that the registered entity is recognised as having a separate legal personality under the national law of the country in which it has its registered office
After the registration the account and the contact(s)
are not active yet
Upon registration EFSA performs a security check of
the account in few days
Once the account is considered valid EFSA
activate the account and the contact(s) inside
The applicant is ready to use the functionalities of the
portal
Authorisation of delegation to third parties
14
Third Parties
Martin
Sarah
Business OperatorsPotential Applicants
Database of Study Notifications
Martin send a notification on behalf of Sarah
Creates an account relationshipldquoMy Detailsrdquo page ldquoManage Relationshiprdquo button
Example A consultant creates a pre-application ID and add the business operator (the potential applicant not the consultant) in the lsquoBusiness Operatorrsquo field The consultant shares the pre-application ID with other business operator(s)
The third party must notify studies indicating as business operator the applicant they represent Additional applicants of a group of applicants can be indicated with ldquoshare withrdquo functionality
Organisations playing multiple roles
15
SarahBusiness OperatorsPotential Applicants
Third Parties
Martin
LaboratoriesTesting facilities
John
Sarah
Business Operator
Laboratory Third Party
Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
ConnectEFSA Portal - Account Registration
Information related to the contact person of the account Theinformation and the e-mail address must be person specific andlinked to the entity registered No functional and genericmailboxes (eg gmail)
Each account can register a maximum of 6 contact persons(NEW since 30 June)
Information related to the organisation (eg company) Thename inserted will be the account name
A complete billing address is essential for a clear identificationof the company
As regards multinational companies made up of several entities any of these entities may register provided that the registered entity is recognised as having a separate legal personality under the national law of the country in which it has its registered office
After the registration the account and the contact(s)
are not active yet
Upon registration EFSA performs a security check of
the account in few days
Once the account is considered valid EFSA
activate the account and the contact(s) inside
The applicant is ready to use the functionalities of the
portal
Authorisation of delegation to third parties
14
Third Parties
Martin
Sarah
Business OperatorsPotential Applicants
Database of Study Notifications
Martin send a notification on behalf of Sarah
Creates an account relationshipldquoMy Detailsrdquo page ldquoManage Relationshiprdquo button
Example A consultant creates a pre-application ID and add the business operator (the potential applicant not the consultant) in the lsquoBusiness Operatorrsquo field The consultant shares the pre-application ID with other business operator(s)
The third party must notify studies indicating as business operator the applicant they represent Additional applicants of a group of applicants can be indicated with ldquoshare withrdquo functionality
Organisations playing multiple roles
15
SarahBusiness OperatorsPotential Applicants
Third Parties
Martin
LaboratoriesTesting facilities
John
Sarah
Business Operator
Laboratory Third Party
Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Authorisation of delegation to third parties
14
Third Parties
Martin
Sarah
Business OperatorsPotential Applicants
Database of Study Notifications
Martin send a notification on behalf of Sarah
Creates an account relationshipldquoMy Detailsrdquo page ldquoManage Relationshiprdquo button
Example A consultant creates a pre-application ID and add the business operator (the potential applicant not the consultant) in the lsquoBusiness Operatorrsquo field The consultant shares the pre-application ID with other business operator(s)
The third party must notify studies indicating as business operator the applicant they represent Additional applicants of a group of applicants can be indicated with ldquoshare withrdquo functionality
Organisations playing multiple roles
15
SarahBusiness OperatorsPotential Applicants
Third Parties
Martin
LaboratoriesTesting facilities
John
Sarah
Business Operator
Laboratory Third Party
Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Organisations playing multiple roles
15
SarahBusiness OperatorsPotential Applicants
Third Parties
Martin
LaboratoriesTesting facilities
John
Sarah
Business Operator
Laboratory Third Party
Applicants + laboratories and third party can choose when submitting studies if they are submitting them as Business Operator or laboratory
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
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Follow us on Twitter
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Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Pre-Application IDPre-Submission AdviceNotification of Studies
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Pre-Application Identification
Intended Area
Subject of the application
Business Operator(s)
Sarah
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
General Pre-Submission Advice
19
The potential applicant gets the pre-application-
ID
Step 1Pre-application ID
The potential applicantcan ask pre-submission
advice anytime
Sarah
EFSA and RMSEMSprovide advice
Step 2General Pre-Submission Advice
Pre-Submission Advice tool
ConnectEFSA
Step 3Validation of application
EFSA publishes summary of Pre-Submission advice after application is declared validadmissible
National CA
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
General Pre-submission Advice
Potential applicants may request general pre-submission advice
at any time Sarah
EFSA shall provide the requester(s) with its advice in close cooperation with the following national competent authorities
1
The Member State to which the application is going to be submitted the intended rapporteur Member State and where applicable the intended co-rapporteur Member
State
3 The designated rapporteur Member Stateco-rapporteur Member State
2The intended evaluating Member State
Requests for general pre-submission advice
Submitto EFSA
National Authority
Cooperation
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
General Pre-submission Advice - EFSA and CAs
Step 3 Provide the Advice
The written advice shall beprovided within 20 workingdays as of the date of theacceptance of the request
The meeting shall be organisedwithin 20 working days as ofthe date of the acceptance ofthe request
Receipt of the general pre-submission advice
form
Step 1Administrative Check
EFSA verifies that the related questions fall within the scope
Within 15 working days from the receipt EFSA informs the requester and the CAs as to whether the request is accepted or rejected
Step 2 Written or meeting
EFSA prepares the advice and the related summary in close cooperation with the relevant CAs
Step 4Summary of the PSA
EFSA creates a summary providing an overview of the advice and sends it to the requester
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Database of Study Notifications
Step 3Admissibility of application
EFSA publishes study notifications with related studies after confidentiality decision making process
Step 2 Submission of application
RMSEMS performs the admissibility of the application
The Business Operator gets the Pre-Application-ID
Step 1Pre-submission phase
Both actorsNotify Studies(Article 32b)
Sarah
Notification of Studies
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Renewal applicationsRenewal Pre-submission Advice
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Notification of Studies for renewal application
Database of Study Notifications
Step 1Application renewal
The potential applicant gets the
Pre-Application-ID
The potential applicant submit the list intended studies and study design
(Article 32c1)
EFSAProvides advice
Step 2 Public consultation and R-PSA
Sarah
The potential applicant notifies studies (Article 32b)
Step 3Notify studies
Sarah
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Intended Study
29
Link to the EFSA question number of the application related to the authorisation to renew
For renewal the potential applicant should also prefill some information for the pre-application ID
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Pre-application-ID for Renewal fill in intended study information
Fill in relevant information for intended studies
Once all intended studies are
completed submit the list of
intended studies for renewal
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Public consultation on intended studies for renewal
Step 2 Consultation
The consultation of third parties shall remain open for a period of three weeks
Step 3 Comments
All comments received by stakeholders and the public shall be made public by EFSA
Receipt of the list of intended studies for
renewal
Step 4Summary of R-PSA
The results of the consultation of third parties shall be inserted in the summary of the renewal pre-submission advice
Step 1Administrative Check
EFSA launches the consultation of third
parties on the intended studies for renewal
Including on the proposed design
of the studies
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
IUCLID E-Submission
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
E-submission in IUCLID
IUCLID
- Software application to record store maintain and exchange data on chemical substances
- Implements the OECD Harmonised Templates
- Standard data format for EU PPP applications
- Includes a series of tools such as the validation assistant report generator dissemination preview annotation tool
Dossier Creation Process From Mixture Dataset to Dossier Creation
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
E-submission in IUCLID
URL for IUCLIDHyperlink
Video TutorialsHyperlink
IUCLID TrainingsHyperlink
IUCLID 66 First pesticides release in October 2020 (IUCLID 65)
EFSA received in May 2021 the first pesticide dossiers in IUCLID format
The software is updated bi-annually IUCLID 66 release on 27 October 2021
More information are available on the Applications Toolkit webpage
The IUCLID 66 release includes
o updates to the OECD harmonised templates and EU_PPP Formats to support the reporting of studies on micro-organisms and analysis of pesticide residues in food
o Ability to print robust study summaries in RTF format
o Clear separation between confidential and sanitised content and validation rules to support the publication of dossiers for public consultation
o Export of very large dossiers (gt1GB)
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
E-submission in IUCLID
Hyperlink
IUCLID 66 rarr E-Submission
bull TR compliance NoS Confidentiality assessment Dissemination
bull All PESTICIDES Regulated Products dossiers (except authorisation of PPPs)
bull Single point of entry for Applicant European Commission Member States
Application types currently supported
bull Active substance application
bull Microorganisms - active substanceapplication
bull Maximum Residue Levels (MRL)application
bull Basic substances application
Background Material
o IUCLID Active Substance Application Manual
o IUCLID Microbial Active Substances Manual
o IUCLID MRL Application Manual
o IUCLID Basic Substance Application Manual
o Crosswalks IUCLID 65 EU PPP (link link)
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
E-submission in IUCLID
An issue related to IUCLIDthe submission portal was identified early in the summer and it implies a workaround in order to submit a dossier
If the dossier size is gt1GB the dossier must be uploaded by means of an SFTP Client with support from EFSA and ECHA including the scheduling of a slot for submission rarr this solution will be in place until March 2022
Contact hypercareiuclidefsaeuropaeu for support
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Application lifecycle ndash early phases
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Mandate and Dossier Intake for Active substance and MRL
o Receipt of dossiersapplications in IUCLID
o RMSEMS performs Admissibility check (+ NoS check)
o Application registered - Question (dossier + mandate)
o Visible in OpenEFSA Portal
o EFSA publishes non-confidential admissible dossier(+ summary Pre-submission advice)
o Assessment of confidentiality requests
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Confidentiality in the contextof Active Substances in pesticides and MRLs
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
General considerations ndash main changes post-TR
49
As of 27 March 2021
bull All applications received on or after this date are subject to proactive disclosurerequirements under the Transparency Regulation save for information duly justified and accepted as confidential Confidentiality requests on pesticide dossiers just like the dossiers themselves have to be submitted via IUCLID
bull Transparency is the rule confidentiality is the exception
bull In the absence of confidentiality requests submitted with regard to information documents or data supporting the application EFSA will make proactively available to the public the entire dossier including all information documents and data submitted once an application is considered admissible
bull EFSA publishes the application as received once declared admissible
bull Confidentiality decision making starts after admissibility
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
General considerations ndashwho assesses confidentiality
50
EFSANew active substances
RMS
Renewals and Maximum Residue Levels
EFSA
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity RMS initiates confidentiality assessment
bullAssessment in accordance with Art 5 and 6 of EFSArsquos PAs concerning confidentiality in accordance with Article 7(3) and 16 of Regulation (EC) No 11072009
3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by RMS
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by RMS
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline RMS shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
5 Notification of draft decision on confidentiality request(s) to EFSA for comments
6 Notifiction of draft decision on confidentiality request(s) to applicant
7 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has one calendar week to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
8 Decision adopted and notified to applicant
9 Legal action (optional)
bullThe applicant can bring an action challenging the legality of the confidentiality decision under the applicable national law
Main procedural steps underlying confidentiality assessment ndash New active substances
51
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMSEMS
Technical means deemed appropriate by RMS
Technical means deemed appropriate by RMSEMS
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
IUCLID1 Applicant submits confidentiality request(s)
bull See subsequent slides on how to submit confidentiality requests in IUCLID
bull See subsequent slides on how to submit attachments when they are subject to confidentiality requests
2 Upon declaration of admissibilityvalidity EFSA initiates confidentiality assessment
bullAssessment in accordance with Art 9 and 10 of EFSArsquos PAs concerning Transparency and Confidentiality
E-mail (confidentialityrequestassessmentefsaeuropaeu) 3 Request for clarification to applicant (optional)
bullClarifications including if appropriate modifications to confidentiality requests as well as public and non-confidential covered by confidentiality requests ONLY if requested by EFSA
bullClarificationsmodified confidentiality requests and documents must be provided within the deadline set by EFSA
bullIf clarificationsmodified confidentiality requests and documents are not provided within the set deadline EFSA shall reject the confidentiality requests concerned
IUCLID
4 Re-submission of confidentiality request(s) amp documents covered by confidentiality requests (optional)
E-mail (confidentialityrequestassessmentefsaeuropaeu)5 Notification of draft decision on confidentiality request(s) to applicant
E-mail (confidentialityrequestassessmentefsaeuropaeu)6 Comments on draft decision on confidentiality request(s) or withdrawal of application (optional)
bullIn case of disagreements applicant has two calendar weeks to state its views on draft decision or to withdraw its application via a withdrawal notification
bullIf a withdrawal notification was submitted prior to the adoption of a confidentiality decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
E-mail (confidentialityrequestassessmentefsaeuropaeu)7 Decision adopted and notified to applicant
E-mail (confidentialityconfirmatoryapplicationefsaeuropaeu)8 Confirmatory application (optional)
bullApplicant may file a confirmatory application asking EFSA to reconsider its decision
bullConfirmatory applications cannot contain new confidentiality requests
bullMust be submitted within 2 calendar weeks of the notification of the contested decision
bullUpon receipt of a confirmatory application implementation of confidentiality decision is suspended
E-mail (confidentialitysanitisationefsaeuropaeu)9 Withdrawal or legal action (optional)
bullShould the applicant whish to withdraw the application a withdrawal notification must be submitted
bullIf a withdrawal notification was submitted prior to the adoption of a confirmatory decision EFSA the EC and the MSs will not publish the information subject to the confidentiality requests Any information that has already been made public will be deleted by EFSA from its website without delay
bullThe applicant can bring an action challenging the legality of the confirmatory decision pursuant to Article 263 and 278 TFEU
Main procedural steps underlying confidentiality assessment ndash Renewals amp MRLs
52
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Setting a flag
bullSelect confidentiality flag at appropriate level
bullBefore setting a flag always verify whether according to the IUCLID pesticide filtering rules (IUCLID filter rules here) the relevant field(s) can be subject to (a) confidentiality request(s)
Justification
bullClearly identify the information including personal data claimed confidential
a) where the flag is set at the level of a IUCLID section (ie not at the level of a specific field) clearly identify the precise field
or attachment subject to the confidentiality request
b) for attachments refer to the exact page paragraph and line or part as appropriate where the piece of information claimed confidential is located and quote the specific piece of information claimed confidential
bullProvide a legal reference to relevant item from closed positive list(s) of items that can be claimed confidential
bullProvide a verifiable justification
bullDo not use the template currently available (see slide 8)
Submission of confidentiality requests in IUCLID - General
53
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Submission of confidentiality requests in IUCLID ndashJustification positive list
Confidentiality requests only on items in closed positive list
54
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Submission of confidentiality requests in IUCLID ndash Justification substantive requirements
Information publicly available
For confidentiality requests on information other than personal data verifiable justification based on all the below elements must be provided
b) Financial presumption statement indicating whether disclosure would potentially cause harm to the applicant beyond 5 of gross annual turnovergross annual earnings
Declaration that information was acquired legitimately
a) Novelty presumption statement indicating whether info is up to five years old
Potential harm to a significant degree
Verifiable justification
Environmental information
c) If novelty or financial criterion are not satisfied provide additional reasons to demonstrate potential harm to significant degree
55
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Article 39e(1) GFL
bullConcerns name and address of applicant names of authors of published or publicly available studies and names of participants and observers in meetings of the Scientific Committee Scientific Panels their working groups and ad hoc working groups on the subject matter
bullInformation to be proactively published by EFSA confidentiality requests not admissible
Article 39e(2) GFL
bullConcerns names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information
bullConfidentiality requests must be submitted clearly identifying the personal data claimed confidential
Article 39e(3) GFL
bullResidual category including eg signatures names of study directors or GPS coordinates
bullConfidentiality requests may be submitted clearly identifying the personal data claimed confidential and the legal basis for protecting that personal data
bullApplicant is expected to confirm whether the data qualify as personal data as defined under Article 3(1) of Regulation (EU) 20181725 and the reason why
Certain IUCLID fields should never contain personal data
bullCertain sections or fields cannot be claimed confidential (eg the e-mail address provided under lsquoLegal entityrsquo - see filtering rules here)
bullNo personal data must be inserted in these sections or fields
Submission of confidentiality requests in IUCLID ndash Personal Data
56
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Submission of confidentiality requests in IUCLID ndash Justification procedural requirements
Current justification template not to be used
bull Applicants are not supposed to use the confidentiality
templates currently available in IUCLID as they are not adapted to
EFSArsquos regulatory framework
8
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Submission of attachments in IUCLID
58
For each attachment a public version
bull For each attachment submitted there must always be a public version under lsquoAttached (sanitised) documents for publicationrsquo
bull If no confidentiality request is submitted no other version of the attachment than the public version is to be submitted
Confidentiality request on attachment
bull The field for confidential attachments (lsquoAttached confidential documentrsquo) is to be used only if the applicant submits a corresponding confidentiality request
bull All information including personal data covered by the confidentiality request must be duly blackened in the public version of the attachment
bull Applicants should box or earmark all information claimed confidential in the confidential version of attachments
bull In addition to the public version a confidential version must be submitted for each document regarding which there is at least one confidentiality request
Sanitisation of personal data in
attachments
bull Names and addresses of natural persons involved in vertebrate testing or in obtaining toxicological information [Article 39e(2) GFL] must be always sanitised in attachments
bull Names and signatures of individuals must be always sanitised in attachments and corresponding confidentiality requests submitted
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
How to verify your confidentiality requests
59
Generate the Confidentiality Report
bull The Confidentiality Report is available under the lsquoUploaded IUCLID
reportsrsquo
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
60
The Confidentiality Report allows the applicant to identify
1) the IUCLID sub-sections andor fields where a
confidentiality flag has been set (with hyperlink)
2) the corresponding justification provided
How to verify your confidentiality requests
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
How to verify attachments
61
Generate Attachments Report
bull To have an overview on the correct submission
of attachments you can use the IUCLID report
lsquoAttachments Full Metadatarsquo
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Public Consultation
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
EFSArsquos (main) types of PCs
Draft scientific output
DARRAR (PEST)
List of intended studies for application for renewal
Non-confidential version of a validated application
Draft Risk Assessment Protocol
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Overview of the process
PC on the list of intended studies for application renewal
Business operator
10 working days max
Business operator
10 working days max
1
2
Submits the list of intended studies for renewal
Administrative check
3
Public consultation
4Publication of third-
party comments
5
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Promotion
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to the PSA
summary
Together with the PSA
summary
Annex to the PSA
summary
Together with the PSA
summaryAim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
Aim Inform the elaboration of the renewal pre-submission advice to a potential applicant
When Pre-application phase (ahead of renewal)
3 calendar weeks for NAS and MRL60 days for AIR
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Overview of the process
1
2
Business operator
Submits an application requests confidentiality
Confidentiality assessment
Business operator
Submits an application requests confidentiality
Confidentiality decision
Confidentiality assessment
3
4
5
Public consultation
Promotion
Publication of third-party comments
OpenEFSADissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific output
Public consultation
3 calendar weeks for NAS and MRL60 days for AIR
Promotion
Publication of third-party comments
OpenEFSA Dissemination
portal
Right after the PC
Publication of consultationrsquos
outcomeAnnex to
the opinion
Together with the final
scientific outputAim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
Aim Collect new or additional evidencedatainformation to assess an application
When After the confidentiality assessment of the dossier
if no confidentiality assessment is requested by the applicant the consultation is run on the published dossier made available through the OpenEFSA portal Step 2 is skipped
PC on the non-confidential version of an admissible dossierapplication
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Public interface The ConnectEFSA community portal
Screen
Click this link httpsconnectefsaeuropaeuRMspublicconsultation
How to access the portal
1
Click on lsquoPublic Consultationsrsquo2
2
1
3
Display the list of plannedopenclosed consultations
3
The portal is easily accessible from the EFSA
website
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Leave a comment
Also not registereduser can accessupcoming open andclosed publicconsultations
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
The user can submit the comments on hisher personal capacity or onbehalf of an organisation In the latter case additional information isrequested
Leave a comment - Submission
To be able to submit the comments the user mustconfirm that heshe has read and understood the privacynotice
The user can alsorequest to NOTdisclose hisherpersonalinformation byflagging thischeckbox
User can submitthe comments byusing this buttonOnce thecomments aresubmitted theuser cannotsubmit othercomments for thesame publicconsultation
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Open EFSA - Publishing of comments
Open EFSA
CalendarClosed
consultations
Public consultation
details including all comments
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Peer Review Adoption and Publication
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Risk assessment Peer Review Phase (Active substance MRL)
Additional data request (ADR)
Assessment of confidentiality requests on
submitted ADR
ApprovalAdoption of the scientific output
(Conclusion Reasoned Opinion)
Preparation of draft scientific output and
subsequent finalisation
Peer review (RA)
03Preparation of the reporting table (for
AS)
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Output Publication amp Dissemination phase(Active substance MRL)
Notification on approvedadopted scientific output
Publication of scientific output and supporting evidences
Correction of a published scientific output (if applicable)
04Output
Publication amp Dissemination
Editorial check and corrections
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
FAQ from Active Substances and MRLs applicants
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Question and answer (1)
75
We are preparing an AIR dossierwhich already fall under the newRegulation (EU) 20201740
Indeed further to the CommissionImplementing Regulation (EU)20202007 the EU approval ofAureobasidium Pullulans has beenextended to 31 January 2025According to the new Regulation noapplication form is required For thisdossier new studies have beenlaunched but none were notified asthey all started before 27th March2021
How to inform EFSA about the list ofintended studies for new dossiersfalling under the new Regulation (EU)20201740 Should they be notifiedeven if started before 27th March
bull If there are no studies currently planned no list ofintended studies is to be submitted Also for applicationsfalling under Regulation (EU) 20201740 no application form isto be submitted
bull For applications submitted as of 27 March 2021 studiesalready completed or ongoing on this date are not subject toArticle 32b notification obligations
bull For further information please consult the Administrativeguidance on submission of dossiers and assessment reports forthe peer-review of pesticide active substances and on themaximum residue level (MRL) application procedure and theQuestions and Answers on the EFSA Practical Arrangements
According to Article 32b of theGeneral Food Law studiescommissioned or carried to as of the27 March 2021 to support anapplication must be notified to EFSAwithout delay
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Question and answer (2)
76
We applied for a New Pre-application ID for Renewal last week
However the status is still as draftldquo and an error message is displayed when trying to notify the study
How to solve this issue
bull The status of a pre-application ID for renewal remains ldquodraftrdquo until theuser submits the list of intended studies in the ConnectEFSA portal
bull After this step the status turns into ldquoSubmittedrdquo and the user can nolonger edit the record or add intended studies
bull While the steps related to the renewal pre-submission advice are ongoing itis not possible to notify and link studies according to Article 32b of theGeneral Food Law For this reason EFSA invites to submit the list ofintended studies for renewals at least 5 months before the date ofintended commissioning of such studies
However if you have in the list a study which is going to start you can notify itoutside the pre-application ID without waiting for the renewal pre-submissionadvice with a ldquoparallel notificationrdquoOnce you receive the renewal pre-submission advice you will have thepossibility to add the study notified under Article 32 b using the function Addstudy
This parallel notification is explained indetail in the webinar Notification of studiesand Pre-submission Advice We invite youto watch the recording available here andcheck the slides 50-59 in the relatedpresentation
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Question and answer (3)
77
I intend to notify a new study on behalf of 9 companies of a Taskforce in a running renewal procedure It appears I can only include one Business Operator
How do I mention all companies in the notification
In case of a task-forcescenario multiple actorscan access one pre-application ID associatedto a renewal procedure
bull To act on behalf of the task-force all business operatorsneed to establish an account relationship with youas a consultant through these steps
Going to the ldquoMy Detailsrdquo page Clicking on ldquoManage Relationshiprdquo Adding the country and the name of the third-party
organisation
bull Please note that the business operator must select ldquoonbehalf ofrdquo as account relationship type as it is theonly way to allow you to operate (view and edit)
bull At this point you can create a pre-application ID forrenewal Please make sure to indicate the mainpotential applicant in the field lsquoBusiness operatorrsquo (seeArticle 4(2) of EFSArsquos Practical Arrangements on pre-submission phase and public consultations)
bull Once created the pre-application ID is to beshared with all other business operators takingpart in the task-force using the lsquoshare withrsquofunction to allow all business operators to access theinformation In this way all companies composing thetask force will be mentioned in the notifications
Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
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Question and answer (4)
78
How does EFSA deal with completed studiesthat were not notified since their use was notplanned at European level but at national level(either active substance or MRL)
bull As a general rule the information related to studiesneeds to be notified in the database before thestarting date of the study
bull Notwithstanding the above the EFSA database will notblock delayed notifications submitted after the startingdate of the study However when submitting acorresponding application the applicant will be requiredto present a justification for any given delay Thepresentation of accurate and objective justifications for adelayed study notification is a key step to avoid proceduralconsequences being applied in case of deviations from theapplicable rules and process in the context of Article 32b ofthe GFL
In application of Article32b(2) of the General FoodLaw potential applicants andlaboratories or externaltesting facilities must notifyEFSA without delay of allstudies commissioned orcarried out by them as soonas it is known that thosestudies will be used tosupport an application towhich Union Law containsprovisions for EFSA to providea scientific output
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
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efsaeuropaeuenrss
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careersefsaeuropaeu ndash job alerts
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plants_efsa
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animals_efsa
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Linkedincomcompanyefsa
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efsaeuropaeuencontactaskefsa
Stay connected
Questions amp answers session
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Join our new LinkedIn group
ldquoEFSA support to applicantsrdquo
A space where you will find
bull Information and support materials
bull Updates on the developments and progresses of IT tools and platforms
bull Alerts on new training material and upcoming events
bull Answers to the most frequently asked questions
bull Clarification from your peers
httpswwwlinkedincomgroups9083910
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
In case we did not manage to answer all your questions please feel free to re-submit them via EFSA Ask a question webform (EFSAConnect athttpsconnectefsaeuropaeuRMsnew-ask-efsa-request)
The recording of todays webinar will be available on the EFSA website in fewdays
Please take few minutes to fill out the evaluation form that you will receiveshortly in your inbox Your feedback is essential to improve our future events
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected
Subscribe to
efsaeuropaeuennewsnewsletters
efsaeuropaeuenrss
Receive job alerts
careersefsaeuropaeu ndash job alerts
Follow us on Twitter
efsa_eu
plants_efsa
methods_efsa
animals_efsa
Follow us Linked in
Linkedincomcompanyefsa
Contact us
efsaeuropaeuencontactaskefsa
Stay connected