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REACH-IT, IUCLID and other IT toolsFollowed by practical examples
IUCLID
REACH 2018 SME workshop – road to successful registration9-10 March 2017, Vienna, Austria
Francois Le Goff
Computational Assessment and Dissemination Unit
European Chemicals Agency
IT tools for REACH
3
IT tools for REACH
Data generation tools
Data preparation
Submission and use
Chesar
REACH-IT
ECHA Registered substances
eChemPortal
5
• IUCLID (International Uniform Chemical Information Database) is a software application to record, maintain and exchange scientific data on chemicals in a regulatory context, e.g., under the EU Biocides and EU REACH
• REACH data shall be submitted in IUCLID format
IUCLID
6
Drivers for changes
• Changes in requirements
• Feedback received
• Interactions with Competent Authorities and Industry IT working groups
• SME visits by ECHA staff and SME workshops
• Helpdesk
• Technological upgrades
• Quality observations on dossiers
• Needs for enhanced dissemination
IUCLID6
https://iuclid6.echa.europa.eu/
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Search by UUID
View your dossiers
Create new or modify your
existing substances here
Store chemical information on particular chemicals
once in the database and link it from there to any
IUCLID section.
Import files: LE, substance datasets, reference substances
Validate the substance datasets and also the final dossiers in order to minimize the risk
for errors
View what information will be published on
the ECHA website
Create a template to reuse same
endpoint data in diferentdatasets.
Embedded Help System (F1)
IUCLID 6 functionalities
How to create specific dossiers (e.g. how to create a registration dossier)
Field by field help
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Help needed? Press F1
Embedded Help System (F1)
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Dataset content
• Click on ‘TOC’ to display the table of content of the dataset
• By default, the view is ‘REACH Complete’
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Adapting view to submission types
• Adapt the view according to your needs (e.g. preparation of a registration dossier as a member of a joint submission)
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IUCLID: section tree
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IUCLID: general information
• Section 1:• Substance identification
• Composition(s)
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IUCLID: general information
• Section 2:• 2.1 Classification and Labelling (joint or
individual)
• 2.3 PBT assessment (if CSR is required)
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IUCLID: use and exposure data
Section 1:Substance identification
Composition(s)
• Section 3: manufacture, use and exposure (CSR sections 9-10 extract -structured fields)• Section 3.2 – Estimated quantities
• Section 3.5 – Life cycle description: brief description of uses based on the REACH use descriptor system
• Section 3.7 – Exposure scenarios, exposure and risk assessment
Sections 4 – 7 (OECD Harmonised templates)
Section 13: assessment reportsThe CSR document is attached to this section as a Word or PDF file
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IUCLID: hazard information
Section 1:Substance identification
Composition(s)
Section 3: manufacture, use and exposure (CSR sections 9-10 extract -structured fields)
Section 3.2 – Estimated quantities
Section 3.5 – Life cycle description: brief description of uses based on the REACH use descriptor system
Section 3.7 – Exposure scenarios, exposure and risk assessment
• Sections 4 – 7 (OECD Harmonised Templates)
Section 13: assessment reportsThe CSR document is attached to this section as a Word or PDF file
20
IUCLID: assessment reports
Section 1:Substance identification
Composition(s)
Section 3: manufacture, use and exposure (CSR sections 9-10 extract -structured fields)
Section 3.2 – Estimated quantities
Section 3.5 – Life cycle description: brief description of uses based on the REACH use descriptor system
Section 3.7 – Exposure scenarios, exposure and risk assessment
Se)
• Section 11: Guidance on safe use
• Section 13: assessment reports• The Chemical safety Report document is
attached to this section as a Word or PDF file
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IUCLID: section tree
Mandatory sections are indicated with an asterisk: *
• This is only an indication and the Validation Assistant should be run to verify the completeness of the dossier
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• IUCLID 6 is record based
• Right-click on a section name to create a new record or an endpoint summary
• Fill-in the information
Filling-in a dataset
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Filling-in a dataset
• Use free text templates to help you enter the data
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• Every value must be followed by a unit
• Every ‘other’ must be followed by a justification in the designated free text field
• Every justification must be (scientifically) meaningful
Filling-in a dataset: tips
Data entry examples
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• Section 1.1: Identification
• ‘Other identifiers’ table to capture identifiers used previously, or in other regulatory contexts
Substance identification
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• Section 1.2: Composition
• Type of composition:
• Legal entity composition = own composition provided by each registrant
• Boundary composition (Substance Identity Profile) = joint submissioncomposition provided bythe lead registrant
Substance identification
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• Substance identification
profile (SIP)
• The collectively agreed boundaries of the substance in scope of a registration
• Constituents, impurities, additives
• Concentration ranges
• Manufacturing process (UVCB)
• Forms (if applicable)
• Extracted to the REACH-IT joint submission page
Substance identification
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• Substance identification profile (SIP)
• The ‘glue’ between registrant-specific compositions and the jointly provided hazard data, C&L, PBT assessment.
Substance identification
Registrant 4
composition
Registrant 1
composition Data package:
• Hazard information
• Hazard assessment
• PBT assessment
• C&L
Boundaries:
• Constituents
• Impurities, additives with
C&L impact
• Concentrations
• Forms
• Manufacturing process
Registrant 2
compositionRegistrant 3
composition
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• Section 1.4: Analytical information• For each row, the ‘Purpose of analysis’ and ‘Analysis type’ (multi-
select) picklist fields must be filled in.
• Either an attachment must exist in the 'Attached methods/results' field, or a reason for not providing it must be indicated in the field ‘Rationale for no results’ combined with an explanation in the 'Justification' free-text field.
• At least one identification and one quantification analysis must be provided (Purpose of analysis); these can be combined in one row.
Substance identification
Use and exposure information
• Section 3.5:
• Describe activities/processes of each use
• Allocate uses into life cycle stages
• Each use is a separate record
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• Section 3.5:• Existing information
migrated
• Each use must contain at least one contributing activity for the environment (ERC) and one for workers/consumers (PROC/PC/AC)
• Technical function and indication of subsequent service life must be provided
Use and exposure information
Opt-out from the joint submission
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• Provide the data in your own dataset
Opt-out from the joint submission
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• Select the relevant records and add a justification for each opt-out, in section 14
Validation Assistant
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• Access the substance datasets list
• Right-click on the dataset and select ‘Validate’
Validation Assistant
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• Select the submission type
Validation Assistant
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• Fill-in the dossier header information
Validation Assistant
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• Validation assistant report
Validation Assistant
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• Right-click on a failure to access the error location
Validation Assistant
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• Select the dataset
• Right-click and create dossier
Dossier creation
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• Select the correct dossier type
Dossier creation wizard
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• Fill-in the dossier header
Dossier creation wizard
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• Fill-in the dossier header for update
Dossier creation wizard
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Technical Completeness Check
Technical Completeness Check (TCC) is performedin accordance with Article 20(2) of the REACH Regulation
It consists of:
automated checks that can be replicated usingthe validation assistant
manual verification by ECHA staff which cannotbe replicated using the validation assistant
52
Scope of the manual verifications
• As of 21 June 2016, the automated completeness check is complemented with additional manual verifications by ECHA staff
• To ascertain that all the information required by the legislation has been included
• Both new registrations and updates of existing dossiers
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Scope of the manual verifications
• The manual checks are integrated in the completeness check process
• These checks cannot be replicated using the Validation Assistant plug-in
• Make sure that your descriptions on substance identification and any deviations from the standard information requirements are justified and reported
• If you receive a communication that your dossier is not complete, carefully follow the advice included in Annex 1 of the letter
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Areas for manual verification
• Substance identification
• Data waivers
• Chemical safety reports (CSRs)
• Testing proposals on vertebrate animals
• More information on the areas of the additional verifications can be found at: https://echa.europa.eu/documents/10162/13652/manual_completeness_check_en.pdf
Exercise
56
Exercise
Context
You are the lead of a joint submission of 10-100 tonnes. Prepare your registration dossier.
Tasks
• Log-in to IUCLID and import the substance dataset. Find your substance dataset in IUCLID
• Run the Validation Assistant and correct all the failures
• Create a dossier for lead standard registration of 10-100 tonnes; own tonnage is the same. Lead provides Guidance on safe use and CSR on behalf of the members.
• Export your dossier
57
Section 3.3 Sites
• If you indicated in section 1.1 that your 'Role in the supply chain' is 'Manufacturer', then you must provide at least one production site in section 3.3. To this end, you must create a record in section 3.3 and link a 'Site' to it. The contact address of each site must be provided; as a minimum the fields 'Site name', 'Address', 'Town' and 'Country' must be filled in. In addition, to indicate the site as a production site, you must link it using the field 'Related manufacture/own use' to at least one manufacture record in section 3.5.1.
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Section 7 summary
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Amendments to Annexes VII and VIII due tonew or revised OECD test guidelines
Section 7.3.1: Skin corrosion/irritation
Section 7.3.2: Eye irritation
Section 7.4.1: Skin sensitisation
Non-animal testing is now the default approach to gather information.
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Example: Section 7.4.1 Skin sensitisation
62
Triggers for the initiative and proposed solution
• Triggers
• The need to maintain an operational IUCLID version has been raised as a burden for Small and Medium size Enterprises (SMEs)
• The usage of IUCLID for non-frequent users is seen as complex
• Solution
• Provide IUCLID 6 as a Cloud service
Always work on the latest version of the application
Reduced risks of data loss (backups
managed by ECHA)
Facilitate working anywhere (easier remote access)
and delegation to consultants
Possibilities for better online
support
No cost for managing
installations and hardware
Data is more secure because
of reduced number of local
copies
63
Milestones
1. Infrastructure setup: internal milestone
2. IUCLID Cloud trial• first access to the service
• IUCLID data can be browsed with a web interface and edited with a ‘IUCLID app’
3. IUCLID Cloud services for SMEs available (mid 2017)
4. Easier dossier preparation with the help of tasks (end 2017)
M2M1 M3 M4
64
Conclusions
66
Conditions
Member in a jointsubmission?
No previoussubmission in
IUCLID
Only onecomposition to
register
Provide additionalstudy or own
record
Yes
Yes
Yes
No
No
No
Yes
No
67
IUCLID 6, IUCLID Cloud, online dossiers, how to choose?
Online dossiers
• All substances are registered as a member of a joint submission
IUCLID Cloud
• SMEs
IUCLID 6
• All other cases
All these solutions are based on the IUCLID 6 technology
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Summary
1
• Find your co-registrants
• Join the joint submission
2
• Create a dataset and fill in the information • Run the Validation Assistant on the dataset
3• Create the dossier
• Run the Validation Assistant on the dossier
4• Submit the dossier to REACH-IT
5
• Read the tasks and messages
• Pay the invoice
• Receive the registration number
71
Useful links
• IUCLID 6 website https://iuclid6.echa.europa.eu/
• ECHA website support section https://echa.europa.eu/support
• REACH 2018 Roadmap: https://echa.europa.eu/reach-2018
• Manuals on preparing dossiers http://echa.europa.eu/manuals
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