Jan WEBER - qsb.webcast.fiqsb.webcast.fi/e/echa/echa_2015_0901_biocides_stakeholders_day_… · IT usability • Videos • On-site training with MSCAs Import 24 languages Compare

Jan WEBER Biocides Assessment Unit ECHA

• Joined ECHA in 2013 • R4BP 3 product manager

• Responsible for activities

related to development and maintenance of R4BP 3 and the SPC editor

IT state of play and analysis of needs: Planning for the future

Biocides Stakeholders’ Day

Jan Weber

R4BP 3 Product Manager

European Chemicals Agency

1 September 2015

IT tools: a road trip

1. Our destination

2. Our current state of play

3. The road ahead

YOU

ARE

HERE

2

Find most of what you need in one place

• Convenience for customers

• High user acceptance

R4BP 3 as a one-stop shop

3

• Central submission tool

• Convenient data management

• Established communication channel

• Secure data repository

One-Stop Shop

4

1. Our destination


3. The road ahead

YOU

ARE

HERE


5

Back in 2014…

Data in R4BP 3

6

Data from R4BP2: corrections

0

100

200

300

400

500

600

700

Wrongly expired assets Orphan assets Orphan cases

7

12 % faulty


8

12 % fixed

?


9

Transitional measure - SPC placeholder for assets migrated from R4BP2

Quality content needed to support:

• Initiation of new related cases

• Dissemination from Q3 2016

SPC: major change in data model

10

SPC data

11

SPC data

12

Jul Aug Sep May Mar Dec Jan Feb Apr Sep Oct Nov Jun

R4BP 3

SPC Editor

SHD 2014

27 new

processes

+++

Changes

and

renewals

Grouped

changes

Same

biocidal

product

Market

areas

Compare

and

languages

Data

import

YOU

ARE

HERE

IT tools: progressing

13

Improvements

Import

14

Compare

Import

Improvements

15

24

languages

Compare

Import

Improvements

16

IT usability

• Videos

• On-site training with MSCAs

Import 24

languages

Compare

Changes

Same

biocidal

product

+27

processes

17

• Pros and cons

YOU

ARE

HERE

GO SLOW

IT tools: maintenance mode

18

1. Our destination


3. The road ahead

YOU

ARE

HERE


19

YOU

ARE

HERE

• Upcoming landmarks

• Project planning

• Collaboration

Meta-SPC

Amendmts

SBP

regulation

>50

processes

IUCLID 6

Review

Programme

Regulation

The road ahead

20

• Release 2016

• Simplified installation

• Enhanced help

Upcoming

IUCLID 6

Meta-SPC

New amendments Same Biocidal Product Regulation

Review Programme Regulation

+50 processes

21

Upcoming • SPC editor update

• R4BP 3 update

• Analysis done

IUCLID 6

Meta-SPC



+50 processes

22

IUCLID 6

Meta-SPC



+50 processes

Upcoming • Same biocidal product from family member

• Meta-SPC support

23

Upcoming • Participants management

• Declaration of interest to notify

• Take over role of participant

IUCLID 6

Meta-SPC



+50 processes

24

Upcoming Case types needed in the future e.g. Union authorisation related IUCLID 6

Meta-SPC



+50 processes

25

• 1 year

• 3 years

YOU

ARE

HERE

Meta-SPC

Amendmts

SBP

regulation

>50

processes

IUCLID 6

Review

Programme

Regulation

Project planning

26

BPR IT User Group founded 2011

Industry + MSCAs + Commission + ECHA

Join us for the Seventh

meeting on

9 November 2015

in Brussels!

More info: [email protected]

Collaboration is key

27

Take home message

1. Real and correct data crucial

2. Help us to help you

3. More development ahead

YOU

ARE

HERE

On the way to a ‘perfect’

one-stop shop

29

Thank you

Subscribe to our news at echa.europa.eu/subscribe

Follow us on Twitter

@EU_ECHA

Follow us on Facebook

Facebook.com/EUECHA

[email protected]

Henna PIHA Support, Forum & HelpNet Secretariat ECHA • Joined ECHA in 2011 • Head of the HelpNet

Secretariat and leader of the Regulatory advice and HelpNet Secretariat team

• Before joining ECHA she

worked on risk assessment and risk management of chemicals at DG Joint Research Centre and at the Finnish Environment Institute

Available support

Biocides Stakeholders’ Day

Henna Piha

Team leader, Regulatory advice and HelpNet Secretariat

European Chemicals Agency

1 September 2015

1. Where to go when you have a question?

2. Support on IT tools

3. Biocides guidance

4. Particular topics of interest

Overview

2





Overview

3

• Relevant information is available from:

• Guidance, Q&As, newsletter, videos and webinars – all on ECHA’s website

• Commission’s website and CIRCA BC

• National competent authority websites

• Stakeholder organisations

Check

available

information

4

It’s a joint effort

ECHA

European Commission

Member States

5

We have a network

ECHA

HelpNet

European Commission

ASOs, European Enterprise Network

National helpdesks • Harmonised

advice

• FAQs

• Knowledge building and sharing

6

Getting started pages

• Entry point to EU chemicals legislation for companies not yet familiar with it

• Companies can easily identify their role in the supply chain

echa.europa.eu>support>getting started

7

SME guide

• Overview of EU chemicals legislation: it explains REACH, CLP and BPR in 23 languages

• Practical advice:

• How to find your way through the legislation

• Provides links on EU and national funding

• Lists useful sources of information

• echa.europa.eu>support>getting started

8

Contact ECHA:

echa.europa.eu/en/contact

9

http://echa.europa.eu/en/contact

Remit of the ECHA Helpdesk

Regulatory advice:

• Active substance approval

• Low risk active substances, Annex I to the BPR

• Union authorisation

• Article 95

• Technical equivalence and chemical similarity check

• Review Programme management

10

Remit of the ECHA Helpdesk

Regulatory advice:

• BPC procedures

• Classification, labelling and packaging (Active substances)

• Data requirements

• Data sharing, including the inquiry process

• Dissemination

• ECHA fees

11

Remit of the ECHA helpdesk

IT tools support:

• R4BP 3, IUCLID 5 and SPC functionalities

• Dossier preparation

• Industry submission questions e.g. invoices, submission status and requirements

• R4BP2 data migration status

• Account management

• Bugs

12

• National biocides helpdesks are the first contact point for regulatory advice

• Also non-EU companies need to identify the relevant national helpdesk to contact

• If your submission step is with your national authority, please contact them

Contact your national helpdesk

echa.europa.eu/support/helpdesks/national-helpdesks/list-of-national-helpdesks

13

http://echa.europa.eu/web/guest/support/helpdesks/national-helpdesks/list-of-national-helpdesks










Go to your national helpdesk

• I have a biocidal product but I do not know to what product type it belongs to

• I make a product available on the market but I do not know if it is a biocidal product or a plant protection product

• Is my product a treated article or a biocidal product? (Article 3(3))

• Should I apply for mutual recognition or parallel trade?

14





Overview

15

BPR IT tools support

16

Biocides submission manuals

17

Video tutorials

18





Overview

19

ECHA Guidance on BPR

• How to fulfil the information requirements (A) and perform the required assessments (B)

• Principles for the evaluation of applications (C)

Just published!

20

Planned publication dates

By end 2016

By end 2016

The rest ready by the beginning of

2017

Just published!

21

Planned Guidance updates

• Volume III Human health, Part B: Sept/Oct 2015

• Volume IV Environment, Part B: By end of 2016

• Volume V Micro-organisms: By mid 2016 http://echa.europa.eu/support/guidance/consultation-procedure/ongoing-bpr

22

http://echa.europa.eu/support/guidance/consultation-procedure/ongoing-bpr






Transitional Guidance

• Initiated under the BPD; valid until relevant new documents are ready

• New Transitional Guidance for disinfectants PTs 1-5 to be published in Dec 2015/Jan 2016

23

Practical guides

24

Practical guides: data sharing

• Special series published in April 2015

• Include e.g. templates for letters of access and data-sharing agreements

• Translations are on their way

25





Overview

26

Data sharing

• Practical guide - special series on data sharing

• Web page on data sharing echa.europa.eu/regulations/biocidal-products-regulation/data-sharing

• ECHA decisions on data-sharing disputes under BPR

echa.europa.eu/regulations/biocidal-product-regulation/data-sharing/echa-decisions-on-data-sharing-disputes-under-bpr

• Further tips to negotiations echa.europa.eu/regulations/reach/registration/data-sharing/practical-advice-for-data-sharing-negotiations

27

http://echa.europa.eu/regulations/biocidal-products-regulation/data-sharing







http://echa.europa.eu/regulations/biocidal-product-regulation/data-sharing/echa-decisions-on-data-sharing-disputes-under-bpr





















http://echa.europa.eu/regulations/reach/registration/data-sharing/practical-advice-for-data-sharing-negotiations













Biocidal product family

• Note for Guidance

• Implementing the new concept of biocidal product families (CA-Nov14-Doc.5.8 - Final.rev1 - Implementing the new BPF concept)

• SPC template

• Updated SPC template for biocidal product families echa.europa.eu/support/dossier-submission-tools/r4bp/supporting-documents

• Application instructions for R4BP 3

• Addendum to the Biocides Submission Manuals: specific instructions for biocidal product family applications

echa.europa.eu/support/dossier-submission-tools/r4bp/biocides-submission-manuals

28

http://echa.europa.eu/support/dossier-submission-tools/r4bp/supporting-documents







http://echa.europa.eu/support/dossier-submission-tools/r4bp/biocides-submission-manuals









Treated articles

• Note for Guidance

• Frequently asked questions on treated articles

echa.europa.eu/regulations/biocidal-products-regulation/treated-articles

• Article 3(3) Commission decisions echa.europa.eu/regulations/biocidal-products-regulation/legislation

29

http://echa.europa.eu/regulations/biocidal-products-regulation/treated-articles







http://echa.europa.eu/regulations/biocidal-products-regulation/legislation





Thank you

Subscribe to our news at echa.europa.eu/subscribe

Follow us on Twitter

@EU_ECHA

Follow us on Facebook

Facebook.com/EUECHA

[email protected]

Mike BALDRY Regulatory Affairs Consultant Chemours Chemical Solutions • Consultant in BPR, REACH

and CLP for substances and formulated products

• Chemist and biologist, member of Cefic-European Biocidal Products Forum Management Committee and Chair of the British Standards Technical Committee for Efficacy Test Methods for Disinfectants

Industry Experience of Navigating Through the Biocidal Products Regulation Mike Baldry Regulatory Affairs Consultant, Chemours Chemical Solutions

1st September 2015

Support available to industry to assist compliance with the BPR 1st September 2015

Chemours

• Spun-off from DuPont on 1st July 2015

• US$ 6 billion sales in 2014

• Three business units – Titanium Technologies,

Fluoroproducts and Chemical Solutions

• Products include Ti-Pure™, Teflon™ Opteon™, Viton™,

cyanides, Virkon™

• Impact of BPR

– active substance importer and supplier

– biocidal product formulator and reseller

1st September 2015 BPR support 3

Questions

• What, when, where, which, why, how?

• Needs include:

– General information on the BPR

– Guidance on requirements and processes

– Help with problems

– Interpretation of specific issues

• Questioners may have no or little knowledge, some

awareness, various levels of experience or be an expert


Answers

• European Commission

• ECHA

• National Helpdesks

• Colleagues

• Trade associations

• News services

• Consultants

• Contract Research Organisations

• Lawyers


Official European Support

• European Commission

• ECHA

• Primarily information on websites

• *situation as of mid-August 2015

• *English language versions shown

• *personal experience and views


European Commission 1st September 2015

European Commission


European Commission

• Located at DG Environment, not DG Sante

• Generally, an overview of the main provisions of the BPR

• Contains links to legislation and to ECHA website

• Some use as an introduction to the BPR, but lacks details

• http://ec.europa.eu/environment/chemicals/biocides


Official Journal 1st September 2015

Official Journal


Official Journal

• Provides formal, comprehensive texts of Decisions, Regulations and Judgements

• Powerful search tool

• Includes many documents of peripheral interest

• Does not include guidance documents or databases

• Available in all official EU languages

• Legal texts often not easy to comprehend due to legal language and cross-references

• http://eur-lex.europa.eu


EUR-Lex search function


CIRCABC 1st September 2015

CIRCABC


CIRCABC

• Indirect navigation

• https://circabc.europa.eu

• “Browse categories”, “Health and Food Safety”,

“Biocides”, “Library”

• Navigation between pages is peculiar

• Public access to biocides information but much of the

CIRCABC site has restricted access, e.g. “Information”

• Not easy to identify new documents

• Mixture of the useful and the obsolete so be careful –

information may be outdated or only proposals


CIRCABC – only parts are public


CIRCABC – look for subfolder updates


Contains sub-folders; 60th CA meeting folder last modified 10th June

CIRCABC Library – useful information

• Approved substances and substances included in Annex I of the Regulation assessment reports

• Substances not approved…..

• CA meetings policy discussions at CA meetings

• Competent authorities, helpdesks and stakeholders

• Documents finalised at CA meetings agreed positions on some specific topics, including under BPD!

• Practical Guides - Special Series on data sharing, letters of access and consortium

• Review programme for existing active substances

• Study reports miscellaneous documents including information on fees and sustainable use


CIRCABC Library – outdated information

• Creosote Stakeholder Consultation

• Manual of decisions

• Notes for Guidance (in stakeholders consultation)

• PA&MRFG meetings (open session)

• R4BP

• Reports in accordance with Art 24

• Study on the implementation of 98/8

• Treated articles


European Chemicals Agency 1st September 2015

ECHA


ECHA

• Comprehensive website

• Covers not only BPR but also REACH, CLP and PIC

• Provides a lot of useful guidance, databases, process

descriptions and helpful documents

• Describes work of Biocidal Products Committee

• Regularly updated

– SIGN UP FOR WEEKLY NEWSLETTER

• Can be difficult to find what you want


ECHA BPR information - Regulations

• Understanding BPR – describes major concepts

• Legislation – consolidated version of BPR, subsidiary

legislation, specific decisions, BPD legal texts

• Processes – active substance approval, biocidal product

authorisation, technical equivalence, Article 95

compliance, data sharing,

• Links to IT tools

• Nanomaterials

• Treated articles

• Research and Development


ECHA BPR information – other pages

• Home page - news headlines, public consultations,

events, new guidance, webinars

• Addressing Chemicals of Concern - active substances

which are candidates for substitution

• Information on Chemicals – databases on active

substances, biocidal products and Article 95 list

• Support – guidance documents (look for the BPR

information, as mostly REACH)

• Support – emission scenario documents, R4BP3 links,

SME information


ECHA - Finding Information

• Website reflects ECHA approach based on data and

processes

• Will only tell what is known – will not (cannot) answer

unresolved issues

• When trying to find something:

– search box often not very helpful

– easier to look at each main page for required information

– keep clicking and look for likely useful links down, left and right

– outline of site structure at bottom of each page

– REACH and CLP pages can provide useful information on

substances


ECHA - Helpdesk

• The ECHA Helpdesk advises on BPR, CLP, PIC and

REACH, although national helpdesks are first point of

contact

• Helpdesk supports ECHA IT tools, such as R4BP 3

– Learn how to use R4BP3 (and that includes authorities) or pay

somebody who knows what they are doing

– R4BP3 needs to work 24/7 (with limited maintenance windows)

with support every business day

• Helpdesk needs to provide same-day solutions to simple

errors or problems

• Default 15 day message irritates users and discredits

ECHA


Help me!

• Everybody has different needs

• Different knowledge, problems, questions, language,

approach

• Some questions have no answers or several answers

– Experience from BPD carried over to BPR, but policies and

processes mainly developed for rodenticides, insecticides and

wood preservatives may not be applicable to disinfectants and

preservatives or in the new legislative framework

– Little previous consideration of issues specific to disinfectants

such as efficacy and commodities

– No experience of new features of BPR such as in situ generation

of active substances, biocidal product families and treated articles


Conclusions

• A great deal of information is available on-line

• Knowing where to look is sometimes a problem

• Keeping up to date is important

• Specific cases will always raise questions – need to

discuss with relevant evaluating authority

• Need workable solutions to unresolved issues and

guidance available when needed

• It’s improving!


Thank you 1st September 2015

Questions and answers

Submit a question for the Q&A session online at:

http://echa.europa.eu/shdqa