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Guidance activities Structure, process and where are we now?

Guidance activities Structure, process and where are we now?. 7.2. ECHA guidance development. 72 nd meeting of representatives of MS CAs for the implementation of BPR. Johan NOUWEN, Head of Unit A2 - Support , Forum and HelpNet Secretariat European Chemicals Agency.

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Guidance activities Structure, process and where are we now?

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  1. Guidance activitiesStructure, process and whereare we now? 7.2. ECHA guidancedevelopment 72nd meeting of representatives of MS CAs for the implementation of BPR Johan NOUWEN, Head of Unit A2 - Support, Forum and HelpNet Secretariat European Chemicals Agency

  2. My presentation will cover …. • The structure of the BPR guidance • The Guidance Consultation Process in a nutshell • Where are we now – what has been published? • What are we working on? CA-May 2017

  3. The original structure of the BPR guidance CA-May 2017

  4. TheNEWorganisation of the BPR structure CA-May 2017

  5. New BPR GUIDANCE Diagram 2017[https://echa.europa.eu/guidance-documents/guidance-on-biocides-legislation] CA-May 2017

  6. Who reads Guidance ….? CA-May 2017

  7. Statistics CA-May 2017

  8. Guidance Consultation Process in a nutshell CA-May 2017

  9. “Partners” of the ECHA Secretariat • Non-institutional partners (Accredited Stakeholder Organisations) • ECHA Committees & Forum • European Commission and Member State Competent Authorities echa.europa.eu

  10. How are ECHA Partners involved? • Identification of guidance needs. • Drafting of the guidance • Consultation of ECHA partners • Publication of main interim and final documents • Outcome of a consultation echa.europa.eu

  11. 1. Identification of guidance needs echa.europa.eu

  12. 2. Drafting of the Guidance • ECHA coordinates drafting of the guidance • At this stage, a significant contribution may come from in-house as well as from external experts (e.g. via a workshop)

  13. 3. Consultation of ECHA partners

  14. What is a “PEG”? • Partner Expert Group • Made up from: • Nominations by Competent Authorities (CAs), Accredited Stakeholder Organisations (ASOs), European Commission or ECHA • Includes nominations from BPC WGs/ad hoc WGs • Can include ECHA nominated “experts” if required • Established by ECHA • Invite CAs to nominate a representative – CAs responsibility to contact BPC WG members • Invite ASOs to nominate a representative • The membership is published on ECHA’s website CA-May 2017

  15. 3. Consultation of ECHA partners • Committees and/or Forum consulted to: • Avoid disagreement at the end • Feed-in potentially available top-level expertise • Consultation of Member State Competent Authorities (MSCAs) and the European Commission • Obligatory for new guidance and updates (other than corrigenda) echa.europa.eu • 16

  16. 4. Publication of main interim and final documents

  17. 4. Publication of main interim and final documents • The draft texts and the feedback from of consultation of the Partner Expert Group “PEG”, Committees and/or Forum and Competent authorities (Biocides CA for BPR) can be seen on the ECHA website: • Text sent • Comments made • ECHA response – including reasons when rejected • Resulting draft text for next stage of consultation and final text of the new/updated guidance after completion of the process echa.europa.eu • 18

  18. 5. Outcome of a consultation • Is ultimately a published new version of a document • Added value points are: • Involves all stakeholders, including Commission, Biocides CAs, industry, BPR enforcement authorities – and is transparent! • Should meet deadlines while achieving buy-in. • All efforts will be made to reach consensus for achieving the basic objective:  Guidance that is useful and acceptable to those using it (industry, authorities and those enforcing the legislation) echa.europa.eu • 19

  19. Where are we now ….?….. what has been published to support the BPR CA-May 2017

  20. …so what is alredy published ? Part A + Part B v1.0 (active subs.) Part A CA-May 2017

  21. What are we working on this year….? CA-May 2017

  22. Guidance activities for 2017 ↓ 2017 ↓ 2017 ↓ 2017 UPDATE to start in 2017/2018 Vol I Parts B+C Consultation Summer 2017 Publication December 2017 Vol III B+C updates (i) ARTFood Guidance Project 1: Livestock exposure: publication October 2017 (ii) Project 2: Dietary risk/non-professional users: consultation Feb 2017/publication September 2017 Vol IV Parts B+C: consultation in progress. Publication July 2017 Disinfection By-Products Vol II Parts B+C: UPDATES to Section 5 in Q2 2017. (i) PT8 – to add appendix + (ii) PT5 – to revise section Vol II Part A: UPDATE in 2017

  23. … already started with the aim to publish this year or early in 2018 • Vol I • Parts B+C are going to be added to Part A • Vol II Efficacy • Part A to be brought in line with Parts B+C • PT5 to be updated following ECHA Disinfectants project • PT8 to add a new appendix on “Annex A of EN-599” • Vol III Human Health • Update to add new section “Livestock exposure” (ARTFood Project 1) • Update to add new section “Dietary risk/non-professional users” (ARTFood Project 2) • Vol IV Environment • Update to add guidance on BPs and to add Part C CA-May 2017

  24. … in the pipeline for initiating later this year • Vol II Efficacy • Updates to revise PT18+19 and to add PT11 & PT12 • Vol IV Environment • A second update to address flagged issues from current update • Vol V –Technical Equivalence • Update to guidance following experience since first published in 2018 CA-May 2017

  25. Any questions? CA-May 2017

  26. Thank you for listening!

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