The work programme for active substances ECHA s approach to tackle the workload Biocides Symposium May, Bratislava

Transcription

1 The work programme for active substances ECHA s approach to tackle the workload Biocides Symposium May, Bratislava Erik van de Plassche Chair Biocial Products Committee

2 Content 1. Biocidal Products Committee: achievements so far 1. Active substance approval and Review Programme 1. Tackle the workload meeting the 224 dead-line

3 Biocidal Products Committee Achievements so-far First opinions adopted See: guest/about-us/who-weare/biocidal-productscommittee

4 Biocidal Products Committee (BPC) ttp://echa.europa.eu/web/guest

5 Structure of the BPC and its Working Groups Biocidal Products Committee (Permanent WGs) Working groups Efficacy Analytical methods Physical-chemical properties (APCP) Human health Environment (Ad hoc WGs) Ad hoc Working groups Human exposure Assessment of residue transfer to food Environmental exposure

6 Achievements so far: Preparatory phase ( 3 meetings: BPC and WGs established Rules of procedure Working procedures for approval active substances, Union authorisation, technical and scientific matters concerning mutual recognition and Article 75(1)(g) requests Code of conduct for participation of applicants Involvement of stakeholders Templates, communication platform (CIRCA BC) and dedicated web-page BPC on ECHA web-site Work programme Organisation ECHA: BPC: chair and scientific support (2) Permanent and ad-hoc WGs: chairs and scientific support (13) Coordination active substance approval process (1) Administrative support

7 Achievements so far: Operational phase 214 ( 2 BPC and WG meetings 3 opinions adopted for active substance approval: permethrin (PT 8 and 18) and tralopyril (PT 21) 2 opinions adopted following Article 75(1)(g) requests from the Commission Opinions published on dedicated web-page BPC Opinion template established Continuous refinement of working procedures for active substance approval: for example introducing a 3 days commenting period for CARs coming directly to the BPC (without discussion at Permanent Working Groups)

8 Work programme BPC opinion Number of opinions Existing active substances: Review Programme New active substances: Article 11 of BPD New active substances: Article 7 of BPR Renewal of approval under Article 14 of BPR Union authorisation 1 Technical and scientific matters 3 3 concerning mutual recognition 2 3 Inclusion in Annex I 1 1 Review of inclusion in Annex I

9 Active substance approval and Review Programme A changing process Commission note on principles for taking decisions on active substance approval (CA March 214) Review Regulation 1451/27 will be replaced

10 Peer review process main steps Competent authority report (CAR) A) Public consultation Only if potential candidate for substitution B) Commenting phase MSCAs, applicant C) Permanent Working Group discussions Efficacy APCP Human health Environment D) Follow-up E) Biocidal Products Committee Commission decision making

11 Status of approval active substances Review Programme: List of approved active substances: ~1 entries Number of existing active substance PT combinations under evaluation: ~ 15 CARs submitted by eca before 1 September 213 but not finalised -> defined as the backlog CARs to be submitted by eca after 1 September 213: ~ 4 under evaluation Evaluations of new active substances not finalised and submitted under BPD: ~ 3 under evaluation Submissions under BPR: 3 evaluations on-going

12 Change in process No additional data generated after CAR is submitted Multiple dossiers: combined CAR required Backlog : CLH and PBT (where relevant): submission by eca to ECHA as soon as possible CAR submission by eca after 1 September 213: CLH (where relevant): submit CLH dossier to ECHA ultimately at the time of submission of the CAR If suspected by eca to meet exclusion or substitution criteria by eca: highly preferable and therefore strongly recommended to obtain RAC opinion or scientific advice of PBT or ED EG before submission of CAR by eca to ECHA

13 Change in decision making Backlog : i) normally 1 years; ii) substitution: maximum of 1 years; iii) exclusion: 5 years CARs submitted by eca to ECHA after 1 September 213: provisions BPR apply Exclusion and subsitution criteria, POP criteria, treated articles, nanomaterials and possibility Annex I inclusion have to be addressed in all CARs and in the BPC opinion

14 Assessment of substitution criteria and public consultation Assessment of substitution criteria limited to Article 1(1)(a, b and d): i) targeted by derogation according to Article 5(2); ii) respiratory sensitisation; iii) PBT criteria: 2 out of 3 Consultation of applicant on information to be published ECHA relies on evaluation eca in CAR for deciding on launching public consultation Further discussion on assessment based on limited data package

15 Replacement Review Regulation Regulation 1451/27: Annex I (list of existing active substances) and Annex II (overview Review Programme) Draft Commission Delegated Regulation on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in the BPR (CA- May-Doc3.1): repeals and replaces Regulation 1451/27 (foreseen adoption second half 214): 27 days for BPC opinion from the start of preparation new dead-lines for Member States for submission of CAR per group of PTs

16 New dead-lines (Annex III of draft regulation) Product Type CAR Start process BPC opinion 8, 14, 16, 18, 19 and 21 31/12/215 31/3/216 3, 4 and 5 31/12/216 31/3/217 1 and 2 31/12/218 31/3/219 6 and 13 31/12/219 31/3/22 7, 9 and 1 31/12/22 31/3/221 11, 12, 15, 17, 2 and 22 31/12/222 31/9/223

17 Tackle the workload meeting the 224 deadline More dossiers? ECHA dossier manager

18 Review Programme Part 1 of Annex II of new Review Regulation establishes the Review Programme Increasing the workload? Part 2 of Annex II of new Review Regulation : takeover possiblity for 84 active substance PT combinations Transitional provisions for treated articles in Article 94 Management of in situ generated active substances in the context of the BPR (CA May 214): take-over possibility for precursors or active substance

19 Tackle the workload meeting the 224 deadline Shared responsibility partnership approach Resources available in Member States ECHA approach: Early Working Group discussions or e-consultations -> hazard assessment Optimise agendas for Working Group and BPC meetings -> several active substances for one PT Dossier manager: contact point between eca and ECHA

20 Thank you!