The work programme for active substances – ECHA’s approach to tackle the workload

Biocides Symposium 2014 22 – 23 May, Bratislava

Erik van de Plassche Chair Biocial Products Committee

Content

1. Biocidal Products Committee: achievements so far

1. Active substance approval and

Review Programme

1. Tackle the workload – meeting the 2024 dead-line

Biocidal Products Committee

Achievements so-far

First opinions adopted See: http://echa.europa.eu/web/guest/about-us/who-we-are/biocidal-products-committee

Biocidal Products Committee (BPC)

ttp://echa.europa.eu/web/guest

Structure of the BPC and its Working Groups

Biocidal Products

Committee

Working groups

Efficacy

Analytical methods Physical-chemical properties (APCP)

Human health

Environment

Ad hoc Working groups

Human exposure

Assessment of residue transfer to

food

Environmental exposure

(Permanent WGs)

(Ad hoc WGs)

Achievements so far: • Preparatory phase 2012 – 2013 (http://echa.europa.eu/):

• 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 2014 - 2016

• 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

Achievements so far:

• Operational phase 2014 (http://echa.europa.eu/): • 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 30 days commenting period for CARs coming directly to the BPC (without discussion at Permanent Working Groups)

Work programme 2014 - 2016 ● BPC opinion ● Number of

opinions ● 2

014

● 2015

● 2016

● ● Existing active substances: Review

Programme ● 5

0 ● 5

0 ● 5

0 ● New active substances: Article 11

of BPD ● 5 ● 1

0 ● 1

0 ● New active substances: Article 7 of

BPR ● 0 ● 6 ● 6

● Renewal of approval under Article 14 of BPR

● 0 ● 0 ● 0

● Union authorisation ● 0 ● 10

● 20

● Technical and scientific matters concerning mutual recognition

● 30

● 30

● 30

● Inclusion in Annex I ● 0 ● 1 ● 1 ● Review of inclusion in Annex I ● 0 ● 0 ● 0 ● Requests of Commission or MS

● 2 ● 0 ● 0

Active substance approval and Review Programme A changing process Commission note on principles for taking decisions on active substance approval (CA March 2014) Review Regulation 1451/2007 will be replaced

Peer review process – main steps

E) Biocidal Products Committee

D) Follow-up

Competent authority report (CAR)

A) Public consultation Only if potential candidate for

substitution

Commission decision making

C) Permanent Working Group discussions

B) Commenting phase MSCAs, applicant

Efficacy APCP Human health Environment

Status of approval active substances

• Review Programme: • List of approved active substances: ~100 entries • Number of existing active substance PT combinations

under evaluation: • ~ 150 CARs submitted by eCA before 1 September 2013 but not

finalised -> defined as the “backlog” • CARs to be submitted by eCA after 1 September 2013: ~ 400

under evaluation

• Evaluations of new active substances not

finalised and submitted under BPD: ~ 30 under evaluation

• Submissions under BPR: 3 evaluations on-going

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

2013: • 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

Change in decision making

• ”Backlog”: i) normally 10 years; ii) substitution: maximum of 10 years; iii) exclusion: 5 years

• CARs submitted by eCA to ECHA after 1

September 2013: 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

Assessment of substitution criteria and public consultation • Assessment of substitution criteria limited to

Article 10(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

Replacement Review Regulation

• Regulation 1451/2007: 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 1451/2007 (foreseen adoption second half 2014): • 270 days for BPC opinion from the start of preparation • new dead-lines for Member States for submission of

CAR per group of PTs

New dead-lines (Annex III of draft regulation)

• Product Type • CAR • Start process BPC opinion

• 8, 14, 16, 18, 19 and 21 • 31/12/2015 • 31/3/2016

• 3, 4 and 5 • 31/12/2016 • 31/3/2017

• 1 and 2 • 31/12/2018 • 31/3/2019

• 6 and 13 • 31/12/2019 • 31/3/2020

• 7, 9 and 10 • 31/12/2020 • 31/3/2021

• 11, 12, 15, 17, 20 and 22 • 31/12/2022 • 31/9/2023

Tackle the workload – meeting the 2024 deadline

More dossiers? ECHA dossier manager

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”: take-

over 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 2014): take-over possibility for precursors or active substance

Tackle the workload – meeting the 2024 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

Thank you!