Biocidal Products Committee
Biocidal Products Committee
The Biocidal Products Committee (BPC) prepares the opinions of ECHA related to several BPR processes. The final decisions are taken by the European Commission. The processes are:
- Applications for approval and renewal of approval of active substances
- Review of approval of active substances
- Applications for inclusion in Annex I of active substances meeting the conditions laid down in Article 28 and review of the inclusion of such active substances in Annex I
- Identification of active substances which are candidates for substitution
- Applications for Union authorisation of biocidal products and for renewal, cancellation and amendments of Union authorisations, except where the applications are for administrative changes
- Scientific and technical matters concerning mutual recognition in accordance with Article 38
- At the request of the Commission or of the Member States, the BPC is also responsible for preparing an opinion on any other questions that may arise from the operation of the BPR relating to risks to human or animal health or the environment, or to technical guidance.
Composition
Each Member State is entitled to appoint one member to the BPC for a renewable term of three years. They may also appoint an alternate member.
Applicants may participate in BPC discussions. The agenda for each BPC meeting is published at the latest 21 days before a meeting. If applicants wish to participate for their agenda item, they should contact the BPC Secretariat (BPC (at) echa.europa.eu) and in particular follow the approach described in section 3 of the Code of Conduct for Applicants Participating in the BPC and its Working Groups.
Committee's activities
- List of BPC members with their CVs and Declarations of interest
- Meetings (dates, agendas and minutes)
- Rules of procedure of the BPC [PDF]
- Rules for accessing S-CIRCABC interest groups
- List of Accredited Stakeholder Organisations [PDF]
- Code of Conduct for applicants participating in the BPC and its Working Groups [PDF]
- Work programme for BPC 2024-2025 for active substance approvals [PDF]
BPC Opinions
Working procedures
- E-consultations and early Working Group discussions [PDF]
- Working procedure for opinions on technical and scientific matters concerning mutual recognition [PDF]
- Framework for requests according to Article 75 (1)(g) of the BPR [PDF]
- New information in active substance and Union authorisation opinion forming [PDF]
- Working procedure for active substance approval and renewal [PDF] (applicable from 8 October 2024)
- Validation PBT and ED status
- ED assessment for active substances where the CAR was submitted before entry into force of the BPR: literature review [PDF]
- Principles for the assessment of endocrine disrupting properties in active substance approval [PDF]
- Timelines for the opinion-forming of AS applications
- Applicability of new guidance and guidance-related documents [PDF]
- Procedure for redefinition of an active substance according to Article 13 of Regulation (EU) No 1062/2014 [PDF]
- Procedure for the submission, evaluation and dissemination of data generated after active substance approval [PDF]
- Note for eCA's on how to act in case an applicant in the Review Programme does not provide in time information requested during the evaluation phase [PDF]
- Working procedure for Union authorisation application (26/06/2024) [PDF]
- Timelines for the opinion-forming of Union Authorisation applications
- Linguistic review of SPC translations for Union authorisation and for major changes applications of Union authorisation (09/10/2024) [PDF]
- Post-authorisation conditions for Union authorisation [PDF]
- Guiding principles on providing data during Union Authorisation process (31/01/2024) [PDF]
- Working procedure for renewal of a Union authorisation (09/10/2024) [PDF]
- Guidelines for applicants on submission of applications of renewal of a Union authorisations (09/10/2024) [PDF]
- Criteria to choose full evaluation in the context of renewal of a Union authorisation (09/10/2024) [PDF]
- Linguistic review of the translations of the summary of product characteristics (SPC) for renewal of a Union authorisation (09/10/2024) [PDF]
- Working Procedure for major changes application of a Union Authorisation (26/06/2024) [PDF]
- Working procedure for minor changes application of a Union authorisation (26/06/2024) [PDF]
- Union authorisation application of same biocidal products