Active substance Approval under the EU Biocides Regulation 528/2012 (EU BPR)
This page outlines the UK process for applications to support an active substance for inclusion in the list of approved substances under EU Regulation (528/2012).
All biocidal products to be placed on the market require an authorisation, and authorisation can only be obtained once the active substances contained in that biocidal product has been approved (included on the Union list) under the EU Biocides Regulation 528/2012 (EU BPR).
The approval of active substances takes place at Union level and the subsequent authorisation of the biocidal products at Member State level.
Before considering the submission of a dossier for the inclusion of an active substance on the Union list, it is necessary to establish whether the active substance is:
- a new active substance. If it was not on the EU market before or by 14 May 2000 and/or is not notified, e.g. is not currently being supported in the review programme for an appropriate product type;
- an existing active substance if it has been notified for the correct product type and is currently part of the BPD review programme. In this instance, it may be possible to:
- contact the current participant and discuss the option of data sharing; or
- wait for the outcome of the review and see if the active substance gets inclusion on the Union list.
Details of the current status of the review programme for existing substances are available from the EU Commission .
Active Substance Application Process
The following bullet points are the UK Competent Authority (CA) understanding of the approval of an active substance process. Where relevant hyperlinks are given to additional guidance where it is available and when new guidance should be used (BPC guidance on Applicability time of new guidance and guidance-related documents in active substance approval).
- Preparation for dossier submission - guidance on how to compile a dossier in support of an active substance under 582/2012 including UK CA guidance on what data are required.
- Applicant submits application to ECHA, informing them which Member State (MS) they would like to evaluate their dossier (e-CA) and providing evidence that that MS CA agrees to do so.
- ECHA informs the applicant of the ECHA fee
- Once ECHA’s fee is paid the application is formally accepted and the e-CA is informed of the date of acceptance of the application and its unique identification code.
- e-CA informs the applicant of their fee
- Validation of the application is carried out by the e-CA. (All necessary data requirements need to be addressed)
- If there is
- insufficient information – the applicant has 90 days to provide additional information; or
- sufficient information – the e-CA validates the application and informs the applicant, ECHA and other CAs.
- Evaluation of the application begins and it completed within the time frames in EU BPR (after the evaluation e-CA fee is paid)
- Where the UK is the e-CA we will circulates the findings of our evaluation to UK government departments and applicant for comment
- The e-CA assessment report and conclusions of evaluation are submitted to ECHA
- In some cases it may be possible to introduce new information during the peer review process that could change the conclusions of the e-CA (BPC guidance on Introducing new information during the peer review process of active substance approval).
- Working groups discussions take place to form a draft ECHA opinion
- Biocidal Products Committee (BPC) meets to finalise discussions
- ECHA prepares and submits an opinion on the approval of the active to the Commission
- Commission decision is taken on approval or non-approval of the active substance.
- Approved actives are included in a Union list of approved active substances