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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).

Introduction

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:

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).

Updated 2016-05-20