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Preparation for Dossier Submission under the EU Biocides Regulation 528/2012 (EU BPR)

This page provides information to help applicants comply a dossier for the approval of an active substance under the EU Biocides Regulation (EU BPR) where HSE will be the evaluating Competent Authority.

Introduction

Applicants who wish to apply to get an active substance approved (included in Union list of approved substances) under EU Biocides Regulation 528/2012 (EU BPR) will first need to submit an application to the European Chemicals Agency (ECHA), and inform them which Member State (MS) they would like to evaluate their dossier. The applicant will also need to provide written evidence that that MS CA agrees to do so.

Active substance dossier

An active substance dossier should consist of four main documents and needs to cover:

Guidance is available, from the European Chemicals Agency (ECHA) website where links to the following can be located:

Applicants should note that:

How to apply

Each application for active substance approval must be submit the using the relevant R4BP application form to the European Chemicals Agency (ECHA). 

The applicant must submit the data for each active substance using the free software package IUCLID (International Uniform Chemical Information Database).

HSE is prepared to have (and, indeed, encourages) a initial meeting with applicants, before their dossier submission, to discuss potential issues and the basis of justifications (to reduce potential problems later in the process) and the proposed timescale for submission (to allow better work scheduling).

Updated 2014-06-03