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:

• the data required according to the 528/2012 and related guidance documents (in Document VI);
• summaries of that data in a set format (in Document III);
• assessments of the hazard, exposures and risks of the active substance in a product (in Document II);
• and a summary document (Document I).

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

• Information requirements for active substances and biocidal products in accordance with the Annex II of EU BPR
• Technical Notes for Guidance(TNsG) on Data Requirements;
• TNsG on Dossier Preparation and Study Evaluation;
• TNsG on Human Exposure;
• TNsG on Annex I inclusion;
• Technical Guidance Document (TGD) on Risk Assessment
• Environmental Emission Scenario Documents

Applicants should note that:

• All data endpoints should be considered. HSE considers that for 'chemistry', 'efficacy' and 'human health', all the specified data requirements must be addressed (either via data or a robust scientific justification) whilst the 'Environment' data requirements are not all mandatory. Environmental data requirements are dependent upon both the nature of the active substance and its use/exposure pattern and can be addressed via provision of data or robust scientific justifications.
• Guidance on non-submission of data is provided in the general introduction to the guidance on data requirements for active substances. Where justifications are to be submitted for important endpoints, it may be wise to discuss these with HSE before submission so that any issues can be identified, and HSE can discuss these with other MSs (as appropriate) to determine their acceptability.

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).