Applicants who wish to apply to get an active substance on to Annex I of the BPD need to submit a dossier to an appropriate Member State (MS). For a new active substance the applicant can choose the MS to which they submit a dossier (providing they contact the MS first and get agreement that the MS is prepared to accept the dossier), while for an existing substance the dossier should be submitted to the Rapporteur Member State (RMS) stated in the Review Regulations, available via the EU Commission website
A dossier should consist of four main documents and needs to cover: the data required according to the BPD 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 Bureau (ECB) website where links to the following can be located:
- 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
A simplified version of core data requirements is available from the HSE. There is also an Approved Code of Practice (ACOP) for any tests carried out in support of an application under the Biocidal Products Regulations.
Applicants should note that:
- all data endpoints should be considered. The UK CA 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 and biocidal products available on the European Chemicals Bureau web pages. Where justifications are to be submitted for important endpoints, it may be wise to discuss these with the relevant MS before submission so that any issues can be identified, and the RMS can discuss these with other MSs (as appropriate) to determine their acceptability.
- An International Uniform Chemical Information Database (IUCLID) submission is also required for each active substance dossier. Whilst the current version of IUCLID is available from the ECB, the UK CA will accept an IUCLID submission generated in older versions.
The UK CA is prepared to have a free 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).