Preparation for Dossier Submission

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 Joint Research Centre-Institute for Health and Consumer Protection (JRC-IHCP) 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. 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 and biocidal products available on the Joint Research Centre-Institute for Health and Consumer Protection (JRC-IHCP) 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 electronic dossier submission is required. Files in Documents I to III should be primarily in .doc format, although .xls and other file formats may also be used where necessary. Files in Document VI should be primarily in .pdf format. The dossier should be structured in a cascading folder style so that it is clear where files belong. The dossier may be compressed if necessary.
• In addition, for each active substance dossier, applicants must submit the data in electronic format using the software package IUCLID (International Uniform Chemical Information Database) for those parts of the dossiers to which IUCLID applies. The current version, IUCLID5, is available free via a link from the Joint Research Centre-Institute for Health and Consumer Protection (JRC-IHCP) website. The IUCLID submission may be submitted after the .doc/.pdf version.

HSE is prepared to have (and, indeed, encourages) 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).

When an applicant's dossier is ready, it should be submitted in electronic form as detailed above. The electronic dossier may be submitted by email, although its size and complexity can make this difficult. It may therefore be preferable to submit the dossier on disc. Email submission to HSE can be either to a contact established through previous correspondence and/or meeting, or to the UK Biocides CA account, which is UK.BIOCIDES.CA@hse.gsi.gov.uk. It would be helpful if the applicant can also provide HSE with a single paper copy of the dossier. HSE's postal address is on the contact us webpage.