Biocidal products to be placed or to remain on the market will require product authorisation or product registration within 2 years of an active substance being formally included on to Annex I or IA of the BPD. Product authorisations can be applied for in any Member State. At present there are discussions at EU level to agree harmonised procedures for product authorisation. A harmonised approach will help to facilitate mutual recognition of product authorisations between Member States.
For product authorisation, you will need a letter of access to the active substance dossier used for supporting its Annex I inclusion (or you can provide your own dossier). You will need to submit a product dossier (or a letter of access to one) that meets the requirements set out in Annex IIB and the relevant parts of IIIB of the BPD, guidance on data requirements and dossier preparation are available on the European Chemicals Bureau website.
If you decide to obtain the active substance for your biocidal product from a different source to that used in the active substance dossier then you will need to show that the active substance you are using is technically equivalent to that used to support the Annex I Inclusion. In this context technical equivalence means that the specification of the active i.e. purity level and impurity profile, from the two sources is essentially the same. Further information regarding this can be found in the Technical Notes for Guidance (TNsG) on the assessment of Technical Equivalence.
Please note that whilst the active substance dossier is under data protection a letter of access will be required from any companies who do not actually own the data.
For future information regarding product authorisation sign up for our biocides e-bulletin or alternatively consult the EU Commission website for an up-to-date position.
Provisional authorisation
For a new active substance, provisional authorisation of a biocidal product may be granted once the Rapporteur Member State (RMS) has evaluated the new active substance and recommended Annex I inclusion but the new active substance has not yet been included on to Annex I of the BPD. In compliance with Annex IIB of the BPD, the core data set for biocidal products will need to be addressed for provisional authorisation. The provisional authorisation will reflect the conditions and restrictions reflected in the Annex I recommendation. Initially the provisional authorisation will be for a maximum of 3 years until the new active substance gains Annex I inclusion. This period may be extended if a decision on Annex I inclusion has not been made.
Derogations
Regulation 16 of the BPR allows derogations from product authorisation for the purpose of research and development of an unauthorised biocidal product. These are the scientific research and development derogation and the process-orientated research and development (PORD) derogation.
In the case of scientific research and development, the applicant should keep written records containing the identity of the biocidal product or active substance, labelling data, quantities supplied and the name and addresses of the recipients. You will need to comply with a dossier of information containing all the available data on possible effects on human or animal health or impact on the environment. This information must be available to the competent authority if requested.
In the case of a PORD, you should submit the information required for scientific research and development, which is outlined above, to the competent authority before placing the product on the market occurs for experimental purposes. The same information should be submitted to all competent authorities of the Member States where the experiments or tests are to be conducted.
In both of the cases above, if the proposed tests or experiments are likely to have unacceptable adverse effects on human, animal health, or the environment, the competent authority can prohibit them or allow them subject to certain conditions as it considers necessary.
For further information on research requirements under BPR, including our fees for data evaluation, see BPR Research page.
Experimental authorisation (Regulation 17)
Experimental authorisation permits an applicant to undertake research and development (R&D) on a product where there is release into the environment, prior to an application being made for Annex I etc listing.
For further information on experimental authorisation requirements under BPR, including our fees for data evaluation, see BPR Research page.
Emergency authorisation (Regulation 15)
Emergency authorisation allows for the marketing of a non-authorised biocidal product, for a temporary period (not exceeding 120 days), to control a previously unforeseen danger or circumstance that cannot be controlled by any other means. With the permission of the Commission, this time period may be extended. The emergency authorisation will specify conditions and restrictions relating to the placing on the market and the use of the biocidal product.
For the latest information on the costs for the evaluation of product authorisations see our BPD charges page.