Revised position on the provisional authorisation of products containing new and existing active substances

HSE has previously advised that provisional authorisations could not be given to products which contain new and existing active substances until all of the existing active substances in the product were formally listed in Annex I. This was due to considering that Biocidal Products Regulations (BPR) did not apply to these products as they were subject to the transitional arrangements of Schedule 13 of BPR.  In consequence, a product containing new and existing active substances could only be granted a full- or provisional-authorisation, and thus be placed on the market, once all the existing active substances in the product were in Annex I. However, this position has been reviewed as part of the current activity to revise BPR and in terms of ensuring consistency with Biocidal Products Directive (BPD).

After due consideration a new interpretive position has emerged. It is now considered that Schedule 13 applies only to products which contain no active substances other than existing active substances (i.e. products containing only existing active substances). The corollary of this is that BPR applies to products which contain new active substances, whether or not those products contain any existing active substances. Thus, a full- or provisional-authorisation could potentially be granted to such products.

This new interpretation brings BPR into line with the intentions of BPD. The revised BPR will make this position clear.

UK Biocides Competent Authority
July 2009