Registration of a novel biocidal active substance

Client

A specialist biocide regulatory affairs consultancy, on behalf of a biocide manufacturer.

Background

EU manufacturers of biocidal products are required, under the Biocidal Products Regulation (BPR), to submit a dossier of information to the European Chemicals Agency (ECHA). Before a biocidal product can be registered, however, the active substance must also be approved by the Agency. Companies are not permitted to market novel biocidal active substances until such approval has been granted.

Project goals

Technical support at all stages of the submission process.

Approach and outcome

Because the biocidal active substance was novel, there was no prior information on what its toxicological properties might be. Therefore the first stage of the project was to conduct literature searches for data on compounds with similar structures (i.e. a read-across approach), and to carry out in silico modelling to understand the possible hazards of the novel chemical.

With this in place, we then worked with our client and the substance manufacturer to agree a testing strategy considering the BPR requirements and guidance, and were tasked with reviewing the protocols and draft study reports from contract testing laboratories. As there was no existing data on this biocide active, the data package that was commissioned had to cover the full suite of human health and ecotoxicological endpoints.

As the data were generated and the study reports reviewed, agreed and finalised with the laboratories, we prepared summaries for inclusion into IUCLID. At this stage we were in regular contact with the client, the manufacturer and other groups involved in the wider project to ensure that all aspects of the submission were coherent, and that everything was completed in time for the submission deadline.