The toxicological relevance of a biocidal active substance, product or family of products is an important consideration during the evaluation process leading to registration. A significant number of studies and evaluations are done to address requirements in the areas of acute and chronic toxicity, genotoxicity, carcinogenicity, reproductive toxicity, neurotoxicity and toxicokinetics.
The new Biocidal Product Regulation (BPR) (EU) No 528/2012 has brought new aspects and challenges to the toxicological part of the approval process: the new hazard-based exclusion criteria, Comparative Risk Assessment, labelling of active substances as "Candidates for Substitution", the tiered system for determining toxicological data and the mandatory sharing of vertebrate studies, all of which will lead to wide-ranging discussions with national and EU authorities. Previous work under the REACH legislation has provided experience in each of these areas.
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