All biocidal products placed on the European Union market must comply with the Biocidal Products Regulation (EU) 528/2012, abbreviated to BPR. This regulation applies from 1 September 2013 replacing the Biocidal Products Directive (98/8/EC). The BPR requires that all biocidal products placed on the EU must be authorized.
A BPR product application for authorization is composed of a lengthy dossier with detailed information regarding the product’s efficacy, physical chemistry, analytical methods, toxicity to humans, ecotoxicity, environmental fate, human and environmental exposure to the product followed by human health and environmental risk characterization and risk management.
Of all the EU chemical regulations, this is one of the most complicated and costly to comply with (even more so than REACH). Costs involved include regulator fees, testing needs, active substance compliance (i.e. LoA for active listed in BPR article 95), regulatory compliance advisory services as well as consulting services for technical support, dossier elaboration and submission. For product applications with the same active substance and similar product use, many of these costs can be shared between companies, and thus significantly reduce the overall costs of compliance for each company.