Updated data requirements for biocidal active substances and products

The regulation amending the data requirements for active substances and biocidal products (Regulation (EU) 2021/525) has been published recently. The updated data requirements for active substance and biocidal product authorisation shall apply from 15 April 2022 but applicants might choose to apply the requirements from 15 April 2021.

The purpose of this delegated regulation is to amend the information requirements for active substance and biocidal products. In particular, the amendment takes into account new methods for generating better information on toxicological properties (such as irritation, neurotoxicity, genotoxicity, etc.), new testing strategies favouring in vitro over in vivo testing (in order to reduce testing on vertebrates), and a testing strategy and methods for the determination of endocrine disrupting properties in accordance with the criteria set out in Commission Delegated Regulation (EU) 2017/2100.

Be prepared and check your biocidal active substance and/or product dataset for potential data gaps according to the updated data requirements. Please do not hesitate to contact us if our experienced team can assist you.