In situ generated active substances and their products : information requirements and risk assessment for approval and authorisation : recommendations of the BPC Working Groups : version 2

The initial document "Recommendation of the BPC Working Groups: In situ generated active substances - Risk assessment and implications on data requirements for active substances generated in situ and their precursors" was agreed by the four BPC working groups (APCP, Efficacy, TOX and ENV WGs) in 2016 and 2017 and published on the ECHA website in 2017. At their meeting in July 2019, the Biocidal Competent Authorities agreed on the necessity to further develop recommendations also for the biocidal products of in situ generated active substances - isASs (Member State's Competent Authorities for biocidal products, 2019). Therefore, based on the collected experience with the granted approvals of isAS and the assessment of their precursors, the recommendations have been updated (version 2) and a new part on the biocidal products has been included. Current document "Recommendation of the BPC Working Groups (version 2): In situ generated active substances and their products - Information requirements and risk assessment for approval and authorisation." was discussed in all four BPC working groups and agreed in March 2025. Principles applied to "conventional" active substances and biocidal products apply also to the isAS and their products, unless specified otherwise in this document. These recommendations are focusing on additional information needed and on the particularities in the assessment of isAS, their precursor(s) and BPs. These recommendations are intended for BPR applicants for active substance approval and authorisation of biocidal products and for evaluating Member State Competent Authorities (eCAs).