The European Commission released a new version (revision 11) of the guidance document SANCO/221/200 as regards the assessment of the relevance of metabolites in groundwater. Previous version (revision 10) dated 2003.
This new version will apply to dossiers submitted from 01.05.2022 but can be applied earlier by applicants.
The main changes concern Stage 2 of Step 3 as regards the assessment of genotoxicity. The section was amended to:
Other changes were made to reflect the new Regulations and guidance documents that were released since 2003. Clarifications on the scope of the document as regards metabolites formed by microbial pest control agents (micro-organisms) are given.
Guidance Document On The Assessment Of The Relevance Of Metabolites In Groundwater Of Substances Regulated Under Regulation (EC) No 1107/2009 – Sanco/221/2000, rev.11, 21 October 2021
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