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:
- Ensure that the evaluation of the genotoxic potential cover all of the following aspects: gene mutation, structural chromosomal alterations (clastogenicity) and numerical chromosomal alterations (aneugenicity);
- Give an example of a suitable battery of tests: (i) Ames test, (ii) in vitro Mammalian Cell Gene Mutation Test (tk or hprt locus) and (iii) in vitro micronucleus test;
- Provide instructions for alternative/further studies in case of metabolite specificities and in case of equivocal, inconclusive or positive results.
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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