New EFSA Guidance Document on risk assessments for PPP's that have stereoisomers as components
The new EFSA Guidance Document on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities and for transformation products of active substances that may have stereoisomers, came into force on 1 August 2021.
Whilst the guidance document does not introduce new data requirements, it does provide specific options for the applicants on how to address the isomers which can be treated as a special type of metabolites. In fact, the guidance document offers some possibilities which avoid the generation of new data by using assumptions which would allow waiver of new studies.
The EFSA guidance document is applicable from 1 August 2021 (date of dossier submission) to dossiers submitted under Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005. Click here to view the guidance document
Interested in learning more about this guidance document? Our phys-chem experts provided their opinion in the September issue of our Regulatory Newsletter.
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