SANTE Guidance Document Updates

SANTE Guidance Document Updates

On the 1st March 2021, SANTE/2020/12830 Rev.1 was adopted as technical guidance for the European Commission on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes. This guidance document supersedes SANCO/3029/99 rev. 4 and SANCO/825/00 rev. 8.1, harmonizing requirements, where appropriate.

Smithers has created a guide that discusses and evaluates the expectations of the new guidance, specifically in relation to non-radiolabelled risk assessment methods employed for Plant Protection Product registrations with ecotoxicology, environmental fate, physical-chemistry and residue testing. Since the superseded guidance documents were widely referenced for environmental risk assessment methods, this guide is also intended as a useful reference to validation criteria for other industries conducting similar study designs.

Potential impacts and amendments to laboratory practices including planning and reporting of validations are considered in response to the new guidance requirements. Attention is given to the impact on continuing studies and their reporting requirements. Finally, a comparison of the requirements and differences detailed in each of the superseded guidance documents and SANTE/2020/12830 Rev.1 is provided.
 

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Smithers Resource Guide: Updates to SANTE Guidance Document June2021

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