EUROPE: New update of SANCO 7525/VI/95 on comparability, extrapolation, group tolerances and data requirements for setting MRLs

Revision 10.2 of Guidance document SANCO 7525/VI/95 concerning residue trials was adopted by the European Commission on 23 September 2016 and became effective immediately.

This new revision applies to new applications but also to those applications where assessment was already carried out by a Member State under the previous version. In such cases EFSA should use the new version to make its assessment. Where applications are already advanced in the EFSA assessment procedure and use of the new guidance would delay the overall procedure, no retroactive amendments should be carried out. The same principles apply to the Art. 12 review process.

The update concerns Table 3 (recommended extrapolations) and Table 4 (Addendum to Table 3). Some mistakes/errors detected after the adoption of version 10.1 were corrected and some clarifications were made.

To download:

SANCO 7525/VI/95 Rev. 10.2 – GUIDANCE DOCUMENT Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs

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