EUROPE – COM: Update of Working Document on the evaluation of MRL confirmatory data with PRIMo rev. 3.1

The Commission published an update of SANTE/10235/2016 – Rev. 4 “WORKING DOCUMENT on the evaluation of data submitted to confirm MRLs following the review of existing MRLs”. The update concerns the implementation of PRIMo rev 3.1 to article 10 applications and article 12 confirmatory data (Regulation (EC) 396/2005) pending with EFSA on 01.01.2020 or submitted to EFSA as from 01.01.2020. 

For chronic risk assessment STMR values should be used for all existing uses and uses under confirmatory data evaluation. For acute risk assessment only uses subject to confirmatory data should be assessed. When concerns are identified, a stop-the-clock of maximum 2 months is allocated.

This updated working document is accompanied by the Minutes of a PAFF Residues meeting. Special cases on the implementation of PRIMo rev 3.1 in outstanding and future MRL evaluation are developed. Basically it applies since 01.01.2020. Further details are given in the document.

To download: 

SANTE/E4/VW 10235/2016 – Rev. 4 WORKING DOCUMENT on the evaluation of data submitted to confirm MRLs following the review of existing MRLs

Agreed approach on implementation of the PRIMO model rev. 3.1. – PAFF residues 25-26 November 2019, agenda item 5

See also our previous articles: 

EUROPE – EFSA: Update of the Pesticide Residue Intake Model 3 (PRIMo rev. 3.1)

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