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EUROPE – COM : Update of the working document on the evaluation of MRL confirmatory data following Article 12 and risk management decisions

Published by Tanalou Djae at 1 December 2023

Following Standing Committee on Plants, Animals, Food and Feed (SCoPAFF), the European Commission has published on 21 November 2023 an update of working document on the evaluation of data submitted to confirm Maximum Residue Levels (MRLs) following their review in accordance with article 12 of Regulation (EC) 396/2005 and risk management decisions in the absence of such data. This revision 5 of SANTE/10235/2016, replacing version 4.1 of 23 February 2021 in force since 27 March 2021.

The revision 5 indicates that risk managers may decide to lower the MRL to the limit of determination (LOD) when confirmatory data specified in the footnote to the MRL, including those relating to the availability of analytical standards, are not submitted by the interested party within the specified time period.

Furthermore, editorial improvements have been made throughout the document.

Revision 5.0 formalises existing working procedures that are already being followed in case of absence of data to confirm MRLs. Therefore, no new implementation date is necessary for this update.

To download:

SANTE/10235/2016 – Evaluation of data submitted to confirm Maximum Residue Levels (MRLs) following their review in accordance with article 12 of Regulation (EC) 396/20051 and risk management decisions in the absence of such data

See also our previous articles:

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

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