EUROPE – COM : Update of MRL setting procedure (SANTE/2015/10595 rev. 6.1)

The Commission published an update of Technical Guidelines SANTE/2015/10595 “MRL setting procedure in accordance with articles 6 to 11 of Regulation (EC) No 396/2005 and article 8 of Regulation (EC) No 1107/2009”.

The last version (rev. 5.5) was dated February 2021. The purpose was to detail the new requirements in the pre-submission phase and submission application procedure in relation with the implementation of the Transparency Regulation (EU) 2019/1381.

In this new version 6.1, the conditions that lead to the setting of temporary MRLs have been detailed for the following ‘exceptional cases’:

  • Cases of emergency authorisations notably where pesticide residues arise as a result from uses of plant protection products.
  • Cases of environmental contamination, of cross-contamination from storage facilities and handling circuits and cases of contamination due to the transfer of residues from the treated parts of the plant to food products in relation with the active substance persistence.  
  • Cases of natural occurrence of substances unauthorised use as a pesticide and of substances with multiple uses whose residues are not a consequence of uses in plant protection.

These new provisions apply to all MRL applications submitted as of 27 March 2021. For all applications submitted before 27 March 2021, all procedural steps as described in SANTE/2015/10595 Rev. 5.4 continue to apply. 

 

To download: 

Technical Guidelines on the MRL Setting Procedure 2018 – SANTE/2015/10595 Rev. 5.4

Technical Guidelines on the MRL Setting Procedure 2018 – SANTE/2015/10595 Rev. 5.5

Technical Guidelines on the MRL Setting Procedure 2018 – SANTE/2015/10595 Rev. 6.1

 

See also our previous articles: 

EUROPE – COM: Update of MRL setting procedure (SANTE/2015/10595 rev. 5.4)

 

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