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

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. 4) was dated 2016.

In this new version 5.4, the following points have notably been developed:

  • Procedure when the residue definition or toxicological reference values are amended
  • Steps for new toxicological reference values for setting of import tolerances (i.e. case of substances for which no toxicological reference value was agreed upon at EU level)

and the following procedures have been added:

  • Fast-track procedure to set an MRL for a minor crop (on the basis of an extrapolation carried out from a major crop)
  • Withdrawal of MRL application (when no longer necessary or when not fulfilling the requirements)


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


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