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MRL setting in the EU – Guidance Document SANTE/2015/10595 Rev. 4

The procedures for MRL setting in the EU are included in Regulations (EU) 396/2005 and 1107/2009.  A guidance document is available from the EU Commission that is intended to provide clarity on the various steps involved in the procedure, on the timelines and on specific circumstances related to the MRL setting process.  The document does not provide new information on the MRL setting process, rather it acts as a useful condensed source of all relevant information relevant to the process and as such is a helpful resource.

The document includes an overview of the following issues:

  • Current procedures for MRL setting under Reg (EU) 396/2005 – this includes an overview of the current Annexes to Reg (EU) 396/2005, who is involved in the different steps of the process, and the procedural steps for setting, modifying or deleting an MRL. The various responsibilities of the applicant, the evaluating Member State (EMS), the EU Commission, the European Food Safety Authority (EFSA) are also clarified.
  • Clarification of specific cases – this includes requests for Import Tolerances, implementation of Codex Maximum Residue Limits (CXLs), and the setting of Temporary MRLs
  • A number of useful resources are also listed, including links to relevant Data Requirement documents, EU contact points, IT tools, a glossary of commonly used abbreviations, and a flow diagram that indicates the timescale of the various activities involved in the MRL setting procedure.

The document is available on the EU Commission website at

For advice on risk assessment and further information on the registration of plant protection products, biocides or general chemicals, or any other regulatory issues, please contact JSC on +44 (0)1423 520245,

Published 1st November 2016
Categories Agrochemicals, Links, News
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