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MRL setting in the EU – Working Document (SANTE/E4/VW 10235/2016 – Rev. 2)

The procedures for MRL setting in the EU are included in Regulations (EC) 396/2005 and 1107/2009. This Working Document is available from the EU Commission and is referenced in Document SANTE/2015/10595 Rev. 4.  Following an Article 12 review of MRLs, the EFSA Reasoned Opinion may note for a specific MRL that ‘further consideration is needed’. This will probably result in a footnote for the published MRL with an associated requirement to submit confirmatory data within two years of the Amending Regulation to (EC) 396/2005. This document sets out the procedures for the evaluation of data submitted to address the lack of information as indicated in the MRL footnotes.

The Commission agreed that within the time period provided for submission of the MRL confirmatory data, such data will not be considered as necessary information in a Member State evaluation to authorise a plant protection product and its absence will not lead to a delay in the authorisation procedure, unless concerns are justified on a scientific basis.

Main points:

  • EFSA is involved in the assessment of confirmatory data in all cases, including when only residue trials are reported and no change of the MRL is needed.
  • Confirmatory data is submitted to EFSA by the RMS/EMS under an Article 10 application, and the RMS/EMS prepares an Evaluation Report (ER). In case an MRL application for a new use on that active substance has been received by the RMS/EMS, the RMS/EMS prepares one single ER covering both evaluations (combined submission of new use and confirmatory data)
  • The applicant/RMS/EMS compiles the MRL application form and submits it to EFSA and DG SANTE. Under Section 1 (Purpose of the application), the submission of ‘Confirmatory data following Art. 12 review’ is indicated by ticking the relevant box. In case of a combined submission, all relevant boxes are ticked in the application form.
  • EFSA provides a reasoned opinion (in the case of combined submission, one reasoned opinion will cover two question numbers) and publishes the ER as a background document to the reasoned opinion. In exceptional cases, an ad hoc MS consultation might be needed before finalising the reasoned opinion.
  • The Commission submits a draft Regulation deleting the footnote and, where appropriate, amending the MRL to the Standing Committee on Plants, Animals, Food and Feed.
  • The document also considers cases where the European Union Reference Laboratories (EURLs) highlighted that analytical standards were not commercially available and an ‘A’ footnote was added to the MRL residue definition.

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 4th November 2016
Categories Agrochemicals, Links, News
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