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.
The document is available on the EU Commission website at https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_sanco-10235-2016.pdf
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, firstname.lastname@example.org.
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