# Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (Text with EEA relevance), Division III.3.2

Extent: E+W+S+N.I.

The data shall be provided in the form of a total residues depletion study providing quantitative data on the parent drug and its major metabolites in relevant food commodities, and the change in the levels of these over time. Total residues studies usually use radiolabelled drug although data from non-radiolabelled studies may be provided where appropriate (for example if the substance is known not to be metabolised). A separate marker residue depletion study shall often also be provided, using unlabelled drug and monitoring the depletion of the marker residue in relevant food commodities over time. Total residues and marker residue data may be provided by means of a single radiolabelled study that also uses an appropriately validated non-radiolabelled method to monitor depletion of the marker residue.

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Source: https://www.legislation.gov.uk/eur/2018/782/annex/I/division/III/division/III.3/division/III.3.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-III/division-III.3/division-III.3.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.