# Commission Regulation (EU) 2017/880 of 23 May 2017 laying down rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species and a maximum residue limit established for a pharmacologically active substance in one or more species for other species, in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (Text with EEA relevance), Article 4: Minimum criteria for extrapolation

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

The appropriate authority may undertake extrapolation only when all of the following conditions are fulfilled:
(a)a full set of residue data for the reference species is available to the appropriate authority;
(b)the degree to which the pharmacologically active substance is metabolised in the reference species is established;
(c)a suitably validated analytical method is available for the reference species;
(d)when considering extrapolation between unrelated species, the similarity of the metabolic profiles in the reference and concerned species is established;
(e)the extrapolated MRLs result in the Theoretical Maximum Daily Intake (TMDI) not exceeding the Acceptable Daily Intake (ADI);
(f)for substances where the marker residue does not include parent compound, it is confirmed that the marker residue is present in the concerned species/food commodity;
(g)in case of extrapolations between different food commodities, an unused portion of the ADI is available to accommodate the additional food item.

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Source: https://www.legislation.gov.uk/eur/2017/880/article/4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2017-880/article-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.