{
  "url": "https://openlegislation.uk/eu-regulation-2017-880/article-4",
  "json_url": "https://openlegislation.uk/eu-regulation-2017-880/article-4.json",
  "legislation": "eur/2017/880",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2017-880",
  "path": "article/4",
  "kind": "article",
  "number": "4",
  "heading": "Minimum criteria for extrapolation",
  "text": "The appropriate authority may undertake extrapolation only when all of the following conditions are fulfilled:\n(a)a full set of residue data for the reference species is available to the appropriate authority;\n(b)the degree to which the pharmacologically active substance is metabolised in the reference species is established;\n(c)a suitably validated analytical method is available for the reference species;\n(d)when considering extrapolation between unrelated species, the similarity of the metabolic profiles in the reference and concerned species is established;\n(e)the extrapolated MRLs result in the Theoretical Maximum Daily Intake (TMDI) not exceeding the Acceptable Daily Intake (ADI);\n(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;\n(g)in case of extrapolations between different food commodities, an unused portion of the ADI is available to accommodate the additional food item.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Arts. 4-7 substituted (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 9(4); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2017/880/article/4",
    "retrieved_at": "2026-11-01T14:44:54.852676+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}