{
  "url": "https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.6/division-II.6.1/division-II.6.1.3",
  "json_url": "https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.6/division-II.6.1/division-II.6.1.3.json",
  "legislation": "eur/2018/782",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2018-782",
  "path": "annex/I/division/II/division/II.6/division/II.6.1/division/II.6.1.3",
  "kind": "division",
  "number": "II.6.1.3",
  "heading": null,
  "text": "Studies relevant to the establishment of a pharmacological ADI shall identify or characterise the mode of action, the dose-response relationship and identify a NOEL or BMDL, where possible and shall be used as a starting point from which a pharmacological ADI is derived. Where appropriate data are available from studies in humans (e.g. for substances with a history of use in human medicine) these shall usually be the most useful in identifying a pharmacological NOEL or BMDL. Guidance published by the appropriate authority on the establishment of pharmacological ADI shall be followed.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Annex 1 para. 2(6) 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), 10(4)(g); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "Approach to establish a pharmacological acceptable daily intake (ADI) (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001530.jsp&mid=)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2018/782/annex/I/division/II/division/II.6/division/II.6.1/division/II.6.1.3",
    "retrieved_at": "2026-11-01T14:44:06.594245+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."
}