{
  "url": "https://openlegislation.uk/eu-regulation-2019-1871/article-4",
  "json_url": "https://openlegislation.uk/eu-regulation-2019-1871/article-4.json",
  "legislation": "eur/2019/1871",
  "legislation_title": "Commission Regulation (EU) 2019/1871 of 7 November 2019 on reference points for action for non-allowed pharmacologically active substances present in food of animal origin and repealing Decision 2005/34/EC (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2019-1871",
  "path": "article/4",
  "kind": "article",
  "number": "4",
  "heading": "Substance-specific risk assessment",
  "text": "1. A request shall be addressed to the Food Standards Agency for a substance-specific risk assessment as to whether reference points for action are adequate to protect human health, in particular for substances:\n(a) that cause blood dyscrasias or allergy (excluding skin sensitisation);\n(b) that are high potency carcinogens;\n(c) for which genotoxicity cannot be excluded, if there is experimental or other evidence that the use of the toxicological screening value of 0,0025 μg/kg b.w. per day may not be adequately health protective.\n2. The Secretary of State shall, where appropriate, submit a request to the Food Standards Agency for a substance-specific risk assessment as to whether a reference point for action is adequate to protect human health, where application of the method laid down in Article 3(4) indicates that the toxicological screening value, divided by the relevant food intake, is lower than the analytical capability of the official control laboratories, and that there is little or no possibility of significant improvement in the analytical capability within a short to medium time frame.\n3. Where the substance specific risk assessment is inconclusive, due to uncertainties regarding certain aspects of the toxicological or exposure assessment, and no guarantees are available on whether the lowest analytically achievable concentration is sufficiently safe for consumers, the approved laboratories shall endeavour to improve the sensitivity of analytical methods in order to be able to enforce lower concentrations and the reference points for action shall be set at levels which are low enough to stimulate improvement of the lowest achievable levels.\n(4.) In paragraph 3, “approved laboratory” has the meaning given in—\n(a) as regards England and Scotland, regulation 2 of the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) (England and Scotland) Regulations 2015;\n(b) as regards Wales, regulation 2 of the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) (Wales) Regulations 2019.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Art. 4(1) substituted (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 7(4)(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Art. 4(2) substituted (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 7(4)(b)(i)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Art. 4(2) substituted (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 7(4)(b)(ii)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in Art. 4(3) substituted (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 7(4)(c)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Art. 4(4) inserted (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 7(4)(d)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2019/1871/article/4",
    "retrieved_at": "2026-11-01T14:43:02.342515+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."
}