{
  "url": "https://openlegislation.uk/eu-regulation-2003-2160/article-12",
  "json_url": "https://openlegislation.uk/eu-regulation-2003-2160/article-12.json",
  "legislation": "eur/2003/2160",
  "legislation_title": "Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2003-2160",
  "path": "article/12",
  "kind": "article",
  "number": "12",
  "heading": "Approval of laboratories, quality requirements and approved testing methods",
  "text": "1. Laboratories participating in control programmes pursuant to Articles 5 and 7 shall, for the purposes of analysing samples to test for the presence of zoonoses and zoonotic agents referred to in Annex I, column 1:\n(a) be designated by the competent authority; and\n(b) apply quality assurance systems that conform to the requirements of the current ISO standard at the latest ... within 24 months of the addition of new zoonoses or zoonotic agents to Annex I, column 1.\n2. Laboratories shall regularly participate in collaborative testing organised or coordinated by the ... reference laboratory.\n3. Subject to paragraph 4, testing for the presence of zoonoses and zoonotic agents referred to in Annex I, column 1, shall be carried out using the methods and protocols recommended by international standardisation bodies, as reference methods.\nAlternative methods may be used if they have been validated in accordance with internationally recognised rules and offer equivalent results to those obtained by the relevant reference method.\n...\n(4.) Where in the opinion of the appropriate authority it is necessary to do so, the appropriate authority may, by regulations, approve other methods for testing.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in Art. 12(1)(b) substituted (31.12.2020) by The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 3(15)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Art. 12(1)(b) omitted (31.12.2020) by virtue of The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 3(15)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Word in Art. 12(2) omitted (31.12.2020) by virtue of The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 3(15)(b); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in Art. 12(3) inserted (31.12.2020) by The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 3(15)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in Art. 12(3) omitted (31.12.2020) by virtue of The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 3(15)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Art. 12(4) inserted (31.12.2020) by The Zoonotic Disease Eradication and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/740), regs. 1, 3(15)(d); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2003/2160/article/12",
    "retrieved_at": "2026-11-01T14:55:49.335446+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."
}