{
  "url": "https://openlegislation.uk/eu-regulation-2013-503/article-4",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-503/article-4.json",
  "legislation": "eur/2013/503",
  "legislation_title": "Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2013-503",
  "path": "article/4",
  "kind": "article",
  "number": "4",
  "heading": "Requirements for the performance of studies for applications submitted under Articles 5(3) and 17(3)",
  "text": "1. Toxicological studies shall be conducted in facilities which comply with the:\n(a) requirements of Directive 2004/10/EC; or\n(b) ‘OECD Principles on Good Laboratory Practice’ (GLP), if carried out outside Great Britain.\nThe applicant shall provide evidence to demonstrate such compliance.\n2. Studies, other than toxicological studies, shall:\n(a) comply with the principles of Good Laboratory Practice (GLP) laid down in Directive 2004/10/EC; or\n(b) be conducted by organisations accredited under the relevant ISO standard.\n3. Information on the study protocols and the results obtained from the studies referred to in paragraphs 1 and 2 shall be comprehensive and include the raw data in an electronic format, suitable for carrying out statistical or other analysis.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Art. 4(1)(b) substituted (31.12.2020) by by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 49 (as substituted by S.I. 2020/1504, regs. 1(2), 17(9)); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/503/article/4",
    "retrieved_at": "2026-11-01T14:48:39.117159+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."
}