{
  "url": "https://openlegislation.uk/eu-regulation-2012-307/article-4",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-307/article-4.json",
  "legislation": "eur/2012/307",
  "legislation_title": "Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2012-307",
  "path": "article/4",
  "kind": "article",
  "number": "4",
  "heading": "Evidence required for the purposes of advice by an expert committee under Article 8 of Regulation 1925/2006",
  "text": "1. In preparing advice for the purpose of Article 8 of Regulation (EC) No 1925/2006, the Committee shall consider the available and relevant generally accepted scientific evidence demonstrating that the conditions specified in Article 8(1) of Regulation (EC) No 1925/2006 are met , including:\n(a) Evidence demonstrating the addition of the substance to food or use of the substance in the manufacture of food.\nSuch evidence shall include information on the current placing on the market of food products containing the substance as referred to in paragraph 1 of Article 3 of this Regulation.\n(b) In cases referred to in Article 3(2)(a), evidence demonstrating that intake of the substance greatly exceeds normal conditions of consumption of a balanced and varied diet, as assessed in accordance with Article 3(3).\nSuch evidence shall include scientific data that represents actual dietary intake of the substance obtained from the most recently available dietary intake surveys or food consumption surveys. The inclusion of foods to which the substance has been added and/or food supplements containing the substance may be taken into account. ...\n(c) Evidence demonstrating a potential risk to consumers from consumption of the substance.\nThis evidence shall consist of relevant scientific data including unpublished validated reports, scientific opinions by a public risk assessment body or independent and peer-reviewed articles. A summary of the scientific data and the list of references of the scientific data shall be provided.\n2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n3. Where an expert committee is asked to provide advice for the purposes of Article 8 of Regulation (EC) No 1925/2006, it shall make public the evidence referred to in paragraph 1.\n4. ... The expert committee shall adopt a scientific opinion within a specified time limit as laid down by Article 29(3) of Regulation (EC) No 178/2002.\n5. Interested parties may submit comments to the appropriate authority within 30 days from the publication by the expert committee of its opinion , except in cases of urgency.",
  "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 Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Art. 4(1) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Art. 4(1)(b) omitted (31.12.2020) by virtue of The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Art. 4(2) omitted (31.12.2020) by virtue of The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(c); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Art. 4(3) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(d); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Words in Art. 4(4) omitted (31.12.2020) by virtue of The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(e)(i); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Words in Art. 4(4) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Words in Art. 4(5) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(f)(i); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Words in Art. 4(5) substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(f)(ii); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F10",
      "text": "Words in Art. 4(5) inserted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(f)(iii); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F11",
      "text": "Art. 4 heading substituted (31.12.2020) by The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651), regs. 1(1), 43(4)(a); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2012/307/article/4",
    "retrieved_at": "2026-11-01T14:49:29.497913+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."
}