{
  "url": "https://openlegislation.uk/eu-regulation-2011-234/article-6",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-234/article-6.json",
  "legislation": "eur/2011/234",
  "legislation_title": "Commission Regulation (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2011-234",
  "path": "article/6",
  "kind": "article",
  "number": "6",
  "heading": "Specific data required for risk assessment of food additives",
  "text": "1. In addition to data to be provided pursuant to Article 5, information shall be provided on:\n(a) the identity and characterisation of the additive, including the proposed specifications and analytical data;\n(b) where applicable, the particle size, particle size distribution and other physicochemical characteristics;\n(c) the manufacturing process;\n(d) presence of impurities;\n(e) the stability, reaction and fate in foods to which the additive is added;\n(f) where applicable, the existing authorisations and risk assessments;\n(g) proposed normal and maximum use levels in ... food categories ..., or in a newly proposed food category, or in a more specific foodstuff belonging to one of these categories;\n(h) a dietary exposure assessment;\n(i) the biological and toxicological data.\n2. As regards to the biological and toxicological data, referred to in point (i) of paragraph 1, the following core areas shall be covered:\n(a) toxicokinetics;\n(b) subchronic toxicity;\n(c) genotoxicity;\n(d) chronic toxicity/carcinogenicity;\n(e) reproductive and developmental toxicity.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in Art. 6(1)(g) omiited (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 10(3)(a) (with reg. 23)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Art. 6(1)(g) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 10(3)(b) (with reg. 23)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2011/234/article/6",
    "retrieved_at": "2026-11-01T14:50:16.215738+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."
}