{
  "url": "https://openlegislation.uk/eu-regulation-2011-234/article-10",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-234/article-10.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/10",
  "kind": "article",
  "number": "10",
  "heading": "Specific data required for risk assessment of flavourings",
  "text": "1. In addition to data to be provided pursuant to Article 5, information shall be provided on:\n(a) the manufacturing process;\n(b) specifications;\n(c) where applicable, information on particle size, particle size distribution and other physicochemical characteristics;\n(d) where applicable the existing authorisations and evaluations;\n(e) the proposed uses in food and proposed normal and maximum use levels in ... categories ... or in a more specified type of product within the categories;\n(f) the data on dietary sources;\n(g) the dietary exposure assessment;\n(h) the biological and toxicological data.\n2. As regards to the biological and toxicological data, referred to in point (h) of paragraph 1, the following core areas shall be covered:\n(a) examination for structural/metabolic similarity to flavouring substances in an existing flavouring group evaluation (FGE);\n(b) genotoxicity;\n(c) subchronic toxicity, where applicable;\n(d) developmental toxicity, where applicable;\n(e) chronic toxicity and carcinogenicity data, where applicable.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in Art. 10(1)(e) 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(5)(a) (with reg. 23)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Art. 10(1)(e) 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(5)(b) (with reg. 23)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2011/234/article/10",
    "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."
}