{
  "url": "https://openlegislation.uk/eu-regulation-2011-234/article-9",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-234/article-9.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/9",
  "kind": "article",
  "number": "9",
  "heading": "Data required for risk management of food enzymes",
  "text": "1. The dossier submitted in support of an application shall include the information necessary to verify whether there is a reasonable technological need and whether the proposed use does not mislead the consumer within the meaning of points (b) and (c) of Article 6 of Regulation (EC) No 1332/2008.\n2. In order to ensure the verification referred to in paragraph 1, appropriate and sufficient information shall be provided on:\n(a) the identity of the food enzyme, including reference to the specifications;\n(b) the function and technological need, including a description of the typical process(es) in which the food enzyme may be applied;\n(c) the effect of the food enzyme on the final food;\n(d) why the use would not mislead the consumer;\n(e) the proposed normal and maximum use levels where applicable;\n(f) the dietary exposure assessment ... .",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Art. 9(2)(f) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 145; 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2011/234/article/9",
    "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."
}