{
  "url": "https://openlegislation.uk/eu-decision-2010-331/introduction",
  "json_url": "https://openlegislation.uk/eu-decision-2010-331/introduction.json",
  "legislation": "eudn/2010/331",
  "legislation_title": "Commission Decision of 14 June 2010 authorising the placing on the market of Ferric Sodium EDTA as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2010) 3729) (Only the German text is authentic) (2010/331/EU)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2010-331",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Decision\nof 14 June 2010\nauthorising the placing on the market of Ferric Sodium EDTA as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council\n(notified under document C(2010) 3729)\n(Only the German text is authentic)\n(2010/331/EU)\nTHE EUROPEAN COMMISSION,\nHaving regard to the Treaty on the Functioning of the European Union,\nHaving regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, and in particular Article 7 thereof,\nWhereas:\n(1)\nOn 4 September 2006 the company Akzo Nobel Chemicals GmbH made a request to the competent authorities of the United Kingdom to place Ferric Sodium EDTA on the market as a novel food ingredient.\n(2)\nOn 11 September 2006 the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that an additional assessment was required.\n(3)\nThe Commission informed all Member States about the request on 27 November 2006. EFSA was requested to carry out the assessment on 22 December 2006.\n(4)\nOn 26 November 2009 following a request from the Commission, the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted an opinion on the safety of Ferric Sodium EDTA. In the opinion EFSA concluded that EDTA is of no safety concern as long as the intake of EDTA does not exceed 1,9 mg EDTA per kg bodyweight per day.\n(5)\nCommission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses, Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements and/or Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods lay down specific provision for the use of vitamins, minerals and other substances in food. The use of Ferric Sodium EDTA should be authorised without prejudice to the requirements of this legislation. The limits set in Annex II of this Decision relate exclusively to EDTA as such and are without prejudice to any limits for the addition of iron to foods. On the basis of the scientific assessment it is established that Ferric Sodium EDTA complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.\n(6)\nIn order to ensure that children will not exceed the Acceptable Daily Intake (ADI) of EDTA it appears appropriate to set limits for the addition of EDTA to foods.\n(7)\nThe measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,\nHAS ADOPTED THIS DECISION:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 43, 14.2.1997, p. 1."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ L 269, 14.10.2009, p. 9."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "OJ L 183, 12.7.2002, p. 51."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "OJ L 404, 30.12.2006, p. 26."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2010/331/introduction",
    "retrieved_at": "2026-11-01T15:16:06.260476+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."
}