{
  "url": "https://openlegislation.uk/eu-decision-2013-49/introduction",
  "json_url": "https://openlegislation.uk/eu-decision-2013-49/introduction.json",
  "legislation": "eudn/2013/49",
  "legislation_title": "Commission Implementing Decision of 22 January 2013 authorising the placing on the market of synthetic zeaxanthin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2013) 110) (Only the Dutch text is authentic) (2013/49/EU)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2013-49",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Implementing Decision\nof 22 January 2013\nauthorising the placing on the market of synthetic zeaxanthin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council\n(notified under document C(2013) 110)\n(Only the Dutch text is authentic)\n(2013/49/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 1 June 2004, the company DSM Nutritional Products VML made a request to the competent authorities of the Netherlands to place synthetic zeaxanthin on the market as a novel food ingredient.\n(2)\nOn 16 June 2005 the competent food assessment body of the Netherlands issued its initial assessment report. In that report it came to the conclusion that synthetic zeaxanthin with a maximum intake for not more than 20 mg per person per day, would not present a significant risk for human health. However, it concluded that the data presented were not sufficient to complete the safety assessment.\n(3)\nTherefore an additional assessment was required.\n(4)\nThe Commission forwarded the initial assessment report to all Member States on 1 August 2005 for additional comments.\n(5)\nOn 2 February 2007 the applicant informed the Commission that the use of zeaxanthin should be limited to be used only as an ingredient in food supplements.\n(6)\nThe Commission consulted the European Food Safety Authority (EFSA) on 20 March 2007.\n(7)\nOn 24 April 2008 the EFSA adopted a Scientific Opinion on the safety of ‘synthetic zeaxanthin as an ingredient in food supplements’ concluding that based on the existing data, the safety of synthetic zeaxanthin as an ingredient in food supplements at the proposed level of 20 mg per person per day has not been established.\n(8)\nOn 25 January 2012 the applicant provided additional information and proposed an intake of synthetic zeaxanthin as an ingredient in food supplements of up to 2 mg per person per day.\n(9)\nFollowing a request from the Commission, EFSA was asked to update its opinion on the safety of synthetic zeaxanthin as a novel food ingredient in food supplements in the light of the additional information. On 13 September 2012, EFSA adopted a ‘Statement on the safety of synthetic zeaxanthin as an ingredient in food supplements’ concluding that the use level proposed by the applicant does not raise safety concerns.\n(10)\nOn the basis of the scientific assessment, it is established that synthetic zeaxanthin complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.\n(11)\nThe intentional addition of synthetic zeaxanthin to food for colouring purposes falls within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives and should be authorised in accordance with that Regulation.\n(12)\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": "EFSA Journal (2008) 728, 1-27."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "EFSA Journal 2012: 10(10):2891."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "OJ L 354, 31.12.2008, p. 16."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2013/49/introduction",
    "retrieved_at": "2026-11-01T15:15:11.612812+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."
}