{
  "url": "https://openlegislation.uk/eu-decision-2011-497/introduction",
  "json_url": "https://openlegislation.uk/eu-decision-2011-497/introduction.json",
  "legislation": "eudn/2011/497",
  "legislation_title": "Commission Implementing Decision of 9 August 2011 authorising the placing on the market of fermented black bean extract as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2011) 5645) (Only the English text is authentic) (2011/497/EU)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2011-497",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Implementing Decision\nof 9 August 2011\nauthorising the placing on the market of fermented black bean extract as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council\n(notified under document C(2011) 5645)\n(Only the English text is authentic)\n(2011/497/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 8 July 2008 the company Cantox Health Sciences International on behalf of CBC Co. Ltd (Japan) made a request to the competent authorities of United Kingdom to place fermented black bean extract on the market as a novel food ingredient for use in food supplements.\n(2)\nOn 28 January 2009 the competent food assessment body of United Kingdom issued its initial assessment report. In that report it came to the conclusion that fermented black bean extract was acceptable as a novel food ingredient provided that the product specifications and use levels are maintained.\n(3)\nThe Commission forwarded the initial assessment report to all Member States on 5 February 2009.\n(4)\nWithin the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections to the marketing of the product were raised in accordance with that provision.\n(5)\nTherefore the European Food Safety Authority (EFSA) was consulted on 19 August 2009.\n(6)\nOn 8 April 2011, EFSA in the ‘Scientific Opinion on the safety of a “fermented black bean extract” (Touchi) as a Novel Food ingredient’ came to the conclusion that fermented black bean extract was safe under the proposed use and conditions of use.\n(7)\nOn the basis of the scientific assessment, it is established that fermented black bean extract complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97, without prejudice to the specific provisions of 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 to 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 certain other substances to foods.\n(8)\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 2011; 9(5):2136. [20 pp.]"
    },
    {
      "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/2011/497/introduction",
    "retrieved_at": "2026-11-01T15:15:42.503164+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."
}