{
  "url": "https://openlegislation.uk/eu-decision-2009-348/introduction",
  "json_url": "https://openlegislation.uk/eu-decision-2009-348/introduction.json",
  "legislation": "eudn/2009/348",
  "legislation_title": "Commission Decision of 23 April 2009 authorising the placing on the market of lycopene as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2009) 2975) (Only the German text is authentic) (2009/348/EC)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2009-348",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Decision\nof 23 April 2009\nauthorising the placing on the market of lycopene as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council\n(notified under document number C(2009) 2975)\n(Only the German text is authentic)\n(2009/348/EC)\nTHE COMMISSION OF THE EUROPEAN COMMUNITIES,\nHaving regard to the Treaty establishing the European Community,\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 12 October 2005 the company BASF made a request to the competent authorities of the Netherlands to place synthetic lycopene on the market as a novel food ingredient; on 19 October 2006 the competent food assessment body of the Netherlands issued its initial assessment report. In that report it came to the conclusion that lycopene is acceptable to be used in the proposed range of foodstuffs.\n(2)\nThe Commission forwarded the initial assessment report to all Member States on 10 November 2006.\n(3)\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; therefore the European Food Safety Authority (EFSA) was consulted on 13 June 2007 and issued its opinion on 10 April 2008.\n(4)\nIn that opinion the EFSA came to the conclusion that the lycopene may be safely used as a food ingredient for the proposed uses. However, EFSA concluded that the consumption of lycopene by the average user will stay below the acceptable daily intake (ADI), but that some users of lycopene may exceed the ADI. Therefore, it appears appropriate to establish a list of foods acceptable for the addition of lycopene.\n(5)\nOn 4 December 2008 EFSA adopted the ‘Scientific Opinion of the Scientific Panel on dietetic products, nutrition and allergies on a request from the Commission related to the safety of lycopene from Blakeslea trispora cold water dispersion (CWD).’ This opinion came to the conclusions that lycopene preparations intended for use in foods and food supplements are formulated as suspensions in edible oils, direct compressible or water-dispersible powders. As lycopene may undergo oxidative changes in such formulations, sufficient antioxidative protection should be ascertained.\n(6)\nIt also appears appropriate to collect intake data for a number of years following the authorisation in order to review this authorisation in the light of any further information on the safety of lycopene and its consumption. Particular attention should be given to the collection of data regarding the levels of lycopene in breakfast cereals. However, this requirement under the present Decision, applies to the use of lycopene as a novel food ingredient and not to the use of lycopene as a food colour, that falls within the scope of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption.\n(7)\nOn the basis of the scientific assessment, it is established that the synthetic lycopene complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.\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": "OJ L 40, 11.2.1989, p. 27."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2009/348/introduction",
    "retrieved_at": "2026-11-01T15:16:30.841792+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."
}