{
  "url": "https://openlegislation.uk/eu-decision-2008-968/introduction",
  "json_url": "https://openlegislation.uk/eu-decision-2008-968/introduction.json",
  "legislation": "eudn/2008/968",
  "legislation_title": "Commission Decision of 12 December 2008 authorising the placing on the market of arachidonic acid-rich oil from Mortierella alpina as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2008) 8080) (Only the English text is authentic) (2008/968/EC)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2008-968",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Decision\nof 12 December 2008\nauthorising the placing on the market of arachidonic acid-rich oil from Mortierella alpina 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(2008) 8080)\n(Only the English text is authentic)\n(2008/968/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 18 June 1999 the company Abbott Laboratories (now Suntory Limited, Japan) made a request to the competent authorities of the Netherlands to place arachidonic acid-rich oil from Mortierella alpina on the market as a novel food ingredient.\n(2)\nOn 19 October 2005 the competent food assessment body of the Netherlands issued its initial assessment report. In that report it came to the conclusion that arachidonic acid-rich oil from Mortierella alpina can safely be used in infant formulae and formulae for premature infants.\n(3)\nThe Commission forwarded the initial assessment report to all Member States on 17 November 2005.\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 26 June 2007.\n(6)\nOn 10 July 2008 EFSA adopted the ‘Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to the safety of “fungal oil from Mortierella alpina”.’\n(7)\nIn the opinion the EFSA came to the conclusion that the fungal oil from Mortierella alpina is a safe source of arachidonic acid to be used in infant formulae and follow-on formulae.\n(8)\nAnnex I and Annex II to Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC specify the rules for the addition of long chain (20 and 22 carbon atoms) polyunsaturated fatty acids and in particular of arachidonic acid to infant formulae and follow-on formulae.\n(9)\nOn the basis of the scientific assessment, it is established that fungal oil from Mortierella alpina complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.\n(10)\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 401, 30.12.2006, p. 1."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2008/968/introduction",
    "retrieved_at": "2026-11-01T15:16:36.989795+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."
}