{
  "url": "https://openlegislation.uk/eu-regulation-2016-372/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2016-372/introduction.json",
  "legislation": "eur/2016/372",
  "legislation_title": "Commission Regulation (EU) 2016/372 of 15 March 2016 refusing to authorise a health claim made on foods and referring to the reduction of disease risk (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2016-372",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EU) 2016/372\nof 15 March 2016\nrefusing to authorise a health claim made on foods and referring to the reduction of disease risk\n(Text with EEA relevance)\nTHE EUROPEAN COMMISSION,\nHaving regard to the Treaty on the Functioning of the European Union,\nHaving regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, and in particular Article 17(3) thereof,\nWhereas:\n(1)\nPursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.\n(2)\nRegulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’.\n(3)\nFollowing receipt of an application the Authority is to inform without delay the other Member States and the Commission thereof, and to deliver an opinion on the health claim concerned.\n(4)\nThe Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.\n(5)\nFollowing an application from Lycotec Ltd, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to L-tug lycopene and reduction of blood low-density lipoprotein (LDL)-cholesterol (Question No EFSA-Q-2014-00590). The claim proposed by the applicant was worded as follows: ‘L-tug lycopene has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease’.\n(6)\nOn 26 February 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that on the basis of the data presented, a cause and effect relationship had not been established between the consumption of L-tug lycopene and reduction of blood LDL-cholesterol concentrations. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.\n(7)\nThe measure provided for in this Regulation is in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,\nHAS ADOPTED THIS REGULATION:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 404, 30.12.2006, p. 9."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "EFSA Journal 2015;13(2):4025."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2016/372/introduction",
    "retrieved_at": "2026-11-01T14:45:59.498367+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."
}