{
  "url": "https://openlegislation.uk/eu-regulation-2018-199/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2018-199/introduction.json",
  "legislation": "eur/2018/199",
  "legislation_title": "Commission Regulation (EU) 2018/199 of 9 February 2018 refusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children's development and health (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2018-199",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EU) 2018/199\nof 9 February 2018\nrefusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children's development and health\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 18(5) 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’, for a scientific assessment, as well as to the Commission and the Member States for information.\n(3)\nThe Authority is 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 Probi AB, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Lactobacillus plantarum 299v (Lp299v) and an increase of non-haem iron absorption (Question No EFSA- Q-2015-00696). The claim proposed by the applicant was worded as follows: ‘Lactobacillus plantarum 299v increases non-haem iron absorption’.\n(6)\nOn 25 July 2016, the Commission and the Member States received the scientific opinion from the Authority, which concluded that the evidence provided was insufficient to establish a cause and effect relationship between the consumption of Lp299v and an increase of non-haem iron absorption. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.\n(7)\nThe comments from the applicant received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the measures provided for in this Regulation.\n(8)\nThe measures provided for in this Regulation are 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 2016;14(7):4550."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2018/199/introduction",
    "retrieved_at": "2026-11-01T14:44:16.801873+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."
}