{
  "url": "https://openlegislation.uk/eu-regulation-2019-651/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2019-651/introduction.json",
  "legislation": "eur/2019/651",
  "legislation_title": "Commission Regulation (EU) 2019/651 of 24 April 2019 refusing to authorise a health claim made on foods and referring to children's development and health (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2019-651",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EU) 2019/651\nof 24 April 2019\nrefusing to authorise a health claim made on foods and referring 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 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 are 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 H.J. Heinz Supply Chain Europe B.V., submitted pursuant to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to ‘Nutrimune®’ and immune defence against pathogens in the gastrointestinal tract and upper respiratory tract (Question No EFSA-Q-2016-00008). The claim proposed by the applicant was worded as follows: ‘“Nutrimune®” supports the immune defence in the gastrointestinal and upper respiratory tract of young children’.\n(6)\nOn 30 January 2017, the Commission and the Member States received the scientific opinion from the Authority, which concluded that on the basis of the data presented, the scientific evidence is insufficient to establish a cause and effect relationship between the consumption of ‘Nutrimune®’ (a pasteurised cow's skim milk fermented with Lactobacillus paracasei CBA L74) and the immune defence against pathogens in the gastrointestinal and upper respiratory tracts. 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 out 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 2017;15(1):4679."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2019/651/introduction",
    "retrieved_at": "2026-11-01T14:43:27.567429+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."
}