{
  "url": "https://openlegislation.uk/eu-regulation-2008-353/annex/division-2/division-1",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-353/annex/division-2/division-1.json",
  "legislation": "eur/2008/353",
  "legislation_title": "Commission Regulation (EC) No 353/2008 of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2008-353",
  "path": "annex/division/2/division/1",
  "kind": "division",
  "number": "1",
  "heading": null,
  "text": "The application shall contain all scientific data, published and unpublished, in favour and not in favour that are pertinent to the health claim, together with a comprehensive review of the data from human studies in order to demonstrate that the health claim is substantiated by the totality of the scientific data and by weighing the evidence. Data from studies in humans addressing the relationship between consumption of the food and the claimed effect is required for substantiation of a health claim.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2008/353/annex/division/2/division/1",
    "retrieved_at": "2026-11-01T14:52:19.245945+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."
}