{
  "url": "https://openlegislation.uk/eu-regulation-2008-353/annex/division-3",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-353/annex/division-3.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/3",
  "kind": "division",
  "number": null,
  "heading": "FOOD CHARACTERISTICS",
  "text": "The following information shall be given with regard to the food constituent, the food or the food category for which the health claim is made.\n1.. For a food constituent:\n(a) the source and specifications, such as physical and chemical properties, composition; and\n(b) where applicable, the microbiological constituents of the food constituent.\n2.. For a food or category of food:\n(a) the description of the food or food category, including characterisation of the food matrix and the overall composition including the nutrient content of the food;\n(b) the source and specifications of the food or food category and, in particular, the content of the constituent(s) related to the health claim.\n3.. In all cases:\n(a) where applicable, the variability from batch to batch;\n(b) analytical methods applied;\n(c) where applicable, a summary of the studies undertaken on production conditions, batch-to-batch variability, analytical procedures, and of the results and conclusions of the stability studies, and the conclusions with respect to storage conditions and shelf-life;\n(d) where applicable, the relevant data and rationale that the constituent for which the health claim is made is in a form that is available to be used by the human body;\n(e) if absorption is not necessary to produce the claimed effect, such as for plant sterols, fibres, lactic acid bacteria, the relevant data and rationale that the constituent reaches the target site;\n(f) all available data on factors that could affect the absorption or utilisation in the body of the constituent for which the health claim is made.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Where appropriate internationally recognised specifications may be cited."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2008/353/annex/division/3",
    "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."
}