{
  "url": "https://openlegislation.uk/eu-regulation-2016-1411/annex",
  "json_url": "https://openlegislation.uk/eu-regulation-2016-1411/annex.json",
  "legislation": "eur/2016/1411",
  "legislation_title": "Commission Regulation (EU) 2016/1411 of 24 August 2016 refusing to authorise certain health claims 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-2016-1411",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": "Rejected health claims",
  "text": "Application — Relevant provisions of Regulation (EC) No 1924/2006\nNutrient, substance, food or food category\nClaim\nEFSA opinion reference\nArticle 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data\nCaffeine\nCaffeine helps to increase alertness *\n* For intakes of caffeine between 40 mg per serving and 75 mg per serving.\nQ-2013-00399\nArticle 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data\nClarinol® and Tonalin®\nThe consumption of Clarinol® or Tonalin® contributes to a reduction in body fat mass.\nQ-2014-00580\nArticle 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data\nSYNBIO®\nSYNBIO® persists in the intestinal tract and favours the natural regularity contributing to maintain and improve human intestinal well-being'.\nQ-2014-00567\nArticle 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data\nFRUIT UP®\nFRUIT UP® reduces post-prandial blood glucose responses compared to high-glycaemic carbohydrates.\nQ-2014-00405\nArticle 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data\nA combination of pomegranate pomace extract and greater galangal rhizome powder\nA combination of standardised pomegranate pomace extract and greater galangal rhizome powder increases the number of motile spermatozoa in semen.\nQ-2014-00566\nArticle 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data\nBifidobacterium bifidum CNCM I-3426\nBifidobacterium bifidum CNCM I-3426 increases the proportion of healthy days by maintaining normal immune function in healthy adults during everyday life events such as moderate stress.\nQ-2014-00673\nArticle 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data\nCoffee C21 (coffee standardised by its content of caffeoylquinic acids, trigonelline andN-methylpyridinium)\nRegular consumption of coffee C21 contributes to the maintenance of DNA integrity in cells of the body.\nQ-2014-00624",
  "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/2016/1411/annex",
    "retrieved_at": "2026-11-01T14:45:36.659294+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."
}