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)

Regulation (EU) 2016/1411 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

The health claims listed in the Annex to this Regulation shall not be included in the Union list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Supplementary provisions

ANNEXSupplementary provisions

ANNEX Rejected health claims Application — Relevant provisions of Regulation (EC) No 1924/2006 Nutrient, substance, food or food category Claim EFSA opinion reference Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data Caffeine Caffeine helps to increase alertness * * For intakes of caffeine between 40 mg per serving and 75 mg per serving. Q-2013-00399 Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data Clarinol® and Tonalin® The consumption of Clarinol® or Tonalin® contributes to a reduction in body fat mass. Q-2014-00580 Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data SYNBIO® SYNBIO® persists in the intestinal tract and favours the natural regularity contributing to maintain and improve human intestinal well-being'. Q-2014-00567 Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data FRUIT UP® FRUIT UP® reduces post-prandial blood glucose responses compared to high-glycaemic carbohydrates. Q-2014-00405 Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data A combination of pomegranate pomace extract and greater galangal rhizome powder A combination of standardised pomegranate pomace extract and greater galangal rhizome powder increases the number of motile spermatozoa in semen. Q-2014-00566 Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data Bifidobacterium bifidum CNCM I-3426 Bifidobacterium 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. Q-2014-00673 Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data Coffee C21 (coffee standardised by its content of caffeoylquinic acids, trigonelline and N -methylpyridinium) Regular consumption of coffee C21 contributes to the maintenance of DNA integrity in cells of the body. Q-2014-00624

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