
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 24 August 2016.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

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 andN-methylpyridinium) Regular consumption of coffee C21 contributes to the maintenance of DNA integrity in cells of the body. Q-2014-00624