
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 14(1) 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, 17 October 2018.
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 14(1)(a) health claim referring to a reduction of a disease risk. Condensyl® The combination of opuntia fruit dry extract standardised in quercetin and betalain, N-acetyl cysteine, zinc, vitamin B3, E, B6, B2, B9 and B12 in Condensyl® decreases sperm DNA damage (sperm nuclear decondensation index and DNA fragmentation index). High sperm DNA damage (sperm nuclear decondensation index and DNA fragmentation index) is a risk factor for male subfertility/infertility. Q-2016-00665
Article 14(1)(a) health claim referring to a reduction of a disease risk. Sugar-free hard confectionery with at least 90 % erythritol Sugar-free hard confectionery sweetened with at least 90 % Zerose® erythritol has been shown to reduce dental plaque. High content/level of dental plaque is a risk factor in the development of caries. Q-2017-00002
Article 14(1)(a) health claim referring to a reduction of a disease risk. Lactobacillus fermentum CECT 5716 Lactobacillus fermentum CECT 5716 decreases the Staphylococcus load in breast milk. High Staphylococcus load in breast milk is a risk factor for mammary bacterial dysbiosis/mastitis. Q-2016-00318