Commission Regulation (EU) 2018/1555 of 17 October 2018 refusing to authorise certain health claims made on foods and referring to the reduction of disease risk (Text with EEA relevance.)

• CELEX: Regulation (EU) 2018/1555
• Articles: 3

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 .

Schedules & Appendices

ANNEX

ANNEX

Rejected health claims

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