EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11491/2017 
(POOL/E1/2017/11491/11491 -EN.doc)  
[…](2017) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
refusing to authorise certain health claims made on foods and referring to the reduction 
of disease risk  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
refusing to authorise certain health claims made on foods and referring to the reduction 
of disease risk  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the 
Council of 20 December 2006 on nutrition and health  claims made on foods1, and in 
particular Article 17(3) thereof,  
Whereas:  
(1) Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are 
prohibited unless they are authorised by the Commission in accordance with that 
Regulation and included in a list of permitted claims.  
(2) Regulation (EC) No 1924/2006 also provides that applications for authorisations of 
health claims may be submitted by food business operators to the national competent 
authority of a Member State. The national competent authority is to forward valid 
applications to the European Food Safety Authority (EFSA), hereinafter referred to as 
'the Authority'.  
(3) Following receipt of an application , the Authority is to inform without delay the other 
Member States and the Commission thereof, and to deliver an opinion on the health 
claim concerned.  
(4) The Commission is to decide on the authorisation of health claims taking into account 
the opinion delivered by the Authority.  
(5) Following an application from Laboratoire Nurilia , submitted pursuant to Article 
14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an 
opinion on a health claim related to Condensyl® and decreases sperm DNA damage. 
High sperm DNA damage is a risk factor for male subfertility/ infertility  (Question No 
EFSA -Q-2016-00665 )2. The claim proposed by the applicant was  worded as follows: 
"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 Con densyl® 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 ". 
(6) On 5 May 2017 , the Commission and the Member States received the scientif ic 
opinion from the Authority, which concluded that on the basis of the data presented a  
cause and effect relationship has not been established between the consumption of 
                                                 
1 OJ L 404, 30.12.2006, p. 9.  
2 EFSA Journal 2017;15(5) :4775.   
EN 2  EN Condensyl® and the reductio n of sperm DNA damage in the context of reducing the 
risk of male infertility . Accordingly, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised.  
(7) Following an application from Cargill R&D Centre Eu rope, submitted pursuant to 
Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to 
deliver an opinion on a health claim related to sugar -free hard confectionery with at 
least 90% erythritol and reduction of dental plaque which redu ces the risk of caries  
(Question No EFSA -Q-2017-00002 )3. The claim proposed by the applicant was  
worded as follows: "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".  
(8) On 21 July 2017 , the Commission and the Member States received the scientif ic 
opinion from the Authority, which concluded that on the basis of the data presented a  
cause and effect relationship has not been established between the consumption of 
sugar -free hard confectionery with at least 90%  erythritol and reduction of dental 
plaque which reduces the risk of dental caries. Accordingly, as the claim does not 
comply with the requirements of Regula tion (EC) No 1924/2006, it should not be 
authorised.  
(9) Following an application from Biosearch Life , submitted pursuant to Article 14(1)(a) 
of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on 
a health claim related to Lactobacillus  fermentum CECT 5716 and decreases the 
Staphylococcus  load in breast milk. High Staphylococcus  load in breast milk is a risk 
factor for infectious mastitis  (Question No EFSA -Q-2016-00318 )4. The claim 
proposed by the applicant was  worded as fol lows: " 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 ". 
(10) On 24 July 2017 , the Commission and the Member States received th e scientif ic 
opinion from the Authority, which concluded that on the basis of the data presented a  
cause and effect relationship has not been established between the consumption  of 
Lactobacillus  fermentum  CECT 5716 and a reduction of the Staphylococcus  load in 
breast milk which reduces the risk of infectious mastitis.  Accordingly, as the claim 
does not comply with the requirements of Regulation (EC) No 1924/2006, it should 
not be authorised.  
(11) The measures provided for in this Regulation are in accordance wit h the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
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 Articl e 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 . 
                                                 
3 EFSA Journal 2017;15(7):4923.  
4 EFSA Journal  2017;15(7) :4917.   
EN 3  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER