EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/12039/2014 (POOL/E4/2014/12039/12039-EN.doc) […](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
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) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
refusing to authorise certain he alth 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) 
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 foods
1, and in 
particular Article 18(5) 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 al so 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 Eu ropean Food Safety Authority (EFSA ), hereinafter referred to as 
'the Authority', for a scientific assessment, as well as to the Commission and the Member States for information.  
(3) The Authority is to deliver an opini on on the health claim concerned.  
(4) The Commission is to decide on the authoris ation of health claims taking into account 
the opinion delivered by the Authority. 
(5) Following an application from Biocodex, submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006 a nd including a request for protection of proprietary 
data, the Authority was require d to deliver an opinion on a health claim related to the 
effect of citrulline-malate and faster recovery from muscle fatigue after exercise 
(Question No EFSA-Q-2013-00659
2). The claim proposed by the applicant was 
worded as follows: “Maintenance of ATP levels through reduction of lactates in 
excess for an improved recovery from muscle fatigue”. 
(6) On 5 May 2014, the Commission and the Memb er States received the scientific 
opinion from the Authority, which concluded that a health claim on citrulline-malate 
and faster recovery from musc le fatigue after exercise pu rsuant to Article 13(5) of 
Regulation (EC) No 1924/2006 had already be en assessed by the Authority with an 
unfavourable outcome (Question No EFSA-Q-2011-009313). The additional 
information submitted by the applicant, in the context of Question No EFSA-Q-2013-
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2014;12(5):3650. 
3 EFSA Journal 2012;10(5):2699.  
EN 3   EN 00659, did not provide evidence that could be us ed for the scientific substantiation of 
the claim. 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 Comvita New Zealand Limited, submitted pursuant to 
Article 13(5) of Regulation (EC) No 1924/ 2006 and including a re quest for protection 
of proprietary data, the Authority was requi red to deliver an opinion on a health claim 
related to the effect of olive ( Olea europaea  L.) leaf water extract and increase in 
glucose tolerance (Que stion No EFSA-Q-2013-00783
4). The claim proposed by the 
applicant was worded as follows: “Daily in take of supplemental olive leaf extract 
polyphenols contributes to th e reduction of the blood glucose rise after meals”. 
(8) On 5 May 2014, the Commission and the Memb er States received the scientific 
opinion from the Authority, whic h concluded that on the basi s of the data presented, 
the scientific evidence is insufficient to establish a cause and effect relationship 
between the consumption of olive leaf water extract and increase in  glucose tolerance. 
Accordingly, as the claim does not comply with the requirements of Regulation (EC) 
No 1924/2006, it should not be authorised. 
(9) Following an application from Naturex SA, submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006 a nd including a request for protection of proprietary 
data, the Authority was require d to deliver an opinion on a health claim related to the 
effect of Pacran® and defence against bacterial pat hogens in the lower urinary tract 
(Question No EFSA-Q-2013-008895). The claim proposed by the applicant was 
worded as follows: “Pacran® helps to inhibit the adhesion of  P-fimbriated E. coli to the 
urinary tract cells”. 
(10) On 5 May 2014, the Commission and the Memb er States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of 
Pacran® and defence against bacterial pat hogens in the lower urinary tract. 
Accordingly, as the claim does not comply with the requirements of Regulation (EC) 
No 1924/2006, it should not be authorised. 
(11) Following an application from PiLeJe, s ubmitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006 a nd including a request for protection of proprietary 
data, the Authority was require d to deliver an opinion on a health claim related to the 
effect of a combination of Bifidobacterium longum LA 101, Lactobacillus helveticus 
LA 102, Lactococcus lactis LA 103 and Streptococcus thermophilus LA 104 and 
reducing intestinal discomfort  (Question No EFSA-Q-2013-008926). The claim 
proposed by the applicant was worded, inter alia , as follows: “improves intestinal 
comfort”. 
(12) On 5 May 2014, the Commission and the Memb er States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of a 
combination of Bifidobacterium longum LA 101, Lactobacillus helveticus LA 102, 
Lactococcus lactis LA 103 and Streptococcus thermophilus LA 104 and reducing 
gastro-intestinal discomfort. Accordingly, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
                                                 
4 EFSA Journal 2014;12(5):3655. 
5 EFSA Journal 2014;12(5):3656. 
6 EFSA Journal 2014;12(5):3658.  
EN 4   EN (13) Following an application from PiLeJe, s ubmitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006 a nd including a request for protection of proprietary 
data, the Authority was require d to deliver an opinion on a health claim related to the 
effect of a combination of Bifidobacterium longum LA 101, Lactobacillus helveticus 
LA 102, Lactococcus lactis LA 103 and Streptococcus thermophilus LA 104 and 
improvement of bowel function by increasi ng stool frequency (Question No EFSA-Q-
2013-008937). The claim proposed by the applicant was worded, inter alia , as follows: 
“regulates your (intestinal) transit”. 
(14) On 5 May 2014, the Commission and the Memb er States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of a 
combination of Bifidobacterium longum LA 101, Lactobacillus helveticus LA 102, 
Lactococcus lactis LA 103 and Streptococcus thermophilus LA 104 and improvement 
of bowel function by increas ing stool frequency. Accordin gly, as the claim does not 
comply with the requirements of Regul ation (EC) No 1924/2006, it should not be 
authorised. 
(15) Following an application from DoubleGood AB, submitted pursuant to Article 13(5) 
of Regulation (EC) No 1924/2006 and including a request for protection of proprietary 
data, the Authority was require d to deliver an opinion on a health claim related to the 
effect of a combination of L- threonine, L-valine, L-leucine,  L-isoleucine, L-lysine plus 
chromium picolinate and reduction of post-pr andial glycaemic responses (Question No 
EFSA-Q-2013-007568). The claim proposed by the applicant was worded as follows: 
“Contributes to the reduction of  the blood glucose rise when consumed together with a 
carbohydrate rich meal”. 
(16) On 16 July 2014, the Commission and the Member States received the scientific 
opinion from the Authority, in which it was st ated that the applicant did not provide 
any evidence that a reduction in post-pra ndial blood glucose responses achieved by an 
increase in insulin secretion is a benefici al physiological eff ect. Consequently, the 
Authority concluded that, on the basis of the data pres ented, a cause and effect 
relationship had not been established between the consumption of the food, a 
combination of L-threonine, L-valine, L- leucine, L-isoleucine, L-lysine plus 
chromium picolinate, which is the subject of the health claim, and a beneficial 
physiological effect. Accordingly, as the clai m does not comply with the requirements 
of Regulation (EC) No 1924/2006, it should not be authorised. 
(17) Following an application from DSM Nu tritional Products and Kemin Foods,  submitted 
pursuant to Article 13(5) of Regulation (E C) No 1924/2006 and including a request for 
protection of proprietary data , the Authority was required to deliver an opinion on a 
health claim related to the effect of a combination of lutein and zeaxanthin and improved vision under bright light c onditions (Question No EFSA-Q-2013-00875
9). 
The claim proposed by the applicant was word ed as follows: “Lutein together with 
zeaxanthin helps maintain clarity and contrast of sight in bright light conditions”. 
(18) On 16 July 2014, the Commission and the Member States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship had not been  established between the consumption of a 
combination of lutein and zeaxanthin and improved vision under bright light 
                                                 
7 EFSA Journal 2014;12(5):3659. 
8 EFSA Journal 2014;12(7):3752. 
9 EFSA Journal 2014;12(7):3753.  
EN 5   EN conditions. Accordingly, as the claim does not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be authorised. 
(19) The measures provided for in this Regulati on are in accordance with 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 in cluded in the Union list 
of permitted claims as provided for in Ar ticle 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, 
 For the Commission 
 […]  José Manuel BARROSO