EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/11586/2013 (POOL/E4/2013/11586/11586-EN.doc) […](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
refusing to authorise certain health claims ma de 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 Leiber GmbH, submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of Yestimun
® and defence against pathogens in the 
upper respiratory tract (Question No EFSA-Q-2012-00761)2. The claim proposed by 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2013; 11(4):3159.  
EN 3   EN the applicant was worded as follows : “Daily administration of Yestimun® helps to 
maintain the body's defence against pathogens”. 
(6) On 8 April 2013 the Commission and the Me mber States received the scientific 
opinion from the Authority, whic h concluded that on the basis of the data presented, a 
cause and effect relationship could not be  established between the consumption of 
Yestimun® ((1,3)-(1,6)- β-D-glucans from brewer's yeast cell wall) and the claimed 
effect. Accordingly, as the claim does not co mply with the requirements of Regulation 
(EC) No 1924/2006, it should not be authorised. 
(7) Following an application from Vivatech, submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of Transitech® and improvement of bowel function 
which is maintained after cessa tion of consumption of the food  (Question No EFSA-
Q-2013-00087)3. The claim proposed by the applicant was worded as follows: 
“Improves transit and durably regulates it”. 
(8) On 13 June 2013, the Commissi on 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 
Transitech® and the claimed effect. 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 Clasado Limited, submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of Bimuno® GOS and reduction of gastro-intestinal 
discomfort (Question No EFSA-Q-2012-01007)4. The claim proposed by the 
applicant was worded as follows: “Regul ar daily consumption of 1.37 g galacto-
oligosaccharides from Bimuno® may reduce abdominal discomfort”. 
(10) On 18 June 2013, the Commissi on and the Member States received the scientific 
opinion from the Authority, which conc luded that a health claim on Bimuno® GOS 
and reducing gastro-intestinal discomfort pur suant to Article 13(5) of Regulation (EC) 
No 1924/2006 has already been assessed by the Authority with an unfavourable outcome
5 and that the supplementary information submitted by the applicant did not 
provide evidence that could be used for the scientific substantiation of this claim. 
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 Fuko Pharma Ltd, submitted pursuant to Article 13(5) 
of Regulation (EC) No 1924/2006, the Authority  was required to deliver an opinion on 
a health claim related to the effects of Lactobacillus rhamnosus GG and maintenance 
of normal defecation during antibiotic treatment (Question No EFSA-Q-2013-
                                                 
3 EFSA Journal 2013; 11(6):3258. 
4 EFSA Journal 2013; 11(6):3259. 
5 EFSA Journal 2011; 9(12):2472.  
EN 4   EN 00015)6. The claim proposed by the applic ant was worded as follows: “ Lactobacillus 
rhamnosus GG for maintaining normal defecation dur ing oral antibiotic treatment”. 
(12) On 18 June 2013, the Commissi on 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 
Lactobacillus rhamnosus GG and the claimed effect. Accordingly, as the claim does 
not comply with the requirements of Re gulation (EC) No 1924/2006, it should not be 
authorised. 
(13) Following an application from Gelita AG, submitted pursuant to Article 13(5) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to the effects of VeriSol®P and a change in skin elasticity leading 
to an improvement in skin function (Question No EFSA-Q-2012-00839)7. The claim 
proposed by the applicant was worded as follows: “Characteristic collagen peptide mixture (collagen hydrolysate) having a beneficial physiologi cal effect on the 
maintenance of skin health, as indicated by an increased skin elasticity and a reduction 
of wrinkles volume, by contributing to a normal collagen and elastin synthesis”. 
(14) On 20 June 2013, the Commissi on 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 could not be  established between the consumption of 
Verisol
®P and the claimed effect. Accordingly, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(15) The health claims subject to this Regula tion are health claims as referred to in 
Article 13(1)(a) of Regulation (EC) No 1924/2006, which are subject to the 
transitional period laid down in  Article 28(5) of that Regul ation until the adoption of 
the list of permitted health claims provide d that they comply with that Regulation. 
(16) The list of permitted health claims has been established by Commission Regulation 
(EU) No 432/20128 and is applicable since 14 D ecember 2012. As regards claims 
referred to in Article 13(5) of Regulati on (EC) No 1924/2006 for which the evaluation 
by the Authority or consideration by the Commission has not been completed by 
14 December 2012 and which by virtue of this Regulation are not included in the list of permitted health claims, it is appropriate to provide for a transitional period during 
which they may still be used, in order to  allow both food business operators and the 
competent national authorities to adap t to the prohibition of such claims. 
(17) The comments from the applicants and th e members of the public received by the 
Commission pursuant to Article 16(6) of  Regulation (EC) No 1924/2006 have been 
considered when setting the measur es provided for in this Regulation. 
                                                
 
6 EFSA Journal 2013; 11(6):3256. 
7 EFSA Journal 2013; 11(6):3257. 
8 Commission Regulation (EU) No 432/2012 of 16 Ma y 2012 establishing a list of permitted health 
claims made on foods, other than those referring to the reduction of disease risk and to children's 
development and health (OJ L 136, 25.5.2012, p. 1).  
EN 5   EN (18) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health,   
HAS ADOPTED THIS REGULATION: 
Article 1 
1. The health claims listed in the Annex to this Regulation shall not  be included in the 
Union list of permitted claims as provided fo r in Article 13(3) of Regulation (EC) No 
1924/2006. 
2. However, the health claims referred to in  paragraph 1 used prior to the entry into 
force of this Regulation, may continue to  be used for a maximum period of six 
months after the entry into  force of this Regulation. 
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 
 The President  José Manuel BARROSO