EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/70/2015 (POOL/ E4/2015/70/70-
EN.doc) […](2015) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
of XXX  
refusing to authorise a health claim 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) …/… 
of XXX  
refusing to authorise a health claim made on  foods, other than those referring to the 
reduction of disease risk and to ch ildren'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 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 Bimuno
® GOS and reducing gastro-intestinal discomfort 
(Question No EFSA-Q-2014-000222). The claim proposed by the applicant was 
worded as follows: “Regular  daily consumption of 1.37 g galacto-oligosaccharides 
from Bimuno® may reduce abdominal discomfort”. 
(6) 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 
Bimuno® GOS and reducing gastro -intestinal discomfort. In that opinion, the 
Authority also noted that except for one  unpublished human intervention study, all the 
human and non-human studies provided by the applicant for this claim were already 
submitted in previous applications for the same claim, and they were assessed with 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2014; 12(7):3756.  
EN 3   EN unfavourable outcomes3. Accordingly, as the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(7) The comments from the applicant and the 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. 
(8) 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 claim listed in the Annex to this Regulation shall not be included 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 
 The President  Jean-Claude JUNCKER 
                                                
 
3 EFSA Journal 2011;9(12):2472, EFSA Journal 2013;11(6):3259.