EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10220/2016 
(POOL/E1/2016/10220/10220-EN.doc) 
[…](2016) 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 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 hea lth claims made on foodsare prohibited 
unless they are authorised by the Commissi on 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 Beghin-Meiji and Tereos Syral, 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 short-chain fructooligosaccharides from sucrose 
and maintenance of normal defe cation (Question No EFSA-Q-2015-00377
2). The 
applicant has proposed the following wording for the health claim: “maintain normal intestinal regularity” or "maintain intestinal  regularity by increas ing the frequency of 
bowel movements" or "contributes to normal intestinal regularity or normal bowel 
function."  
(6) On 8 January 2016, the Commissi on and the Member States received the scientific 
opinion from the Authority, which concluded th at, on the basis of th e data presented, a 
cause and effect relationship had not been  established between the consumption of 
short-chain fructooligosaccharides from su crose and maintenance of normal defecation 
under the conditions of use proposed by the applicant. Accordingly, as the claim does 
                                                
 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2016;14(1):4366.   
EN 3   EN not comply with the requirements of Re gulation (EC) No 1924/2006, it should not be 
authorised. 
(7) The comments from the applicant rece ived by the Commission pursuant to 
Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the 
measures 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