EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/11095/2014 CIS 
(POOL/E4/2014/11095/11095-EN 
CIS.doc) […](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
refusing to authorise certain health claims made on foods and referring to children's 
development and health 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
refusing to authorise certain health claims  made on foods and referring 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 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 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 (EFS A), hereinafter referred to as 
‘the Authority’. 
(3) Following receipt of an application the Author ity is to inform without delay the other 
Member States and the Comm ission thereof, and to deli ver an opinion 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 Specialised  Nutrition Europe (formerly European 
Dietetic Food Industry Association), s ubmitted pursuant to Article 14(1)(b) of 
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a 
health claim related to beta-palmitate and contribution to softening stools (Question 
No EFSA-Q-2008-174
2). The claim proposed by the applicant was worded, inter alia,  
as follows: ‘Beta-palmitate enrichment contributes to soften stool consistency which helps to increase their frequency’. 
(6) On the basis of the data presented, the Aut hority concluded in its opinion, received by 
the Commission and the Member States on 21 February 2014, that a cause and effect 
relationship has not been established between  the consumption of beta-palmitate and 
softening of stools. Accordingly, as the cl aim does not comply with the requirements 
of Regulation (EC) No 1924/2006, it should not be authorised. 
                                                
 
1 OJ L 404, 30.12.2006, p. 9. 
2 EFSA Journal 2014;12(2):3578.  
EN 3   EN (7) Following an application from Specialised Nutrition Europe, submitted pursuant to 
Article 14(1)(b) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim related to the effects of choline and ‛development 
of brain’ (Question No EFSA-Q-2008-1343). The claim proposed by the applicant 
was worded, inter alia , as follows: ‘Choline is needed for the development of brain of 
infants and young children from  birth to three years’. 
(8) On the basis of the data presented, the Aut hority concluded in its opinion, received by 
the Commission and the Member States on 5 May 2014, that the claimed effect was 
general and non-specific. The Authority considered that the claimed effect, 
‘development of brain’ for infants and young children from birth to three years in 
relation to dietary choline, was not suffici ently defined for a scientific evaluation. 
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 Specialised Nutrition Europe, submitted pursuant to 
Article 14(1)(b) of Regulation (EC) No  1924/2006, the Authority was required to 
deliver an opinion on a health claim re lated to ‘complex carbohydrates’ and 
‘contribute to satiety’ (Question No EFSA-Q-2008-1314). The claim proposed by the 
applicant was worded, inter alia , as follows: ‘Complex carbohydrates contribute to 
satiety’. 
(10) On the basis of the data presented, the Aut hority concluded in its opinion, received by 
the Commission and the Member States on 5 May 2014, that a cause and effect 
relationship has not been established between the consumption of ‘complex 
carbohydrates’ and a beneficial physiologi cal effect for infants and young children 
(from birth to three years of age). Accord ing to the Authority, the applicant did not 
provide evidence to establish that an increas e in satiety is a be neficial physiological 
effect for infants and young ch ildren. Accordingly, as the claim does not comply with 
the requirements of Regulation (EC) No 1924/2006, it should not be authorised. 
(11) In accordance with Article 28(6) of Regulation (EC) No 1924/2006, health claims 
referred to in its Article 14(1)(b) and not  authorised by a decision pursuant to 
Article 17(3) of Regulation (EC) No 1924/ 2006 may continue to be used for six 
months after that decision was taken, provi ded the application fo r authorisation  was 
made before 19 January 2008. Accordingly, as th e health claims listed in the Annex to 
this Regulation fulfil the above conditions, the transitional period laid down in that 
Article should apply. 
(12) 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 for in Article 14(1) of Regulation (EC) No 1924/2006. 
                                                
 
3 EFSA Journal 2014;12(5):3651. 
4 EFSA Journal 2014;12(5):3652.  
EN 4   EN 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