EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/11004/2014 CIS 
(POOL/E4/2014/11004/11004-EN CIS.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 Hassia Mineralquellen GmbH & Co KG, 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 Rosbacher drive
® and increased attention (Question No EFSA-Q-2013-004442). The claim 
proposed by the applicant was, in ter alia, worded as follows: 
“helps/supports/maintains concentration”. 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal 2014;12(2):3576. EN 3   EN (6) On 24 February 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 
Rosbacher drive® and the claimed effect. Accordi ngly, as the claim does not comply 
with the requirements of Regulation (E C) No 1924/2006, it should not be authorised. 
(7) Following an application from Omikron Italia S.r.l., 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 th e effects of Cytidine 5-diphosphocholine 
(CDP-choline or citicoline) and maintenance of normal vision (Question No EFSA-
Q-2013-007573). The claim proposed by the applicant was worded as follows: “CDP-
choline in oral solution as source of cholin e contributes to the maintenance of normal 
function of the ophthalmic nervous structures”.  
(8) On 21 February 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 
cytidine 5'-diphosphocholine 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. 
(9) 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. 
(10) 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 
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 . 
                                                 
3 The EFSA Journal 2014;12(2):3575. EN 4   EN 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