EN    EN EN 
  
EN    EN  EUROPEAN COMMISSION 
Brussels, 
C(2010) final 
Draft 
COMMISSION REGULATION 
of 
refusing to authorise certain he alth claims made on foods and referring to the reduction 
of disease risk and to children 's development and health  
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION REGULATION 
of 
refusing to authorise certain he alth claims made on foods and 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 17(3) thereof, 
Whereas: (1) Pursuant to Regulation (EC) No 1924/2006 hea lth claims made on food are 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. 
(3) Following receipt of an application the Author ity is to inform without delay the other 
Member States and the Comm ission of the application, a nd to deliver an opinion on 
the health claim concerned.  
(4) The Commission is to decide on the authorisa tion of health claims taking into account 
the opinion delivered by the Authority. 
(5) The two opinions referred to in this Regula tion are related to applications for health 
claims referring to children’s development and health, as referred to in Article 14(1)(b) 
of Regulation (EC) No 1924/2006.  
(6) Following an application from Danone Ba by Nutrition, 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 the effect s of Immunofortis®
 on the 
infant's immune system (Question No EFSA-Q-2008-106)2. The claim proposed by 
the applicant was worded as follows: "I mmunofortis® to naturally strengthen your 
baby's immune system". 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal (2010) 8(2):1430.  
EN 3   EN (7) On the basis of the data presented, the Au thority concluded in its opinion received by 
the Commission and the Member States on 4 February 2010 that the information 
provided is insufficient to establish a ca use and effect rela tionship between the 
consumption of Immunofortis® and the claime d effect. Accordingly, as the claim does 
not comply with the requirements of Re gulation (EC) No 1924/2006, it should not be 
authorised.  
(8) Following an application from Vifor Ph arma (Potters), 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 Eye qTM on working 
memory (Question No EFSA-Q-2009-00485)3. The claim proposed by the applicant 
was worded as follows: "Eye q TM (a unique combinati on of High-EPA/DHA/GLA 
omega-3, 6 PUFA) provides the essential nutrients that helps improve working 
memory in children ". The abbreviations us ed by the applicant refer respectively to 
eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), gamma-linolenic acid 
(GLA) and polyunsaturated fatty acids (PUFA). 
(9) On the basis of the data presented, the Aut hority concluded in its opinion received by 
the Commission and the Member States on 4 March 2010 that the information 
provided is insufficient to es tablish a cause and effect re lationship between the intake 
of Eye q TM 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.  
(10) In accordance with Article 28(6) of Regulation (EC) No 1924/2006, health claims 
referred to in its Article 14(1)(b) and not au thorised by a decision pursuant to Article 
17(3) of Regulation (EC) No 1924/2006 may con tinue to be used for six months after 
the adoption of this Regulation, provided an  application was made  before 19 January 
2008. However, as the health claim application relevant to Eye qTM was not made 
before 19 January 2008 the requirement pr ovided for in Article 28(6)(b) is not 
fulfilled, and the transition period laid dow n in that Article is not applicable. 
Accordingly, a transition period of six mont hs should be provided for, to enable food 
business operators to adapt to the requ irements laid down in this Regulation. 
(11) 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. 
(12) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health and neither the European 
Parliament nor the Council have opposed them, 
HAS ADOPTED THIS REGULATION: 
Article 1 
The health claims set out 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. 
However, they may continue to be used for si x months after the entry into force of this 
Regulation. 
                                                 
3 The EFSA Journal (2010) 8(3):1516.  
EN 4   EN 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 
 José Manuel BARROSO  The President  
EN 5   EN ANNEX  
Rejected health claims 
Application – Relevant provisions 
of Regulation (EC) No 1924/2006 Nutrient, substance, food or food 
category Claim EFSA opinion reference 
Article 14(1)(b) health claim 
referring to children’s development 
and health Immunofortis® Immunofortis® to  naturally strengthen 
your baby's immune system Q-2008-106 
Article 14(1)(b) health claim 
referring to children’s development 
and health Eye q TM Eye q TM (a unique combination of High-
EPA/DHA/GLA omega-3, 6 PUFA) 
provides the essential nutrients that helps 
improve working memory in children Q-2009-00485