COMMISSION REGULATION (EU) No 1162/2010  
of 9 December 2010  
refusing to authorise certain health 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 health claims 
made on food 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 also provides that appli ­
cations 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 European Food Safety Authority (EFSA), hereinafter 
referred to as the Authority.  
(3) Following receipt of an application the Authority is to 
inform without delay the other Member States and the 
Commission of the application, and to deliver an opinion 
on the health claim concerned.  
(4) The Commission is to decide on the authorisation of 
health claims taking into account the opinion delivered 
by the Authority.  
(5) The two opinions referred to in this Regulation 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 Baby 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 related to the effects of Immu ­
nofortis® on the infant’s immune system (Question No 
EFSA-Q-2008-106) (  2 ). The claim proposed by the applicant was worded as follows: ‘Immunofortis® to 
naturally strengthen your baby’s immune system’.  
(7) On the basis of the data presented, the Authority 
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 cause 
and effect relationship between the consumption of 
Immunofortis® and the claimed effect. Accordingly, as 
the claim does not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be au- 
thorised.  
(8) Following an application from Vifor Pharma (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 q  TM 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 
combination of High-EPA/DHA/GLA omega-3, 6 PUFA) 
provides the essential nutrients that helps improve 
working memory in children’. The abbreviations used 
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 Authority 
concluded in its opinion received by the Commission 
and the Member States on 4 March 2010 that the 
information provided is insufficient to establish a cause 
and effect relationship 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 authorised by a decision 
pursuant to Article 17(3) of Regulation (EC) No 
1924/2006 may continue to be used for 6 months 
after the adoption of this Regulation, provided an appli ­
cation was made before 19 January 2008. However, as 
the health claim application relevant to Eye q  TM was not 
made before 19 January 2008 the requirement provided 
for in Article 28(6)(b) is not fulfilled, and the transition 
period laid down in that Article is not applicable. 
Accordingly, a transition period of 6 months should be 
provided for, to enable food business operators to adapt 
to the requirements laid down in this Regulation.EN 10.12.2010 Official Journal of the European Union L 326/61  
( 1 ) OJ L 404, 30.12.2006, p. 9.  
( 2 ) The EFSA Journal (2010) 8(2):1430.  (  3 ) The EFSA Journal (2010) 8(3):1516.(11) The comments from the applicants 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 
measures provided for in this Regulation.  
(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing 
Committee on the Food Chain and Animal 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 6 months after the entry into force of this Regulation.  
Article 2  
This Regulation shall enter into force on the 20th day following 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, 9 December 2010.  
For the Commission  
The President  
José Manuel BARROSOEN L 326/62 Official Journal of the European Union 10.12.2010ANNEX  
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-2009-00485EN 10.12.2010 Official Journal of the European Union L 326/63