II 
(Non-legislative acts)  
REGULATIONS  
COMMISSION REGULATION (EU) No 1170/2011  
of 16 November 2011  
refusing to authorise certain health claims made on foods and referring to the reduction of disease 
risk  
(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 also 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 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 thereof, 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) Following an application from Prof. Dr. Moritz 
Hagenmeyer and Prof. Dr. Andreas Hahn, submitted pursuant to Article 14(1)(a) of Regulation (EC) 
No 1924/2006, the Authority was required to deliver 
an opinion on a health claim related to the effects of 
water and reduction of the risk of development of 
dehydration and of concomitant decrease of performance 
(Question No EFSA-Q-2008-05014) (  2 ). The claim 
proposed by the applicant was worded as follows:  
'Regular consumption of significant amounts of water 
can reduce the risk of development of dehydration and 
of concomitant decrease of performance '. 
(6) Article 2(2)(6) of Regulation (EC) No 1924/2006 defines 
reduction of disease risk claims as  'any health claim that 
states, suggests or implies that the consumption of a 
food category, a food or one of its constituents 
significantly reduces a risk factor in the development of 
a human disease '. Upon request for clarification, the 
applicant proposed water loss in tissues or reduced 
water content in tissues as risk factors of dehydration. 
On the basis of the data presented, the Authority 
concluded in its opinion received by the Commission 
and the Member States on 16 February 2011 that the 
proposed risk factors are measures of water depletion 
and thus are measures of the disease. Accordingly, as a 
risk factor in the development of a disease is not shown 
to be reduced, the claim does not comply with the 
requirements of Regulation (EC) No 1924/2006 and it 
should not be authorised.  
(7) Following an application from FrieslandCampina, 
submitted pursuant to Article 14(1)(a) of Regulation 
(EC) No 1924/2006, the Authority was required to 
deliver an opinion on a health claim related to the 
effects of acidic calcium-containing fruit juices on 
reduction of tooth demineralisation (Question No 
EFSA-Q-2009-00501) (  3 ). The claim proposed by the 
applicant was worded, inter alia, as follows:  'Reduced 
risk for dental erosion '.EN 17.11.2011 Official Journal of the European Union L 299/1  
( 1 ) OJ L 404, 30.12.2006, p. 9.  ( 2 ) EFSA Journal  2011; 9(2):1982.  
( 3 ) EFSA Journal  2011; 9(2):1983.(8) Article 2(2)(6) of Regulation (EC) No 1924/2006 defines 
reduction of disease risk claims as  'any health claim that 
states, suggests or implies that the consumption of a 
food category, a food or one of its constituents 
significantly reduces a risk factor in the development of 
a human disease '. Upon request for clarification, the 
applicant proposed tooth demineralisation as a risk 
factor for tooth erosion. On the basis of the data 
presented, the Authority concluded in its opinion 
received by the Commission and the Member States on 
18 February 2011 that a cause and effect relationship 
had not been established between the consumption of 
acidic calcium-containing fruit juices in replacement of 
fruit juice without added calcium and the reduction of 
tooth demineralisation. Accordingly, as the claim does 
not comply with the requirements of Regulation (EC) 
No 1924/2006, it should not be authorised.  
(9) 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.  (10) 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 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.  
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, 16 November 2011.  
For the Commission  
The President  
José Manuel BARROSOEN L 299/2 Official Journal of the European Union 17.11.2011ANNEX  
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)(a) health claim referring to a 
reduction of a disease risk  Water  Regular consumption of significant amounts of 
water can reduce the risk of development of 
dehydration and of concomitant decrease of 
performance  Q-2008-05014  
Article 14(1)(a) health claim referring to a 
reduction of a disease risk  Calcium-containing fruit juices  Reduced risk for dental erosion  Q-2009-00501EN 17.11.2011 Official Journal of the European Union L 299/3