EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
SANCO/11113/2011 Rev. 1 (POOL/E4/2011/11113/11113R1-
EN.doc) 
[…](2011) XXX draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX 
refusing to authorise certain health claims made on foods and referring to the reduction 
of disease risk 
(Text with EEA relevance) 
  
EN 1   EN COMMISSION REGULATION (EU) No …/.. 
of XXX 
refusing to authorise certain he alth 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 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 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 Prof. Dr. Mo ritz 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 devel opment 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: "R egular consumption of significant amounts 
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal 2011; 9(2):1982.  
EN 2   EN of water can reduce the risk of devel opment of dehydration and of concomitant 
decrease of performance".  
(6) Article 2(6) of Regulation (E C) No 1924/2006 defines reducti on of disease risk claims 
as "any health claim that states, suggests or implies that the c onsumption of a food 
category, a food or one of its constituents significantly redu ces a risk f actor in the 
development of a human disease". Upon re quest for clarification, the applicant 
proposed water loss in tissues or reduced wate r content in tissues as risk factors of 
dehydration. On the basis of the data presen ted, the Authority concluded in its opinion 
received by the Commission and the Memb er States on 16 February 2011 that the 
proposed risk factors are measures of wate r 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 th e applicant was worded, inter alia , as follows: 
"Reduced risk for dental erosion".  
(8) Article 2(6) of Regulation (E C) No 1924/2006 defines reducti on of disease risk claims 
as "any health claim that states, suggests or implies that the c onsumption of a food 
category, a food or one of its constituents significantly redu ces a risk f actor in the 
development of a human disease". Upon re quest for clarification, the applicant 
proposed tooth demineralisation as a risk fact or 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 th at a cause and effe ct relationship had 
not been established between the consumption of acidic calc ium-containing fruit juices 
in replacement of fruit juice without added calcium and the reduction of tooth 
demineralisation. Accordingly, as the claim doe s not comply with the requirements of 
Regulation (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 Anim al 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 in cluded in the Union list 
of permitted claims as provided for in Ar ticle 14(1) of Regulation (EC) No 1924/2006. 
                                                 
3 The EFSA Journal 2011; 9(2):1983.  
EN 3   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 4   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)(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  Redu ced risk for dental erosion Q-2009-00501