EN    EN EN 
  
EN    EN  EUROPEAN COMMISSION 
Brussels, 
C(2010) final 
Draft 
COMMISSION REGULATION 
of 
refusing to authorise a health claim made on  foods, other than th ose referring to the 
reduction of disease risk and to ch ildren's development and health  
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION REGULATION 
of 
refusing to authorise a health claim made on  foods, other than th ose referring to the 
reduction of disease risk and to ch ildren'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 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 Commission and to  deliver an opinion on a 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) Following an application from ELVIR S.A.S., submitted on 5 June 2008 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 e ffects of a milk product, rich in fibre and 
protein on the reduction of the sense of hunger (Question No EFSA-Q-2008-396)
2. 
The claim proposed by the applicant was word ed as follows: "This product reduces the 
sense of hunger".  
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal (2008) 894, 1-9.  
EN 3   EN (6) On 19 December 2008, the Commission and the Me mber States received the scientific 
opinion from the Authority. It followed from  the opinion and subse quent clarification 
from the Authority that on the basis of the data presented, a cause and effect 
relationship had not been established betw een the consumption of the milk product, 
rich in fibre and protein and a reduction of th e sense of hunger that is nutritionally or 
physiologically beneficial in terms of eff ect on food energy intake. Considering this, 
the Standing Committee of the Food Chain and Animal Health, at its meeting of 
27 April 2009 concluded that the health claim should be subject to further 
consideration and the Commission subm itted on 24 June 2009 a request to the 
Authority for further advice on a number of elements in relation to the submitted application.  
(7) On 22 July 2009 the Commission and the Memb er States received the response from 
the Authority where it is clarified that th e effect observed could not be attributed 
solely to the food tested b ecause of the lack of information on the dietary conditions of 
the studies. Accordingly, that health claim can not be considered as complying with 
the requirements of Regulation (EC) No  1924/2006, and it should not be authorised. 
(8) 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.  
(9) Health claims referred to in Article 13(1)(c) of Regulation (EC) No 1924/2006 are 
subject to the transition measur es laid down in Article 28(6 ) of that Regulation only if 
they comply with the conditions therein me ntioned, among which that the applications 
for health claims not subject of evaluation a nd authorisation in a Member State have to 
be made before 19 January 2008. As the applic ation for the health claim subject to the 
present Regulation was not made before that date it can not benef it from the transition 
period foreseen in Article 28(6) of that 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 claim set out in the Annex to th is Regulation shall no t be included in the 
Community list of permitted claims as provided for in Article 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 . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States.  
EN 4   EN Done at Brussels, 
 For the Commission 
 José Manuel BARROSO  The President  
EN 5   EN ANNEX  
Rejected health claim  
Application – Relevant 
provisions of 
Regulation (EC) No 
1924/2006 Nutrient, substance, 
food or food category Claim EFSA 
opinion 
reference 
Article 13(5) health 
claim based on newly 
developed scientific evidence and/or including a request for the protection of 
proprietary data Milk product, rich in fibre 
and protein This product reduces 
the sense of hunger Q-2008-396