COMMISSION REGULATION (EU) No 383/2010  
of 5 May 2010  
refusing to authorise a health claim made on foods, other than those 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 18(5) 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 and to deliver an opinion on a 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 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 
effects 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 worded as follows: ‘This product reduces 
the sense of hunger’.  (6) On 19 December 2008, the Commission and the 
Member States received the scientific opinion from the 
Authority. It followed from the opinion and subsequent 
clarification from the Authority that on the basis of the 
data presented, a cause and effect relationship had not 
been established between the consumption of the milk 
product, rich in fibre and protein, and a reduction of the 
sense of hunger that is nutritionally or physiologically 
beneficial in terms of effect 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 
submitted 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 Member 
States received the response from the Authority where 
it is clarified that the effect observed could not be 
attributed solely to the food tested because 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 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.  
(9) Health claims referred to in Article 13(1)(c) of Regulation 
(EC) No 1924/2006 are subject to the transition 
measures laid down in Article 28(6) of that Regulation 
only if they comply with the conditions therein 
mentioned, among which that the applications for 
health claims not subject of evaluation and authorisation 
in a Member State have to be made before 19 January 
2008. As the application for the health claim subject to 
the present Regulation was not made before that date it 
can not benefit from the transition period foreseen in 
Article 28(6) of that 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,EN L 113/4 Official Journal of the European Union 6.5.2010  
( 1 ) OJ L 404, 30.12.2006, p. 9.  
( 2 ) The EFSA Journal  (2008) 894, 1-9.HAS ADOPTED THIS REGULATION:  
Article 1  
The health claim set out in the Annex to this Regulation shall not 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 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, 5 May 2010.  
For the Commission  
The President  
José Manuel BARROSO  
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-2008-396EN 6.5.2010 Official Journal of the European Union L 113/5