COMMISSION REGULATION (EU) No 1161/2010  
of 9 December 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 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 Laboratoire Vie et Santé 
submitted on 29 December 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 Catalgine® 
bouffées de chaleur on reduction in the number of hot 
flushes (Question No EFSA-Q-2009-00852) (  2 ). The 
claim proposed by the applicant was worded as 
follows: ‘Contributes to the reduction in the number of 
hot flushes’.  
(6) On 13 January 2010, the Commission and the Member 
States received the scientific opinion from the Authority, which concluded that on the basis of the data presented, 
a cause and effect relationship had not been established 
between the consumption of Catalgine® bouffées de 
chaleur and the claimed effect. Accordingly, as the 
claim does not comply with the requirements of Regu ­
lation (EC) No 1924/2006, it should not be authorised.  
(7) Health claims referred to in Article 13(1)(a) of Regulation 
(EC) No 1924/2006 are subject to the transition 
measures laid down in Article 28(5) of that Regulation 
only if they comply with the conditions therein 
mentioned, among which that they have to comply 
with the Regulation. As for the claim subject to the 
present Regulation, the Authority concluded that a 
cause and effect relationship had not been established 
between the consumption of the food and the claimed 
effect and thus it does not comply with the Regulation 
(EC) No 1924/2006, it could not benefit from the tran ­
sition period foreseen in Article 28(5) of that Regulation. 
A transition period of six months is provided for to 
enable food business operators to adapt to the 
requirements laid down in this Regulation.  
(8) 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 claim set out in the Annex to this Regulation shall 
not be included in the Union list of permitted claims as 
provided for in Article 13(3) of Regulation (EC) No 1924/2006.  
However, it may continue to be used for six months after the 
entry into force of this Regulation.  
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 .EN 10.12.2010 Official Journal of the European Union L 326/59  
( 1 ) OJ L 404, 30.12.2006, p. 9.  
( 2 ) The EFSA Journal 2010; 8(1):1422.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 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  Catalgine® bouffées de chaleur  Contributes to the reduction in the number of hot 
flushes  Q-2009-00852EN L 326/60 Official Journal of the European Union 10.12.2010