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 the 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 Laboratoire Vie et Santé  submitted on 29 December 
2008 pursuant to Article 13(5) of Regulat ion (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 numbe r 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".  
                                                 
1 OJ L 404, 30.12.2006, p. 9. 
2 The EFSA Journal 2010; 8(1):1422.  
EN 3   EN (6) On 13 January 2010, the Commission and the Member States received the scientific 
opinion from the Authority, whic h 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 clai med effect. Accordingly, as the claim does 
not comply with the requirements of Re gulation (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 measur es 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 cl aim subject to the present Regulation, the 
Authority concluded that a cause and eff ect relationship had not been established 
between the consumption of the food and th e claimed effect and thus it does not 
comply with the Regulation (EC) No  1924/2006, it could not benefit from the 
transition period foreseen in Article 28(5) of  that Regulation. A transition period of six 
months is provided for to enable food busin ess operators to adapt to the requirements 
laid down in this Regulation.  
(8) 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 this Re gulation shall not be incl uded in the Union list 
of permitted claims as provided for in Ar ticle 13(3) of Regulation (EC) No 1924/2006. 
However, it may continue to be used for si x 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 . 
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 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-
00852