EN    EN EN 
 EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2009) final 
Draft 
COMMISSION REGULATION 
of 
on the authorisation of health claims made on food, other than those 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 
on the authorisation of health claims made on food, other than those referring to the 
reduction of disease risk and to ch ildren's development and health  
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
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 foods1, 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 and are forwar ded by that authority to the European Food 
Safety Authority, hereinafter re ferred to as the Authority.  
(3) Following receipt of an application the Author ity is to inform without delay the other 
Member States and the Commissi on and to deliver an opinion on a health claim 
concerned.  
(4) The Commission is to decide on the aut horisaton taking into account the opinion 
delivered by the Authority. 
(5) Following an application from Pierre Fabre Dermo Cosmetique submitted 14 April 
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 Elancyl Global 
Silhouette® on the regulation of body compositi on in people with light to moderate 
overweight (Question No EFSA-Q-2008-285) . The claim proposed by the applicant 
was worded as follows: "Clinically tested as  of 14 days. Your silhouette is apparently 
and globally redrawn, resculpted and refined at 28 days".  
(6) On the basis of the data submitted the Authority concluded that a cause and effect 
relationship is not established between th e consumption of Elancyl Global Silhouette® 
in the quantities and duration proposed by th e applicant and the claimed effect. On 
12 August 2008, the Commission and the Member  States received the opinion and 
                                                
 
1 OJ L 404, 30.12.2006, p. 9–25 [corrigendum: OJ L 12, 18.1.2007, p. 3–18]. EN 3   EN since the claim does not comply with the c onditions set out in Regulation (EC) No 
1924/2006, it should not be authorised. 
(7) Following an application from Valio Ltd submitted 8 July 2008, pursuant to Article 
13(5) of Regulation (EC) No 1924/2006, the Au thority was required to deliver an 
opinion on a health claim rela ted to the effects of LGG®  MAX on gastro-intestinal 
discomfort  (Question No EFSA-Q-2008-444) . The claim proposed by the applicant 
was worded as follows:  "LGG® MAX helps to reduce gastro-intestinal discomfort".  
(8) On the basis of the data submitted, the Authority concluded that a cause and effect 
relationship is not established between th e consumption of LGG® MAX (Mixture A 
or Mixture B) and the cl aimed effect. On 30 August 2008 the Commission and the 
Member States received the opinion and since the claim does not comply with the conditions set out in Regulation (EC) No 1924/2006, it should not be authorised. 
(9) 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 measur es provided for in this Regulation. 
(10) The health claim "LGG® MAX helps to re duce gastro-intestinal discomfort" is a 
health claim as referred to Article 13( 1)(a) of Regulation (EC) No 1924/2006 and 
therefore subject to the transition measur e laid down in Article 28(5) of that 
Regulation. As the Authority concluded that  a cause and effect relationship is not 
established between the consumption of L GG®MAX and the claimed effect the claim 
does not comply with Regulation (EC) No 1924/2006, and therefore the transition 
period foreseen in Article 28(5) is not appl icable. A transition period of six months is 
provided by the Commission only to enable food business operators to adapt to the 
requirements of Regulation (EC) No 1924/2006. Th e health claim "Clinically tested as 
of 14 days. Your silhouette is apparently and globally redrawn, re sculpted and refined 
at 28 days" is a health claim as referred to  Article 13(1)(c) of Regulation (EC) No 
1924/2006 and therefore subject to  the transition measure laid  down in Article 28(6) of 
that Regulation. As the application was submitted later than 19 January 2008 the 
requirement provided under letter b) of Artic le 28(6) is not fulfilled, and therefore the 
transition period foreseen in Article 28(6) is  not applicable. A tran sition period of six 
months is provided by the Commission only to enable food business operators to adapt 
to the requirements of this Commission Regulation. 
(11) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Health claims listed in the Annex may not be made on food on the Community market.  
Article 1 a 
Health claims listed in the Anne x may continue to be used for six months after the entry into 
force of this Regulation.  EN 4   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 
 Androulla VASSILIOU  Member of the Commission EN 5   EN ANNEX  
Application – Legal basis 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 Elancyl Global 
Silhouette® Clinically tested as of 
14 days. Your silhouette is apparently and globally redrawn, resculpted and refined at 28 days. EFSA-Q-
2008-285 
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data LGG® MAX 
multispecies probiotic LGG® MAX helps to 
reduce gastro-intestinal discomfort. EFSA-Q-
2008-444