COMMISSION REGULATION (EC) No 984/2009  
of 21 October 2009  
refusing to authorise certain health claims made on food, other than those referring to the 
reduction of disease risk and to children’s development and health  
(Text with EEA relevance)  
THE COMMISSION OF THE EUROPEAN COMMUNITIES,  
Having regard to the Treaty establishing 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 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 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 authorisaton of 
health claims taking into account the opinion delivered 
by the Authority.  
(5) Following an application from Pierre Fabre Dermo 
Cosmétique submitted on 14 April 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 Elancyl Global 
Silhouette® on the regulation of body composition in 
people with light to moderate overweight (Question No 
EFSA-Q-2008-285) (  2 ). 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 12 August 2008, 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 was not established 
between the consumption of Elancyl Global Silhouette® 
in the quantities and duration proposed by the applicant 
and the claimed effect. Accordingly, as the claim does 
not comply with the requirements of Regulation 
(EC) No 1924/2006, it should not be authorised.  
(7) Following an application from Valio Ltd submitted on 
8 July 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 LGG® MAX on gastro-intestinal discomfort 
(Question No EFSA-Q-2008-444) (  3 ). The claim 
proposed by the applicant was worded as follows: 
‘LGG® MAX helps to reduce gastro-intestinal discomfort’.  
(8) On 30 August 2008 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 was not established 
between the consumption of LGG® MAX (Mixture A 
or Mixture B) and the claimed effect. Accordingly, as 
the claim does not comply with the requirements of 
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 measures provided 
for in this Regulation.  
(10) The health claim ‘LGG® MAX helps to reduce 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 measure 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 LGG® MAX 
and the claimed effect the claim does not comply with 
Regulation (EC) No 1924/2006, and therefore the tran ­
sition period foreseen in Article 28(5) is not applicable. 
A transition period of six months should be provided for, 
to enable food business operators to adapt to the 
requirements of Regulation (EC) No 1924/2006. The 
health claim ‘Clinically tested as of 14 days. Your 
silhouette is apparently and globally redrawn, resculpted 
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 inEN 22.10.2009 Official Journal of the European Union L 277/13  
( 1 ) OJ L 404, 30.12.2006, p. 9.  
( 2 ) The EFSA Journal  (2008) 789, pp. 1-2.  (  3 ) The EFSA Journal  (2008) 853, pp. 1-2.Article 28(6) of that Regulation. However, as the appli ­
cation was not made before 19 January 2008, the 
requirement provided for in Article 28(6)(b) is not 
fulfilled, and the transition period laid down in that 
Article is not applicable. Accordingly, a transition 
period of six months should be provided for, to enable 
food business operators to adapt to the requirements of 
this Commission Regulation.  
(11) The measures provided for in this Regulation 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 set out in the Annex to this Regulation may not 
be made on food on the Community market.  
Article 2  
Health claims set out in the Annex to this Regulation may 
continue to be used for six months after the entry into force 
of this Regulation.  
Article 3  
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, 21 October 2009.  
For the Commission  
Androulla VASSILIOU  
Member of the Commission  
ANNEX  
REJECTED HEALTH CLAIMS  
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  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-2008-444EN L 277/14 Official Journal of the European Union 22.10.2009