II 
(Non-legislative acts)  
REGULATIONS  
COMMISSION REGULATION (EU) No 432/2011  
of 4 May 2011  
refusing to authorise certain health claims 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 Gencor Pacific Inc, 
submitted on 10 November 2009 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 ethanol-water 
extract of  Caralluma fimbriata  (Slimaluma®) on help to 
reduce waist circumference (Question No EFSA-Q- 
2010-00027) (  2 ). The claim proposed by the applicant 
was worded, as follows: ‘Slimaluma® helps to reduce 
waist circumference’.  
(6) On 12 May 2010 and on 18 May 2010, the Commission 
and the Member States received the scientific opinion 
from the Authority and its amendment respectively, 
which concluded that on the basis of the data submitted, 
a cause and effect relationship had not been established 
between the consumption of Slimaluma® and the 
beneficial physiological effect as defined by the Authority, 
namely, reduction of waist circumference leading to an 
improvement in adverse health effects associated with an 
excess abdominal fat. 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 Gencor Pacific Inc, 
submitted on 10 November 2009 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 ethanol-water 
extract of  Caralluma fimbriata  (Slimaluma®) on help to 
reduce body fat (Question No EFSA-Q-2010-00028) (  3 ). 
The claim proposed by the applicant was worded, as 
follows: ‘Slimaluma® helps to reduce body fat’.EN 5.5.2011 Official Journal of the European Union L 115/1  
( 1 ) OJ L 404, 30.12.2006, p. 9.  ( 2 ) The  EFSA Journal  2010; 8 (5):1602.  
( 3 ) The  EFSA Journal  2010; 8 (5):1602.(8) On 12 May 2010, the Commission and the Member 
States received the scientific opinion from the Authority, 
which concluded that on the basis of the data submitted, 
a cause and effect relationship had not been established 
between the consumption of Slimaluma® 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) Following an application from Gencor Pacific Inc, 
submitted on 10 November 2009 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 ethanol-water 
extract of  Caralluma fimbriata  (Slimaluma®) on help to 
reduce body weight (Question No EFSA-Q-2010- 
00029) (  1 ). The claim proposed by the applicant was 
worded, as follows: ‘Slimaluma® helps to reduce body 
weight’.  
(10) On 12 May 2010, the Commission and the Member 
States received the scientific opinion from the Authority, 
which concluded that on the basis of the data submitted, 
a cause and effect relationship had not been established 
between the consumption of Slimaluma® 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.  
(11) Following an application from Gencor Pacific Inc, 
submitted on 10 November 2009 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 ethanol-water 
extract of  Caralluma fimbriata  (Slimaluma®) on 
decreased energy intake (Question No EFSA-Q-2010- 
00030) (  2 ). The claim proposed by the applicant was 
worded, as follows: ‘Slimaluma® helps to reduce caloric 
intake’.  
(12) On 12 May 2010, the Commission and the Member 
States received the scientific opinion from the Authority, 
which concluded that on the basis of the data submitted, 
a cause and effect relationship had not been established 
between the consumption of Slimaluma® 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.  
(13) Following an application from Gencor Pacific Inc, 
submitted on 10 November 2009 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 ethanol-water extract 
of Caralluma fimbriata  (Slimaluma®) on help to control 
hunger/appetite (Question No EFSA-Q-2010-00031) (  3 ). 
The claim proposed by the applicant was worded, as 
follows: ‘Slimaluma® helps to control hunger/appetite’.  
(14) On 12 May 2010, the Commission and the Member 
States received the scientific opinion from the Authority, 
which concluded that on the basis of the data submitted, 
a cause and effect relationship had not been established 
between the consumption of Slimaluma® and the 
beneficial physiological effect as defined by the Authority, 
namely, reduction of appetite leading to a reduction in 
subsequent energy intake. Accordingly, as the claim does 
not comply with the requirements of Regulation (EC) 
No 1924/2006, it should not be authorised.  
(15) Following an application from Leiber GmbH, submitted 
on 2 October 2009 pursuant to Article 13(5) of Regu ­
lation (EC) No 1924/2006, the Authority was required to 
deliver an opinion on a health claim related to the effects 
of Yestimun® on immune responses (Question No EFSA- 
Q-2008-667) (  4 ). The claim proposed by the applicant 
was worded, inter alia, as follows: ‘Daily administration 
of Yestimun® strengthens the body’s defence during the 
cold season’.  
(16) On 27 May 2010, the Commission and the Member 
States received the scientific opinion from the Authority, 
which concluded that on the basis of the data submitted, 
a cause and effect relationship had not been established 
between the consumption of Yestimun® and the 
initiation of appropriate innate and adaptive immune 
responses. Accordingly, as the claim does not comply 
with the requirements of Regulation (EC) No 1924/2006, 
it should not be authorised.  
(17) Following an application from Laboratoires 
innéov SNC, submitted on 30 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 black ­
currant seed oil ( Ribes nigrum ), fish oil, lycopene from 
tomato ( Lycopersicon esculentum ) extract, vitamin C and 
vitamin E on help to improve dry skin conditions 
(Question No EFSA-Q-2009-00767) (  5 ). The claim 
proposed by the applicant was worded, inter alia, as 
follows: ‘Helps to improve dry skin condition’.EN L 115/2 Official Journal of the European Union 5.5.2011  
( 1 ) The  EFSA Journal  2010; 8 (5):1604.  
( 2 ) The  EFSA Journal  2010; 8 (5):1605.  ( 3 ) The  EFSA Journal  2010; 8 (5):1606.  
( 4 ) The  EFSA Journal  2010; 8 (5):1607.  
( 5 ) The  EFSA Journal  2010; 8 (5):1608.(18) On 25 May 2010, the Commission and the Member 
States received the scientific opinion from the Authority, 
which concluded that on the basis of the data submitted, 
a cause and effect relationship had not been established 
between the intake of a combination of blackcurrant seed 
oil ( Ribes nigrum ), fish oil, lycopene from tomato ( Lyco ­
persicon esculentum ) extract, vitamin C and vitamin E 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.  
(19) 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.  
(20) The health claims related to Slimaluma® are health 
claims as referred to in point (c) of Article 13(1) of 
Regulation (EC) No 1924/2006 and are therefore 
subject to the transition period laid down in 
Article 28(6) of that Regulation. However, as the appli ­
cations were not made before 19 January 2008, the 
requirement provided for in point (b) of Article 28(6) 
of that Regulation is not fulfilled, and therefore those 
claims may not benefit from the transition period 
provided for in that Article.  
(21) The health claims related to Yestimun®, and to black ­
currant seed oil ( Ribes nigrum ), fish oil, lycopene from 
tomato ( Lycopersicon esculentum ) extract, vitamin C and 
vitamin E, are health claims as referred to in point (a) 
of Article 13(1) of Regulation (EC) No 1924/2006 and 
are therefore subject to the transition period laid down in 
Article 28(5) of that Regulation. As the Authority 
concluded that cause and effect relationships have not 
been established between the foods and the respective 
claimed effects, the two claims do not comply with Regulation (EC) No 1924/2006, and therefore they 
may not benefit from the transition period provided 
for in that Article.  
(22) In order to ensure that this Regulation is fully complied 
with, both food business operators and the national 
competent authorities should take the necessary actions 
to ensure that, at the latest six months following the 
entry into force of this Regulation, products bearing 
the health claims listed in its Annex are no longer 
present on the market.  
(23) 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 claims 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, products bearing these health claims placed on the 
market or labelled prior to the date referred to in Article 2 may 
remain on the market for a maximum period of six months 
after that date.  
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, 4 May 2011.  
For the Commission  
The President  
José Manuel BARROSOEN 5.5.2011 Official Journal of the European Union L 115/3ANNEX  
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  Ethanol-water extract of  Caralluma 
fimbriata  (Slimaluma®)  Slimaluma® helps to 
reduce waist circum ­
ference  Q-2010-00027  
Article 13(5). Health claim based on 
newly developed scientific evidence 
and/or including a request for the 
protection of proprietary data  Ethanol-water extract of  Caralluma 
fimbriata  (Slimaluma®)  Slimaluma® helps to 
reduce body fat  Q-2010-00028  
Article 13(5). Health claim based on 
newly developed scientific evidence 
and/or including a request for the 
protection of proprietary data  Ethanol-water extract of  Caralluma 
fimbriata  (Slimaluma®)  Slimaluma® helps to 
reduce body weight  Q-2010-00029  
Article 13(5). Health claim based on 
newly developed scientific evidence 
and/or including a request for the 
protection of proprietary data  Ethanol-water extract of  Caralluma 
fimbriata  (Slimaluma®)  Slimaluma® helps to 
reduce caloric intake  Q-2010-00030  
Article 13(5). Health claim based on 
newly developed scientific evidence 
and/or including a request for the 
protection of proprietary data  Ethanol-water extract of  Caralluma 
fimbriata  (Slimaluma®)  Slimaluma® helps to 
control hunger/appetite  Q-2010-00031  
Article 13(5). Health claim based on 
newly developed scientific evidence 
and/or including a request for the 
protection of proprietary data  Yestimun®  Daily administration of 
Yestimun® strengthens 
the body’s defence 
during the cold season  Q-2008-667  
Article 13(5). Health claim based on 
newly developed scientific evidence 
and/or including a request for the 
protection of proprietary data  Combination of blackcurrant seed 
oil (Ribes nigrum) , fish oil, 
lycopene from tomato  (Lycopersicon 
esculentum)  extract, vitamin C and 
vitamin E  Helps to improve dry 
skin condition  Q-2009-00767EN L 115/4 Official Journal of the European Union 5.5.2011