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5.5.2011 Official
Journal
of
the
European
Union L
115/1
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,
(4)
The Commission is to decide on the authorisation of
health claims taking into account the opinion delivered
by the Authority.
Having regard to the Treaty on the Functioning of the European
Union,
(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
Having regard to Regulation (EC) No 1924/2006 of the
health claim related to the effects of ethanol-water
European Parliament and of the Council of 20 December
extract of Caralluma fimbriata (Slimaluma) on help to
2006 on nutrition and health claims made on foods ( 1 ), and
reduce waist circumference (Question No EFSA-Q-
in particular Article 18(5) thereof,
2010-00027) ( 2 ). The claim proposed by the applicant
was worded, as follows: ‘Slimaluma helps to reduce
waist circumference’.
Whereas:
(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,
(1) Pursuant
to
Regulation
(EC)
No
1924/2006
health
claims
which concluded that on the basis of the data submitted,
made on food are prohibited unless they are authorised
a cause and effect relationship had not been established
by the Commission in accordance with that Regulation
between the consumption of Slimaluma and the
and included in a list of permitted claims.
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
(2) Regulation
(EC)
No
1924/2006
also
provides
that
appli
comply with the requirements of Regulation (EC)
cations for authorisations of health claims may be
No 1924/2006, it should not be authorised.
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
(7) Following
an
application
from
Gencor
Pacific
Inc,
referred to as ‘the Authority’.
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
(3)
Following receipt of an application the Authority is to
reduce body fat (Question No EFSA-Q-2010-00028) ( 3 ).
inform without delay the other Member States and the
The claim proposed by the applicant was worded, as
Commission and to deliver an opinion on a health claim
follows: ‘Slimaluma helps to reduce body fat’.
concerned.
( 2 ) The EFSA Journal 2010; 8 (5):1602.
( 1 ) OJ L 404, 30.12.2006, p. 9.
( 3 ) The EFSA Journal 2010; 8 (5):1602.

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L 115/2
EN
Official Journal of the European Union
5.5.2011
(8)
On 12 May 2010, the Commission and the Member
Article 13(5) of Regulation (EC) No 1924/2006,
States received the scientific opinion from the Authority,
the Authority was required to deliver an opinion on a
which concluded that on the basis of the data submitted,
health claim related to the effects of ethanol-water extract
a cause and effect relationship had not been established
of Caralluma fimbriata (Slimaluma) on help to control
between the consumption of Slimaluma and the
hunger/appetite (Question No EFSA-Q-2010-00031) ( 3 ).
claimed effect. Accordingly, as the claim does not
The claim proposed by the applicant was worded, as
comply with the requirements of Regulation (EC)
follows: ‘Slimaluma helps to control hunger/appetite’.
No 1924/2006, it should not be authorised.
(9) Following
an
application
from
Gencor
Pacific
Inc, (14) On 12 May 2010, the Commission and the Member
submitted on 10 November 2009 pursuant to
States received the scientific opinion from the Authority,
Article 13(5) of Regulation (EC) No 1924/2006, the
which concluded that on the basis of the data submitted,
Authority was required to deliver an opinion on a
a cause and effect relationship had not been established
health claim related to the effects of ethanol-water
between the consumption of Slimaluma and the
extract of Caralluma fimbriata (Slimaluma) on help to
beneficial physiological effect as defined by the Authority,
reduce body weight (Question No EFSA-Q-2010-
namely, reduction of appetite leading to a reduction in
00029) (
subsequent energy intake. Accordingly, as the claim does

1 ). The claim proposed by the applicant was
worded, as follows: ‘Slimaluma helps to reduce body
not comply with the requirements of Regulation (EC)
weight’.
No 1924/2006, it should not be authorised.
(10) On 12 May 2010, the Commission and the Member
(15) Following
an
application
from
Leiber
GmbH,
submitted
States received the scientific opinion from the Authority,
on 2 October 2009 pursuant to Article 13(5) of Regu
which concluded that on the basis of the data submitted,
lation (EC) No 1924/2006, the Authority was required to
a cause and effect relationship had not been established
deliver an opinion on a health claim related to the effects
between the consumption of Slimaluma and the
of Yestimun on immune responses (Question No EFSA-
claimed effect. Accordingly, as the claim does not
Q-2008-667) ( 4 ). The claim proposed by the applicant
comply with the requirements of Regulation (EC)
was worded, inter alia, as follows: ‘Daily administration
No 1924/2006, it should not be authorised.
of Yestimun strengthens the body’s defence during the
cold season’.
(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
(16) On 27 May 2010, the Commission and the Member
Authority was required to deliver an opinion on a
States received the scientific opinion from the Authority,
health claim related to the effects of ethanol-water
which concluded that on the basis of the data submitted,
extract of Caralluma fimbriata (Slimaluma) on
a cause and effect relationship had not been established
decreased energy intake (Question No EFSA-Q-2010-
between the consumption of Yestimun and the
00030) ( 2 ). The claim proposed by the applicant was
initiation of appropriate innate and adaptive immune
worded, as follows: ‘Slimaluma helps to reduce caloric
responses. Accordingly, as the claim does not comply
intake’.
with the requirements of Regulation (EC) No 1924/2006,
it should not be authorised.
(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,
(17) Following an application from Laboratoires
a cause and effect relationship had not been established
innéov SNC, submitted on 30 December 2008
between the consumption of Slimaluma and the
pursuant to Article 13(5) of Regulation (EC) No
claimed effect. Accordingly, as the claim does not
1924/2006, the Authority was required to deliver an
comply with the requirements of Regulation (EC)
opinion on a health claim related to the effects of black
No 1924/2006, it should not be authorised.
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
(13) Following an application from Gencor Pacific Inc,
follows: ‘Helps to improve dry skin condition’.
submitted on 10 November 2009 pursuant to
( 3 ) The EFSA Journal 2010; 8 (5):1606.
( 1 ) The EFSA Journal 2010; 8 (5):1604.
( 4 ) The EFSA Journal 2010; 8 (5):1607.
( 2 ) The EFSA Journal 2010; 8 (5):1605.
( 5 ) The EFSA Journal 2010; 8 (5):1608.

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EN
5.5.2011 Official
Journal
of
the
European
Union L
115/3
(18) On 25 May 2010, the Commission and the Member
Regulation (EC) No 1924/2006, and therefore they
States received the scientific opinion from the Authority,
may not benefit from the transition period provided
which concluded that on the basis of the data submitted,
for in that Article.
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
(22) In
order
to
ensure
that
this
Regulation
is
fully
complied
persicon esculentum) extract, vitamin C and vitamin E and
with, both food business operators and the national
the claimed effect. Accordingly, as the claim does not
competent authorities should take the necessary actions
comply with the requirements of Regulation (EC)
to ensure that, at the latest six months following the
No 1924/2006, it should not be authorised.
entry into force of this Regulation, products bearing
the health claims listed in its Annex are no longer
present on the market.
(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
(23) The
measures
provided
for
in
this
Regulation
are
in
been considered when setting the measures provided
accordance with the opinion of the Standing
for in this Regulation.
Committee on the Food Chain and Animal Health and
neither the European Parliament nor the Council have
opposed them,
(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
HAS ADOPTED THIS REGULATION:
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)
Article 1
of that Regulation is not fulfilled, and therefore those
The health claims set out in the Annex to this Regulation shall
claims may not benefit from the transition period
not be included in the Union list of permitted claims as
provided for in that Article.
provided for in Article 13(3) of Regulation (EC) No 1924/2006.
(21) The health claims related to Yestimun, and to black
However, products bearing these health claims placed on the
currant seed oil (Ribes nigrum), fish oil, lycopene from
market or labelled prior to the date referred to in Article 2 may
tomato (Lycopersicon esculentum) extract, vitamin C and
remain on the market for a maximum period of six months
vitamin E, are health claims as referred to in point (a)
after that date.
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
Article 2
concluded that cause and effect relationships have not
been established between the foods and the respective
This Regulation shall enter into force on the 20th day following
claimed effects, the two claims do not comply with
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 BARROSO

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L 115/4
EN
Official Journal of the European Union
5.5.2011
ANNEX
Rejected health claims
Application — Relevant provisions of
Nutrient, substance, food or food
Regulation (EC) No 1924/2006
category
Claim
EFSA opinion
reference
Article 13(5). Health claim based on Ethanol-water extract of Caralluma Slimaluma helps to Q-2010-00027
newly developed scientific evidence fimbriata (Slimaluma)
reduce waist circum
and/or including a request for the
ference
protection of proprietary data
Article 13(5). Health claim based on Ethanol-water extract of Caralluma Slimaluma helps to Q-2010-00028
newly developed scientific evidence fimbriata (Slimaluma)
reduce body fat
and/or including a request for the
protection of proprietary data
Article 13(5). Health claim based on Ethanol-water extract of Caralluma Slimaluma helps to Q-2010-00029
newly developed scientific evidence fimbriata (Slimaluma)
reduce body weight
and/or including a request for the
protection of proprietary data
Article 13(5). Health claim based on Ethanol-water extract of Caralluma Slimaluma helps to Q-2010-00030
newly developed scientific evidence fimbriata (Slimaluma)
reduce caloric intake
and/or including a request for the
protection of proprietary data
Article 13(5). Health claim based on Ethanol-water extract of Caralluma Slimaluma helps to Q-2010-00031
newly developed scientific evidence fimbriata (Slimaluma)
control hunger/appetite
and/or including a request for the
protection of proprietary data
Article 13(5). Health claim based on Yestimun Daily
administration
of
Q-2008-667
newly developed scientific evidence
Yestimun strengthens
and/or including a request for the
the body’s defence
protection of proprietary data
during the cold season
Article 13(5). Health claim based on Combination of blackcurrant seed Helps to improve dry Q-2009-00767
newly developed scientific evidence oil (Ribes nigrum), fish oil, skin condition
and/or including a request for the lycopene from tomato (Lycopersicon
protection of proprietary data
esculentum) extract, vitamin C and
vitamin E

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