HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 296/26
EN
Official Journal of the European Union
15.11.2011
COMMISSION REGULATION (EU) No 1160/2011
of 14 November 2011
on the authorisation and refusal of authorisation of certain health claims made on foods and
referring to the reduction of disease risk
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(6) On the basis of the data presented, the Authority
concluded in its opinion received by the Commission
and the Member States on 8 December 2010 that a
Having regard to the Treaty on the Functioning of the European
cause and effect relationship had been established
Union,
between the consumption of oat beta-glucan and
lowering of blood LDL-cholesterol concentrations.
Accordingly, a health claim reflecting this conclusion
should be considered as complying with the requirements
Having regard to Regulation (EC) No 1924/2006 of the
of Regulation (EC) No 1924/2006, and should be
European Parliament and of the Council of 20 December
included in the Union list of permitted claims.
2006 on nutrition and health claims made on foods ( 1 ), and
in particular Article 17(3) thereof,
Whereas:
(7) Article
16(4)
of
Regulation
(EC)
No
1924/2006
provides

that an opinion in favour of authorising a health claim
should include certain particulars. Accordingly, those
particulars should be set out in Annex I to this Regu
(1) Pursuant
to
Regulation
(EC)
No
1924/2006
health
claims
lation as regards the authorised claim and include, as the
made on foods are prohibited unless they are authorised
case may be, the revised wording of the claim, specific
by the Commission in accordance with that Regulation
conditions of use of the claim, and, where applicable,
and included in a list of permitted claims.
conditions or restrictions of use of the food and/or an
additional statement or warning, in accordance with the
rules laid down in Regulation (EC) No 1924/2006 and in
(2) Regulation
(EC)
No
1924/2006
also
provides
that
appli
line with the opinions of the Authority.
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
(8)
One of the objectives of Regulation (EC) No 1924/2006
the European Food Safety Authority (EFSA), hereinafter
is to ensure that health claims are truthful, clear and
referred to as ‘the Authority’.
reliable and useful to the consumer, and that wording
and presentation are taken into account in that respect.
Therefore where the wording of claims has the same
(3)
Following receipt of an application the Authority is to
meaning for consumers as that of an authorised health
inform without delay the other Member States and the
claim, because they demonstrate the same relationship
Commission thereof, and to deliver an opinion on the
that exists between a food category, a food or one of
health claim concerned.
its constituents and health, they should be subject to the
same conditions of use indicated in the Annex to this
Regulation.
(4)
The Commission is to decide on the authorisation of
health claims taking into account the opinion delivered
by the Authority.
(9) Following
an
application
from
HarlandHall
Ltd
(on
behalf
of the Soya Protein Association, the European Vegetable
(5) Following
an
application
from
CreaNutrition
AG,
Protein Federation and the European Natural Soyfood
submitted pursuant to Article 14(1)(a) of Regulation
Manufacturers Association), submitted pursuant to
(EC) No 1924/2006, the Authority was required to
Article 14(1)(a) of Regulation (EC) No 1924/2006, the
deliver an opinion on a health claim related to the
Authority was required to deliver an opinion on a health
effects of oat beta-glucan on lowering blood cholesterol
claim related to the effects of soy protein on the
(Question No EFSA-Q-2008-681) ( 2 ). The claim proposed
reduction of blood cholesterol concentrations (Question
by the applicant was worded as follows: ‘The inclusion of
No EFSA-Q-2009-00672) ( 3 ). The claim proposed by the
oat beta-glucan as part of a balanced diet can actively
applicants was worded as follows: ‘Soy protein has been
lower/reduce blood LDL (low-density lipoprotein) and
shown to lower/reduce blood cholesterol; blood
total cholesterol’.
cholesterol lowering may reduce the risk of (coronary)
heart disease’.
( 1 ) OJ L 404, 30.12.2006, p. 9.
( 2 ) EFSA Journal 2010; 8(12):1885.
( 3 ) EFSA Journal 2010; 8(7):1688.

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EN
15.11.2011 Official
Journal
of
the
European
Union L
296/27
(10) On the basis of the data presented, the Authority
(13) The
comments
from
the
applicants
and
the
members
of
concluded in its opinion received by the Commission
the public received by the Commission pursuant to
and the Member States on 30 July 2010 that a cause
Article 16(6) of Regulation (EC) No 1924/2006 have
and effect relationship had not been established between
been considered when setting the measures provided
the consumption of soy protein and the claimed effect.
for in this Regulation.
Accordingly, as the claim does not comply with the
requirements of Regulation (EC) No 1924/2006, it
should not be authorised.
(14) 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
(11) Following
an
application
from
Danone
France,
submitted
neither the European Parliament nor the Council have
pursuant to Article 14(1)(a) of Regulation (EC) No
opposed them,
1924/2006, the Authority was required to deliver an
opinion on a health claim related to the effects of
Actimel, a fermented milk product containing Lactoba
HAS ADOPTED THIS REGULATION:
cillus casei DN-114 001 and yoghurt symbiosis on the
reduction of the presence of Clostridium difficile toxins in
Article 1
the gut (Question No EFSA-Q-2009-00776) ( 1 ). The
claim proposed by the applicant was worded as
1. The
health
claim
listed
in
Annex
I
to
this
Regulation
may
follows: ‘Fermented milk containing the probiotic Lacto
be made on foods on the European Union market in
bacillus casei DN-114001 and yogurt symbiosis decreases
compliance with the conditions laid down in that Annex.
presence of Clostridium difficile toxins in the gut (of
susceptible ageing people). Presence of Clostridium
2. The
health
claim
referred
to
paragraph
1
shall
be
included
difficile toxins is associated with the incidence of acute
in the Union list of permitted claims as provided for in
diarrhoea’.
Article 14(1) of Regulation (EC) No 1924/2006.
(12) On the basis of the data presented, the Authority
Article 2
concluded in its opinion received by the Commission
and the Member States on 8 December 2010 that the
The health claims listed in Annex II to this Regulation shall not
evidence provided is insufficient to establish a cause and
be included in the Union list of permitted claims as provided
effect relationship between the consumption of Actimel
for in Article 14(1) of Regulation (EC) No 1924/2006.
and reduction of the risk of C. difficile diarrhoea by
reducing the presence of C. difficile toxins. Accordingly,
Article 3
as the claim does not comply with the requirements of
Regulation (EC) No 1924/2006, it should not be auth
This Regulation shall enter into force on the 20th day following
orised.
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, 14 November 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) EFSA Journal 2010; 8(12):1903.

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L 296/28
ANNEX I
PERMITTED HEALTH CLAIM
Application — Relevant
Conditions and/or restrictions
provisions of Regulation (EC)
Applicant — Address
Nutrient, substance, food
of use of the food and/or
EFSA opinion
EN
No 1924/2006
or food category
Claim
Conditions of use of the claim
additional statement or
reference
warning

Article 14(1)(a) health claim CreaNutrition AG, Oat beta-glucan Oat
beta-glucan
has
been
shown
Information shall be given to the consumer
Q-2008-681
referring to a reduction of a Business Park, 6301
to lower/reduce blood cholesterol. that the beneficial effect is obtained with a
disease risk
Zug, Switzerland
High cholesterol is a risk factor in daily intake of 3 g of oat beta-glucan.
the development of coronary heart
disease.
The claim can be used for foods which
provide at least 1 g of oat beta glucan per
quantified portion.
Off
icial
ANNEX II
Jour
REJECTED HEALTH CLAIMS
nal
Application — Relevant provisions of Regulation (EC)
of
No 1924/2006
Nutrient, substance, food or food category Claim EFSA
opinion
reference
the
European
Article 14(1)(a) health claim referring to a Soy protein Soy
protein
has
been
shown
to
lower/reduce
blood
cholesterol;
blood
Q-2009-00672
reduction of a disease risk
cholesterol lowering may reduce the risk of (coronary) heart disease
Article 14(1)(a) health claim referring to a Actimel Lactobacillus casei DN-114 001 plus Fermented milk containing the probiotic Lactobacillus casei DN-114 001 and Q-2009-00776
Union
reduction of a disease risk
yoghurt symbiosis
yoghurt symbiosis decreases presence of Clostridium difficile toxins in the gut
(of susceptible ageing people). Presence of Clostridium difficile toxins is
associated with the incidence of acute diarrhoea.
15.11.2011

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