HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 310/38
EN
Official Journal of the European Union
9.11.2012
COMMISSION REGULATION (EU) No 1048/2012
of 8 November 2012
on the authorisation of a health claim made on foods and referring to the reduction of disease risk
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
proposed by the applicant was worded as follows: ‘Barley
beta-glucan has been shown to lower/reduce blood
cholesterol. Blood cholesterol lowering may reduce the
Having regard to the Treaty on the Functioning of the European
risk of (coronary) heart disease’.
Union,
(6) On the basis of the data presented, the Authority
concluded in its opinion received by the Commission
Having regard to Regulation (EC) No 1924/2006 of the
and the Member States on 8 December 2011 that a
European Parliament and of the Council of 20 December
cause and effect relationship had been established
2006 on nutrition and health claims made on foods ( 1 ), and
between the consumption of barley beta-glucans and
in particular Article 17(3) thereof,
lowering of blood LDL-cholesterol concentrations.
Accordingly, a health claim reflecting this conclusion
should be considered as complying with the requirements
Whereas:
of Regulation (EC) No 1924/2006, and should be
included in the Union list of permitted claims. The
meta-analysis and information pertaining to the
(1) Pursuant
to
Regulation
(EC)
No
1924/2006
health
claims
production process of barley ‘betafiber’ (Barliv TM ),
made on foods are prohibited unless they are authorised
claimed by the applicant as proprietary, were not
by the Commission in accordance with that Regulation
considered necessary by the Authority for reaching its
and included in a list of permitted claims.
conclusion. It is therefore considered that the
requirement laid down in point (c) of Article 21(1) of
Regulation (EC) No 1924/2006 is not fulfilled and
accordingly, protection of proprietary data should not
(2) Regulation
(EC)
No
1924/2006
also
provides
that
appli
be granted.
cations for authorisations of health claims may be
submitted by food business operators to the national
competent authority of a Member State. The national
(7) Following
an
application
from
Valens
Int.
d.o.o.,
competent authority is to forward valid applications to
submitted pursuant to Article 14(1)(a) of Regulation
the European Food Safety Authority (EFSA), hereinafter
(EC) No 1924/2006, the Authority was required to
referred to as ‘the Authority’.
deliver an opinion on a health claim related to the
effects of barley beta-glucans on lowering of blood
cholesterol and reduced risk of (coronary) heart disease
(3)
Following receipt of an application the Authority is to
(Question No EFSA-Q-2011-00799)
( 4 ). The claim
inform without delay the other Member States and the
proposed by the applicant was worded as follows:
Commission thereof, and to deliver an opinion on the
‘Barley beta-glucan has been shown to reduce blood
health claim concerned.
cholesterol. Blood cholesterol lowering may reduce the
risk of heart disease’.
(4)
The Commission is to decide on the authorisation of
(8) On the basis of the data presented, the Authority
health claims taking into account the opinion delivered
concluded in its opinion received by the Commission
by the Authority.
and the Member States on 8 December 2011 that a
cause and effect relationship had been established
between the consumption of barley beta-glucans and
(5) Following
an
application
from
Cargill
Incorporated,
lowering of blood LDL-cholesterol concentrations.
submitted pursuant to Article 14(1)(a) of Regulation
Accordingly, a health claim reflecting this conclusion
(EC) No 1924/2006 and requesting the protection of
should be considered as complying with the requirements
proprietary data for one meta-analysis
( 2 ) and for
of Regulation (EC) No 1924/2006, and should be
information pertaining to the production process of
included in the Union list of permitted claims.
barley ‘betafiber’ (Barliv TM ), the Authority was required
to deliver an opinion on a health claim related to the
effects of barley beta-glucans on lowering of blood
(9) Article
16(4)
of
Regulation
(EC)
No
1924/2006
provides
cholesterol and reduced risk of (coronary) heart disease
that an opinion in favour of authorising a health claim
(Question No EFSA-Q-2011-00798)
(
should include certain particulars. Accordingly, those

3 ). The claim
particulars should be set out in the Annex to this Regu
lation as regards the authorised claim and include, as the
( 1 ) OJ L 404, 30.12.2006, p. 9.
case may be, the revised wording of the claim, specific
( 2 ) Harland JI, 2011 (unpublished); Meta-analysis of the effects of barley
beta-glucan on blood lipids.
( 3 ) The EFSA Journal (2011); 9(12):2470.
( 4 ) The EFSA Journal (2011); 9(12):2471.

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EN
9.11.2012 Official
Journal
of
the
European
Union L
310/39
conditions of use of the claim, and, where applicable,
(12) The
measures
provided
for
in
this
Regulation
are
in
conditions or restrictions of use of the food and/or an
accordance with the opinion of the Standing
additional statement or warning, in accordance with the
Committee on the Food Chain and Animal Health and
rules laid down in Regulation (EC) No 1924/2006 and in
neither the European Parliament nor the Council have
line with the opinions of the Authority.
opposed them,
(10) One of the objectives of Regulation (EC) No 1924/2006
HAS ADOPTED THIS REGULATION:
is to ensure that health claims are truthful, clear and
reliable and useful to the consumer, and that wording
Article 1
and presentation are taken into account in that respect.
Therefore where the wording of claims has the same
1. The
health
claim
listed
in
the
Annex
to
this
Regulation
meaning for consumers as that of an authorised health
may be made on foods on the European Union market in
claim, because they demonstrate the same relationship
compliance with the conditions laid down in that Annex.
that exists between a food category, a food or one of
its constituents and health, they should be subject to the
2. The
health
claim
referred
to
in
paragraph
1
shall
be
same conditions of use indicated in the Annex to this
included in the Union list of permitted claims as provided for
Regulation.
in Article 14(1) of Regulation (EC) No 1924/2006.
(11) The
comments
from
the
applicants
and
the
members
of
Article 2
the public received by the Commission pursuant to
Article 16(6) of Regulation (EC) No 1924/2006 have
This Regulation shall enter into force on the twentieth day
been considered when setting the measures provided
following that of its publication in the Official Journal of the
for in this Regulation.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 November 2012.
For the Commission
The President
José Manuel BARROSO

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L 310/40
ANNEX
Permitted health claim
Conditions
and/or
EN
Application — Relevant
Nutrient,
restrictions of

provisions of Regulation (EC)
Applicant — Address
substance, food
Claim
Conditions of use of the claim
use of the food
EFSA opinion
No 1924/2006
or food
and/or
reference
category
additional
statement or
warning
Article 14(1)(a) health claim Cargill Incorporated, acting through Cargill Barley beta- Barley beta-glucan has been shown Information shall be given to the
Q-2011-00798
referring to a reduction of a Health and Nutrition, c/o Cargill R & D glucan
to lower/reduce blood cholesterol. consumer that the beneficial effect is
disease risk
Centre Europe, Havenstraat 84, 1800
High cholesterol is a risk factor in obtained with a daily intake of 3 g of
Vilvoorde, Belgium
the development of coronary heart barley beta-glucan.
disease.
Off
The claim can be used for foods which
Valens Int. d.o.o., Kidrieva ulica 24b,
provide at least 1 g of barley beta-
Q-2011-00799
icial
SI-3000 Celje, Slovenia
glucan per quantified portion.
Jour
nal
of
the
European
Union
9.11.2012

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Document Outline

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