HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 14/8
EN
Official Journal of the European Union
18.1.2014
REGULATIONS
COMMISSION REGULATION (EU) No 40/2014
of 17 January 2014
authorising a health claim made on foods, other than those referring to the reduction of disease risk
and to children's development and health and amending Regulation (EU) No 432/2012
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
referred to as ‘the Authority’, for a scientific assessment,
as well as to the Commission and the Member States for
information.
Having regard to the Treaty on the Functioning of the European
Union,
(4)
The Commission is to decide on the authorisation of
health claims taking into account the opinion delivered
Having regard to Regulation (EC) No 1924/2006 of the
by the Authority.
European Parliament and of the Council of 20 December
2006 on nutrition and health claims made on foods ( 1 ), and
in particular Article 18(4) thereof,
(5) In
order
to
stimulate
innovation,
health
claims
which
are
based on newly developed scientific evidence and/or
Whereas:
which include a request for the protection of proprietary
data shall undergo an accelerated type of authorisation.
(1) Regulation
(EC)
No
1924/2006
provides
that
health
claims made on food are prohibited unless they are auth
orised by the Commission in accordance with that Regu
lation and included in a list of permitted claims.
(6) Following
an
application
from
Nordic
Sugar
A/S,
submitted 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 sugar
beet fibre on the increase of faecal bulk (Question No
(2) Pursuant
to
Article
13(3)
of
Regulation
(EC)
No
EFSA-Q-2011-00972) ( 3 ). The claim proposed by the
1924/2006, Commission Regulation (EU) No
applicant was worded as follows: ‘Sugar beet fibre
432/2012 ( 2 ) was adopted, which established a list of
increases faecal bulk’.
permitted health claims made on foods other than
those referring to the reduction of disease risk and to
children's development and health
(7) On
8
December
2011,
the
Commission
and
the
Member
States received the scientific opinion from the Authority
(3) Regulation
(EC)
No
1924/2006
also
provides
that
appli
which concluded that on the basis of the data presented,
cations for authorisations of health claims areto be
a cause and effect relationship had been established
submitted by food business operators to the national
between the consumption of sugar beet fibre and the
competent authority of a Member State. The national
claimed effect. Accordingly, a health claim reflecting
competent authority is to forward valid applications to
this conclusion should be considered as complying
the European Food Safety Authority (EFSA), hereinafter
with the requirements of Regulation (EC) No
1924/2006 and should be included in the Union list
( 1 ) OJ L 404, 30.12.2006, p. 9.
of permitted claims, established by Regulation (EU) No
( 2 ) Commission Regulation (EU) No 432/2012 of 16 May 2012 estab
432/2012.
lishing a list of permitted health claims made on foods, other than
those referring to the reduction of disease risk and to children’s
development and health (OJ L 136, 25.5.2012, p. 1).
( 3 ) EFSA Journal 2011;9(12):2468.

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EN
18.1.2014 Official
Journal
of
the
European
Union
L
14/9
(8)
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 the
wording and the presentation are taken into account in
that respect. Therefore, where the wording of claims used
Article 1
by the applicant has the same meaning for consumers as
The health claim set out in the Annex to this Regulation shall
that of an authorised health claim, because they demon
be included in the Union list of permitted claims as provided
strate the same relationship that exists between a food
for in Article 13(3) of Regulation (EC) No 1924/2006.
category, a food or one of its constituents and health,
they should be subject to the same conditions of use as
those listed in the Annex to this Regulation.
Article 2
(9) In
accordance
with
Article
20
of
Regulation
(EC)
No The Annex to Regulation (EU) No 432/2012 is amended in
1924/2006, the Register of nutrition and health claims
accordance with the Annex to this Regulation.
containing all authorised health claims should be updated
in order to take into account this Regulation.
(10) Regulation (EU) No 432/2012 should therefore be
Article 3
amended accordingly.
This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
(11) The
Member
States
have
been
consulted,
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 January 2014.
For the Commission
The President
José Manuel BARROSO

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L 14/10
ANNEX
In the Annex to Regulation (EU) No 432/2012, the following entry is inserted in an alphabetical order:
Nutrient, substance, food or food
Conditions and/or restrictions of use
Relevant entry number in the
category
Claim
Conditions of use of the claim
of the food and/or additional
EFSA Journal number
Consolidated List submitted to EFSA
statement or warning
for its assessment
EN

‘Sugar beet fibre Sugar
beet
fibre
contributes
to
The claim may be used only for
2011;9(12):2468’
an increase in faecal bulk
food which is high in that fibre
as referred to in the claim HIGH
FIBRE as listed in the Annex to
Regulation (EC) No 1924/2006.
Off
icial
Jour
nal
of
the
European
Union
18.1.2014

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Document Outline

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