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12.7.2011 Official
Journal
of
the
European
Union L
182/5
COMMISSION REGULATION (EU) No 665/2011
of 11 July 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,
follows: ‘Chewing of sugar-free chewing gum reminer
alises tooth enamel which reduces the risk of dental
caries’.
Having regard to the Treaty on the Functioning of the European
Union,
(7) On the basis of the data presented, the Authority
Having regard to Regulation (EC) No 1924/2006 of the
concluded in its opinion received by the Commission
European Parliament and of the Council of 20 December
and the Member States on 1 October 2010 that a
2006 on nutrition and health claims made on foods ( 1 ), and
cause and effect relationship has been established
in particular Article 17(3) thereof,
between the consumption of sugar-free chewing gum
and the claimed effect. Accordingly, a health claim
reflecting this conclusion should be considered as
Whereas:
complying with the requirements of Regulation (EC) No
1924/2006, and it should be included in the Union list
of permitted claims.
(1) Pursuant
to
Regulation
(EC)
No
1924/2006
health
claims
made on foods are prohibited unless they are authorised
by the Commission in accordance with that Regulation
and included in a list of permitted claims.
(8) Following
an
application
from
Wrigley
GmbH,
submitted
pursuant to Article 14(1)(a) of Regulation (EC) No
1924/2006, the Authority was required to deliver an
(2) Regulation
(EC)
No
1924/2006
also
provides
that
appli
opinion on a health claim related to the effects of
cations for authorisations of health claims may be
sugar-free chewing gum and neutralisation of plaque
submitted by food business operators to the national
acids which reduces the risk of dental caries (Question
competent authority of a Member State. The national
No EFSA-Q-2010-00120) ( 3 ). The claim proposed by the
competent authority is to forward valid applications to
applicant was worded as follows: ‘Chewing of sugar-free
the European Food Safety Authority (EFSA), hereinafter
chewing gum neutralises plaque acids which reduces the
referred to as ‘the Authority’.
risk of dental caries’.
(3)
Following receipt of an application the Authority is to
inform without delay the other Member States and the
(9) On the basis of the data presented, the Authority
Commission thereof, and to deliver an opinion on the
concluded in its opinion received by the Commission
health claim concerned.
and the Member States on 1 October 2010 that a
cause and effect relationship has been established
between the consumption of sugar-free chewing gum
(4)
The Commission is to decide on the authorisation of
and the claimed effect. Accordingly, a health claim
health claims taking into account the opinion delivered
reflecting this conclusion should be considered as
by the Authority.
complying with the requirements of Regulation (EC) No
1924/2006, and it should be included in the Union list
of permitted claims.
(5) The
three
opinions
referred
to
in
this
Regulation
are
related to applications for reduction of disease risk
claims, as referred to in Article 14(1)(a) of Regulation
(EC) No 1924/2006.
(10) 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
(6) Following
an
application
from
Wrigley
GmbH,
submitted
particulars should be set out in Annex I to this Regu
pursuant to Article 14(1)(a) of Regulation (EC) No
lation as regards the authorised claims and include, as the
1924/2006, the Authority was required to deliver an
case may be, the revised wording of the claims, specific
opinion on a health claim related to the effects of
conditions of use of the claims, and, where applicable,
sugar-free chewing gum and reduction of tooth demin
conditions or restrictions of use of the food and/or an
eralisation (Question No EFSA-Q-2010-00119) ( 2 ). The
additional statement or warning, in accordance with the
claim proposed by the applicant was worded as
rules laid down in Regulation (EC) No 1924/2006 and in
line with the opinions of the Authority.
( 1 ) OJ L 404, 30.12.2006, p. 9.
( 2 ) The EFSA Journal 2010; 8(10):1775.
( 3 ) The EFSA Journal 2010; 8(10):1776.

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L 182/6
EN
Official Journal of the European Union
12.7.2011
(11) One of the objectives of Regulation (EC) No 1924/2006
Article 16(6) of Regulation (EC) No 1924/2006 have
is to ensure that health claims are truthful, clear and
been considered when setting the measures provided
reliable and useful to the consumer, and that wording
for in this Regulation.
and presentation are taken into account in that respect.
Therefore, where the wording of claims has the same
meaning for consumers as that of an authorised health
(15) The
measures
provided
for
in
this
Regulation
are
in
claim, because they demonstrate the same relationship
accordance with the opinion of the Standing
that exists between a food category, a food or one of
Committee on the Food Chain and Animal Health and
its constituents and health, they should be subject to the
neither the European Parliament nor the Council have
same conditions of use, as indicated in Annex I.
opposed them,
(12) Following an application from GP International Holding
HAS ADOPTED THIS REGULATION:
BV, submitted pursuant to Article 14(1)(a) of Regulation
(EC) No 1924/2006, the Authority was required to
Article 1
deliver an opinion on a health claim related to the
effects of OPC Plus on the reduction of the risk of
1. The
health
claims
listed
in
Annex
I
to
this
Regulation
may
chronic venous insufficiency (Question No EFSA-Q-
be made on foods on the European Union market in
2009-00751) ( 1 ). The claim proposed by the applicant
compliance with the conditions laid down in that Annex.
was worded as follows: ‘OPC Plus has been shown to
increase the microcirculation and may therefore reduce
the risk of chronic venous insufficiency’.
2. The
health
claims
referred
to
in
paragraph
1
shall
be

included in the Union list of permitted claims as provided for
in Article 14(1) of Regulation (EC) No 1924/2006.
(13) On the basis of the data presented, the Authority
concluded in its opinion received by the Commission
and the Member States on 7 September 2010 that a
Article 2
cause and effect relationship had not been established
The health claim listed in Annex II to this Regulation shall not
between the consumption of OPC Plus and the claimed
be included in the Union list of permitted claims as provided
effect. Accordingly, as the claim does not comply with
for in Article 14(1) of Regulation (EC) No 1924/2006.
the requirements of Regulation (EC) No 1924/2006, it
should not be authorised.
Article 3
(14) The
comments
from
the
applicants
and
the
members
of
This Regulation shall enter into force on the 20th day following
the public received by the Commission pursuant to
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, 11 July 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) The EFSA Journal 2010; 8(7):1691.

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12.7.2011 Off
ANNEX I
PERMITTED HEALTH CLAIMS
Conditions and/or
Application – Relevant
Nutrient, substance,
restrictions of use of
EN
provisions of Regulation (EC)
Applicant – Address
food or food
Claim
Conditions of use of the claim
the food and/or
EFSA opinion reference

No 1924/2006
category
additional statement
or warning
Article 14(1)(a) health claim Wrigley GmbH, Scientific and Regu Sugar-free
Sugar-free chewing gum helps Information shall be given to the
Q-2010-00119
referring to reduction of latory Affairs EMEAI, Biberger chewing gum
reduce tooth demineralisation. consumer that the beneficial effect
disease risk
Str. 18, 82008 Unterhaching,
Tooth demineralisation is a risk is obtained with chewing of 2-3 g
GERMANY
factor in the development of of sugar-free chewing gum for 20
dental caries.
minutes, at least three times per
day after meals.
Article 14(1)(a) health claim Wrigley GmbH, Scientific and Regu Sugar-free
Sugar-free chewing gum helps Information shall be given to the
Q-2010-00120
referring to reduction of latory Affairs EMEAI, Biberger Str. chewing gum
neutralise plaque acids. Plaque consumer that the beneficial effect
icial
disease risk
18, 82008 Unterhaching, GERMANY
acids are a risk factor in the devel is obtained with chewing of 2-3 g
Jour
opment of dental caries.
of sugar-free chewing gum for 20
minutes, at least three times per
nal
day after meals.
of
the
European
ANNEX II
Union
REJECTED HEALTH CLAIM
Application – Relevant provisions of
Nutrient, substance, food or food
Regulation (EC) No 1924/2006
category
Claim EFSA
opinion
reference
Article 14(1)(a) health claim referring to a reduction of a disease
OPC Plus OPC
Plus
has
been
shown
to
increase
the
microcirculation
and
Q-2009-00751
risk
may therefore reduce the risk of chronic venous insufficiency
L
182/7

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