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31.10.2013 Official
Journal
of
the
European
Union L
289/49
COMMISSION REGULATION (EU) No 1066/2013
of 30 October 2013
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,
claimed effect. Accordingly, as the claim does not comply
with the requirements of Regulation (EC) No 1924/2006,
it should not be authorised.
Having regard to the Treaty on the Functioning of the European

Union,
(7) Following
an
application
from
Merck
Consumer
Healthcare, submitted pursuant to Article 13(5) of Regu
Having regard to Regulation (EC) No 1924/2006 of the
lation (EC) No 1924/2006, the Authority was required to
European Parliament and of the Council of 20 December
deliver an opinion on a health claim related to the effects
2006 on nutrition and health claims made on foods ( 1 ), and
of glucosamine and maintenance of normal joint
in particular Article 18(5) thereof,
cartilage (Question No EFSA-Q-2011-01113) ( 3 ). The
claim proposed by the applicant was worded, inter alia,
Whereas:
as follows: ‘Glucosamine contributes to the maintenance
of normal joint cartilage’.
(1) Pursuant
to
Regulation
(EC)
No
1924/2006
health
claims
made on foods are prohibited unless they are authorised
(8)
On 16 May 2012, the Commission and the Member
by the Commission in accordance with that Regulation
States received the scientific opinion from the Authority,
and included in a list of permitted claims.
which concluded that on the basis of the data presented,
a cause and effect relationship had not been established
between the consumption of glucosamine and the
(2) Regulation
(EC)
No
1924/2006
also
provides
that
appli
claimed effect. Accordingly, as the claim does not
cations for authorisations of health claims may be
comply with the requirements of Regulation (EC) No
submitted by food business operators to the national
1924/2006, it should not be authorised.
competent authority of a Member State. The national
competent authority is to forward valid applications to
the European Food Safety Authority (EFSA), hereinafter
(9) Following
an
application
from
Extraction
Purification
referred to as ‘the Authority’ for a scientific assessment,
Innovation France, submitted pursuant to Article 13(5)
as well as to the Commission and the Member States for
of Regulation (EC) No 1924/2006, the Authority was
information.
required to deliver an opinion on a health claim related

to the consumption of wheat polar lipid extract and
protection of the skin against dehydration (Question
(3) The
Authority
is
to
deliver
an
opinion
on
the
health
No EFSA-Q-2011-01122) ( 4 ). The claim proposed by
claim concerned.
the applicant was worded, inter alia, as follows: ‘Con
tributes to improve skin hydration’.
(4)
The Commission is to decide on the authorisation of
health claims taking into account the opinion delivered
(10) On
5
July
2012,
the
Commission
and
the
Member
States
by the Authority.
received the scientific opinion from the Authority, which
concluded that on the basis of the data presented, a cause
and effect relationship had not been established between
(5) Following
an
application
from
Béres
Pharmaceuticals
Ltd,
the consumption of wheat polar lipid extract and the
submitted pursuant to Article 13(5) of Regulation (EC)
claimed effect. Accordingly, as the claim does not
No 1924/2006, the Authority was required to deliver an
comply with the requirements of Regulation (EC) No
opinion on a health claim related to the effects of gluco
1924/2006, it should not be authorised.
samine and maintenance of joints (Question No EFSA-Q-
2011-00907) ( 2 ). The claim proposed by the applicant
was worded as follows: ‘Glucosamine contributes to the
(11) Following
an application from Lesaffre International/
protection of joint cartilage exposed to excessive motion
Lesaffre Human Care, submitted pursuant to Article 13(5)
or loading and helps to improve the range of motion in
of Regulation (EC) No 1924/2006, the Authority was
joints’.
required to deliver an opinion on a health claim related
to the effects of Saccharomyces cerevisiae var. boulardii
CNCM I-3799 and reducing gastro-intestinal discomfort
(6)
On 5 December 2011, the Commission and the Member
(Question No EFSA-Q-2012-00271)
( 5 ). The claim
States received the scientific opinion from the Authority,
proposed by the applicant was worded as follows: ‘Sac
which concluded that on the basis of the data presented,
charomyces cerevisiae var. boulardii CNCM I-3799 helps
a cause and effect relationship had not been established
maintain intestinal comfort’.
between the consumption of glucosamine and the
( 3 ) EFSA Journal 2012; 10(5):2691.
( 1 ) OJ L 404, 30.12.2006, p. 9.
( 4 ) EFSA Journal 2012; 10(7):2773.
( 2 ) EFSA Journal 2011; 9(12):2476.
( 5 ) EFSA Journal 2012; 10(7):2801.

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L 289/50
EN
Official Journal of the European Union
31.10.2013
(12) On 17 July 2012, the Commission and the Member
(18) On 17 July 2012, the Commission and the Member
States received the scientific opinion from the Authority,
States received the scientific opinion from the Authority,
which concluded that on the basis of the data presented,
which concluded that on the basis of the data presented,
a cause and effect relationship could not be established
a cause and effect relationship had not been established
between the consumption of Saccharomyces cerevisiae var.
between the consumption of a combination of flaxseed
boulardii CNCM I-3799 and the claimed effect. Accord
oil and vitamin E and the claimed effect. Accordingly, as
ingly, as the claim does not comply with the
the claim does not comply with the requirements of
requirements of Regulation (EC) No 1924/2006, it
Regulation (EC) No 1924/2006, it should not be auth
should not be authorised.
orised.
(13) Following two applications from Nutrilinks Sarl,
submitted pursuant to Article 13(5) of Regulation (EC)
(19) Following
an
application
from
Nutrilinks
Sarl,
submitted
No 1924/2006, the Authority was required to deliver an
pursuant to Article 13(5) of Regulation (EC) No
opinion on a health claim related to the effects of a
1924/2006, the Authority was required to deliver an
combination of thiamin, riboflavin, niacin, pantothenic
opinion on a health claim related to the effects of
acid, pyridoxine, D-biotin and pumpkin seed oil
Opti EFAX and maintenance of normal blood LDL-
(Cucurbita pepo L.) and maintenance of normal hair
cholesterol concentrations (Question No EFSA-Q-2012-
(Question No EFSA-Q-2012-00334 and EFSA-Q-2012-
00339) ( 4 ). The claim proposed by the applicant was
00335) (
worded as follows: ‘Opti

1 ). The claim proposed by the applicant was
EFAX helps to maintain
worded, inter alia, as follows: ‘Helps to increase hair
healthy blood levels of LDL cholesterol’.
number’.
(20) On 17 July 2012, the Commission and the Member
(14) On 17 July 2012, the Commission and the Member
States received the scientific opinion from the Authority,
States received the scientific opinion from the Authority,
which concluded that on the basis of the data presented,
which concluded that on the basis of the data presented,
a cause and effect relationship had not been established
a cause and effect relationship had not been established
between the consumption of Opti
between the consumption of a combination of thiamin,
EFAX and the claimed
effect. Accordingly, as the claim does not comply with
riboflavin, niacin, pantothenic acid, pyridoxine, D-biotin
the requirements of Regulation (EC) No 1924/2006, it
and pumpkin seed oil (Cucurbita pepo L.) and the claimed
should not be authorised.
effect. Accordingly, as the claim does not comply with
the requirements of Regulation (EC) No 1924/2006, it
should not be authorised.
(21) Following
an
application
from
Nutrilinks
Sarl,
submitted
pursuant to Article 13(5) of Regulation (EC) No
(15) Following
an
application
from
Nutrilinks
Sarl,
submitted
1924/2006, the Authority was required to deliver an
pursuant to Article 13(5) of Regulation (EC) No
opinion on a health claim related to the effects of
1924/2006, the Authority was required to deliver an
Opti EFAX and maintenance of normal blood HDL-
opinion on a health claim related to the effects of
cholesterol concentrations (Question No EFSA-Q-2012-
Rhodiola rosea L. extract and reduction of mental fatigue
00340) ( 5 ). The claim proposed by the applicant was
(Question No EFSA-Q-2012-00336)
( 2 ). The claim
worded as follows: ‘Opti EFAX helps to maintain
proposed by the applicant was worded, inter alia, as
healthy blood levels of HDL cholesterol’.
follows: ‘Helps to reduce tiredness in case of stress’.
(22) On 17 July 2012, the Commission and the Member
(16) On 17 July 2012, the Commission and the Member
States received the scientific opinion from the Authority,
States received the scientific opinion from the Authority,
which concluded that on the basis of the data presented,
which concluded that on the basis of the data presented,
a cause and effect relationship had not been established
a cause and effect relationship had not been established
between the consumption of Opti
between the consumption of Rhodiola rosea L. extract and

EFAX and the claimed
effect. Accordingly, as the claim does not comply with
the claimed effect. Accordingly, as the claim does not
the requirements of Regulation (EC) No 1924/2006, it
comply with the requirements of Regulation (EC) No
should not be authorised.
1924/2006, it should not be authorised.
(17) Following
an
application
from
Nutrilinks
Sarl,
submitted
(23) Following
an
application
from
Nutrilinks
Sarl,
submitted
pursuant to Article 13(5) of Regulation (EC) No
pursuant to Article 13(5) of Regulation (EC) No
1924/2006, the Authority was required to deliver an
1924/2006, the Authority was required to deliver an
opinion on a health claim related to the effects of a
opinion on a health claim related to the effects of
combination of flaxseed oil and vitamin E and main
KF2BL20, which is a combination of keratin, copper,
tenance of the skin permeability barrier function
zinc, niacin, pantothenic acid, pyridoxine and D-biotin,
(Question No EFSA-Q-2012-00337)
( 3 ). The claim
and maintenance of normal hair (Question No EFSA-Q-
proposed by the applicant was worded, inter alia, as
2012-00381) ( 6 ). The claim proposed by the applicant
follows: ‘Contributes to maintain skin permeability
was worded, inter alia, as follows: ‘Helps to maintain
barrier function’.
hair strength’.
( 1 ) EFSA Journal 2012; 10(7):2807.
( 4 ) EFSA Journal 2012; 10(7):2802.
( 2 ) EFSA Journal 2012; 10(7):2805.
( 5 ) EFSA Journal 2012; 10(7):2803.
( 3 ) EFSA Journal 2012; 10(7):2819.
( 6 ) EFSA Journal 2012; 10(7):2808.

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EN
31.10.2013 Official
Journal
of
the
European
Union L
289/51
(24) On 17 July 2012, the Commission and the Member
presented, a cause and effect relationship could not be
States received the scientific opinion from the Authority,
established between the consumption of Transitech and
which concluded that on the basis of the data presented,
the claimed effect. Accordingly, as the claim does not
a cause and effect relationship had not been established
comply with the requirements of Regulation (EC) No
between the consumption of KF2BL20 and the claimed
1924/2006, it should not be authorised.
effect. Accordingly, as the claim does not comply with
the requirements of Regulation (EC) No 1924/2006, it
should not be authorised.
(31) Following
an
application
from
Nutrilinks
Sarl,
submitted
pursuant to Article 13(5) of Regulation (EC) No
1924/2006, the Authority was required to deliver an
(25) Following
an
application
from
Nutrilinks
Sarl,
submitted
opinion on a health claim related to the effects of
pursuant to Article 13(5) of Regulation (EC) No
Femilub and maintenance of vaginal moisture
1924/2006, the Authority was required to deliver an
(Question No EFSA-Q-2012-00571)
( 4 ). The claim
opinion on a health claim related to the effects of
proposed by the applicant was worded, inter alia, as
hyaluronic acid and protection of the skin against dehy
follows: ‘Helps to reduce vaginal dryness’.
dration (Question No EFSA-Q-2012-00382) ( 1 ). The
claim proposed by the applicant was worded, inter alia,
as follows: ‘Helps to maintain good skin hydration’.
(32) On 26 September 2012, the Commission and the
Member States received the scientific opinion from the
(26) On 17 July 2012, the Commission and the Member
Authority, which concluded that on the basis of the data
States received the scientific opinion from the Authority,
presented, a cause and effect relationship had not been
which concluded that on the basis of the data presented,
established between the consumption of Femilub and
a cause and effect relationship had not been established
the claimed effect. Accordingly, as the claim does not
between the consumption of hyaluronic acid and the
comply with the requirements of Regulation (EC) No
claimed effect. Accordingly, as the claim does not
1924/2006, it should not be authorised.
comply with the requirements of Regulation (EC) No
1924/2006, it should not be authorised.
(33) Following
an
application
from
Nutrilinks
Sarl,
submitted
pursuant to Article 13(5) of Regulation (EC) No
(27) Following
an
application
from
Nutrilinks
Sarl,
submitted
1924/2006, the Authority was required to deliver an
pursuant to Article 13(5) of Regulation (EC) No
opinion on a health claim related to the effects of a
1924/2006, the Authority was required to deliver an
combination of lycopene, vitamin E, lutein and
opinion on a health claim related to the effects of
selenium and protection of the skin from UV-induced
Opti EFAX and maintenance of normal blood concen
damage (Question No EFSA-Q-2012-00592) ( 5 ). The
trations of triglycerides (Question No EFSA-Q-2012-
claim proposed by the applicant was worded, inter alia,
00383) ( 2 ). The claim proposed by the applicant was
as follows: ‘Helps to prepare sensitive skin from the
worded as follows: ‘Opti EFAX helps to maintain
inside to improve their tolerance to the sun’.
healthy blood levels of triglycerides.’
(34) On 27 September 2012, the Commission and the
(28) On 17 July 2012, the Commission and the Member
Member States received the scientific opinion from the
States received the scientific opinion from the Authority,
Authority, which concluded that on the basis of the data
which concluded that on the basis of the data presented,
presented, a cause and effect relationship had not been
a cause and effect relationship had not been established
established between the consumption of a combination
between the consumption of Opti EFAX and the claimed
of lycopene, vitamin E, lutein and selenium and the
effect. Accordingly, as the claim does not comply with
claimed effect. Accordingly, as the claim does not
the requirements of Regulation (EC) No 1924/2006, it
comply with the requirements of Regulation (EC) No
should not be authorised.
1924/2006, it should not be authorised.
(29) Following an application from Vivatech, submitted
pursuant to Article 13(5) of Regulation (EC) No
(35) Following
an
application
from
Glanbia
Nutritionals
plc,
1924/2006, the Authority was required to deliver an
submitted pursuant to Article 13(5) of Regulation (EC)
opinion on a health claim related to the effects of Tran
No 1924/2006, the Authority was required to deliver an
sitech and ‘improves transit and durably regulates it’
opinion on a health claim related to the effects of
(Question No EFSA-Q-2012-00296)
(
Prolibra and ‘Helps to reduce body fat while preserving

3 ). The claim
proposed by the applicant was worded as follows:
lean muscle’ (Question No EFSA-Q-2012-00001) ( 6 ). The
‘Improves transit and durably regulates it’.
claim proposed by the applicant was worded as follows:
‘Helps to reduce body fat while preserving lean muscle’.
(30) On 26 September 2012, the Commission and the
Member States received the scientific opinion from the
(36) On
8
November
2012,
the
Commission
and
the
Member
Authority, which concluded that on the basis of the data
States received the scientific opinion from the Authority,
( 1 ) EFSA Journal 2012; 10(7):2806.
( 4 ) EFSA Journal 2012; 10(9):2888.
( 2 ) EFSA Journal 2012; 10(7):2804.
( 5 ) EFSA Journal 2012; 10(9):2890.
( 3 ) EFSA Journal 2012; 10(9):2887.
( 6 ) EFSA Journal 2012; 10(11):2949.

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L 289/52
EN
Official Journal of the European Union
31.10.2013
which concluded that on the basis of the data presented,
requirement provided for in point (b) of Article 28(6) of
a cause and effect relationship could not be established
that Regulation is not fulfilled, and therefore this claim
between the consumption of Prolibra and the claimed
may not benefit from the transitional period provided for
effect. Accordingly, as the claim does not comply with
in that Article.
the requirements of Regulation (EC) No 1924/2006, it
should not be authorised.
(42) The
other
health
claims
subject
to
this
Regulation
are
health claims as referred to in point (a) of Article 13(1)
of Regulation (EC) No 1924/2006, which are subject to
(37) Following
an
application
from
Nutrilinks
Sarl,
submitted
the transitional period laid down in Article 28(5) of that
pursuant to Article 13(5) of Regulation (EC) No
Regulation until the adoption of the list of permitted
1924/2006, the Authority was required to deliver an
health claims provided that they comply with that Regu
opinion on a health claim related to the effects of
lation.
Eff EXT and ‘Helps to support joint function by main
taining low levels of plasma C-reactive protein’ (Question
No EFSA-Q-2012-00386) ( 1 ). The claim proposed by the
(43) The
list
of
permitted
health
claims
has
been
established
applicant was worded, inter alia, as follows: ‘Helps to
by Commission Regulation (EU) No 432/2012 ( 3 ) and is
support joint function by maintaining low levels of
applicable since 14 December 2012. As regards claims
plasma C-reactive protein’.
referred to in Article 13(5) of Regulation (EC) No
1924/2006 for which the evaluation by the Authority
or consideration by the Commission has not been
completed by 14 December 2012 and which by virtue
(38) On 27 September 2012, the Commission and the
of this Regulation are not included in the list of
Member States received the scientific opinion from the
permitted health claims, it is appropriate to provide for
Authority, which noted that the claim refers to a
a transitional period during which they may still be used,
reduction of inflammation indicated by a lowered
in order to allow both food business operators and the
concentration of plasma C-reactive protein and
competent national authorities to adapt to the
concluded that on the basis of the data presented, a
prohibition of such claims.
reduction of inflammation in the context of diseases
such as osteoarthritis or rheumatoid arthritis is a thera
peutic target for the treatment of a disease.
(44) 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
been considered when setting the measures provided
(39) Regulation
(EC)
No
1924/2006
complements
the
general
for in this Regulation.
principles of Directive 2000/13/EC of the European
Parliament and of the Council of 20 March 2000 on
the approximation of the laws of the Member States
(45) The
measures
provided
for
in
this
Regulation
are
in
relating to the labelling, presentation and advertising of
accordance with the opinion of the Standing
foodstuffs ( 2 ). Article 2(1)(b) of Directive 2000/13/EC
Committee on the Food Chain and Animal Health and
provides that the labelling shall not attribute to any
neither the European Parliament nor the Council have
foodstuff the property of preventing, treating or curing
opposed them,
a human disease, or refer to such properties. Accordingly,
as the attribution of medicinal properties to foods is
prohibited, the claim related to the effects of Eff EXT
HAS ADOPTED THIS REGULATION:
should not be authorised.
Article 1
(40) The
health
claim
related
to
the
effects
of Eff EXT and
1. The
health
claims
listed
in
the
Annex
to
this
Regulation
‘Helps to support joint function by maintaining low
shall not be included in the Union list of permitted claims as
levels of plasma C-reactive protein’, is a health claim
provided for in Article 13(3) of Regulation (EC) No 1924/2006.
attributing medicinal properties to the food subject to
the claim and is therefore prohibited for foods.
2. However,
the
health
claims
referred
to
in
paragraph
1
used prior to the entry into force of this Regulation, may
continue to be used for a maximum period of six months
(41) The
health
claim
related
to
Prolibra
and
‘Helps
to
after the entry into force of this Regulation.
reduce body fat while preserving lean muscle’ is a
health claim as those referred to in point (c) of
Article 13(1) of Regulation (EC) No 1924/2006 which
Article 2
are subject to the transitional period laid down in
Article 28(6) of that Regulation. However, as the appli
This Regulation shall enter into force on the twentieth day
cation was not made before 19 January 2008, the
following that of its publication in the Official Journal of the
European Union.
( 1 ) EFSA Journal 2012; 10(9):2889.
( 2 ) OJ L 109, 6.5.2000, p. 29.
( 3 ) OJ L 136, 25.5.2012, p. 1.

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EN
31.10.2013 Official
Journal
of
the
European
Union L
289/53
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 30 October 2013.
For the Commission
The President
José Manuel BARROSO

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L 289/54
EN
Official Journal of the European Union
31.10.2013
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 Glucosamine Glucosamine
contributes
to
Q-2011-00907
newly developed scientific evidence
the protection of joint
and/or including a request for the
cartilage exposed to
protection of proprietary data
excessive motion or loading
and helps to improve the
range of motion in joints
Article 13(5) health claim based on Glucosamine Glucosamine
contributes
to
Q-2011-01113
newly developed scientific evidence
the maintenance of normal
and/or including a request for the
joint cartilage
protection of proprietary data
Article 13(5) health claim based on Wheat polar lipid extract Contributes
to
improve
skin
Q-2011-01122
newly developed scientific evidence
hydration
and/or including a request for the
protection of proprietary data
Article 13(5) health claim based on Saccharomyces cerevisiae var. Saccharomyces cerevisiae var. Q-2012-00271
newly developed scientific evidence boulardii CNCM I-3799
boulardii CNCM I-3799
and/or including a request for the
helps maintain intestinal
protection of proprietary data
comfort
Article 13(5) health claim based on A combination of thiamin, Helps to increase hair Q-2012-00334 &
newly developed scientific evidence riboflavin, niacin, pantothenic number
Q-2012-00335
and/or including a request for the acid, pyridoxine, D-biotin and
protection of proprietary data
pumpkin seed oil (Cucurbita
pepo L.)
Article 13(5) health claim based on Rhodiola rosea L. extract Helps
to
reduce
tiredness
in
Q-2012-00336
newly developed scientific evidence
case of stress
and/or including a request for the
protection of proprietary data
Article 13(5) health claim based on A combination of flaxseed oil Contributes to maintain skin Q-2012-00337
newly developed scientific evidence and vitamin E
permeability barrier function
and/or including a request for the
protection of proprietary data
Article 13(5) health claim based on Opti EFAX Opti EFAX helps to maintain Q-2012-00339
newly developed scientific evidence
healthy blood levels of LDL
and/or including a request for the
cholesterol
protection of proprietary data

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EN
31.10.2013 Official
Journal
of
the
European
Union L
289/55
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 Opti EFAX Opti EFAX helps to maintain Q-2012-00340
newly developed scientific evidence
healthy blood levels of HDL
and/or including a request for the
cholesterol
protection of proprietary data
Article 13(5) health claim based on KF2BL20 Helps
to
maintain
hair
Q-2012-00381
newly developed scientific evidence
strength
and/or including a request for the
protection of proprietary data
Article 13(5) health claim based on Hyaluronic acid Helps
to
maintain
good
skin
Q-2012-00382
newly developed scientific evidence
hydration
and/or including a request for the
protection of proprietary data
Article 13(5) health claim based on Opti EFAX Opti EFAX helps to maintain Q-2012-00383
newly developed scientific evidence
healthy blood levels of trig
and/or including a request for the
lycerides
protection of proprietary data
Article 13(5) health claim based on Transitech Improves
transit
and
durably
Q-2012-00296
newly developed scientific evidence
regulates it
and/or including a request for the
protection of proprietary data
Article 13(5) health claim based on Femilub Helps
to
reduce
vaginal
Q-2012-00571
newly developed scientific evidence
dryness
and/or including a request for the
protection of proprietary data
Article 13(5) health claim based on A combination of lycopene, Helps to prepare sensitive Q-2012-00592
newly developed scientific evidence vitamin E, lutein and skin from the inside to
and/or including a request for the selenium
improve their tolerance to
protection of proprietary data
the sun
Article 13(5) health claim based on Prolibra Helps
to
reduce
body
fat
Q-2012-00001
newly developed scientific evidence
while preserving lean muscle
and/or including a request for the
protection of proprietary data
Article 13(5) health claim based on Eff EXT Helps
to
support
joint
Q-2012-00386
newly developed scientific evidence
function by maintaining
and/or including a request for the
low levels of plasma
protection of proprietary data
C-reactive protein

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Document Outline

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