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24.10.2013 Official
Journal
of
the
European
Union L
282/39
COMMISSION REGULATION (EU) No 1017/2013
of 23 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,
a low-calorie diet (Question No EFSA-Q-2011-00016) ( 2 ).
The claim proposed by the applicant was worded as
follows: ‘Contributes to reduce the adipocytes size at
the abdominal level, in the context of a low-calorie diet’.
Having regard to the Treaty on the Functioning of the European
Union,
(6) On
30
September
2011,
the
Commission
and
the
Member States received the scientific opinion from the
Having regard to Regulation (EC) No 1924/2006 of the
Authority, which concluded that on the basis of the data
European Parliament and of the Council of 20 December
presented, a cause and effect relationship had not been
2006 on nutrition and health claims made on foods ( 1 ), and
established between the consumption of ‘hypo-caloric
in particular Article 18(5) thereof,
snacks (KOT products)’ and a beneficial physiological
effect related to the reduction of subcutaneous
adipocyte size at the abdominal level. Accordingly, as
the claim does not comply with the requirements of
Whereas:
Regulation (EC) No 1924/2006, it should not be auth
orised.
(1) Pursuant
to
Regulation
(EC)
No
1924/2006
health
claims
made on foods are prohibited unless they are authorised
(7) Following
an
application
from
Valio
Ltd,
submitted
by the Commission in accordance with that Regulation
pursuant to Article 13(5) of Regulation (EC) No
and included in a list of permitted claims.
1924/2006, the Authority was required to deliver an
opinion on a health claim related to the effects of
isoleucyl-prolyl-proline (IPP) and valyl-prolyl-proline
(VPP) on maintenance of normal blood pressure
(2) Regulation
(EC)
No
1924/2006
also
provides
that
appli
(Question No EFSA-Q-2011-00121)
( 3 ). The claim
cations for authorisations of health claims may be
proposed by the applicant was worded as follows:
submitted by food business operators to the national
‘Peptides IPP and VPP help to maintain normal blood
competent authority of a Member State. The national
pressure’.
competent authority is to forward valid applications to
the European Food Safety Authority (EFSA), hereinafter
referred to as ‘the Authority’.
(8) On
30
September
2011,
the
Commission
and
the
Member States 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
(3)
Following receipt of an application the Authority is to
inform without delay the other Member States and the
established between the consumption of IPP and VPP and
Commission thereof and to deliver an opinion on the
the claimed effect. Accordingly, as the claim does not
health claim concerned.
comply with the requirements of Regulation (EC) No

1924/2006, it should not be authorised.
(4)
The Commission is to decide on the authorisation of
(9) Following
an
application
from
Diana
Naturals,
submitted
health claims taking into account the opinion delivered
pursuant to Article 13(5) of Regulation (EC) No
by the Authority.
1924/2006, the Authority was required to deliver an
opinion on a health claim related to the effects of
Appl’In polyphenolic apple extract powder (Malus
domestica) on reduction of post-prandial glycaemic
(5) Following
an
application
from
Ceprodi
KOT,
submitted
responses (Question No EFSA-Q-2011-00190) ( 4 ). The
pursuant to Article 13(5) of Regulation (EC) No
claim proposed by the applicant was worded as
1924/2006, the Authority was required to deliver an
follows: ‘Appl’In contributes to decrease glycaemic
opinion on a health claim related to the effects of
response in women’.
‘hypo-caloric snacks (KOT products)’ on reduction of
adipocyte size at the abdominal level in the context of
( 2 ) EFSA Journal 2011; 9(9):2381.
( 3 ) EFSA Journal 2011; 9(9):2380.
( 1 ) OJ L 404, 30.12.2006, p. 9.
( 4 ) EFSA Journal 2011; 9(10):2383.

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L 282/40
EN
Official Journal of the European Union
24.10.2013
(10) On
5
October
2011,
the
Commission
and
the
Member
(anagen) of the hair cycle (Question No EFSA-Q-2011-
States received the scientific opinion from the Authority,
00896) ( 3 ). The claim proposed by the applicant was
which concluded that on the basis of the data presented,
worded as follows: ‘Spermidine prolongs the growing
a cause and effect relationship had not been established
phase (anagen) of the hair cycle’.
between the consumption of Appl’In and the claimed
effect. Accordingly, as the claim does not comply with
the requirements of Regulation (EC) No 1924/2006, it
should not be authorised.
(16) On
7
December
2011,
the
Commission
and
the
Member
States received the scientific opinion from the Authority,
which concluded that on the basis of the data presented,
the claimed effect is related to pathological conditions
(11) Following
an
application
from
Tchibo
GmbH,
submitted
leading to the shortening of the anagen phase of hair
pursuant to Article 13(5) of Regulation (EC) No
growth and relates thus to the treatment of a disease.
1924/2006, the Authority was required to deliver an
opinion on a health claim related to the consumption
of coffee C21 and reduction of spontaneous DNA strand
(17) Regulation
(EC)
No
1924/2006
complements
the
general
breaks (Question No EFSA-Q-2011-00783) ( 1 ). The claim
principles of Directive 2000/13/EC of the European
proposed by the applicant was worded as follows:
Parliament and of the Council of 20 March 2000 on
‘Regular consumption of Coffee C21 contributes to the
the approximation of the laws of the Member States
maintenance of DNA integrity in cells of the body’.
relating to the labelling, presentation and advertising of
foodstuffs ( 4 ). Article 2(1)(b) of Directive 2000/13/EC
provides that the labelling shall not attribute to any
foodstuff the property of preventing, treating or curing
(12) On 5 December 2011, the Commission and the Member
a human disease, or refer to such properties. Accordingly,
States received the scientific opinion from the Authority,
as the attribution of medicinal properties to foods is
which concluded that on the basis of the data presented,
prohibited, the claim related to the effects of spermidine
a cause and effect relationship had not been established
should not be authorised.
between the consumption of coffee C21 and the claimed
effect. Accordingly, as the claim does not comply with
the requirements of Regulation (EC) No 1924/2006, it
should not be authorised.
(18) Following
an
application
from
Clasado
Ltd,
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
(13) Following an application from Kao Corporation,
galacto-oligosaccharides from Bimuno (Bimuno
submitted pursuant to Article 13(5) of Regulation (EC)
GOS) and reducing gastro-intestinal discomfort
No 1924/2006, the Authority was required to deliver an
(Question No EFSA-Q-2011-00401)
( 5 ). The claim
opinion on a health claim related to the effects of
proposed by the applicant was worded as follows:
diacylglycerol (DAG) oil and reduction of body weight
‘Regular daily consumption of 1,37 g galacto-oligos
(Question No EFSA-Q-2011-00751)
( 2 ). The claim
accharides from Bimuno may reduce intestinal discom
proposed by the applicant was worded as follows: ‘Sub
fort’.
stituting your usual vegetable oil with DAG oil helps in
the management of body weight through weight loss’
(19) On
8
December
2011,
the
Commission
and
the
Member
States received the scientific opinion from the Authority,
(14) On 5 December 2011, the Commission and the Member
which concluded that on the basis of the data presented,
States received the scientific opinion from the Authority,
a cause and effect relationship had not been established
which concluded that on the basis of the data presented,
between the consumption of Bimuno GOS and the
a cause and effect relationship had not been established
claimed effect. Accordingly, as the claim does not
between the consumption of DAG oil (as a replacement
comply with the requirements of Regulation (EC) No
of triacylglycerol oils) and the claimed effect. Accord
1924/2006, it should not be authorised.
ingly, as the claim does not comply with the
requirements of Regulation (EC) No 1924/2006, it
should not be authorised.
(20) 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
(15) Following
an
application
from
Giuliani
S.p.A.,
submitted
beet fibre and decreasing intestinal transit time (Question
pursuant to Article 13(5) of Regulation (EC) No
No EFSA-Q-2011-00971) ( 6 ). The claim proposed by the
1924/2006 and including a request for protection of
applicant was worded as follows: ‘Sugar beet fibre
proprietary data, the Authority was required to deliver
decreases intestinal transit time’.
an opinion on a health claim related to the effects of
spermidine and prolongation of the growing phase
( 3 ) EFSA Journal 2011; 9(12):2466.
( 4 ) OJ L 109, 6.5.2000, p. 29.
( 1 ) EFSA Journal 2011; 9(12):2465.
( 5 ) EFSA Journal 2011; 9(12):2472.
( 2 ) EFSA Journal 2011; 9(12):2469.
( 6 ) EFSA Journal 2011; 9(12):2467.

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EN
24.10.2013 Official
Journal
of
the
European
Union L
282/41
(21) On 8 December 2011, the Commission and the Member
completed by 14 December 2012 and which by virtue
States received the scientific opinion from the Authority,
of this Regulation are not included in the list of
which concluded that on the basis of the data presented,
permitted health claims, it is appropriate to provide for
a cause and effect relationship had not been established
a transitional period during which they may still be used,
between the consumption of sugar beet fibre and the
in order to allow both food business operators and the
claimed effect. Accordingly, as the claim does not
competent national authorities to adapt to the
comply with the requirements of Regulation (EC) No
prohibition of such claims.
1924/2006, it should not be authorised.
(26) The
comments
from
the
applicants
and
the
members
of
(22) The
health
claim
related
to
the
effects
of
spermidine
and
the public received by the Commission pursuant to
prolongation of the growing phase (anagen) of the hair
Article 16(6) of Regulation (EC) No 1924/2006 have
cycle, is a health claim attributing medicinal properties to
been considered when setting the measures provided
the food subject to the claim and is therefore prohibited
for in this Regulation.
for foods.
(23) The
health
claims
related
to
‘hypo-caloric
snacks
(KOT
(27) The
measures
provided
for
in
this
Regulation
are
in
products)’ and to diacylglycerol (DAG) oil are health
accordance with the opinion of the Standing
claims as those referred to in point (c) of Article 13(1)
Committee on the Food Chain and Animal Health and
of Regulation (EC) No 1924/2006 which are subject to
neither the European Parliament nor the Council have
the transitional period laid down in Article 28(6) of that
opposed them,
Regulation. However, as the applications were not made
before 19 January 2008, the requirement provided for in
HAS ADOPTED THIS REGULATION:
point (b) of Article 28(6) of that Regulation is not
fulfilled, and therefore those claims may not benefit
from the transitional period provided for in that Article.
Article 1
1. The
health
claims
listed
in
the
Annex
to
this
Regulation
(24) The
other
health
claims
subject
to
this
Regulation
are
shall not be included in the Union list of permitted claims as
health claims as referred to in point (a) of Article 13(1)
provided for in Article 13(3) of Regulation (EC) No 1924/2006.
of Regulation (EC) No 1924/2006, which are subject to
the transitional period laid down in Article 28(5) of that
Regulation until the adoption of the list of permitted
2. However,
the
health
claims
referred
to
in
paragraph
1
health claims provided that they comply with that Regu
used prior to the entry into force of this Regulation, may
lation.
continue to be used for a maximum period of six months
after the entry into force of this Regulation.
(25) The list of permitted health claims has been established
by Commission Regulation (EU) No 432/2012 ( 1 ) and is
Article 2
applicable since 14 December 2012. As regards claims
referred to in Article 13(5) of Regulation (EC) No
This Regulation shall enter into force on the twentieth day
1924/2006 for which the evaluation by the Authority
following that of its publication in the Official Journal of the
or consideration by the Commission has not been
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 October 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 136, 25.5.2012, p. 1.

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L 282/42
EN
Official Journal of the European Union
24.10.2013
ANNEX
Rejected health claims
Application – Relevant provisions Nutrient, substance, food or
of Regulation (EC) No 1924/2006
food category
Claim EFSA
opinion
reference
Article 13(5) health claim
‘Hypo-caloric snacks (KOT Contributes to reduce the
Q-2011-00016
based on newly developed
products)’
adipocytes size at the
scientific evidence and/or
abdominal level, in the
including a request for the
context of a low-calorie diet
protection of proprietary data
Article 13(5) health claim
Isoleucyl-prolyl-proline
Peptides IPP and VPP help to Q-2011-00121
based on newly developed
(IPP) and valyl-prolyl-
maintain normal blood
scientific evidence and/or
proline (VPP)
pressure
including a request for the
protection of proprietary data
Article 13(5) health claim
Appl’In polyphenolic
Appl’In contributes to
Q-2011-00190
based on newly developed
apple extract powder
decrease glycaemic response
scientific evidence and/or
(Malus domestica)
in women
including a request for the
protection of proprietary data
Article 13(5) health claim
Coffee C21 Regular
consumption
of
Q-2011-00783
based on newly developed
Coffee C21 contributes to
scientific evidence and/or
the maintenance of DNA
including a request for the
integrity in cells of the body
protection of proprietary data
Article 13(5) health claim
Diacylglycerol (DAG) oil Substituting
your
usual
Q-2011-00751
based on newly developed
vegetable oil with DAG oil
scientific evidence and/or
helps in the management of
including a request for the
body weight through weight
protection of proprietary data
loss
Article 13(5) health claim
Spermidine Spermidine
prolongs
the
Q-2011-00896
based on newly developed
growing phase (anagen) of
scientific evidence and/or
the hair cycle
including a request for the
protection of proprietary data
Article 13(5) health claim
Bimuno (Bimuno GOS) Regular
daily
consumption Q-2011-00401
based on newly developed
of 1,37 g galacto-oligos
scientific evidence and/or
accharides from Bimuno
including a request for the
may reduce intestinal
protection of proprietary data
discomfort
Article 13(5) health claim
Sugar beet fibre Sugar
beet
fibre
decreases
Q-2011-00971
based on newly developed
intestinal transit time
scientific evidence and/or
including a request for the
protection of proprietary data

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