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4.9.2013 Official
Journal
of
the
European
Union L
235/3
COMMISSION REGULATION (EU) No 851/2013
of 3 September 2013
authorising certain health claims 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,
lation (EC) No 1924/2006, the Authority was required to
deliver an opinion on a health claim related to the effects
of a reformulated acidic non-alcoholic drink on reduction
Having regard to the Treaty on the Functioning of the European
of tooth demineralisation (Question No EFSA-Q-2010-
Union,
00784) ( 3 ). The claim proposed by the applicant
was worded as follows: ‘ “Toothkind” drinks help to
maintain healthy teeth’.
Having regard to Regulation (EC) No 1924/2006 of the
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,
(7) On
16
December
2010,
the
Commission
and
the
Member States received the scientific opinion from the
Authority which concluded that on the basis of the data
Whereas:
presented, a cause and effect relationship had been estab
lished between the consumption of typical conventional
juice drinks at an exposure frequency of four times per
(1) Regulation
(EC)
No
1924/2006
provides
that
health
day and of typical sugar-containing beverages (8-12 g
claims made on food are prohibited unless they are auth
sugars/100 ml) at an exposure frequency of seven times
orised by the Commission in accordance with that Regu
per day and tooth demineralisation. Furthermore, it
lation and included in a list of permitted claims.
concluded that replacement of those beverages with
‘toothkind’ drinks may contribute to reduced tooth
demineralisation.
(2) Pursuant
to
Article
13(3)
of
Regulation
(EC)
No
1924/2006, Commission Regulation (EU) No
432/2012 ( 2 ) was adopted, which established a list of
permitted health claims made on foods other than
(8) Following
consultation
with
the
Member
States,
the
those referring to the reduction of disease risk and to
Commission requested additional advice from the Auth
children’s development and health.
ority, inter alia, on whether the beneficial effect is shown

or expected to be shown for less frequent consumers of
conventional juice drinks and typical sugar-containing
(3) Regulation
(EC)
No
1924/2006
also
provides
that
appli
non-alcoholic beverages. The Authority in its opinion
cations for authorisations of health claims are to be
of 8 July 2011 (Question No EFSA-Q-2011-00781) ( 4 )
submitted by food business operators to the national
concluded that a beneficial effect on maintaining tooth
competent authority of a Member State. The national
mineralisation may be expected for people who consume
competent authority is to forward valid applications to
conventional juice drinks or sugar-containing non-
the European Food Safety Authority (EFSA), hereinafter
alcoholic beverages and who are also frequent
referred to as ‘the Authority’, for a scientific assessment,
consumers of sugars and/or acids from other beverages
as well as to the Commission and the Member States for
or foods that can contribute to tooth demineralisation, if
information.
one or more servings of conventional juice drinks or
sugar-containing non-alcoholic beverages are substituted
by an equivalent number of servings of ‘toothkind’ juice
(4)
The Commission is to decide on the authorisation of
drink. Furthermore, it was clarified that ‘reduction of
health claims taking into account the opinion delivered
tooth demineralisation’ has a similar meaning to ‘main
by the Authority.
tenance of tooth mineralisation’. Accordingly, a health
claim reflecting this conclusion and accompanied by
specific conditions of use should be considered as
(5) In
order
to
stimulate
innovation,
health
claims
which
are
complying with the requirements of Regulation (EC) No
based on newly developed scientific evidence and/or
1924/2006, and it should be included in the Union list
which include a request for the protection of proprietary
of permitted claims, established by Regulation (EU) No
data shall undergo an accelerated type of authorisation.
432/2012.
(6) Following
an
application
from
GlaxoSmithKline
Services
Unlimited, submitted pursuant to Article 13(5) of Regu
(9) The
Authority
indicated
in
its
opinion
that
its
conclusions could not have been reached without
considering 15 studies claimed by the applicant as
( 1 ) OJ L 404, 30.12.2006, p. 9.
proprietary. Those studies are the following:
( 2 ) Commission Regulation (EU) No 432/2012 of 16 May 2012 estab
lishing a list of permitted health claims made on foods, other than
those referring to the reduction of disease risk and to children’s
( 3 ) The EFSA Journal 2010; 8(12):1884.
development and health (OJ L 136, 25.5.2012, p. 1).
( 4 ) The EFSA Journal 2011; 9(7):2293.

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L 235/4
EN
Official Journal of the European Union
4.9.2013
— Adams G, North M, De’Ath J. Principal Investigator:
(sucrose) and a negative control (sorbitol) on the pH
West NX, 2004. An investigation into the Erosive
of dental plaque. GlaxoSmithKline Report N1010201,
Effect of Hot Drinks. GlaxoSmithKline Report
UK,
NHCMA0303, UK,
— Adams G, North M. Principal Investigator Duggal MS,
— Gard’ner K, Moohan M, Smith S. Principal Investi
2003. Development of Intra-Oral Cariogenicity (ICT)
gator: Ong TJ, 2003a. A single blind, four-way
Model #3. GlaxoSmithKline Report NHCMA0301,
crossover study to investigate the effect of two
UK,
formulations of fruit drinks in comparison to a
positive control (sucrose) and a negative control (sor
bitol) on the pH of dental plaque. GlaxoSmithKline
Report N1010199, UK,
— Adnitt C, Adams G, North M. Principal Investigator
Toumba KJ., 2005. Development of Intra-Oral Cario
genicity (ICT) Model #4. GlaxoSmithKline Report
NHCMA0302, UK,
— Gard’ner K, Moohan M, Smith S. Principal Investi
gator: Jackson R, 2003b. A single blind, four-way
crossover study to investigate the effect of two
formulations of fruit drinks in comparison to a
— Broughton J, North, M, Roman L. Principal Inves
positive control (sucrose) and a negative control (sor
tigator Toumba KJ., 2006. Development of Intra-
bitol) on the pH of dental plaque. GlaxoSmithKline
Oral Cariogenicity (ICT) Model #5. GlaxoSmithKline
Report N1010200, UK,
Report NHCMA0401, UK,
— Hollas M, McAuliffe T, Finke M. Principal Investigator:
— De’Ath, J, North M, Smith S. Principal Investigator:
West NX, 2005. An investigation into the effect of a
Ong TJ., 2002a. A single blind, four-way crossover
modified blackcurrant drink on tooth enamel with
study to investigate the effect of two formulations of
and without additional tooth brushing. Glaxo
fruit drinks in comparison to a positive control
SmithKline Report NMA0501, UK,
(sucrose) and a negative control (sorbitol) on the
pH of dental plaque. GlaxoSmithKline Report
N1760182, UK,
— May R, and Hughes JM. Principal Investigator:
Toumba KJ, 1998c. A single blind, five-way
— De’Ath J, North M, Smith S. Principal Investigator:
crossover study to investigate the effect of three
Jackson R, 2002b. A single blind, four-way
new formulations of fruit drinks in comparison to
crossover study to investigate the effect of two
a positive control (sucrose) and a negative control
formulations of fruit drinks in comparison to a
(sorbitol) on the pH of dental plaque. Glaxo
positive control (sucrose) and a negative control (sor
SmithKline Report N1010068, UK,
bitol) on the pH of dental plaque. GlaxoSmithKline
Report N1760183, UK,
— May R, and Moohan M. Principal Investigator: Duggal
MS, 1999. A single blind, three-way crossover study
— De’Ath J, North M, Smith S. Principal Investigator:
to investigate the effect of a new formulation of fruit
Preston A, 2002c. A single blind, four-way
drink in comparison to a positive control (sucrose)
crossover study to investigate the effect of two
and a negative control (sorbitol) on the pH of dental
formulations of fruit drinks in comparison to a
plaque in children. GlaxoSmithKline Report
positive control (sucrose) and a negative control (sor
N1010104, UK,
bitol) on the pH of dental plaque. GlaxoSmithKline
Report N1760184, UK,
— May R, Darby-Dowan A, Smith S. Principal Investi
— De’Ath J, Moohan M, Smith S. Principal Investigator:
gator: Curzon M, 1998a. A single blind, five-way
Toumba KJ, 2003. A single blind, four-way crossover
crossover healthy volunteer study to investigate the
study to investigate the effect of two formulations of
effect of a new orange and a new strawberry formu
fruit drinks in comparison to a positive control
lation of fruit drink in comparison to a blackcurrant

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EN
4.9.2013 Official
Journal
of
the
European
Union L
235/5
fruit drink and two control treatments on the pH of
— Laville M, Rabasa-Lhoret R, Normand S and Braesco
dental plaque. GlaxoSmithKline Report N1010021,
V, 2005. Measurement of metabolic outcome of
UK,
carbohydrates of two types of cereal products,
— May R, Hughes JM. Principal Investigator: Duggal MS,
1998b. A single blind, five-way crossover study to
— Rabasa-Lhoret R, Peronnet F, Jannot C, Fuzellier G
investigate the effect of three new formulations of
and Gausseres N, 2007. Metabolic fate of four
fruit drinks in comparison to a positive control
cereal products consumed as part of a breakfast by
(sucrose) and a negative control (sorbitol) on the
healthy female subjects,
pH of dental plaque. GlaxoSmithKline Report
N1010067, UK.
— Vinoy S, Aubert R and Chapelot D, 2000. A cereal
product high in slowly available glucose increases
(10) All
the
justifiable
information
provided
by
the
applicant
subsequent satiety feelings and decreases glucose
has been assessed by the Commission and it is
and insulin responses.
considered that the requirements laid down in
Article 21(1) of Regulation (EC) No 1924/2006 are
(14) All
the
justifiable
information
provided
by
the
applicant
fulfilled for all 15 studies claimed as proprietary. By
has been assessed by the Commission and it is
letter dated 12 June 2013, the applicant informed the
considered that the requirements laid down in
Commission that there have been some changes to the
Article 21(1) of Regulation (EC) No 1924/2006 are
structure and location of its business. Therefore, the
fulfilled for the studies claimed as proprietary. By letter
applicant formally requested that protection of
dated 1 October 2012, the applicant informed the
proprietary data is granted to GlaxoSmithKline Services
Commission about the restructuring process, by means
Unlimited and its affiliates, GSK House, 980 Great West
of which the Kraft Foods group span off its business,
Road, Brentford, TW89GS, United Kingdom. Accord
thereby creating two fully independent groups, one of
ingly, the scientific data and other information included
them being the Mondelēz International group. As from
in those studies may not be used for the benefit of a
1 October 2012, Kraft Foods Europe — Biscuits R & D
subsequent applicant for a period of five years from the
belongs to the Mondelēz International group, and the
date of authorisation, under the conditions laid down in
applicant formally requested that the protection of
Article 21(1) of Regulation (EC) No 1924/2006.
proprietary data is granted to the Mondelēz International
group. Accordingly, the scientific data and other
(11) Following
an
application
from
Kraft
Foods
Europe
—
Biscuits R & D submitted pursuant to Article 13(5) of
information included in those studies may not be used
Regulation (EC) No 1924/2006, the Authority was
for the benefit of a subsequent applicant for a period of
required to deliver an opinion on a health claim related
five years from the date of authorisation, under the
to the effects of slowly digestible starch (SDS) in starch-
conditions laid down in Article 21(1) of Regulation
containing foods and reduction of post-prandial
(EC) No 1924/2006.
glycaemic responses (Question No EFSA-Q-2010-
00966) (
(15) Following
an
application
from
Barry
Callebaut
Belgium

1 ). The claim proposed by the applicant was
worded as follows: ‘Slowly digestible starch provides
NV submitted pursuant to Article 13(5) of Regulation
carbohydrates that are regularly and continuously
(EC) No 1924/2006, the Authority was required to
absorbed and released. They contribute to a moderate
deliver an opinion on a health claim related to the
post-prandial glycaemic response’.
effects of cocoa flavanols on endothelium-dependent
vasodilation (Question No EFSA-Q-2012-00002)
( 2 ).
(12) On 21 July 2011, the Commission and the Member
The claim proposed by the applicant was worded as
States received the scientific opinion from the
follows: ‘Cocoa flavanols help maintain endothelium-
Authority which concluded that on the basis of the
dependent vasodilation which contributes to healthy
data presented, a cause and effect relationship had been
blood flow’.
established between the consumption of SDS, as
compared to the consumption of rapidly digestible
(16) On 17 July 2012, the Commission and the Member
starch (RDS), in cereal products and reduced post-
States received the scientific opinion from the
prandial glycaemic responses. Accordingly, a health
Authority which concluded that on the basis of the
claim reflecting this conclusion should be considered as
data presented a cause and effect relationship had been
complying with the requirements of Regulation (EC) No
established between the consumption of cocoa flavanols
1924/2006 and should be included in the Union list of
and the claimed effect. Accordingly, a health claim
permitted claims, established by Regulation (EU) No
reflecting this conclusion should be considered as
432/2012.
complying with the requirements of Regulation (EC) No
1924/2006 and should be included in the Union list of
(13) The
Authority
indicated
in
its
opinion
that
the
four
studies claimed as proprietary by the applicant were
permitted claims, established by Regulation (EU) No
required to establish conditions of use for this specific
432/2012.
claim. Those studies are the following:
(17) The Authority indicated in its opinion that its
— Brand-Miller JC, Holt S, Atkinson F, Fuzellier G and
conclusions could not have been reached without
Agnetti V, 2006. Determination of the postprandial
considering one human intervention study claimed by
responses to two cereal foods eaten alone or as part
the applicant as proprietary. That study is Grassi D,
of a mixed meal,
Desideri G, Necozione S, Di Giosia P, Cheli P, Barnabei
( 1 ) The EFSA Journal 2011; 9(7):2292.
( 2 ) The EFSA Journal 2012; 10(7):2809.

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L 235/6
EN
Official Journal of the European Union
4.9.2013
R, Allegaert L, Bernaert H and Ferri C, 2011. Cocoa
(22) The
comments
from
the
applicants
and
the
members
of
consumption dose-dependently improves flow-mediated
the public received by the Commission pursuant to
dilation and arterial stiffness and decreases blood
Article 16(6) of Regulation (EC) No 1924/2006 have
pressure in healthy subjects.
been considered when setting the measures provided
for in this Regulation.
(18) All
the
justifiable
information
provided
by
the
applicant
has been assessed by the Commission and it is
(23) Regulation (EU) No 432/2012 should therefore be
considered that the requirements laid down in
amended accordingly.
Article 21(1) of Regulation (EC) No 1924/2006 are
fulfilled for the study claimed as proprietary. Accordingly,
(24) The
Member
States
have
been
consulted,
the scientific data and other information included in that
study may not be used for the benefit of a subsequent
HAS ADOPTED THIS REGULATION:
applicant for a period of five years from the date of
authorisation, under the conditions laid down in that
Article 1
Article.
1. The health claims set out in the Annex to this Regulation
shall be included in the Union list of permitted claims as
(19) One of the objectives of Regulation (EC) No 1924/2006
provided for in Article 13(3) of Regulation (EC) No 1924/2006.
is to ensure that health claims are truthful, clear and
reliable and useful to the consumer, and that the
2. The
use
of
health
claims
referred
to
in
paragraph
1
shall
wording and the presentation are taken into account in
be restricted to the applicants for a period of five years after the
that respect. Therefore, where the wording of claims used
entry into force of this Regulation. After the expiry of that
by the applicant has the same meaning for consumers as
period, those health claims may be used, in conformity with
that of an authorised health claim, because they demon
the conditions applying to them, by any food business operator.
strate the same relationship that exists between a food
category, a food or one of its constituents and health,
Article 2
they should be subject to the same conditions of use as
those listed in the Annex to this Regulation.
The scientific data and other information included in the appli

cations, which are claimed by the applicants as proprietary and
without the submission of which the health claims could not
(20) In
accordance
with
Article
20
of
Regulation
(EC)
No
have been authorised, are restricted for use for the benefit of the
1924/2006, the Register of nutrition and health claims
applicants for a period of five years from the date of entry into
containing all authorised health claims should be updated
force of this Regulation under the conditions laid down in
in order to take into account this Regulation.
Article 21(1) of Regulation (EC) No 1924/2006.
(21) Since
the
applicants
claim
protection
of
proprietary
data,
Article 3
it is considered appropriate to restrict the use of these
The Annex to Regulation (EU) No 432/2012 is amended in
claims in favour of the applicants for a period of five
accordance with the Annex to this Regulation.
years. However, the authorisation of these claims
restricted for the use of an individual operator does
Article 4
not prevent other applicants from applying for authori
sation to use the same claims in case the application is
This Regulation shall enter into force on the twentieth day
based on data and studies other than those protected
following that of its publication in the Official Journal of the
under Article 21 of Regulation (EC) No 1924/2006.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 September 2013.
For the Commission
The President
José Manuel BARROSO

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4.9.2013 Off
ANNEX
In the Annex to Regulation (EU) No 432/2012, the following entries are inserted in an alphabetical order:
Conditions and/or restrictions
Nutrient, substance, food or food
of use of the food and/or
Relevant entry number in the
category
Claim
Conditions of use of the claim
additional statement or
EFSA Journal number
Consolidated List submitted to
EN
warning
EFSA for its assessment

‘Reformulated, non-alcoholic, acidic Replacing sugar-containing, acidic In order to bear the claim, reformulated acidic
— 2010;8(12):1884
—
drink with:
drinks, such as soft drinks drinks shall comply with the description of
— less than 1 g fermentable carbo (typically 8-12
g sugars/100
ml), the food subject to the claim
hydrate per 100 ml (sugars and with reformulated drinks
other carbohydrates except contributes to the maintenance of
polyols),
tooth mineralisation (*)
— calcium in a range from 0,3 to
0,8 mol per mol acidulant,
— display of pH between 3,7-4,0.
icial
Slowly digestible starch Consumption
of
products
high
in
The claim may be used only on food where
— 2011;9(7):2292
—
Jour
slowly digestible starch (SDS) raises the digestible carbohydrates provide at least
nal
blood glucose concentration less 60 % of the total energy and where at least
after a meal compared to 55 % of those carbohydrates is digestible
of
products low in SDS (**)
starch, of which at least 40 % is SDS
the
European
Cocoa flavanols Cocoa
flavanols
help
maintain
the
Information shall be given to the consumer
— 2012;10(7):2809
—
elasticity of blood vessels, which that the beneficial effect is obtained with a
contributes to normal blood daily intake of 200 mg of cocoa flavanols.
flow (***)
Union
The claim can be used only for cocoa
beverages (with cocoa powder) or for dark
chocolate which provide at least a daily
intake of 200 mg of cocoa flavanols with a
degree of polymerisation 1-10
(*) Authorised on 24.9.2013 restricted to the use of GlaxoSmithKline Services Unlimited and its affiliates, GSK House, 980 Great West Road, Brentford, TW89GS, United Kingdom, for a period of five years.
(**) Authorised on 24.9.2013 restricted to the use of Mondelēz International group, Three Parkway North Deerfield, IL 60015, United States of America, for a period of five years.
(***) Authorised on 24.9.2013 restricted to the use of Barry Callebaut Belgium NV, Aalstersestraat 122, B-9280 Lebbeke-Wieze, Belgium, for a period of five years.’
L
235/7

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