HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 160/4
EN
Official Journal of the European Union
12.6.2013
COMMISSION REGULATION (EU) No 536/2013
of 11 June 2013
amending Regulation (EU) No 432/2012 establishing 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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
tionship has been established between a food category, a
food or one of its constituents and the claimed effect for
two health claims ( 6 ).
Having regard to the Treaty on the Functioning of the European
(4) The
Commission
has
finalised
its
consideration
of
all
Union,
health claims submitted for evaluation except for four
categories of claims made on specific groups of food
or one of their constituents. Those categories include
Having regard to Regulation (EC) No 1924/2006 of the
claims on plant or herbal substances, commonly
European Parliament and of the Council of 20 December
known as ‘botanical substances’, claims on specific food
2006 on nutrition and health claims made on foods (
stuffs, namely foods for use in very low calorie diets and

1 ), and
in particular Article 13(3) thereof,
foods with reduced lactose content, claims on caffeine
and a claim on carbohydrates.
(5) As
regards
botanical
substances,
Member
States
and
Whereas:
stakeholders expressed concerns as regards the difference
in consideration given to the evidence based on ‘tradi
tional use’ on the one hand under Regulation (EC) No
1924/2006 in relation to health claims and on the other
(1) Pursuant
to
Article
13(3)
of
Regulation
(EC)
No
hand under Directive 2001/83/EC of the European
1924/2006, the Commission adopted Regulation (EU)
Parliament and of the Council of 6 November 2001
No 432/2012 of 16 May 2012 establishing a list of
on the Community code relating to medicinal products
permitted health claims made on foods other than
for human use ( 7 ) concerning the use as traditional herbal
those referring to the reduction of disease risk and to
medicinal products. Since the Commission considers that
children’s development and health ( 2 ). The list as estab
these concerns are relevant and require further reflection
lished by Regulation (EU) No 432/2012 contains 222
and consultation, a decision on claims relating to
permitted health claims, corresponding to 497 entries
botanical substances ( 8 ) should only be taken once
in the consolidated list ( 3 ) submitted to the European
those steps have been completed.
Food Safety Authority (the Authority) for a scientific
assessment.
(6) As
regards
the
health
claims
referring
to
the
effects
of
very low calorie diets ( 9 ) and foods with reduced lactose
content ( 10 ), the current revision of the legislation on
foodstuffs for particular nutritional uses (
(2)
However, at the time of the adoption of the list of

11 ) might have
permitted health claims, there were a number of health
an impact on those health claims. In order to avoid
claims whose evaluation by the Authority or
potential inconsistencies with that legislation, a decision
consideration by the Commission was not finalised (
on the health claims referring to those foodstuffs should

4 ).
only be taken once that revision has been finalised.
(7) As
regards
the
health
claims
referring
to
the
effects
of
(3)
For health claims on micro-organisms which, in its initial
caffeine ( 12 ), Member States expressed concerns in
assessment, the Authority considered insufficiently char
relation to the safety of caffeine intake within different
acterised and health claims for which it concluded that
target groups of the population. Since the Commission
‘the evidence provided is insufficient to establish a cause
considers that these concerns are relevant and require
and effect relationship’, the Commission and Member
further scientific advice by the Authority, a decision on
States agreed that they would not be able to consider
claims relating to caffeine should only be taken once that
their inclusion or non-inclusion in the list of permitted
step has been completed.
claims unless a further assessment was carried out by the
Authority. The Authority finalised its assessments on
( 6 ) Corresponding to entries ID 2926 and ID 1164 in the consolidated
these health claims and published its opinions on
list.
5 June and 7 August 2012 ( 5 ) concluding that, on the
( 7 ) OJ L 311, 28.11.2001, p. 67.
basis of the data submitted, a cause and effect rela
( 8 ) Corresponding to 2078 entries (IDs) in the consolidated list.
( 9 ) Corresponding to entry ID 1410 in the consolidated list.
( 10 ) Corresponding to entries ID 646, ID 1224, ID 1238, ID 1339 in
( 1 ) OJ L 404, 30.12.2006, p. 9.
the consolidated list.
( 2 ) OJ L 136, 25.5.2012, p. 1.
( 11 ) COM(2011) 353 final.
( 3 ) http://www.efsa.europa.eu/en/topics/topic/article13.htm
( 12 ) Corresponding to entries ID 737, ID 1486, ID 1488, ID 1490, ID
( 4 ) Corresponding to 2232 entries (IDs) in the consolidated list.
736, ID 1101, ID 1187, ID 1485, ID 1491, ID 2063, ID 2103, ID
( 5 ) http://www.efsa.europa.eu/en/publications.htm
2375 in the consolidated list.

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EN
12.6.2013 Official
Journal
of
the
European
Union L
160/5
(8)
As regards the health claim referring to the beneficial
normal ammonia clearance and for another claim on the
effects of carbohydrates ( 1 ), some Member States raised
effect of L-tyrosine ( 5 ) on the normal synthesis of cate
concerns as to its authorisation, because they consider it
cholamines a cause and effect relationship has been
being potentially confusing to the consumer, particularly
established. The Commission and the Member States
in light of national dietary advice to reduce sugars
have considered whether health claims reflecting those
consumption. Since the Commission considers that, for
conclusions should be authorised. On the basis of the
this specific claim, conflicting objectives need to be
data submitted and of the current scientific knowledge,
reconciled, further analysis will be required for setting
the Authority concluded that no conditions of use can be
conditions of use for that claim. Therefore, a decision
defined which would accompany the health claim on L-
on the claim relating to carbohydrates should only be
arginine ( 6 ), while for the health claim on L-tyrosine, the
taken once this analysis has been completed.
Authority proposed as appropriate conditions of use that
‘a food should be at least a source of protein as per
Annex to Regulation (EC) No 1924/2006’ ( 7 ). In the
Authority’s response of 9 November 2012 to the
(9) In
order
to
ensure
transparency
and
legal
security
for
all
request of the Commission for clarification, the
interested parties, claims the consideration of which has
Authority noted that its conclusions for those claims
not yet been completed will remain published on the
were based on the known biochemical role of the two
website of the Commission ( 2 ) and may continue to be
amino acids, as contained in protein. It added that it
used pursuant to paragraphs 5 and 6 of Article 28 of
could not provide a quantitative indication of the
Regulation (EC) No 1924/2006.
necessary daily intake of L-tyrosine and L-arginine per
se to produce the respective beneficial physiological
effects. Accordingly, it is not possible to establish
(10) Health
claims
corresponding
to
the
conclusions
of
the
specific conditions for the use of those claims to
Authority that a cause and effect relationship has been
ensure that the amino acids are contained in the final
established between a food category, a food or one of its
product in a quantity that will produce the respective
constituents and the claimed effect and which comply
beneficial physiological effects in accordance with point
with the requirements of Regulation (EC) No
(i) of Article 5(1)(b) of Regulation (EC) No 1924/2006.
1924/2006 should be authorised under Article 13(3) of
In the absence of such specific conditions of use the
that Regulation, and included in the list of permitted
beneficial effect of the substance to which the claim
claims established by Regulation (EU) No 432/2012 ( 3 ).
relates cannot be assured. Therefore, those claims could
be misleading the consumer and should not be included
in the lists of permitted health claims.
(11) Article
13(3)
of
Regulation
(EC)
No
1924/2006
provides
that permitted health claims must be accompanied with
all necessary conditions (including restrictions) for their
(14) This Regulation should apply six months after the date of
use. Accordingly, the list of permitted claims should
its entry into force to enable food business operators to
include the wording of the claims and specific conditions
adapt to its requirements, including the prohibition
of use of the claims, and where applicable, conditions or
according to Article 10(1) of Regulation (EC) No
restrictions of use and/or an additional statement or
1924/2006 of those health claims whose evaluation by
warning, in accordance with the rules laid down in Regu
the Authority and whose consideration by the
lation (EC) No 1924/2006 and in line with the opinions
Commission has been completed.
of the Authority.
(15) In line with Article 20(1) of Regulation (EC) No
(12) Pursuant
to
Article
6(1)
and
Article
13(1)
of
Regulation
(EC) No 1924/2006 health claims need to be based on
1924/2006, the Register of nutrition and health claims
generally accepted scientific evidence. Accordingly, health
containing all authorised health claims and those rejected
claims that did not receive a favourable assessment on
and the reasons for their rejection should be updated in
their scientific substantiation by the Authority, during
the light of the present Regulation and its deferred appli
either the initial assessment or during the ‘further
cation.
assessment’ process, should not be authorised.
(16) Comments
and positions from the members of the
(13) Authorisation may also legitimately be withheld if health
public and interested stakeholders, received by the
claims do not comply with other general and specific
Commission have been adequately considered when
requirements of Regulation (EC) No 1924/2006, even
setting the measures provided for in this Regulation.
in the case of a favourable scientific assessment by the
Authority. The Authority concluded that for one claim
on the effect of L-arginine ( 4 ) on the maintenance of
(17) Regulation (EU) No 432/2012 should therefore be
amended accordingly.
( 1 ) Corresponding to entries ID 603 and ID 653 in the consolidated list.
( 2 ) http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm
( 3 ) Corresponding to 16 entries (IDs) in the consolidated list, as they
( 5 ) Corresponding to entry ID 1928 in the consolidated list.
appear in the Annex to this Regulation.
( 6 ) http://www.efsa.europa.eu/en/efsajournal/doc/2051.pdf
( 4 ) Corresponding to entry ID 4683 in the consolidated list.
( 7 ) http://www.efsa.europa.eu/en/efsajournal/doc/2270.pdf

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L 160/6
EN
Official Journal of the European Union
12.6.2013
(18) The measures provided for in this Regulation are in accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health, and neither the European Parliament nor the
Council have opposed them,
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Regulation (EU) No 432/2012 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.
It shall apply from 2 January 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 11 June 2013.
For the Commission
The President
José Manuel BARROSO

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12.6.2013 Off
ANNEX
In the Annex to Regulation (EU) No 432/2012, the following entries of permitted health claims are inserted in alphabetical order:
Relevant entry
Nutrient, substance, food or
Conditions and/or restrictions of use
number in the
EN
food category
Claim
Conditions of use of the claim
of the food and/or additional
EFSA Journal number
Consolidated List
statement or warning
submitted to EFSA

for its assessment
Alpha-cyclodextrin Consumption
of
alpha- The claim may be used for food which contains at least 5 g of
2012; 10(6):2713 2926
cyclodextrin as part of a
alpha-cyclodextrin per 50 g of starch in a quantified portion as
starch-containing meal
part of the meal. In order to bear the claim information shall be
contributes to the reduction given to the consumer that the beneficial effect is obtained by
of the blood glucose rise
consuming the alpha-cyclodextrin as part of the meal.
after that meal
Docosahexaenoic acid
DHA contributes to the
The claim may be used only for food which provides a daily intake The claim shall not be used for
2010; 8(10):1734 533,
691,
3150
icial
(DHA)
maintenance of normal
of 2 g of DHA and which contains DHA in combination with foods targeting children.
blood triglyceride levels
eicosapentaenoic acid (EPA). In order to bear the claim, information
Jour
shall be given to the consumer that the beneficial effect is obtained
nal
with a daily intake of 2 g of DHA. When the claim is used on food
supplements and/or fortified foods information shall also be given
of
to consumers not to exceed a supplemental daily intake of 5 g of
the
EPA and DHA combined.
European
Docosahexaenoic acid and DHA and EPA contribute to The claim may be used only for food which provides a daily intake The claim shall not be used for
2009; 7(9):1263
502, 506, 516,
Eicosapentaenoic acid
the maintenance of normal of 3 g of EPA and DHA. In order to bear the claim, information foods targeting children.
2010; 8(10):1796
703, 1317, 1324
Union
(DHA/EPA)
blood pressure
shall be given to the consumer that the beneficial effect is obtained
with a daily intake of 3 g of EPA and DHA. When the claim is used
on food supplements and/or fortified foods information shall also
be given to consumers not to exceed a supplemental daily intake of
5 g of EPA and DHA combined.
Docosahexaenoic acid and DHA and EPA contribute to The claim may be used only for food which provides a daily intake The claim shall not be used for
2009; 7(9):1263
506, 517, 527,
Eicosapentaenoic acid
the maintenance of normal of 2 g of EPA and DHA. In order to bear the claim, information foods targeting children.
2010; 8(10):1796
538, 1317,
(DHA/EPA)
blood triglyceride levels
shall be given to the consumer that the beneficial effect is obtained
1324, 1325
with a daily intake of 2 g of EPA and DHA. When the claim is used
on food supplements and/or fortified foods information shall also
be given to consumers not to exceed a supplemental daily intake of
5 g of EPA and DHA combined.
Dried plums of ‘prune’
Dried plums/prunes
The claim may be used only for food which provides a daily intake
2012; 10(6):2712 1164
cultivars (Prunus domestica contribute to normal bowel of 100 g of dried plums (prunes). In order to bear the claim,
L.)
function
information shall be given to the consumer that the beneficial
L
effect is obtained with a daily intake of 100 g of dried plums
160/7
(prunes).

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L 160/8
Relevant entry
Nutrient, substance, food or
Conditions and/or restrictions of use
number in the
food category
Claim
Conditions of use of the claim
of the food and/or additional
EFSA Journal number
Consolidated List
statement or warning
submitted to EFSA
for its assessment
Fructose Consumption
of
foods
In order to bear the claim, glucose and/or sucrose should be
2011; 9(6):2223 558
containing fructose leads to replaced by fructose in sugar-sweetened foods or drinks so that
a lower blood glucose rise
the reduction in content of glucose and/or sucrose, in these foods
EN

compared to foods
or drinks, is at least 30 %.
containing sucrose or
glucose
Off
icial
Jour
nal
of
the
European
Union
12.6.2013

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