Ref. Ares(2014)271780 - 05/02/2014
EUROPEAN
COMMISSION
Brussels, XXX
SANCO/12712/2012 Rev. 3
(POOL/E4/2012/12712/12712R3-
EN.doc)
[…](2013) XXX draft
COMMISSION REGULATION (EU) No …/..
of XXX
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)
EN EN
COMMISSION REGULATION (EU) No …/..
of XXX
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,
Having regard to the Treaty on the Functioning of the European Union,
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 foods1, and in
particular Article 13(3) thereof,
Whereas:
(1)
Pursuant to Article 13(3) of Regulation (EC) No 1924/2006, the Commission adopted
Regulation (EU) No 432/2012 of 16 May 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 health2. The list as established by Regulation (EU) No
432/2012 contains 222 permitted health claims, corresponding to 497 entries in the
consolidated list3 submitted to the European Food Safety Authority ('the Authority')
for a scientific assessment.
(2)
However, at the time of the adoption of the list of permitted health claims, there were a
number of health claims whose evaluation by the Authority or consideration by the
Commission was not finalised4.
(3)
For health claims on micro-organisms which, in its initial assessment, the Authority
considered insufficiently characterised and health claims for which it concluded that
'the evidence provided is insufficient to establish a cause and effect relationship', the
Commission and Member States agreed that they would not be able to consider their
inclusion or non-inclusion in the list of permitted claims unless a further assessment
was carried out by the Authority. The Authority finalised its assessments on these
health claims and published its opinions on 5 June and 7 August 20125 concluding
that, on the basis of the data submitted, a cause and effect relationship has been
established between a food category, a food or one of its constituents and the claimed
effect for two health claims6.
(4)
The Commission has finalised its consideration of all health claims submitted for
evaluation except for three categories of claims made on specific groups of food or
1
OJ L 404, 30.12.2006, p. 9.
2
OJ L 136, 25.5.2012, p. 1.
3 http://www.efsa.europa.eu/en/topics/topic/article13.htm
4
Corresponding to 2232 entries (IDs) in the consolidated list.
5 http://www.efsa.europa.eu/en/publications.htm
6
Corresponding to entries ID 2926 and ID 1164 in the consolidated list.
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one of their constituents. Those categories include claims on plant or herbal
substances, commonly known as 'botanical substances', claims on specific foodstuffs,
namely foods for use in very low calorie diets and foods with reduced lactose content,
and claims on caffeine.
(5)
As regards botanical substances, Member States and stakeholders expressed concerns
as regards the difference in consideration given to the evidence based on 'traditional
use' on the one hand under Regulation (EC) No 1924/2006 in relation to health claims
and on the other hand under Directive 2001/83/EC of the European Parliament and of
the Council of 6 November 2001 on the Community code relating to medicinal
products for human use7 concerning the use as traditional herbal medicinal products.
Since the Commission considers that these concerns are relevant and require further
reflection and consultation, a decision on claims relating to botanical substances8
should only be taken once those steps have been completed.
(6)
As regards the health claims referring to the effects of very low calorie diets9 and
foods with reduced lactose content10, the current revision of the legislation on
foodstuffs for particular nutritional uses11 might have an impact on those health
claims. In order to avoid potential inconsistencies with that legislation, a decision on
the health claims referring to those foodstuffs should only be taken once that revision
has been finalised.
(7)
As regards the health claims referring to the effects of caffeine12, Member States
expressed concerns in relation to the safety of caffeine intake within different target
groups of the population. Since the Commission considers that these concerns are
relevant and require further scientific advice by the Authority, a decision on claims
relating to caffeine should only be taken once that step has been completed.
(8)
In order to ensure transparency and legal security for all interested parties, claims the
consideration of which has not yet been completed will remain published on the
website of the Commission13 and may continue to be used pursuant to paragraphs 5
and 6 of Article 28 of Regulation (EC) No 1924/2006.
(9)
Health claims corresponding to the conclusions of the Authority that a cause and effect
relationship has been established between a food category, a food or one of its
constituents and the claimed effect and which comply with the requirements of
Regulation (EC) No 1924/2006 should be authorised under Article 13(3) of that
Regulation, and included in the list of permitted claims established by Regulation
(EU) No 432/201214.
(10)
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
use. Accordingly, the list of permitted claims should include the wording of the claims
and specific conditions of use of the claims, and where applicable, conditions or
7
OJ L 311, 28.11.2001, p. 67.
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 the consolidated list.
11
COM (2011)353 final.
12
Corresponding to entries ID 737, ID 1486, ID 1488, ID 1490, ID 736, ID 1101, ID 1187, ID 1485,
ID 1491, ID 2063, ID 2103, ID 2375 in the consolidated list.
13
http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm
14
Corresponding to 18 entries (IDs) in the consolidated list, as they appear in the Annex to this
Regulation.
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restrictions of use and/or an additional statement or warning, in accordance with the
rules laid down in Regulation (EC) No 1924/2006 and in line with the opinions of the
Authority.
(11)
Pursuant to Article 6(1) and Article 13(1) of Regulation (EC) No 1924/2006 health
claims need to be based on generally accepted scientific evidence. Accordingly, health
claims that did not receive a favourable assessment on their scientific substantiation by
the Authority, during either the initial assessment or during the 'further assessment'
process, should not be authorised.
(12)
Authorisation may also legitimately be withheld if health claims do not comply with
other general and specific requirements of Regulation (EC) No 1924/2006, even in the
case of a favourable scientific assessment by the Authority. The Authority concluded
that for one claim on the effect of L-arginine15 on the maintenance of normal ammonia
clearance and for another claim on the effect of L-tyrosine16 on the normal synthesis of
catecholamines a cause and effect relationship has been established. The Commission
and the Member States have considered whether health claims reflecting those
conclusions should be authorised. On the basis of the data submitted and of the current
scientific knowledge, the Authority concluded that no conditions of use can be defined
which would accompany the health claim on L-arginine17, while for the health claim
on L-tyrosine, the 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
1924/2006'18.
In the Authority's response of 9 November 2012 to the request of the
Commission for clarification, the Authority noted that its conclusions for those claims
were based on the known biochemical role of the two amino acids, as contained in
protein. It added that it could not provide a quantitative indication of the 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 specific conditions for
the use of those claims to ensure that the amino acids are contained in the final product
in a quantity that will produce the respective beneficial physiological effects in
accordance with point (i) of Article 5(1)(b) of Regulation (EC) No 1924/2006. In the
absence of such specific conditions of use the beneficial effect of the substance to
which the claim relates cannot be assured. Therefore, those claims could be misleading
the consumer and should not be included in the lists of permitted health claims.
(13)
This Regulation should apply six months after the date of its entry into force to enable
food business operators to adapt to its requirements, including the prohibition
according to Article 10(1) of Regulation (EC) No 1924/2006 of those health claims
whose evaluation by the Authority and whose consideration by the Commission has
been completed.
(14)
In line with Article 20(1) of Regulation (EC) No 1924/2006, the Register of nutrition
and health claims containing all authorised health claims and those rejected and the
reasons for their rejection should be updated in the light of the present Regulation and
its deferred application.
15
Corresponding to entry ID 4683 in the consolidated list.
16
Corresponding to entry ID 1928 in the consolidated list.
17
http://www.efsa.europa.eu/en/efsajournal/doc/2051.pdf
18
http://www.efsa.europa.eu/en/efsajournal/doc/2270.pdf
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(15)
Comments and positions from the members of the public and interested stakeholders,
received by the Commission have been adequately considered when setting the
measures provided for in this Regulation.
(16)
Regulation (EU) No 432/2012 should therefore be amended accordingly.
(17)
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 …
[six months after the date of its entry into force].
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the Commission
The
President
José Manuel BARROSO
EN
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ANNEX
Regulation (EU) No 432/2012 is amended as follows:
In the Annex, the following entries of permitted health claims are inserted in an alphabetical order:
Conditions and/or
Relevant entry
restrictions of use
Nutrient,
number in the
of the food and/or
EFSA Journal
substance, food
Claim
Conditions of use of the claim
Consolidated List
additional
number
or food category
submitted to EFSA
statement or
for its assessment
warning
The claim may be used for food which
Consumption of alpha-
contains at least 5 g of alpha-cyclodextrin per
cyclodextrin as part of a
50 g of starch in a quantified portion as part
starch-containing meal
Alpha-
of the meal. In order to bear the claim
contributes to the
2012;10(6):2713
2926
cyclodextrin
information shall be given to the consumer
reduction of the blood
that the beneficial effect is obtained by
glucose rise after that
consuming the alpha-cyclodextrin as part of
meal
the meal.
The claim may be used only for food which
provides a daily intake of 2 g of DHA and
which contains DHA in combination with
eicosapentaenoic acid (EPA). In order to
bear the claim, information shall be given to
DHA contributes to the
The claim shall not
Docosahexaenoic
the consumer that the beneficial effect is
maintenance of normal
be used for foods 2010;8(10):1734 533,
691,
3150
acid (DHA)
obtained with a daily intake of 2 g of DHA.
blood triglyceride levels
targeting children.
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.
EN
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EN
Conditions and/or
Relevant entry
restrictions of use
Nutrient,
number in the
of the food and/or
EFSA Journal
substance, food
Claim
Conditions of use of the claim
Consolidated List
additional
number
or food category
submitted to EFSA
statement or
for its assessment
warning
The claim may be used only for food which
provides a daily intake of 3 g of EPA and
DHA. In order to bear the claim, information
shall be given to the consumer that the
Docosahexaenoic
DHA and EPA
beneficial effect is obtained with a daily The claim shall not
acid and
contribute to the
2009; 7(9):1263
502, 506, 516, 703,
intake of 3 g of EPA and DHA. When the be used for foods
Eicosapentaenoic
maintenance of normal
2010;8(10):1796
1317, 1324
claim is used on food supplements and/or targeting children.
acid (DHA/EPA)
blood pressure
fortified foods information shall also be given
to consumers not to exceed a supplemental
daily intake of 5
g of EPA and DHA
combined.
The claim may be used only for food which
provides a daily intake of 2 g of EPA and
DHA. In order to bear the claim, information
shall be given to the consumer that the
Docosahexaenoic
DHA and EPA
beneficial effect is obtained with a daily The claim shall not
acid and
contribute to the
2009; 7(9):1263
506, 517, 527, 538,
intake of 2 g of EPA and DHA. When the be used for foods
Eicosapentaenoic
maintenance of normal
2010;8(10):1796
1317, 1324, 1325
claim is used on food supplements and/or targeting children.
acid (DHA/EPA)
blood triglyceride levels
fortified foods information shall also be given
to consumers not to exceed a supplemental
daily intake of 5
g of EPA and DHA
combined.
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EN
Conditions and/or
Relevant entry
restrictions of use
Nutrient,
number in the
of the food and/or
EFSA Journal
substance, food
Claim
Conditions of use of the claim
Consolidated List
additional
number
or food category
submitted to EFSA
statement or
for its assessment
warning
The claim may be used only for food which
Dried plums of
provides a daily intake of 100 g of dried
Dried plums/prunes
'prune' cultivars
plums (prunes). In order to bear the claim,
contribute to normal
2012;10(6):2712
1164
(
Prunus
information shall be given to the consumer
bowel function
domestica L.)
that the beneficial effect is obtained with a
daily intake of 100 g of dried plums (prunes).
Consumption of foods
In order to bear the claim, glucose and/or
containing fructose
sucrose should be replaced by fructose in
leads to a lower blood
sugar-sweetened foods or drinks so that the
Fructose
2011;9(6):2223
558
glucose rise compared
reduction in content of glucose and/or
to foods containing
sucrose, in these foods or drinks, is at least
sucrose or glucose
30%.
EN
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EN
Conditions and/or
Relevant entry
restrictions of use
Nutrient,
number in the
of the food and/or
EFSA Journal
substance, food
Claim
Conditions of use of the claim
Consolidated List
additional
number
or food category
submitted to EFSA
statement or
for its assessment
warning
In order to bear the claim, information shall
be given to the consumer that the beneficial
effect is obtained with a daily intake of 130 g
of carbohydrates from all sources.
The claim may be used for food which
contains at least 20 g carbohydrates which are
Carbohydrates
metabolised by humans, excluding polyols,
contribute to the
per quantified portion and complies with the
Carbohydrates
2011;9(6):2226
603,
653
maintenance of normal
nutrition claim LOW SUGARS as listed in
brain function
the Annex of Regulation (EC) No 1924/2006.
The claim may also be used for dextrose
tablets. When the claim is used on dextrose
tablets, information shall also be given to the
consumer that intake of added sugars from all
sources shall not exceed 10% of the total
daily energy intake (=50g/day).
EN
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Document Outline