欧盟Eurlex法规详细信息

L 119/4
EN
Official Journal of the European Union
7.5.2011
COMMISSION REGULATION (EU) No 440/2011
of 6 May 2011
on the authorisation and refusal of authorisation of certain health claims made on foods and
referring to children’s development and health
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) The
eight
opinions
referred
to
in
this
Regulation
are
related to applications for health claims referring to the
effects of essential fatty acids on children’s development
and health, as referred to in Article 14(1)(b) of Regu
lation (EC) No 1924/2006.
Having regard to the Treaty on the Functioning of the European
Union,
(6) Following
three
applications
from
Mead
Johnson
&
Company, submitted on 19 January 2008 pursuant to
Article 14(1)(b) of Regulation (EC) No 1924/2006 and
Having regard to Regulation (EC) No 1924/2006 of the
requesting the protection of proprietary data for nineteen
European Parliament and of the Council of 20 December
studies, the Authority was required to deliver three
2006 on nutrition and health claims made on foods ( 1 ), and
opinions on health claims related to the effects of doco
in particular Article 17(3) thereof,
sahexaenoic acid (DHA) and arachidonic acid (ARA) on
visual development (Question No EFSA-Q-2008-211 ( 2 ),
EFSA-Q-2008-688 ( 3 ) and EFSA-Q-2008-689 ( 4 )). The
claims proposed by the applicant were worded,
Whereas:
respectively, as follows: ‘DHA and ARA contribute to
the optimal visual development of infants and young
children’, ‘Lipil contributes to optimal visual devel
opment of infants and young children’ and ‘Enfamil
Premium contributes to optimal visual development of
(1) Pursuant
to
Regulation
(EC)
No
1924/2006
health
claims
infants’. Lipil and Enfamil Premium, as stated by the
made on foods are prohibited unless they are authorised
applicant, contain DHA and ARA at specific levels and
by the Commission in accordance with that Regulation
ratio.
and included in a list of permitted claims.
(7) On the basis of the data submitted, the Authority
concluded in its opinions received by the Commission
(2) Regulation
(EC)
No
1924/2006
also
provides
that
appli
on 13 February and 23 March 2009 respectively that a
cations for authorisations of health claims may be
cause and effect relationship had been established
submitted by food business operators to the national
between the intake of infant and follow-on formulae
competent authority of a Member State. The national
supplemented with DHA and the visual development in
competent authority is to forward valid applications to
infants either breastfed until weaning or having received
the European Food Safety Authority (EFSA), hereinafter
a DHA-enriched formula containing 0,3 % of fatty acids
referred to as ‘the Authority’.
as DHA from birth until weaning. The Authority noted
that it could not have reached this conclusion without
considering seven studies claimed by the applicant as
proprietary. Further, the Authority concluded that a
cause and effect relationship had not been established
(3)
Following receipt of an application the Authority is to
between the intake of ARA and the claimed effect.
inform without delay the other Member States and the
Commission of the application, and to deliver an opinion
on a health claim concerned.
(8) In
the
Authority’s
responses
of
3
September
2009
to
comments received pursuant to Article 16(6) of Regu
lation (EC) No 1924/2006 and of 3 December 2009
to the request of the Commission for advice relating,
(4)
The Commission is to decide on the authorisation of
inter alia, to the applications referred to in Question
health claims taking into account the opinion delivered
No EFSA-Q-2008-211, EFSA-Q-2008-688 and EFSA-Q-
by the Authority. Any decision to amend the lists of
2008-689, it was concluded that the claimed effect could
permitted health claims shall include the particulars
be extended to foods intended to infants while they are
referred to in Article 16(4) of Regulation (EC) No
being weaned, as defined in Commission Directive
1924/2006 including, inter alia, and as the case may
be, specific conditions of use.
( 2 ) The EFSA Journal (2009), 1003, 1-8.
( 3 ) The EFSA Journal (2009), 941, 1-14.
( 1 ) OJ L 404, 30.12.2006, p. 9.
( 4 ) The EFSA Journal (2009), 1004, 1-8.

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EN
7.5.2011 Official
Journal
of
the
European
Union L
119/5
2006/125/EC ( 1 ). Accordingly and without prejudice to
Authority was required to deliver an opinion on a health
Directive 2009/39/EC of the European Parliament and
claim related to the effects of DHA on cognitive devel
of the Council ( 2 ) and specific Directives applicable to
opment (Question No EFSA-Q-2008-773) ( 4 ). The claim
certain groups of foodstuffs for particular nutritional
proposed by the applicant was worded as follows: ‘DHA
uses, a health claim reflecting this conclusion and accom
is important for early development of the brain in the
panied by specific conditions of use should be considered
foetus (unborn child) and infant. Maternal DHA supply
as complying with the requirements of Regulation (EC)
contributes to the child’s cognitive development’.
No 1924/2006, and it should be included in the Union
list of permitted claims.
(9) Following the receipt of the Authority’s opinions in
relation to the applications referred to in Question No
(13) On the basis of the data submitted, the Authority
concluded in its opinion received by the Commission
EFSA-Q-2008-211, EFSA-Q-2008-688 and EFSA-Q-
on 23 April 2009 that there was insufficient evidence
2008-689, the Commission went back to the applicant
to establish a cause and effect relationship between the
for further clarification on the justification provided
consumption of supplementary DHA during pregnancy
regarding the seven studies claimed as proprietary and
and lactation and cognitive development in unborn
in particular regarding the ‘exclusive right of reference’
children or breastfed infants.
as referred to in Article 21(1)(b) of Regulation (EC) No

1924/2006. All the justifiable information provided by
the applicant has been assessed. As all seven studies had
been published prior to the submission of the appli
cations for authorisation of the health claims and in
the light of the objectives of Regulation (EC) No
1924/2006 among which is the protection of the
investment made by innovators in gathering the
(14) However,
in
the
Authority’s
responses
of
4
August
2009
information and data supporting an application under
to comments received pursuant to Article 16(6) of Regu
that Regulation, their protection is not justified and
lation (EC) No 1924/2006 and of 3 December 2009 to a
accordingly it should not be granted.
request from the Commission for advice related, inter

alia, to the applications referred to in Question No
EFSA-Q-2008-675 and EFSA-Q-2008-773, it was
concluded that as DHA is a major structural and func
tional long chain polyunsaturated fatty acid, it can
(10) Following
an
application
from
Merck
Selbstmedikation
contribute to the normal brain development and to the
GmbH, submitted on 16 January 2008 pursuant to
normal development of the eye of the foetus and
Article 14(1)(b) of Regulation (EC) No 1924/2006, the
breastfed infants. Further, it was clarified that most
Authority was required to deliver an opinion on a health
DHA is provided to breastfed infants via breast milk in
claim related to the effects of DHA on visual devel
which the DHA concentration is dependent both on
opment of the unborn child and breastfed infant
maternal DHA dietary intake and on maternal DHA
(Question No EFSA-Q-2008-675)
( 3 ). The claim
stores. Accordingly, health claims reflecting these
proposed by the applicant was worded as follows:
conclusions and accompanied by specific conditions of
‘DHA is important for early development of the eyes in
use should be considered as complying with the
the foetus (unborn child) and infant. Maternal DHA
requirements of Regulation (EC) No 1924/2006, and
supply contributes to the child’s visual development’.
they should be included in the Union list of permitted
claims.
(11) On the basis of the data submitted, the Authority
concluded in its opinion received by the Commission
on 23 April 2009 that there was insufficient evidence
to establish a cause and effect relationship between the
(15) Article
16(4)
of
Regulation
(EC)
No
1924/2006
provides
consumption of supplementary DHA during pregnancy
that an opinion in favour of authorising a health claim
and lactation and visual development in unborn children
should include certain particulars. Accordingly, those
or breastfed infants.
particulars should be set out in the Annex to the
present Regulation as regards the authorised claim and
include, as the case may be, the revised wording of the
claim, specific conditions of use of the claim, and, where
(12) Following
an
application
from
Merck
Selbstmedikation
applicable, conditions or restrictions of use of the food
GmbH, submitted on 16 January 2008 pursuant to
and/or an additional statement or warning, in accordance
Article 14(1)(b) of Regulation (EC) No 1924/2006, the
with the rules laid down in Regulation (EC) No
1924/2006 and in line with the opinions of the
Authority.
( 1 ) OJ L 339, 6.12.2006, p. 16.
( 2 ) OJ L 124, 20.5.2009, p. 21.
( 3 ) The EFSA Journal (2009), 1006, 1-12.
( 4 ) The EFSA Journal (2009), 1007, 1-14.

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L 119/6
EN
Official Journal of the European Union
7.5.2011
(16) One of the objectives of Regulation (EC) No 1924/2006
Accordingly, as risk managers could not establish
is to ensure that health claims are truthful, clear and
specific conditions of use in accordance with
reliable and useful to the consumer, and that wording
Article 16(4) of the Regulation (EC) No 1924/2006,
and presentation are taken into account in that respect.
and given that the lack of such specific conditions of
Therefore, where the wording of claims has the same
use means that the beneficial effect of the product
meaning for consumers as that of an authorised health
could not be assured, which amounts to misleading the
claim, because they demonstrate the same relationship
consumer, this health claim should not be included in
that exists between a food category, a food or one of
the lists of permitted health claims.
its constituents and health, they should be subject to the
same conditions of use indicated in the Annex to this
Regulation.
(20) 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
(17) Following three applications from Mead Johnson &
for in this Regulation. The Commission took also into
Company, submitted on 19 January 2008 pursuant to
account all relevant advice from the Authority, including
Article 14(1)(b) of Regulation (EC) No 1924/2006, the
opinions on labelling reference intake values for n-3
Authority was required to deliver three opinions on
and n-6 polyunsaturated fatty acids (Question No
health claims related to the effects of DHA and ARA
EFSA-Q-2009-00548 ( 4 )) and on dietary reference
on brain development (Question No EFSA-Q-2008-
values for fat including saturated fatty acids, poly
212 ( 1 ), EFSA-Q-2008-690
( 2 ) and EFSA-Q-2008-
unsaturated fatty acids, monounsaturated fatty acids,
691 ( 3 )). The claims proposed by the applicant were
trans-fatty acids, and cholesterol (Question No EFSA-Q-
worded, respectively, as follows: ‘DHA and ARA
2008-466 ( 5 )).
contribute to the optimal brain development of infants
and young children’, ‘Lipil contributes to optimal brain
development of infants and young children’ and
‘Enfamil Premium contributes to optimal brain devel
(21) In
accordance
with
Article
28(6)
of
Regulation
(EC)
No
opment of infants and young children’. Lipil and
1924/2006, health claims referred to in its
Enfamil Premium as stated by the applicant contain
Article 14(1)(b) and not authorised by a decision
DHA and ARA at specific levels and ratio.
pursuant to Article 17(3) of Regulation (EC) No
1924/2006 may continue to be used for 6 months
after the adoption of this Regulation, provided an appli
cation was made before 19 January 2008. Accordingly,
the transition period laid down in that Article is
(18) On the basis of the data submitted, the Authority
applicable to health claims listed in Annex II to this
concluded in its opinions received by the Commission
Regulation.
on 23 March 2009 that there was insufficient evidence
to establish a cause and effect relationship between the
consumption of DHA and ARA, Lipil and Enfamil
Premium, respectively, and the claimed effect.
(22) 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,
(19) In
the
Authority’s
responses
of
3
September
2009
to
comments received pursuant to Article 16(6) of Regu
lation (EC) No 1924/2006 and of 3 December 2009
to the request of the Commission for advice relating,
HAS ADOPTED THIS REGULATION:
inter alia, to the applications referred to in Question
No EFSA-Q-2008-690, EFSA-Q-2008-691 and EFSA-Q-
2008-212, it was concluded that as DHA is a major
structural and functional long chain polyunsaturated
Article 1
fatty acid, it can contribute to the normal brain devel
opment of the foetus, infants and young children.
1. The
health
claims
listed
in
Annex
I
to
this
Regulation
may
Therefore, the Commission and the Member States
be made on foods on the European Union market in
considered whether a health claim reflecting this
compliance with the conditions laid down in that Annex.
conclusion should be authorised. However, on the basis
of the data submitted in the three applications and of the
current scientific knowledge, the Authority could not
provide specific advice on the appropriate conditions of
2. The
health
claims
referred
to
in
paragraph
1
shall
be
use that should accompany this health claim.
included in the Union list of permitted claims referred to in
Article 14(1) of Regulation (EC) No 1924/2006.
( 1 ) The EFSA Journal (2009), 1000, 1-13.
( 2 ) The EFSA Journal (2009) 1001, 1-8.
( 4 ) The EFSA Journal (2009), 1176, 1-11.
( 3 ) The EFSA Journal (2009) 1002, 1-8.
( 5 ) The EFSA Journal 2010; 8(3) 1461.

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EN
7.5.2011 Official
Journal
of
the
European
Union L
119/7
Article 2
1. The health claims listed in Annex II to this Regulation shall not be included in the Union list of
permitted claims as provided for in Article 14(1) of Regulation (EC) No 1924/2006.
2. However,
they
may
continue
to
be
used
for
6
months
after
the
entry
into
force
of
this
Regulation.
Article 3
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 6 May 2011.
For the Commission
The President
José Manuel BARROSO

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L 119/8
ANNEX I
Permitted health claims
Conditions and/or
Application – Relevant provisions
restrictions of use of
EFSA opinion
EN
of Regulation (EC) No 1924/2006
Applicant – Address
Nutrient, substance, food
or food category
Claim Conditions
of
use
of
the
claim
the food and/or
additional statement
reference

or warning
Article 14(1)(b) health claim Mead Johnson &
Docosahexaenoic
Docosahexaenoic acid (DHA) Information shall be given to the consumer that
Q-2008-211,
referring to children’s devel Company, 3 rue Joseph acid (DHA)
intake contributes to the normal the beneficial effect is obtained with a daily
Q-2008-688,
opment and health
Monier-BP 325, 92506
visual development of infants up intake of 100 mg of DHA.
Q-2008-689
Rueil-Malmaison Cedex,
to 12 months of age.
France
When the claim is used on follow-on formula,
the food shall contain at least 0,3 % of the total
fatty acids as DHA.
Off
Article 14(1)(b) health claim Merck Selbstmedikation Docosahexaenoic
Docosahexaenoic acid (DHA) Information shall be given to pregnant and
Q-2008-675
referring to children’s devel GmbH, Roesslerstrasse
acid (DHA)
maternal intake contributes to the lactating women that the beneficial effect is
icial
opment and health
96, 64293 Darmstadt,
normal development of the eye of obtained with a daily intake of 200 mg of
Jour
Germany
the foetus and breastfed infants.
DHA in addition to the recommended daily
intake for omega-3 fatty acids for adults, i.e.
nal
250 mg DHA and eicosapentaenoic acid (EPA).
of
The claim can be used only for food which
the
provides a daily intake of at least 200 mg DHA.
European
Article 14(1)(b) health claim Merck Selbstmedikation Docosahexaenoic
Docosahexaenoic acid (DHA) Information shall be given to pregnant and
Q-2008-773
referring to children’s devel GmbH, Roesslerstrasse
acid (DHA)
maternal intake contributes to the lactating women that the beneficial effect is
opment and health
96, 64293 Darmstadt,
normal brain development of the obtained with a daily intake of 200 mg of
Union
Germany
foetus and breastfed infants.
DHA in addition to the recommended daily
intake for omega-3 fatty acids for adults, i.e.
250 mg DHA and EPA.
The claim can be used only for food which
provides a daily intake of at least 200 mg DHA.
7.5.2011

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7.5.2011 Off
ANNEX II
Rejected health claims
Application – Relevant provisions of Regulation (EC)
No 1924/2006
Nutrient, substance, food or food category Claim EFSA
opinion
reference
EN
Article 14(1)(b) health claim referring to children’s devel Docosahexaenoic acid (DHA) and arachidonic acid Docosahexaenoic acid (DHA) and arachidonic acid
Q-2008-212

opment and health
(ARA)
(ARA) contribute to the optimal brain development of
infants and young children.
Article 14(1)(b) health claim referring to children’s devel Lipil Lipil
contributes
to
optimal
brain
development
of
Q-2008-690
opment and health
infants and young children.
Article 14(1)(b) health claim referring to children’s devel Enfamil Premium Enfamil
Premium
contributes
to
optimal
brain
Q-2008-691
opment and health
development of infants and young children.
icial
Jour
nal
of
the
European
Union
L
119/9

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