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,  
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 foods (  1 ), and 
in particular Article 17(3) thereof,  
Whereas:  
(1) Pursuant to Regulation (EC) No 1924/2006 health claims 
made on foods are prohibited unless they are authorised 
by the Commission in accordance with that Regulation 
and included in a list of permitted claims.  
(2) Regulation (EC) No 1924/2006 also provides that appli ­
cations for authorisations of health claims may be 
submitted by food business operators to the national 
competent authority of a Member State. The national 
competent authority is to forward valid applications to 
the European Food Safety Authority (EFSA), hereinafter 
referred to as ‘the Authority’.  
(3) Following receipt of an application the Authority is to 
inform without delay the other Member States and the 
Commission of the application, and to deliver an opinion 
on a health claim concerned.  
(4) The Commission is to decide on the authorisation of 
health claims taking into account the opinion delivered 
by the Authority. Any decision to amend the lists of 
permitted health claims shall include the particulars 
referred to in Article 16(4) of Regulation (EC) No 
1924/2006 including, inter alia, and as the case may 
be, specific conditions of use.  (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.  
(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 
requesting the protection of proprietary data for nineteen 
studies, the Authority was required to deliver three 
opinions on health claims related to the effects of doco ­
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, 
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 
infants’. Lipil® and Enfamil® Premium, as stated by the 
applicant, contain DHA and ARA at specific levels and 
ratio.  
(7) On the basis of the data submitted, the Authority 
concluded in its opinions received by the Commission 
on 13 February and 23 March 2009 respectively that a 
cause and effect relationship had been established 
between the intake of infant and follow-on formulae 
supplemented with DHA and the visual development in 
infants either breastfed until weaning or having received 
a DHA-enriched formula containing 0,3 % of fatty acids 
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 
between the intake of ARA and the claimed effect.  
(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, 
inter alia, to the applications referred to in Question 
No EFSA-Q-2008-211, EFSA-Q-2008-688 and EFSA-Q- 
2008-689, it was concluded that the claimed effect could 
be extended to foods intended to infants while they are 
being weaned, as defined in Commission DirectiveEN L 119/4 Official Journal of the European Union 7.5.2011  
( 1 ) OJ L 404, 30.12.2006, p. 9.  ( 2 ) The EFSA Journal (2009), 1003, 1-8.  
( 3 ) The EFSA Journal (2009), 941, 1-14.  
( 4 ) The EFSA Journal (2009), 1004, 1-8.2006/125/EC (  1 ). Accordingly and without prejudice to 
Directive 2009/39/EC of the European Parliament and 
of the Council (  2 ) and specific Directives applicable to 
certain groups of foodstuffs for particular nutritional 
uses, a health claim reflecting this conclusion and accom ­
panied by specific conditions of use should be considered 
as complying with the requirements of Regulation (EC) 
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 
EFSA-Q-2008-211, EFSA-Q-2008-688 and EFSA-Q- 
2008-689, the Commission went back to the applicant 
for further clarification on the justification provided 
regarding the seven studies claimed as proprietary and 
in particular regarding the ‘exclusive right of reference’ 
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 
information and data supporting an application under 
that Regulation, their protection is not justified and 
accordingly it should not be granted.  
(10) Following an application from Merck Selbstmedikation 
GmbH, submitted on 16 January 2008 pursuant to 
Article 14(1)(b) of Regulation (EC) No 1924/2006, the 
Authority was required to deliver an opinion on a health 
claim related to the effects of DHA on visual devel ­
opment of the unborn child and breastfed infant 
(Question No EFSA-Q-2008-675) (  3 ). The claim 
proposed by the applicant was worded as follows: 
‘DHA is important for early development of the eyes in 
the foetus (unborn child) and infant. Maternal DHA 
supply contributes to the child’s visual development’.  
(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 
consumption of supplementary DHA during pregnancy 
and lactation and visual development in unborn children 
or breastfed infants.  
(12) Following an application from Merck Selbstmedikation 
GmbH, submitted on 16 January 2008 pursuant to 
Article 14(1)(b) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health 
claim related to the effects of DHA on cognitive devel ­
opment (Question No EFSA-Q-2008-773) (  4 ). The claim 
proposed by the applicant was worded as follows: ‘DHA 
is important for early development of the brain in the 
foetus (unborn child) and infant. Maternal DHA supply 
contributes to the child’s cognitive development’.  
(13) 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 
consumption of supplementary DHA during pregnancy 
and lactation and cognitive development in unborn 
children or breastfed infants.  
(14) However, in the Authority’s responses of 4 August 2009 
to comments received pursuant to Article 16(6) of Regu ­
lation (EC) No 1924/2006 and of 3 December 2009 to a 
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 
contribute to the normal brain development and to the 
normal development of the eye of the foetus and 
breastfed infants. Further, it was clarified that most 
DHA is provided to breastfed infants via breast milk in 
which the DHA concentration is dependent both on 
maternal DHA dietary intake and on maternal DHA 
stores. Accordingly, health claims reflecting these 
conclusions and accompanied by specific conditions of 
use should be considered as complying with the 
requirements of Regulation (EC) No 1924/2006, and 
they should be included in the Union list of permitted 
claims.  
(15) Article 16(4) of Regulation (EC) No 1924/2006 provides 
that an opinion in favour of authorising a health claim 
should include certain particulars. Accordingly, those 
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 
applicable, conditions or restrictions of use of the food 
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.EN 7.5.2011 Official Journal of the European Union L 119/5  
( 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.(16) One of the objectives of Regulation (EC) No 1924/2006 
is to ensure that health claims are truthful, clear and 
reliable and useful to the consumer, and that wording 
and presentation are taken into account in that respect. 
Therefore, where the wording of claims has the same 
meaning for consumers as that of an authorised health 
claim, because they demonstrate the same relationship 
that exists between a food category, a food or one of 
its constituents and health, they should be subject to the 
same conditions of use indicated in the Annex to this 
Regulation.  
(17) Following three applications from Mead Johnson & 
Company, submitted on 19 January 2008 pursuant to 
Article 14(1)(b) of Regulation (EC) No 1924/2006, the 
Authority was required to deliver three opinions on 
health claims related to the effects of DHA and ARA 
on brain development (Question No EFSA-Q-2008- 
212 (  1 ), EFSA-Q-2008-690 (  2 ) and EFSA-Q-2008- 
691 (  3 )). The claims proposed by the applicant were 
worded, respectively, as follows: ‘DHA and ARA 
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 ­
opment of infants and young children’. Lipil® and 
Enfamil® Premium as stated by the applicant contain 
DHA and ARA at specific levels and ratio.  
(18) On the basis of the data submitted, the Authority 
concluded in its opinions received by the Commission 
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.  
(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, 
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 
fatty acid, it can contribute to the normal brain devel ­
opment of the foetus, infants and young children. 
Therefore, the Commission and the Member States 
considered whether a health claim reflecting this 
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 
use that should accompany this health claim. Accordingly, as risk managers could not establish 
specific conditions of use in accordance with 
Article 16(4) of the Regulation (EC) No 1924/2006, 
and given that the lack of such specific conditions of 
use means that the beneficial effect of the product 
could not be assured, which amounts to misleading the 
consumer, this health claim should not be included in 
the lists of permitted health claims.  
(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 
for in this Regulation. The Commission took also into 
account all relevant advice from the Authority, including 
opinions on labelling reference intake values for n-3 
and n-6 polyunsaturated fatty acids (Question No 
EFSA-Q-2009-00548 (  4 )) and on dietary reference 
values for fat including saturated fatty acids, poly ­
unsaturated fatty acids, monounsaturated fatty acids, 
trans-fatty acids, and cholesterol (Question No EFSA-Q- 
2008-466 (  5 )). 
(21) In accordance with Article 28(6) of Regulation (EC) No 
1924/2006, health claims referred to in its 
Article 14(1)(b) and not authorised by a decision 
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 
applicable to health claims listed in Annex II to this 
Regulation.  
(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,  
HAS ADOPTED THIS REGULATION:  
Article 1  
1. The health claims listed in Annex I to this Regulation may 
be made on foods on the European Union market in 
compliance with the conditions laid down in that Annex.  
2. The health claims referred to in paragraph 1 shall be 
included in the Union list of permitted claims referred to in 
Article 14(1) of Regulation (EC) No 1924/2006.EN L 119/6 Official Journal of the European Union 7.5.2011  
( 1 ) The EFSA Journal (2009), 1000, 1-13.  
( 2 ) The EFSA Journal (2009) 1001, 1-8.  
( 3 ) The EFSA Journal (2009) 1002, 1-8.  ( 4 ) The EFSA Journal (2009), 1176, 1-11.  
( 5 ) The EFSA Journal 2010; 8(3) 1461.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 BARROSOEN 7.5.2011 Official Journal of the European Union L 119/7ANNEX I  
Permitted health claims  
Application – Relevant provisions 
of Regulation (EC) No 1924/2006  Applicant – Address  Nutrient, substance, food 
or food category  Claim  Conditions of use of the claim  Conditions and/or 
restrictions of use of 
the food and/or 
additional statement 
or warning  EFSA opinion 
reference  
Article 14(1)(b) health claim 
referring to children’s devel ­
opment and health  Mead Johnson & 
Company, 3 rue Joseph 
Monier-BP 325, 92506 
Rueil-Malmaison Cedex, 
France  Docosahexaenoic 
acid (DHA)  Docosahexaenoic acid (DHA) 
intake contributes to the normal 
visual development of infants up 
to 12 months of age.  Information shall be given to the consumer that 
the beneficial effect is obtained with a daily 
intake of 100 mg of DHA. 
When the claim is used on follow-on formula, 
the food shall contain at least 0,3 % of the total 
fatty acids as DHA.  Q-2008-211, 
Q-2008-688, 
Q-2008-689  
Article 14(1)(b) health claim 
referring to children’s devel ­
opment and health  Merck Selbstmedikation 
GmbH, Roesslerstrasse 
96, 64293 Darmstadt, 
Germany  Docosahexaenoic 
acid (DHA)  Docosahexaenoic acid (DHA) 
maternal intake contributes to the 
normal development of the eye of 
the foetus and breastfed infants.  Information shall be given to pregnant and 
lactating women that the beneficial effect is 
obtained with a daily intake of 200 mg of 
DHA in addition to the recommended daily 
intake for omega-3 fatty acids for adults, i.e. 
250 mg DHA and eicosapentaenoic acid (EPA). 
The claim can be used only for food which 
provides a daily intake of at least 200 mg DHA.  Q-2008-675  
Article 14(1)(b) health claim 
referring to children’s devel ­
opment and health  Merck Selbstmedikation 
GmbH, Roesslerstrasse 
96, 64293 Darmstadt, 
Germany  Docosahexaenoic 
acid (DHA)  Docosahexaenoic acid (DHA) 
maternal intake contributes to the 
normal brain development of the 
foetus and breastfed infants.  Information shall be given to pregnant and 
lactating women that the beneficial effect is 
obtained with a daily intake of 200 mg of 
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.  Q-2008-773EN L 119/8 Official Journal of the European Union 7.5.2011ANNEX II  
Rejected health claims  
Application – Relevant provisions of Regulation (EC) 
No 1924/2006  Nutrient, substance, food or food category  Claim  EFSA opinion reference  
Article 14(1)(b) health claim referring to children’s devel ­
opment and health  Docosahexaenoic acid (DHA) and arachidonic acid 
(ARA)  Docosahexaenoic acid (DHA) and arachidonic acid 
(ARA) contribute to the optimal brain development of 
infants and young children.  Q-2008-212  
Article 14(1)(b) health claim referring to children’s devel ­
opment and health  Lipil®  Lipil® contributes to optimal brain development of 
infants and young children.  Q-2008-690  
Article 14(1)(b) health claim referring to children’s devel ­
opment and health  Enfamil® Premium  Enfamil® Premium contributes to optimal brain 
development of infants and young children.  Q-2008-691EN 7.5.2011 Official Journal of the European Union L 119/9