EN    EN EN 
SANCO/13017/2010 Rev. 2 (POOL/E4/2010/13017/13017R2-EN.doc)  
EN    EN  EUROPEAN COMMISSION 
Brussels, 
C(2010) final 
Draft 
COMMISSION REGULATION 
of 
on the authorisation and refusal of authorisat ion of certain health claims made on foods 
and referring to children's development and health  
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION REGULATION 
of 
on the authorisation and refusal of authorisat ion 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 al so provides that applications 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 Eu ropean Food Safety Authority (EFSA ), hereinafter referred to as 
'the Authority'. 
(3) Following receipt of an application the Author ity 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 authorisa tion 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 Regula tion are related to applications for health 
claims referring to the eff ects of essential fatty acids on children’s development and 
health, as referred to in Article 14( 1)(b) of Regulation (EC) No 1924/2006.  
                                                
 
1 OJ L 404, 30.12.2006, p. 9.  
EN 3   EN (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 pr oprietary data for nineteen  studies, the Authority was 
required to deliver three opinions on heal th claims related to the effects of 
docosahexaenoic acid (DHA) and arachidoni c acid (ARA) on visual development 
(Question No EFSA-Q-2008-2112, EFSA-Q-2008-6883 and EFSA-Q-2008-6894). 
The claims proposed by the applicant were  worded, respectivel y, as follows: "DHA 
and ARA contribute to the optimal visual  development of infa nts and young children", 
"Lipil® contributes to optimal visual de velopment of infants and young children" and 
"Enfamil® Premium contributes to optimal vi sual development of infants". Lipil® and 
Enfamil® Premium, as stated by the appl icant, 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 2009 and on 23 March 2009 respectiv ely that a cause 
and effect relationship had been established between the intake of  infant and follow-on 
formulae supplemented with DHA and the vi sual 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 wean ing. The Authority noted that it could not 
have reached this conclusion without considering seven studies claimed by the applicant as proprietary. Furt her, the Authority conclude d that a cause and effect 
relationship had not been established betw een the intake of ARA and the claimed 
effect. 
(8) In the Authority's responses of 3 Septem ber 2009 to comments received pursuant to 
Article 16(6) of Regulation (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 eff ect could be extended to foods intended to infants while 
they are being weaned, as defined in Di rective 2006/125/EC. Acco rdingly and without 
prejudice to Directive 2009/39/ EC and specific Directives ap plicable to certain groups 
of foodstuffs for particular nutritional uses , a health claim reflec ting this conclusion 
and accompanied by specific conditions of use should be considered as complying with the requirements of Regulation (E C) No 1924/2006, and it s hould be included in 
the Union list of permitted claims. 
(9) Following the receipt of the Authority's opinions  in relation to the a pplications 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 informati on provided by the applicant has been 
assessed. As all seven studies had been published prior to the submission of the 
applications for authorisation of the health claims and in the light of the objectives of 
Regulation (EC) No 1924/2006 am ong which is the protection of the investment made 
by innovators in gathering the informati on and data supporting an application under 
                                                
 
2 The EFSA Journal (2009), 1003, 1-8. 
3 The EFSA Journal (2009), 941, 1-14. 
4 The EFSA Journal (2009), 1004, 1-8.  
EN 4   EN that Regulation, their protec tion is not justif ied 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 development of the unborn child and breastfed infant (Question 
No EFSA-Q-2008-675)5. The claim proposed by the appl icant was worded as follows: 
"DHA is important for early development of the eyes in the foet us (unborn child) and 
infant. Maternal DHA supply contributes to  the child’s visual development".  
(11) On the basis of the data submitted, the Author ity concluded in its opinion received by 
the Commission on 23 April 2009 that there wa s insufficient evidence to establish a 
cause and effect relationship between the consumption of supplementary DHA during 
pregnancy and lactation and visual deve lopment 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 development (Question No EFSA-Q-2008-773)6. 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 Author ity concluded in its opinion received by 
the Commission on 23 April 2009 that there wa s insufficient evidence to establish a 
cause and effect relationship between the consumption of supplementary DHA during 
pregnancy and lactation and cognitive deve lopment 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 Regulation (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 structur al and functional 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 breas tfed infants. Further, it was clarified that 
most DHA is provided to breastfed in fants via breast milk in which the DHA 
concentration is dependent both on matern al DHA dietary intake and on maternal 
DHA stores. Accordingly, health claims re flecting these conclusions and accompanied 
by specific conditions of use should be consid ered as complying with the requirements 
of Regulation (EC) No 1924/2006, and they sh ould 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 
                                                
 
5 The EFSA Journal (2009), 1006, 1-12. 
6 The EFSA Journal (2009), 1007, 1-14.  
EN 5   EN particulars should be set out in the Annex to the present Regulation as regards the 
authorised claim and include, as the case ma y be, the revised wording of the claim, 
specific conditions of use of the claim,  and, where applicable, conditions or 
restrictions of use of the f ood 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.  
(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 healt h, 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 opini ons on health claims related to the effects 
of DHA and ARA on brain development (Question No EFSA-Q-2008-212
7, EFSA-
Q-2008-6908 and EFSA-Q-2008-6919). The claims proposed by the applicant were 
worded, respectively, as follows: "DHA a nd 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 development 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 wa s insufficient evidence to establish a 
cause and effect relationsh ip between the consumption of DHA and ARA, Lipil® and 
Enfamil® Premium, respectively, and the claimed effect.  
(19) In the Authority's responses of 3 Septem ber 2009 to comments received pursuant to 
Article 16(6) of Regulation (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 structur al and functional long chain polyunsaturated 
fatty acid, it can contribute to the normal br ain development of the foetus, infants and 
young children. Therefore, the Commission and the Member States considered 
whether a health claim reflecting this conc lusion 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 provi de specific advice on the appropriate 
conditions of use that should accompany this  health claim. Accordingly, as risk 
managers could not establish specific c onditions 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 bene ficial effect of th e product could not be 
                                                
 
7 The EFSA Journal (2009), 1000, 1-13. 
8 The EFSA Journal (2009) 1001, 1-8. 
9 The EFSA Journal (2009) 1002, 1-8.   
EN 6   EN assured, which amounts to misleading the cons umer, this health claim should not be 
included in the lists of permitted health claims. 
(20) The comments from the applicants and th e 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 acc ount all relevant advice fr om the Authority, including 
opinions on labelling reference intake va lues for n-3 and n-6 polyunsaturated fatty 
acids ( Question No EFSA-Q-2009-00548
10) and on dietary reference values for fat 
including saturated fatty acids, polyunsatur ated fatty acids, monounsaturated fatty 
acids, trans  fatty acids, and cholesterol ( Question No EFSA-Q-2008-46611).  
(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 six 
months after the adoption of this Regulation, provided an a pplication was made before 
19 January 2008. Accordingly, th e transition period laid down in that Article is 
applicable to health claims liste d in Annex II of this Regulation.  
(22) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al 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 paragr aph 1 shall be included in the Union list of 
permitted claims referred to in Articl e 14(1) of Regulati on (EC) No 1924/2006. 
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 fo r in Article 14(1) of Regulation (EC) No 
1924/2006. 
2. However, they may continue to be used fo r six months after the entry into force of 
this Regulation.  
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
                                                 
10 The EFSA Journal (2009), 1176, 1-11. 
11 The EFSA Journal 2010; 8(3) 1461.  
EN 7   EN This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels,  
 For the Commission 
 José Manuel BARROSO  The President  
EN 8   EN ANNEX I  
Permitted health claims 
Application – 
Relevant 
provisions of 
Regulation 
(EC) No 
1924/2006 Applicant – 
Address Nutrient, 
substance, food 
or food categoryClaim 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 development 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 development 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  Q-2008-675  
EN 9   EN and eicosapentaenoic acid 
(EPA).  
The claim can be used only 
for food which provides a 
daily intake of at least 200 
mg DHA. 
Article 14(1)(b) 
health claim 
referring to children’s development 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-2008-773 
  
EN 10   EN ANNEX 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 development 
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 development 
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 development 
and health Enfamil® Premium Enfamil® Premium contributes to 
optimal brain development of infants and 
young children Q-2008-691