L 119/4 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, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 19242006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods ('), and in particular Article 17(3) thereof, Whereas: 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. 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’. 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. 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. () O] L 404, 30.12.2006, p. 9. ©) 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. 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 (%), EFSA-Q-2008-688 () 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. 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. 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 Directive (%) The EFSA Journal (2009), 1003, 1-8. (*) The EFSA Journal (2009), 941, 1-14. (*) The EFSA Journal (2009), 1004, 1-8.