1.4.2015 Official Journal of the European Union L 88/7 COMMISSION REGULATION (EU) 201 5/539 of 31 March 2015 authorising a health claim made on foods, other than those referring to the reduction of disease risk and to children’s development and health and amending Regulation (EU) No 432/2012 (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 (), and in particular Articles 18(4) and 19 thereof, Whereas: (1) Regulation (EC) No 1924/2006 provides that 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)  Pursuant to Article 13(3) of Regulation (EC) No 1924/2006, Commission Regulation (EU) No 432/2012 (3 was adopted, which establishes 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. (3)  Regulation (EC) No 1924/2006 provides that applications for authorisations of health claims are to 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’, for a scientific assessment, as well as to the Commission and the Member States for information. (4)  The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority. (5)  In order to stimulate innovation, health claims which are based on newly developed scientific evidence and/or which include a request for the protection of proprietary data shall undergo an accelerated type of authorisation. (6)  Following an application from Barry Callebaut Belgium NV submitted pursuant to Article 19(1) of Regulation (EC) No 1924/2006 and including a request for protection of proprietary data, the Authority was required to deliver an opinion on the modification of the authorisation of health claim ‘cocoa flavanols help maintain the elasticity of blood vessels, which contributes to normal blood flow’. That health claim was authorised, pursuant to Article 13(5) of Regulation (EC) No 1924/2006, by Commission Regulation (EU) No 851/2013 (}). The applicant requested an extension of the authorised conditions of use of the claim to a high-flavanols (HF) cocoa extract to be consumed in capsules, tablets or added to ‘other foods, including beverages’. (7)  On 5 May 2014, the Commission and the Member States received a scientific opinion from the Authority (Question No EFSA-Q-2013-00832) () which concluded that on the basis of the data submitted, a cause and effect relationship had been established between the consumption of cocoa flavanols in the HF cocoa extract (i.e. in capsules or tablets) and the claimed effect. (8)  The Authority indicated in its opinion that its conclusions could not have been reached without considering one human intervention study claimed by the applicant as proprietary. (°) () OJ L 404, 30.12.2006, p. 9. (*) Commission 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 health (O] L 136, 25.5.2012, p. 1). (®) Commission Regulation (EU) No 851/2013 of 3 September 2013 authorising certain health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health and amending Regulation (EU) No 432/2012 (OJL 235,4.9.2013, p. 3). (*) EFSA Journal 2014;12(5):3654. (’) ProDigest, 2012. Pharmacokinetic study to assess the bioavailability of the cocoa flavanol epicatechin from different matrices. ProDigest Report nr. PD-2015009/C1-11.