L 310/38 Official Journal of the European Union 9.11.2012 COMMISSION REGULATION (EU) No 1048/2012 of 8 November 2012 on the authorisation of a health claim made on foods and referring to the reduction of disease risk (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: (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. 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 thereof, and to deliver an opinion on the health claim concerned. The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority. Following an application from Cargill Incorporated, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006 and requesting the protection of proprietary data for one meta-analysis (}) and for information pertaining to the production process of barley ‘betafiber (Barlivi™), the Authority was required to deliver an opinion on a health claim related to the effects of barley beta-glucans on lowering of blood cholesterol and reduced risk of (coronary) heart disease (Question No EFSA-Q-2011-00798) (). The claim () O] L 404, 30.12.2006, p. 9. (3 Harland JI, 2011 (unpublished); Meta-analysis of the effects of barley beta-glucan on blood lipids. (®) The EFSA Journal (2011); 9(12):2470. proposed by the applicant was worded as follows: ‘Barley beta-glucan has been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of (coronary) heart disease’. On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 8 December 2011 that a cause and effect relationship had been established between the consumption of barley beta-glucans and lowering of blood LDL-cholesterol concentrations. Accordingly, a health claim reflecting this conclusion should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and should be included in the Union list of permitted claims. The meta-analysis and information pertaining to the production process of barley ‘betafiber (Barliv™), claimed by the applicant as proprietary, were not considered necessary by the Authority for reaching its conclusion. It is therefore considered that the requirement laid down in point (c) of Article 21(1) of Regulation (EC) No 1924/2006 is not fulfilled and accordingly, protection of proprietary data should not be granted. Following an application from Valens Int. d.o.o0. submitted pursuant to Article 14(1)(a) of Regulation (EC) No 19242006, the Authority was required to deliver an opinion on a health claim related to the effects of barley beta-glucans on lowering of blood cholesterol and reduced risk of (coronary) heart disease (Question No EFSA-Q-2011-00799) (¥). The claim proposed by the applicant was worded as follows: ‘Barley beta-glucan has been shown to reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of heart disease’. On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 8 December 2011 that a cause and effect relationship had been established between the consumption of barley beta-glucans and lowering of blood LDL-cholesterol concentrations. Accordingly, a health claim reflecting this conclusion should be considered as complying with the requirements of Regulation (EC) No 1924/2006, and should be included in the Union list of permitted claims. 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 this Regu- lation as regards the authorised claim and include, as the case may be, the revised wording of the claim, specific (%) The EFSA Journal (2011); 9(12):2471.