L 296/26 Official Journal of the European Union 15.11.2011 COMMISSION REGULATION (EU) No 1160/2011 of 14 November 2011 on the authorisation and refusal of authorisation of certain health claims 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 (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. 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 CreaNutrition AG, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of oat beta-glucan on lowering blood cholesterol (Question No EFSA-Q-2008-681) (?). The claim proposed by the applicant was worded as follows: ‘The inclusion of oat beta-glucan as part of a balanced diet can actively lower/reduce blood LDL (low-density lipoprotein) and total cholesterol'. (1) OJ L 404, 30.12.2006, p. 9. (%) EFSA Journal 2010; 8(12):1885. (6) On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 8 December 2010 that a cause and effect relationship had been established between the consumption of oat beta-glucan 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 Annex I to this Regu- lation 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 andfor 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. 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. Following an application from HarlandHall Ltd (on behalf of the Soya Protein Association, the European Vegetable Protein Federation and the European Natural Soyfood Manufacturers Association), 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 soy protein on the reduction of blood cholesterol concentrations (Question No EFSA-Q-2009-00672) (°). The claim proposed by the applicants was worded as follows: ‘Soy protein has been shown to lower/reduce blood cholesterol; blood cholesterol lowering may reduce the risk of (coronary) heart disease’. (%) EFSA Journal 2010; 8(7):1688.