18.11.2014 Official Journal of the European Union L 331/3 COMMISSION REGULATION (EU) No 1226/2014 of 17 November 2014 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 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 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 also 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 European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’. (3)  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. (4)  The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority. (5)  Following an application from Lactalis B&C, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was asked to deliver an opinion on a health claim related to ‘Low fat and low trans spreadable fat rich in unsaturated and omega-3 fatty acids’ and reduction of LDL-cholesterol concentrations (Question No EFSA-Q-2009-00458) (3. The claim proposed by the applicant was worded as follows: ‘Replacing a fat rich in saturatedftrans fatty acids by a fat rich in unsaturated fatty acids helps to reduce LDL cholesterol. LDL cholesterol is a cardiovascular risk factor’. (6)  On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 25 May 2011 that a cause and effect relationship had been established between the consump- tion of mixtures of dietary saturated fatty acids (SFAs) and an increase in blood LDL-cholesterol concentrations, and that replacement of a mixture of SFAs with cis-monounsaturated fatty acids and/or cis-polyunsaturated fatty acids in foods or diets on a gram-per-gram basis reduces 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 clinical intervention study claimed by the applicant as proprietary, was not considered necessary by the Authority for reaching its conclu- sion. It is therefore considered that the requirement laid down in Article 21(1)(c) of Regulation (EC) No 1924/2006 is not fulfilled and accordingly, protection of proprietary data should not be granted. (7)  In its opinion, the Authority concludes that in order to bear the claim, significant amounts of saturated fatty acids should be replaced by monounsaturated and/or polyunsaturated fatty acids in foods or diets on a gram-per- gram basis. Therefore, in order to ensure that a food provides significant amounts of monounsaturated and/or polyunsaturated fatty acids, it is appropriate to limit the use of the claim to fats and oils and to set conditions of use as those referred to in the nutrition claim ‘HIGH UNSATURATED FAT as laid down in the Annex to Regulation (EC) No 1924/2006. () OJL 404, 30.12.2006, p. 9. (¥) EFSA Journal 2011; 9(5):2168.