L 331/8 Official Journal of the European Union 18.11.2014 COMMISSION REGULATION (EU) No 1228/2014 of 17 November 2014 authorising and refusing to authorise 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 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 Abtei Pharma Vertriebs GmbH, submitted pursuant to Article 14(1)(a) of Regu- lation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Calcium and vitamin D3 chewing tablets and bone loss (Question No EFSA-Q-2008-721) (3). The claim proposed by the applicant was worded as follows: ‘Chewing tablets with calcium and vitamin D improve bone density in women 50 years and older. Thus chewing tablets may reduce the risk of osteoporotic fractures’. (6)  On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 7 August 2009 that a cause and effect relationship had been established between the intake of calcium, either alone or in combination with vitamin D, and reducing the loss of bone mineral density (BMD) in postmenopausal women. Reducing the loss of BMD may contribute to a reduction in the risk of bone fractures. Accordingly, two health claims reflecting this conclusion should be considered as complying with the require- ments of Regulation (EC) No 1924/2006, and should be included in the Union list of permitted claims. However, the Authority concluded that the information provided was insufficient to establish conditions of use for the claims. Subsequently, the Commission went back to the Authority to seek further advice to enable the risk managers to set appropriate conditions of use for the relevant health claims. The Authority concluded in its opinion received by the Commission and the Member States on 17 May 2010 (Question No EFSA-Q-2009- 00940) () that at least 1 200 mg of calcium from all sources or at least 1 200 mg of calcium and 800 LU. (20 pg) of vitamin D from all sources should be consumed daily in order to obtain the claimed effect. (7)  When the health claim is made only on calcium, in order to ensure that a food provides a significant quantity of calcium, it is appropriate to set conditions of use which allow the claim to be made only on foods which provide at least 400 mg of calcium per quantified portion. () OJ L 404, 30.12.2006, p. 9. (¥) EFSA Journal (2009) 1180, 1-13. (*) EFSA Journal (2010);8(5):1609.