22.10.2009 Official Journal of the European Union L 277)3 COMMISSION REGULATION (EC) No 983/2009 of 21 October 2009 on the authorisation and refusal of authorisation of certain health claims made on food and referring to the reduction of disease risk and to children’s development and health (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, 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: Pursuant to Regulation (EC) No 1924/2006 health claims made on food 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 19242006 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 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 of the application, and to deliver an opinion on a health claim concerned. The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority. On 19 August 2008, the Commission and the Member States received seven opinions on applications for health claim authorisation from the Authority. On 22 September 2008, the Commission and the Member States received one opinion on an application for health claim authorisation from the Authority. On 22 October 2008, the Commission and the Member States received () O] L 404, 30.12.2006, p. 9. eight opinions on applications for health claim authori- sation from the Authority. On 31 October 2008, the Commission and the Member States received five opinions on applications for health claim authorisation from the Authority. On 14 November 2008, the Commission and the Member States received two opinions on applications for health claim authorisation from the Authority. Six opinions were related to applications for reduction of disease risk claims, as referred to in Article 14(1)(a) of Regulation (EC) No 1924/2006, and seventeen opinions were related to applications for health claims referring to children’s development and health, as referred to in Article 14(1)(b) of Regulation (EC) No 1924/2006. Meanwhile one application for health claim authorisation was withdrawn by the applicant and one application for health claim authorisation will be subject to a further decision. Following an application from Unilever PLC (United Kingdom) and Unilever NV (Netherlands), 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 Plant sterols on blood cholesterol and the risk of coronary heart disease (Question No EFSA-Q-2008- 085) (3. The claim proposed by the applicant was worded as follows: ‘Plant sterols have been proven to lower[reduce blood cholesterol significantly. Blood cholesterol lowering has been proven to reduce the risk of (coronary) heart disease’. On the basis of the data presented, the Authority concluded that a cause and effect relationship was estab- lished between the consumption of plant sterols and the claimed effect. Subject to a revised wording the claim should be considered as complying with the requirements of Regulation (EC) No 1924/2006 and in particular Article 14(1)(a) thereof, and it should be included in the Community list of permitted claims. Following an application from McNeil Nutritionals, 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 plant stanol esters on blood cholesterol and the risk of coronary heart disease (Question No EFSA- Q-2008-118) (). The claim proposed by the applicant was worded as follows: By actively lowering/reducing LDL-cholesterol (by up to 14 % within 2 weeks, by blocking cholesterol absorption,) plant stanol esters reduce the risk of (coronary) heart disease’. () The EFSA Journal (2008) 781, 1-2. (%) The EFSA Journal (2008) 825, 1-13.