L 182/8 Official Journal of the European Union 12.7.2011 COMMISSION REGULATION (EU) No 6662011 of 11 July 2011 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health (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 18(5) thereof, Whereas: 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 Synbiotec S.r.l., submitted pursuant to Article 13(5) of Regulation (EC) No 19242006, the Authority was required to deliver an opinion on a health claim related to the effects of () O] L 404, 30.12.2006, p. 9. Synbio on maintenance and improvement of intestinal well-being (Question No EFSA-Q-2009-00889) (). The claim proposed by the applicant was worded as follows: ‘Synbio persists in the intestinal tract and favours the natural regularity contributing to maintain and improve human intestinal well-being’. On 27 September 2010, the Commission and the Member States received the scientific opinion from the Authority, which concluded that on the basis of the data presented, a cause and effect relationship had not been established between the consumption of Synbio and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. Following an application from MILTE ITALIA SpA, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of Silymarin BIO-C® on increase in production of breast milk (Question No EFSA-Q-2009-00957) (?). The claim proposed by the applicant was worded, inter alia, as follows: ‘Suggested for improving the physiological production of breast milk during breast feeding'. On 28 September 2010, the Commission and the Member States received the scientific opinion from the Authority, which concluded that on the basis of the data presented, a cause and effect relationship had not been established between the consumption of Silymarin BIO-C® and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be auth- orised. All the health claims subject to this Regulation are health claims as referred to in point (a) of Article 13(1) of Regulation (EC) No 1924/2006 and may benefit from the transition period laid down in Article 28(5) of that Regulation. As the Authority concluded that cause and effect relationships have not been established between the foods and the respective claimed effects, the two claims do not comply with Regulation (EC) No 1924/2006, and therefore they may not benefit from the transition period provided for in that Article. () The EFSA Journal 2010; 8(9):1773. (%) The EFSA Journal 2010; 8(9):1774.