4.5.2012 Official Journal of the European Union L 119/9 COMMISSION REGULATION (EU) No 378/2012 of 3 May 2012 refusing to authorise certain health claims made on foods and 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 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. 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 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 SVUS Pharma as, 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 ProteQuine®, a mixture of free amino acids, oligopeptides and nucleotides on increase of suppressed concentrations of secretory immunoglobulin A (SclgA) and reduction of the risk of influenza and common cold (Question No EFSA-Q-2008-397) (?). The claim proposed by the applicant was worded as follows: "Prote- Quine® elevates/maintains the level of SclgA on mucous membranes. Decreased or insufficient level of ScIgA is a risk factor in the development of common cold or influenza". (1) OJ L 404, 30.12.2006, p. 9. () The EFSA Journal 2011; 9(4):2128. (6) On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 13 April 2011 that a cause and effect relationship had not been established between the consumption of ProteQuine® and increasing suppressed concentrations of SclgA and reducing the risk of common cold and influenza. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be auth- orised. Following an application from SVUS Pharma a.s, 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 ProteQuine®, a mixture of free amino acids, oligopeptides and nucleotides, and bovine lactoferrin on increase of suppressed concentrations of secretory immunoglobulin A (ScIgA) and reduction of the risk of common cold with sore throat (Question No EFSA-Q- 2008-398) (°). The claim proposed by the applicant was worded as follows: "ProteQuine® in combination with bovine lactoferrin elevates/maintains the level of SclgA on mucous membranes. Decreased or insufficient level of SclgA is a risk factor in the development of common cold with sore throat and combination of ProteQuine® with bovine lactoferrin reduces the risk of the development of sore throat". On the basis of the data presented, the Authority concluded in its opinion received by the Commission and the Member States on 13 April 2011 that a cause and effect relationship had not been established between the consumption of ProteQuine® and bovine lactoferrin and increasing suppressed concentrations of SclgA and reduction of the risk of common cold with sore throat. 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 CSL - Centro Sperimentale del Latte S.p.A., submitted pursuant to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of a combination of Lactobacillus delbrueckii subsp. bulgaricus strain AY/CSL (LMG P-17224) and Streptococcus  thermophilus ~ strain ~ 9Y/CSL  (LMG P-17225) on beneficial modulation of intestinal microflora (Question No EFSA-Q-2008-273) (¥). The claim proposed by the applicant was worded as follows: "Maintaining the gut health by normalizing the intestinal flora". (®) The EFSA Journal 2011; 9(4):2129. (*) The EFSA Journal 2011; 9(7):2288.