20.2.2014 Official Journal of the European Union L 50/11 COMMISSION REGULATION (EU) No 155/2014 of 19 February 2014 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 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 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 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’ for a scientific assessment, as well as to the Commission and the Member States for information. The Authority is 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 Vitabiotics Ltd, 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 L- tyrosine and contribution to normal synthesis of () O] L 404, 30.12.2006, p. 9. dopamine (Question No EFSA-Q-2011-00319) (3. The claim proposed by the applicant was worded as follows: ‘L-tyrosine is essential for the natural formation of dopamine’. On 20 July 2011, the Commission and the Member States received the scientific opinion from the Authority, which noted that the role of L-tyrosine in the normal synthesis of catecholamines for the general population has already been addressed with a favourable outcome in a previous opinion (°) in the context of evaluation of claims referred to in Article 13(1) of Regulation (EC) No 1924/2006 and that L-tyrosine is the starting point for the synthesis of all catecholamines, including dopamine. Thus, the Authority concluded that a cause and effect relationship had been established between the consumption of L-tyrosine in a protein adequate diet and contribution to normal synthesis of dopamine and proposed as appropriate conditions of use that ‘a food should be at least a source of protein as per Annex to Regulation (EC) No 1924/2006". The Commission and the Member States have considered whether the health claim reflecting those conclusions should be authorised under the proposed conditions of use, since authorisation may also legitimately be withheld if health claims do not comply with other general and specific requirements of Regulation (EC) No 1924/2006, even in the case of a favourable scientific assessment by the Authority. In the Authority’s response of 9 November 2012 to the request of the Commission, inter alia, for clarification in relation to the evidence submitted for the health claim on L-tyrosine and the proposed conditions of use, the Authority noted that its conclusions for this claim were based on the well established biochemical role of L-tyrosine, as contained in protein. It added that, on the basis of the evidence submitted, it could not provide a quantitative indication of the necessary daily intake of L-tyrosine per se to produce the beneficial physiological effect. Therefore, it is not possible to establish specific conditions for the use of this claim to ensure that L-tyrosine is contained in the final product in a quantity that will produce the beneficial physiological effect in accordance with point (i) of Article 5(1)(b) of Regulation (EC) No 1924/2006. In the absence of such specific conditions of use, the beneficial effect of the substance to which the claim relates cannot be assured and thus this claim could be misleading to the consumer. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. (%) EFSA Journal 2011; 9(7):2290. () EFSA Journal 2011; 9(6):2270.