L 160/4 Official Journal of the European Union 12.6.2013 COMMISSION REGULATION (EU) No 536/2013 of 11 June 2013 amending Regulation (EU) No 432/2012 establishing a list of permitted 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 ('), and in particular Article 13(3) thereof, Whereas: (1)  Pursuant to Article 13(3) of Regulation (EC) No 19242006, the Commission adopted Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods other than those referring to the reduction of disease risk and to children’s development and health (2). The list as estab- lished by Regulation (EU) No 432/2012 contains 222 permitted health claims, corresponding to 497 entries in the consolidated list (°) submitted to the European Food Safety Authority (the Authority) for a scientific assessment. (2)  However, at the time of the adoption of the list of permitted health claims, there were a number of health claims whose evaluation by the Authority or consideration by the Commission was not finalised (¥). (3)  For health claims on micro-organisms which, in its initial assessment, the Authority considered insufficiently char- acterised and health claims for which it concluded that ‘the evidence provided is insufficient to establish a cause and effect relationship’, the Commission and Member States agreed that they would not be able to consider their inclusion or non-inclusion in the list of permitted claims unless a further assessment was carried out by the Authority. The Authority finalised its assessments on these health claims and published its opinions on 5 June and 7 August 2012 (°) concluding that, on the basis of the data submitted, a cause and effect rela- (1) OJ L 404, 30.12.2006, p. 9. () OJ L 136, 25.5.2012, p. 1. () http://www.efsa.europa.eu/en/topics/topic/article13.htm () Corresponding to 2232 entries (IDs) in the consolidated list. () http://www.efsa.europa.eufen/publications.htm tionship has been established between a food category, a food or one of its constituents and the claimed effect for two health claims (°). (4 The Commission has finalised its consideration of all health claims submitted for evaluation except for four categories of claims made on specific groups of food or one of their constituents. Those categories include claims on plant or herbal substances, commonly known as ‘botanical substances’, claims on specific food- stuffs, namely foods for use in very low calorie diets and foods with reduced lactose content, claims on caffeine and a claim on carbohydrates. (5)  As regards botanical substances, Member States and stakeholders expressed concerns as regards the difference in consideration given to the evidence based on ‘tradi- tional use’ on the one hand under Regulation (EC) No 1924/2006 in relation to health claims and on the other hand under Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (7) concerning the use as traditional herbal medicinal products. Since the Commission considers that these concerns are relevant and require further reflection and consultation, a decision on claims relating to botanical substances ()) should only be taken once those steps have been completed. (6)  As regards the health claims referring to the effects of very low calorie diets (°) and foods with reduced lactose content (19), the current revision of the legislation on foodstuffs for particular nutritional uses (') might have an impact on those health claims. In order to avoid potential inconsistencies with that legislation, a decision on the health claims referring to those foodstuffs should only be taken once that revision has been finalised. (7)  As regards the health claims referring to the effects of caffeine ('2), Member States expressed concerns in relation to the safety of caffeine intake within different target groups of the population. Since the Commission considers that these concerns are relevant and require further scientific advice by the Authority, a decision on claims relating to caffeine should only be taken once that step has been completed. (°) Corresponding to entries ID 2926 and ID 1164 in the consolidated list. () OJ L 311, 28.11.2001, p. 67. (%) Corresponding to 2078 entries (IDs) in the consolidated list. (°) Corresponding to entry ID 1410 in the consolidated list. (19 Corresponding to entries ID 646, ID 1224, ID 1238, ID 1339 in the consolidated list. (') COM(2011) 353 final. (*») Corresponding to entries ID 737, ID 1486, ID 1488, ID 1490, ID 736, 1D 1101, ID 1187, ID 1485, ID 1491, ID 2063, ID 2103, ID 2375 in the consolidated list.