31.7.2013 Official Journal of the European Union L 204/35 COMMISSION REGULATION (EU) No 739/2013 of 30 July 2013 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Stigmasterol-rich plant sterols as a stabiliser in ready-to-freeze alcoholic cocktails, and the Annex to Commission Regulation (EU) No 231/2012 as regards specifications for Stigmasterol-rich plant sterols food additive (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 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives ('), and in particular Article 10(3) and Article 14 thereof, consumer in liquid form and placed in domestic freezers to produce a semi-frozen beverage. Stigmasterol-rich plant sterols when added to the cocktails as an ice- nucleating agent (stabiliser) ensure that the cocktails will freeze and produce a satisfactory semi-frozen beverage in the consumer’s freezer. Without the use of stigmasterol-rich plant sterols, supercooling of the beverage can occur and ice formation cannot be guar- anteed resulting in product failure. (6)  Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of Having regard to Regulation (EC) No 1331/2008 of the the European Food Safety {\ythority in Qrder to update European Parliament and of the Council of 16 December the Union list of food additives set out in Annex II to 2008 establishing a common authorisation procedure for Regulation (EC) No 1333/2008. food additives, food enzymes and food flavourings (3), and in particular Article 7(5) thereof, (7)  The European Food Safety Authority evaluated the safety of Stigmasterol-rich plant sterols when used as a food Whereas: additive in re.ad.y—to—freeze alcoholic cocktails. and expressed its opinion on 14 May 2012 (*). It considered that the toxicological data available for stigmasterol-rich . plant sterols are insufficient to establish an acceptable ) Anpex I_I to Regulation (EC) No 1333/2008 lays- down a daily intake. However, based on the available data, it Union 1,ISt of f,O.Od additives approved for use in foods concluded that the proposed use and use levels of stig- and their conditions of use. masterol-rich plant sterols as a stabiliser in ready-to- freeze alcoholic cocktails are not of a safety concern. Furthermore, the Authority considers that the average (2 Commission Regulation (EU) No 231/2012 (*) lays down daily intake, taking into account the estimated exposure specifications for food additives listed in Annex II to to plant sterols from all sources (i.e. from new appli- Regulation (EC) No 1333/2008. cations, from natural sources and added as novel food ingredient) will not exceed 3 g/day. (3)  Those lists may be updated in accordance with the common procedure referred to in Article 3(1) of Regu- (8)  Therefore, it is appropriate to authorise the use of Stig- lation (EC) No 1331/2008, either on the initiative of the masterol-rich plant sterols as a stabiliser in ready-to- Commission or following an application. freeze alcoholic cocktails and to assign E 499 as an E- number to that food additive. (4)  An application for the authorisation of use of Stig- masterol-rich plant sterols as a stabiliser in ready-to- (99 Phytosterols, phytostanols and their esters have been freeze alcoholic cocktails was submitted on 11 February 2011 and was made available to the Member States. There is a technological need for the use of Stigmasterol- rich plant sterols as a stabiliser, ice nucleating agent, to generate and maintain the presence of ice dispersions within a range of ready-to-freeze alcoholic cocktails. These products are designed to be purchased by the 354, 31.12.2008, p. 16. previously evaluated by several scientific authorities, including the Scientific Committee for Food, the Joint FAO/WHO Expert Committee on Food Additives and the European Food Safety Authority and are approved for use in various foods within the Union at levels of intake of up to 3 g/day. Those substances are used as novel food ingredients with the purpose of helping hypercholesterolaemic individuals control their LDL- cholesterol blood levels. (*) EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the safety of stigmasterol-rich plant oJ L () OJ L 354, 31.12.2008, p. 1. OJL sterols as food additive. EFSA Journal 2012;10(5):2659. 83, 22.3.2012, p. 1.