L 333/54 Official Journal of the European Union 12.12.2013 COMMISSION IMPLEMENTING REGULATION (EU) No 1321/2013 of 10 December 2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings (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 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended to be used in or on foods (!), and in particular Article 6 thereof, Whereas: Article 10(2) of Regulation (EC) No 2065/2003 provides for the initial establishment of a Union list of authorised smoke flavouring primary products (hereinafter referred to as ‘primary products’). That list is to be established on the basis of applications for authorisation submitted by business operators and the opinion issued by the European Food Safety Authority (the Authority’) on the relevant primary product. In accordance with Article 10 of Regulation (EC) No 2065/2003, the Authority received 14 valid applications for authorisation of primary products before 16 June 2005. Three applications have been withdrawn. Therefore the Authority has evaluated in total 11 primary products. One evaluated application has been withdrawn after completion of the evaluation. According to Article 4(1) of Regulation (EC) No 2065/2003 the authorisation of smoke flavourings may be subject to specific conditions of use and according to Article 9(3) of that Regulation authorisations should be granted for 10 years, renewable in accordance with Article 12 of that Regulation. Primary products and derived smoke flavourings are used in or on food to impart a smoke taste or to complement another flavour without imparting smoke flavour. They are also used to smoke meat, fish and dairy products. The refined exposure study carried out by Rijksinstituut () O] L 309, 26.11.2003, p. 1. voor Volksgezondheid en Milieu (RIVM) (?) shows that regardless of the exposure calculation method used, the main contributors to the high intake are predominantly foods that used to be traditionally smoked, such as cooked smoked sausage and bacon. The food groups that are not traditionally smoked, such as crisps, soups and sauces, do not significantly affect exposure. Because primary products are produced from smoke which is subjected to fractionation and purification processes, the use of smoke flavourings is generally considered to be of less health concern than the use of smoke that is made by burning wood or by heating saw dust or small wood chips (). (5)  The safety assessment of the Authority on the primary product Scansmoke PB1110, adopted on 26 March 2009 (%), concludes that the data provided by the applicant is sufficient to eliminate the concerns over its genotoxicity. However the uses and use levels as orig- inally proposed by the applicant would provide an insuf- ficient margin of safety. The uses and the use levels have been revised to take into account this opinion. The primary product Scansmoke PB1110 should therefore be authorised subject to specific conditions of use. (6)  The safety assessment of the Authority on the primary product Zesti Smoke Code 10, adopted on 29 January 2009 (°) and on 6 July 2011 (), concludes that the data provided by the applicant is sufficient to eliminate the concerns over its genotoxicity. However, the uses and use levels as originally proposed by the applicant provide an insufficient margin of safety. The uses and the use levels have been revised to take into account this opinion. The primary product Zesti Smoke Code 10 should therefore be authorised subject to specific conditions of use. (7)  The safety assessment of the Authority on the primary product Smoke Concentrate 809045, adopted on 29 January 2009 ('), concludes that the data provided by the applicant is sufficient to eliminate the concerns over its genotoxicity. The uses and use levels as proposed by the applicant do not give rise to safety concern. The primary product Smoke Concentrate 809045 should therefore be authorised subject to specific conditions of use. (3) ‘Refined exposure assessment of smoke flavouring primary products with use levels provided by the industry. A pilot study into data collection of use levels.” RIVM Letter report 320026003. (%) EFSA Journal 2008; 724, 1-114. (*) EFSA Journal 2009; ON-1056, 1-23. (°) EFSA Journal 2009; ON-982, 1-24. (%) EFSA Journal 2011; 9(7):2307. (7) EFSA Journal 2009; ON-981, 1-19. 3