12.11.2011 Official Journal of the European Union L 295/1 II (Non-legislative acts) REGULATIONS COMMISSION REGULATION (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives (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, placed on the market and used in foods under the conditions of use specified therein. The additives should be listed on the basis of the categories of food to which they may be added. In order to facilitate the transfer and to enhance transparency of the authorisation procedure, it is appropriate to develop a new food categorisation system which will form the basis of Annex IL . . (4 The established Codex Alimentarius General Standard for Article 30(1) and Article 30(5) thereof, Food Additives (°), food category system has been used as a starting point for developing the Union system. However, that system needs to be adapted to take into Whereas: account the specificity of the existing food additive auth- orisations in the Union. Current sector specific Union provisions on foods have been taken into account. The (1) Regulation (EC) No 1333/2008 provides for the estab- categories are created with the sole purpose of listing the lishment of a Union list of food additives approved for authorised additives and their conditions of use. use in foods and their conditions of use. (2)  Food additives which are currently permitted for use in (5} For reasons of lelr_ity it is necessary to list food ?dditives foods under European Parliament and Council Directive in groups of additives for authorisation for certain foods. 94/35/EC of 30 June 1994 on sweeteners for use in Guidance should be provided to describe the different foodstuffs (), ~European Parliament and  Council categories in order to ensure uniform interpretation. Directive 94/36/EC of 30 June 1994 on colours for When necessary,  interpretation decisions can  be use in foodstuffs *) and European Parliament and adopted in accordan.ce with Article. 19 of Regulation Council Directive 95/2/EC of 20 February 1995 on (EC) No 13332008 in order to clarify whether or not food additives other than colours and sweeteners (%), a particular food belongs to a certain category of food. should be included in Annex II to Regulation (EC) No 1333/2008 after a review of their compliance with Articles 6, 7 and 8 thereof. The review should not include a new risk assessment by the European Food (6)  Nitrites (E 249-250) are needed as a preservative in meat Safety Authority (hereinafter ‘the Authority’). Food additives and uses which are no longer needed shall not be entered in Annex II to that Regulation. Only food additives included in the Union list set out in Annex II to Regulation (EC) No 1333/2008 may be 354, 31.12.2008, p. 16. 237, 10.9.1994, p. 3. 237, 10.9.1994, p. 13. L L L L 61, 18.3.1995, p. 1. products to control the possible growth of harmful bacteria, in particular Clostridium botulinum. The use of nitrites in meat may however lead to formation of nitro- samines which are carcinogenic substances. The current authorisation of nitrites as food additives makes a balance between these effects, taking into account the scientific opinion of the Authority and the need to maintain certain traditional foods on the market. For some traditionally ~manufactured meat products maximum residual limits were set out in Annex IIl to (°) GSFA, Codex STAN 192-1995.