L 119/14 Official Journal of the European Union 4.5.2012 COMMISSION REGULATION (EU) No 380/2012 of 3 May 2012 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the conditions of use and the use levels for aluminium-containing 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(3) in the form of lakes in a wide number of foodstuffs, in general without any indication of the maximum concen- tration levels of aluminium in the lakes. It is therefore appropriate to amend the current conditions of use and reduce the use levels for aluminium-containing food additives, including alumi- nium lakes, to ensure that the revised TWI is not thereof, exceeded. Whereas: (7)  Since manufacturing practices using higher amounts of food additives have been applied since decades, a transi- (1) Annex II to Regulation (EC) No 1333/2008 lays down a tional period should be provided to allow the food Union list of food additives approved for use in foods and their conditions of use. business operators to adapt to the new requirements laid down in this Regulation for the wuses of aluminium-containing food additives others than lakes. (2)  The European Food Safety Authority (EFSA), in its opinion of 22 May 2008 (?) recommended to lower (8)  Labelling of aluminium content in aluminium lakes not the tolerable weekly intake (TWI) for aluminium to intended for sale to the final consumer is currently 1 mg/kg body weight/week. In addition, EFSA considers optional. It should become mandatory within 12 that the revised TWI is generally exceeded for high months from the entry into force of this Regulation in consumers, especially children, in a significant part of order to allow food manufacturers using aluminium lakes the Union. to adapt to the proposed maximum limits for such lakes. Therefore a longer transitional period than 12 months A q hat th . ¢ should be provided to allow the food business operators (3)  EFSA considers that the major route of exposure to to adapt to the new requirements laid down in this aluminium compounds for the general population is Reoulati gulation. through food, both as a consequence of the natural occurrence of aluminium in food and the use of alummlur.n- compounds in fOO(i. processing, md“d‘?g (99  Annex II as amended by Commission Regulation (EU) No food additives. However, EFSA is not able to quantify "o . . . . 1129/2011 (%) is in principle applicable from 1 June the respective role of each source due to the design of 5 A : . . . 2013. In order to facilitate the effective implementation the human dietary studies and the analytical methods o : . . . . L of Annex II, it is appropriate to insert in the Annex the used, which only determine the total aluminium . L . periods of application that do not start on 1 June 2013 content in food. . ) . and are posterior to the entry into force of this Regu- lation. (4 Annex II to Regulation (EC) No 1333/2008 authorises the use of aluminium-containing food additives in a wide number of foodstuffs, often at very high maximum (10)  The aluminium containing carrier bentonite, E 558 is not permitted levels or without any indication of the used any more according to information submitted by maximum concentration levels (Quantum satis). food manufacturers. Therefore, it is not included in Part 1 of Annex III to Regulation (EC) No 1333/2008 and ) should also be deleted from the list of all additives in Part () Annex I to Regulation (EC) No 1333/2008 and B of Annex II to Regulation (EC) No 1333/2008. Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes Il and I to Regulation (EC) No 1333/2008 of the (11)  The aluminium containing food additives calcium European Parliament and of the Council (}) authorise the use of some colours that may contain aluminium () O] L 354, 31.12.2008, p. 16. (®) Scientific Opinion of the Panel on Food Additives, Flavourings, aluminium silicate E 556 and aluminium silicate (kaolin) E 559 should be deleted from the list of all additives in Part B of Annex Il to Regulation (EC) No 1333/2008, since these substances can be replaced by other food additives. Processing Aids and Food Contact Materials (AFC) on Safety of aluminium from dietary intake, The EFSA Journal (2008) 754, p. 1. () OJ L 83, 22.3.2012, p. 1. (*) OJ L 295, 12.11.2011, p. 1.