31.10.2013 Official Journal of the European Union L 289/33 COMMISSION IMPLEMENTING REGULATION (EU) No 1060/2013 of 29 October 2013 concerning the authorisation of bentonite as a feed additive for all animal species (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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (!), and in particular Article 9(2) thereof, Whereas: (1) Regulation (EC) No 1831/2003 provides for the auth- orisation of additives for use in animal nutrition and for the grounds and procedures for granting such auth- orisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). (2)  Bentonite was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive belonging to the group of binders, anticaking agents and coagulants, for use in all animal species, by Commission Directive 82/822/EEC (%). That additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. (3)  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regu- lation, an application was submitted for the re-evaluation of bentonite as a feed additive for all animal species as binders and anticaking agents and, in accordance with Article 7 of that Regulation, for a new authorisation as substance for control of radionuclide contamination, for all animal species. In addition, in accordance with Article 7 of Regulation (EC) No 1831/2003, an appli- cation was submitted for a new authorisation of () OJ L 268, 18.10.2003, p. 29. (%) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (O] L 270, 14.12.1970, p. 1). (}) Forty-first Commission Directive 82/822[EEC of 19 November 1982 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs (O] L 347, 7.12.1982, p. 16). bentonite as substance for reduction of the contami- nation of feed by mycotoxins for all animal species. Those applications request that additive to be classified in the additive category ‘technological additives’ and were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The European Food Safety Authority (the Authority) concluded in its opinions of 2 February 2011 (%), 14 June 2011 (°) and 14 June 2012 (%) that, under the proposed conditions of use, bentonite does not have an adverse effect on animal health, human health or the environment, and that it has the potential to be effi- cacious as binder and anticaking agent and as substance for control of radionuclide contamination for all animal species. It was also recognised that bentonite has the potential to be efficacious as aflatoxin binder for dairy cows and that this conclusion can be extended to all ruminants. The Authority does not consider that there is a need for specific requirements of post-market moni- toring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. Since the provided in vitro studies meet the conditions for the demonstration of the efficacy of the technological additives laid down by Commission Regulation (EC) No 429/2008 (7), in particular under item 4 of Annex II and under item 1.4 of Annex III thereto, and they were recognised able to demonstrate the clear evidence to bind aflatoxin B1 (AfB) and moreover the binding capacity, restricted to aflatoxin B1, was defined as a char- acteristic of the bentonite, the conclusion on efficacy as a substance for reduction of the contamination of feed by mycotoxins can be considered sufficient to be extended to its use on poultry and pigs. The assessment of bentonite shows that the conditions for authorisation, as provided for in Article 5 of Regu- lation (EC) No 1831/2003, are satisfied. Accordingly, the use of that additive should be authorised as specified in the Annexes to this Regulation. 4) EFSA Journal 2011; 9(2):2007. EFSA Journal 2011; 9(6):2276. EFSA Journal 2012; 10(7):2787. 7) Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (O] L 133, 22.5.2008, p. 1).