# Commission Implementing Regulation (EU) No 1060/2013Show full title

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)         

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U.K.

# 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(1), and in particular Article 9(2) thereof,                        

Whereas:

(1)Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and                              procedures for granting such authorisation. 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(3). 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 Regulation, 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 application was submitted                              for a new authorisation of bentonite as substance for reduction of the contamination 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.

(4)The European Food Safety Authority (‘the Authority’) concluded in its opinions of 2 February 2011(4), 14 June 2011(5) and 14 June 2012(6) 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 efficacious 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 monitoring. 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.

(5)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 characteristic 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.

(6)The assessment of bentonite shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No                              1831/2003, are satisfied. Accordingly, the use of that additive should be authorised as specified in the Annexes to this Regulation.

(7)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of bentonite                              as binder and anticaking agent, it is appropriate to allow a transitional period for interested parties to prepare themselves                              to meet the new requirements resulting from the authorisation.

(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain                              and Animal Health,

HAS ADOPTED THIS REGULATION:

# Article 1U.K.

Bentonite specified in the Annexes, belonging to the additive category ‘technological additives’ and to the functional groups                     ‘substances for reduction of the contamination of feed by mycotoxins’, ‘binders’, ‘anticaking agents’ and ‘substances for                     control of radionuclide contamination’ is authorised as an additive in animal nutrition, subject to the conditions laid down                     in those Annexes.                  

# Article 2U.K.

The additive specified in Annex II belonging to the functional groups ‘binders’ and ‘anticaking agents’ and feed containing                     that additive, which are produced and labelled before 19 November 2015 in accordance with the rules applicable before 19 November                     2013 may continue to be placed on the market and used until the existing stocks are exhausted.                  

# Article 3U.K.

This Regulation shall enter into force on the twentieth day following that of its publication in the *Official Journal of the European Union.*                   

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 October 2013.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEX IU.K.

## ANNEX IIU.K.

1

OJ L 268, 18.10.2003, p. 29.                           

2

Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).                           

3

Forty-first Commission Directive 82/822/EEC of 19 November 1982 amending the Annexes to Council Directive 70/524/EEC concerning                              additives in feedingstuffs (OJ L 347, 7.12.1982, p. 16).                           

4

*EFSA Journal* 2011; 9(2):2007.                           

5

*EFSA Journal* 2011; 9(6):2276.                           

6

*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 (OJ L 133, 22.5.2008, p. 1).