# Commission Implementing Regulation (EU) No 374/2013Show full title

Commission Implementing Regulation (EU) No 374/2013 of 23 April 2013 concerning the authorisation of a preparation of Clostridium            butyricum (FERM BP-2789) as a feed additive for chickens reared for laying (holder of authorisation Miyarisan Pharmaceutical            Co. Ltd represented by Miyarisan Pharmaceutical Europe S.L.U.) (Text with EEA relevance)         

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U.K.

# Commission Implementing Regulation (EU) No 374/2013                     

# of 23 April 2013

# concerning the authorisation of a preparation of *Clostridium butyricum* (FERM BP-2789) as a feed additive for chickens reared for laying (holder of authorisation Miyarisan Pharmaceutical Co. Ltd                        represented by Miyarisan Pharmaceutical Europe S.L.U.)                     

# (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.

(2)The use of a preparation of *Clostridium butyricum* (FERM BP-2789), belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive                              for use on chickens for fattening by Commission Regulation (EC) No 903/2009(2) and for minor avian species (excluding laying birds) and for weaned piglets and minor porcine species (weaned) by Commission                              Implementing Regulation (EU) No 373/2011(3).

(3)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for a new use of the preparation                              of *Clostridium butyricum* (FERM BP-2789) for chickens reared for laying, requesting that the additive be classified in the additive category ‘zootechnical                              additives’.

(4)The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003,                              and by the relevant data to support its requests.

(5)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 December 2012(4) that, under the proposed conditions of use, the preparation of *Clostridium butyricum* (FERM BP-2789) does not have an adverse effect on animal health, human health and the environment. It also concluded that                              the additive shows some potential to improve performance in chickens reared for laying. 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.

(6)The assessment of the preparation of *Clostridium butyricum* (FERM BP-2789) 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 preparation should be authorised as specified in the Annex to this Regulation.

(7)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.

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional                     group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition subject to the conditions laid down in that                     Annex.                  

# Article 2U.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, 23 April 2013.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEXU.K.

1

OJ L 268, 18.10.2003, p. 29.                           

2

OJ L 256, 29.9.2009, p. 26.                           

3

OJ L 102, 16.4.2011, p. 10.                           

4

*EFSA Journal* 2013; 11(1):3040.