# Commission Implementing Regulation (EU) No 1108/2014Show full title

Commission Implementing Regulation (EU) No 1108/2014 of 20 October 2014 concerning the authorisation of a preparation of Clostridium            butyricum (FERM BP-2789) as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of authorisation            Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium) (Text with EEA relevance)         

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U.K.

# Commission Implementing Regulation (EU) No 1108/2014                     

# of 20 October 2014

# concerning the authorisation of a preparation of *Clostridium butyricum* (FERM BP-2789) as a feed additive for turkeys for fattening and turkeys reared for breeding ([F1holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium])                     

# (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)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for a new use of a preparation                              of *Clostridium butyricum* (FERM BP-2789). That 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.

(3)The application concerns the authorisation of the preparation of *Clostridium butyricum* (FERM BP-2789) as a feed additive for turkeys for fattening and turkeys reared for breeding, to be classified in the additive                              category ‘zootechnical additives’.

(4)The use of the 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).

(5)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 4 March 2014(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 has the potential to improve performance in turkeys for fattening and that this conclusion can be extended to                              turkeys reared for breeding. 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 Plants, Animals,                              Food and Feed.

HAS ADOPTED THIS REGULATION:

Textual Amendments

F1Substituted by Commission Implementing Regulation (EU) 2017/1126 of 23 June 2017 amending Regulation (EC) No 903/2009 and Implementing Regulations                                 (EU) No 373/2011, (EU) No 374/2013 and (EU) No 1108/2014 as regards the name of the EU representative of the holder of the                                 authorisation of a preparation of Clostridium butyricum (FERM-BP 2789) (Text with EEA relevance).

# 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.

## ANNEXU.K.

1

OJ L 268, 18.10.2003, p. 29.                           

2

Commission Regulation (EC) No 903/2009 of 28 September 2009 concerning the authorisation of the preparation of *Clostridium butyricum* FERM-BP 2789 as a feed additive for chickens for fattening (holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented                              by Miyarisan Pharmaceutical Europe S.L.U) (OJ L 256, 29.9.2009, p. 26).                           

3

Commission Implementing Regulation (EU) No 373/2011 of 15 April 2011 concerning the authorisation of the preparation of *Clostridium butyricum* FERM-BP 2789 as a feed additive for minor avian species except laying birds, weaned piglets and minor porcine species (weaned)                              and amending Regulation (EC) No 903/2009 (holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Miyarisan                              Pharmaceutical Europe S.L.U.) (OJ L 102, 16.4.2011, p. 10).                           

4

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