# Commission Implementing Regulation (EU) No 544/2013Show full title

Commission Implementing Regulation (EU) No 544/2013 of 14 June 2013 concerning the authorisation of a preparation of Bifidobacterium            animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as            a feed additive for chickens for fattening (holder of authorisation Biomin GmbH) (Text with EEA relevance)         

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U.K.

# Commission Implementing Regulation (EU) No 544/2013                     

# of 14 June 2013

# concerning the authorisation of a preparation of *Bifidobacterium animalis* ssp. *animalis DSM 16284, Lactobacillus salivarius* ssp. *salivarius DSM 16351* and *Enterococcus faecium DSM 21913* as a feed additive for chickens for fattening (holder of authorisation Biomin GmbH)                     

# (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 the authorisation of a preparation                              of *Bifidobacterium animalis* ssp. *animalis* DSM 16284, *Lactobacillus salivarius* ssp. *salivarius* DSM 16351 and *Enterococcus faecium* DSM 21913. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC)                              No 1831/2003.

(3)The application concerns the authorisation of a preparation of *Bifidobacterium animalis* ssp. *animalis* DSM 16284, *Lactobacillus salivarius* ssp. *salivarius* DSM 16351 and *Enterococcus faecium* DSM 21913 as a feed additive for chickens for fattening, to be classified in the additive category ‘zootechnical additives’.

(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 14 November 2012(2) that, under the proposed conditions of use, the preparation of *Bifidobacterium animalis* ssp. *animalis* DSM 16284, *Lactobacillus salivarius* ssp. *salivarius* DSM 16351 and *Enterococcus faecium* DSM 21913 does not have an adverse effect on animal health, human health or the environment, and that it has the potential                              to improve the performance of chickens for fattening. 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)The assessment of the preparation of *Bifidobacterium animalis* ssp. *animalis* DSM 16284, *Lactobacillus salivarius* ssp. *salivarius* DSM 16351 and *Enterococcus faecium* DSM 21913 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are                              satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation.

(6)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.

## ANNEXU.K.

Textual Amendments

F1Deleted by Commission Implementing Regulation (EU) 2015/1105 of 8 July 2015 concerning the authorisation of a preparation of Bifidobacterium                                 animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as                                 a feed additive for chickens reared for laying and minor poultry species other than laying, the authorisation of that feed                                 additive for use in water for drinking for chickens for fattening and amending Regulation (EU) No 544/2013 as regards the                                 maximum content of that feed additive in complete feedingstuff and its compatibility with coccidiostats (holder of the authorisation                                 Biomin GmbH) (Text with EEA relevance).

F2Substituted by Commission Implementing Regulation (EU) 2015/1105 of 8 July 2015 concerning the authorisation of a preparation of Bifidobacterium                                 animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as                                 a feed additive for chickens reared for laying and minor poultry species other than laying, the authorisation of that feed                                 additive for use in water for drinking for chickens for fattening and amending Regulation (EU) No 544/2013 as regards the                                 maximum content of that feed additive in complete feedingstuff and its compatibility with coccidiostats (holder of the authorisation                                 Biomin GmbH) (Text with EEA relevance).

1

OJ L 268, 18.10.2003, p. 29.                           

2

*EFSA Journal 2012*; 10(12):2965.