# Commission Implementing Regulation (EU) No 797/2013Show full title

Commission Implementing Regulation (EU) No 797/2013 of 21 August 2013 concerning the authorisation of a preparation of Enterococcus            faecium NCIMB 11181 as a feed additive for calves for rearing and for fattening and weaned piglets (holder of authorisation            Chr. Hansen A/S) and repealing Regulation (EC) No 1333/2004 (Text with EEA relevance)         

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U.K.

# Commission Implementing Regulation (EU) No 797/2013                     

# of 21 August 2013

# concerning the authorisation of a preparation of *Enterococcus faecium* NCIMB 11181 as a feed additive for calves for rearing and for fattening and weaned piglets (holder of authorisation Chr.                        Hansen A/S) and repealing Regulation (EC) No 1333/2004                     

# (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)A preparation of *Enterococcus faecium* NCIMB 11181 was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on calves                              for rearing and for fattening and weaned piglets by Commission Regulation (EC) No 1333/2004(3). That preparation was subsequently entered in the European Union 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 that preparation as a feed additive for calves for rearing and for fattening and weaned                              piglets, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was                              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 opinion of 1 February 2012(4) that, under the proposed conditions of use, the preparation of *Enterococcus faecium* NCIMB 11181 does not have an adverse effect on animal health, human health or on the environment, and that it is efficacious                              in improving zootechnical performance of calves for rearing and for fattening and weaned piglets. 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 *Enterococcus faecium* NCIMB 11181 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.

(6)As a new authorisation is granted in accordance with Regulation (EC) No 1831/2003, Regulation (EC) No 1333/2004 should be                              repealed.

(7)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it                              is appropriate to allow a transitional period for the disposal of existing stocks of the additive, pre-mixtures and compound                              feed containing it, as authorised by Regulation (EC) No 1333/2004.

(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.

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.

Regulation (EC) No 1333/2004 is repealed.

# Article 3U.K.

The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 11 March                     2014 in accordance with the rules applicable before 11 September 2013 may continue to be placed on the market and used until                     the existing stocks are exhausted.                  

# Article 4U.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, 21 August 2013.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEXU.K.

1

OJ L 268, 18.10.2003, p. 29.                           

2

OJ L 270, 14.12.1970, p. 1.                           

3

OJ L 247, 21.7.2004, p. 11.                           

4

*EFSA Journal 2012*; 10(2):2574.