# Commission Implementing Regulation (EU) No 1061/2013Show full title

Commission Implementing Regulation (EU) No 1061/2013 of 29 October 2013 concerning the authorisation of a preparation of Enterococcus            faecium NCIMB 10415 as a feed additive for calves, kids, cats and dogs and amending Regulation (EC) No 1288/2004 (holder of            the authorisation DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o) (Text with EEA relevance)         

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U.K.

# Commission Implementing Regulation (EU) No 1061/2013                     

# of 29 October 2013

# concerning the authorisation of a preparation of *Enterococcus faecium* NCIMB 10415 as a feed additive for calves, kids, cats and dogs and amending Regulation (EC) No 1288/2004 (holder of the authorisation                        DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o)                     

# (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)The preparation of *Enterococcus faecium* NCIMB 10415 was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on calves                              by Commission Regulation (EC) No 1288/2004(3), for sows by Commission Regulation (EC) No 1200/2005(4), for piglets by Commission Regulation (EC) No 252/2006(5), for pigs for fattening by Commission Regulation (EC) No 943/2005(6), and for cats and dogs by Commission Regulation (EC) No 102/2009(7). That preparation 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)The preparation was also authorised for 10 years for chickens for fattening by Commission Implementing Regulation (EU) No                              361/2011(8).

(4)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 preparation of *Enterococcus faecium* NCIMB 10415 as a feed additive for calves, cats and dogs and, in accordance with Article 7 of that Regulation, for a new                              use for kids, 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.

(5)The European Food Safety Authority (‘the Authority’) concluded in its opinions of 29 January 2013(9) that, under the proposed conditions of use, the preparation of *Enterococcus faecium* NCIMB 10415 does not have an adverse effect on animal health, human health or the environment, and that its use increases                              final body weight and/or daily weight gain in calves for rearing and fattening and that can be extrapolated to kids for rearing                              and fattening. It also recognised that the preparation has a beneficial effect in dogs by increasing the intestinal or serum                              concentration of IgA. 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)Since small but significant effects on faecal quality were observed in cats, it was considered sufficient to confirm the efficacy                              in this species.

(7)The assessment of the preparation of *Enterococcus faecium* NCIMB 10415 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 Annex to this Regulation.

(8)As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulation (EC) No 102/2009 should                              be repealed and Regulation (EC) No 1288/2004 should be amended accordingly.

(9)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 interested parties to prepare themselves to meet the new requirements resulting                              from the authorisation.

(10)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.Authorisation

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

## Article 2U.K.Repeal of Regulation (EC) No 102/2009

Regulation (EC) No 102/2009 is repealed.

## Article 3U.K.Amendment to Regulation (EC) No 1288/2004

In Annex I to Regulation (EC) No 1288/2004 the entry on E 1705, *Enterococcus faecium* NCIMB 10415 is deleted.                  

## Article 4U.K.Transitional measures

The preparation specified in Annex as far as its use for calves is concerned, and feed containing that preparation, which                     are produced and labelled before 19 May 2014 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.                  

The preparation specified in Annex as far as its use for cats and dogs is concerned, and feed containing that preparation,                     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 5U.K.Entry into force

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                            

## ANNEXU.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

Commission Regulation (EC) No 1288/2004 of 14 July 2004 concerning the permanent authorisation of certain additives and the                              provisional authorisation of a new use of an additive already authorised in feedingstuffs (OJ L 243, 15.7.2004, p. 10).                           

4

Commission Regulation (EC) No 1200/2005 of 26 July 2005 concerning the permanent authorisation of certain additives in feedingstuffs                              and the provisional authorisation of a new use of an additive already authorised in feedingstuffs (OJ L 195, 27.7.2005, p. 6).                           

5

Commission Regulation (EC) No 252/2006 of 14 February 2006 concerning the permanent authorisations of certain additives in                              feedingstuffs and the provisional authorisations of new uses of certain additives already authorised in feedingstuffs (OJ L 44, 15.2.2006, p. 3).                           

6

Commission Regulation (EC) No 943/2005 of 21 June 2005 concerning the permanent authorisation of additives in feedingstuffs                              (OJ L 159, 22.6.2005, p. 6).                           

7

Commission Regulation (EC) No 102/2009 of 3 February 2009 concerning the permanent authorisation of an additive in feedingstuffs                              (OJ L 34, 4.2.2009, p. 8).                           

8

Commission Implementing Regulation (EU) No 361/2011 of 13 April 2011 concerning the authorisation of *Enterococcus faecium* NCIMB 10415 as a feed additive for chickens for fattening (holder of authorisation DSM Nutritional products Ltd represented                              by DSM Nutritional Products Sp. Z o.o) and amending Regulation (EC) No 943/2005 (OJ L 100, 14.4.2011, p. 22).                           

9

*EFSA Journal* 2013; 11(2):3097 and 3098.