# L_2011138EN.01004301.xml

| 26.5.2011 | EN | Official Journal of the European Union | L 138/43 |
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26.5.2011

EN

Official Journal of the European Union

L 138/43

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COMMISSION IMPLEMENTING REGULATION (EU) No 516/2011

of 25 May 2011

amending Regulation (EC) No 600/2005 as regards the use of the preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 in feed containing formic acid

(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 possibility to modify the authorisation of an additive further to an application from the holder of the authorisation and an opinion of the European Food Safety Authority (‘the Authority’). |
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(1)

Regulation (EC) No 1831/2003 provides for the possibility to modify the authorisation of an additive further to an application from the holder of the authorisation and an opinion of the European Food Safety Authority (‘the Authority’).

| (2) | The preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750, belonging to the group of ‘micro-organisms’, was authorised, without a time limit, in accordance with Council Directive 70/524/EEC (2) as a feed additive for use on sows by Commission Regulation (EC) No 1453/2004 (3), for use on turkeys for fattening and calves up to 3 months by Commission Regulation (EC) No 600/2005 (4) and for use on pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004 (5). |
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(2)

The preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750, belonging to the group of ‘micro-organisms’, was authorised, without a time limit, in accordance with Council Directive 70/524/EEC (2) as a feed additive for use on sows by Commission Regulation (EC) No 1453/2004 (3), for use on turkeys for fattening and calves up to 3 months by Commission Regulation (EC) No 600/2005 (4) and for use on pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004 (5).

| (3) | The Commission received an application requesting a modification of the conditions of the authorisation of the preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 to allow its use in feed for turkeys for fattening containing formic acid. That application was accompanied by the relevant supporting data. The Commission forwarded that application to the Authority. |
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(3)

The Commission received an application requesting a modification of the conditions of the authorisation of the preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 to allow its use in feed for turkeys for fattening containing formic acid. That application was accompanied by the relevant supporting data. The Commission forwarded that application to the Authority.

| (4) | The Authority concluded in its opinion of 7 December 2010 that the compatibility of the preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750, as set out in the Annex, with formic acid for use on turkeys for fattening was established (6). |
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(4)

The Authority concluded in its opinion of 7 December 2010 that the compatibility of the preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750, as set out in the Annex, with formic acid for use on turkeys for fattening was established (6).

| (5) | The conditions provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied. |
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(5)

The conditions provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.

| (6) | Regulation (EC) No 600/2005 should therefore be amended accordingly. |
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(6)

Regulation (EC) No 600/2005 should therefore be amended accordingly.

| (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, |
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(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 1

Annex III to Regulation (EC) No 600/2005 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 20th day following 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, 25 May 2011.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  
  OJ L 270, 14.12.1970, p. 1.

2

(3)  
  OJ L 269, 17.8.2004, p. 3.

3

(4)  
  OJ L 99, 19.4.2005, p. 5.

4

(5)  
  OJ L 370, 17.12.2004, p. 24.

5

(6)  EFSA Journal 2011;9(1):1953.

6

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ANNEX

In Annex III to Regulation (EC) No 600/2005 the entry with number E 1700 concerning the additive Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 is replaced by the following:

| EC No | Additive | Chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
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| CFU/kg of complete feedingstuffs |
| Micro-organisms |
| ‘E 1700 | Bacillus licheniformis

  DSM 5749

  Bacillus subtilis

  DSM 5750
  (In a 1/1 ratio) | Mixture of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 containing a minimum of 3,2 × 109 CFU/g additive (1,6 × 109 of each bacterium) | Turkeys for fattening | — | 1,28 × 109 | 1,28 × 109 | In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
  May be used in compound feed containing one of the following coccidiostats: diclazuril, halofuginone, monensin sodium, robenidine, maduramicin ammonium, lasalocid sodium and the preservative formic acid. | Without a time limit |
| Calves | 3 months | 1,28 × 109 | 1,28 × 109 | In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. | Without a time limit’ |

EC No

Additive

Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

CFU/kg of complete feedingstuffs

Micro-organisms

‘E 1700

Bacillus licheniformis

DSM 5749

Bacillus subtilis

DSM 5750

(In a 1/1 ratio)

Mixture of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 containing a minimum of 3,2 × 109 CFU/g additive (1,6 × 109 of each bacterium)

Turkeys for fattening

—

1,28 × 109

1,28 × 109

In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.

May be used in compound feed containing one of the following coccidiostats: diclazuril, halofuginone, monensin sodium, robenidine, maduramicin ammonium, lasalocid sodium and the preservative formic acid.

Without a time limit

Calves

3 months

1,28 × 109

1,28 × 109

In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.

Without a time limit’

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