# L_2009071EN.01000801.xml

| 17.3.2009 | EN | Official Journal of the European Union | L 71/8 |
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17.3.2009

EN

Official Journal of the European Union

L 71/8

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COMMISSION REGULATION (EC) No 202/2009

of 16 March 2009

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 the ground and procedure for granting such authorisation. |
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(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and the ground and procedure for granting such authorisation.

| (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 in sows by Commission Regulation (EC) No 1453/2004 (3), for use in turkeys for fattening and calves up to three months by Commission Regulation (EC) No 600/2005 (4) which was subsequently amended by Regulation (EC) No 2028/2006 (5), for use in pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004 (6). This additive was subsequently entered in the Community Register of Feed Additives as an existing product, in accordance with Article 10 of Regulation (EC) No 1831/2003. |
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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 in sows by Commission Regulation (EC) No 1453/2004 (3), for use in turkeys for fattening and calves up to three months by Commission Regulation (EC) No 600/2005 (4) which was subsequently amended by Regulation (EC) No 2028/2006 (5), for use in pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004 (6). This additive was subsequently entered in the Community Register of Feed Additives as an existing product, in accordance with Article 10 of Regulation (EC) No 1831/2003.

| (3) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application for an amendment of the authorisation of that preparation was submitted to allow its use in feed containing the coccidiostat lasalocid sodium for turkeys for fattening. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. |
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(3)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application for an amendment of the authorisation of that preparation was submitted to allow its use in feed containing the coccidiostat lasalocid sodium for turkeys for fattening. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

| (4) | The European Food Safety Authority concluded in its opinion of 22 October 2008 that the compatibility of the additive Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 with lasalocid sodium was established (7). |
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(4)

The European Food Safety Authority concluded in its opinion of 22 October 2008 that the compatibility of the additive Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 with lasalocid sodium was established (7).

| (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, 16 March 2009.

For the Commission

Androulla VASSILIOU

Member of the Commission

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

1

(2)  
  OJ L 270, 14.12.1970, p. 1. Directive repealed by Regulation (EC) No 1831/2003.

2

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

3

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

4

(5)  
  OJ L 414, 30.12.2006, p. 26.

5

(6)  
  OJ L 370, 17.12.2004, p. 24.

6

(7)  Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) on a request from the European Commission on the compatibility of the microbial product Bioplus 2B (Bacillus licheniformis and Bacillus subtilis) with lasalocid sodium. The EFSA Journal (2008) 841, p. 1-7.

7

Bacillus licheniformis

Bacillus subtilis

The EFSA Journal

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ANNEX

In Annex III to Regulation (EC) No 600/2005 the entry for E 1700, 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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 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 the coccidiostats:
  diclazuril, halofuginone, monensin sodium, robenidine, maduramicin ammonium and lasalocid sodium. | Without 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 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 the coccidiostats:

diclazuril, halofuginone, monensin sodium, robenidine, maduramicin ammonium and lasalocid sodium.

Without 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 time limit’

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