# L_2006414EN.01002601.xml

| 30.12.2006 | EN | Official Journal of the European Union | L 414/26 |
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30.12.2006

EN

Official Journal of the European Union

L 414/26

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COMMISSION REGULATION (EC) No 2028/2006

of 18 December 2006

amending Regulation (EC) No 600/2005 as regards the authorisation of the feed additive preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750, belonging to the group of microorganisms

(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 for the grounds and procedures 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 for the grounds and procedures for granting such authorisation.

| (2) | The preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750, belonging to the group of ‘microorganisms’, 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), for use in pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004 (5). 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 ‘microorganisms’, 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), for use in pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004 (5). 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 for turkeys for fattening containing the permitted coccidiostat maduramicin ammonium. 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 for turkeys for fattening containing the permitted coccidiostat maduramicin ammonium. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 July 2006 that the compatibility of the additive preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 with maduramicin ammonium was established. The opinion of the Authority also verifies the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003. |
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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 July 2006 that the compatibility of the additive preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 with maduramicin ammonium was established. The opinion of the Authority also verifies the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003.

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

The assessment of that preparation shows that 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 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, 18 December 2006.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

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 370, 17.12.2004, p. 24.

5

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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 for the animal species turkeys for fattening 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 feedingstuff |
| Micro-organisms |
| ‘E 1700 | Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750
  in a 1/1 ratio) | Mixture of Bacillus licheniformis and Bacillus subtilis 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 permitted coccidiostats:






  — | diclazuril, halofuginone, monensin sodium, robenidine and maduramicin ammonium. |

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 feedingstuff

Micro-organisms

‘E 1700

Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750

in a 1/1 ratio)

Mixture of Bacillus licheniformis and Bacillus subtilis 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 permitted coccidiostats:

—

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

Without a time limit’

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