# L_2007256EN.01000501.xml

| 2.10.2007 | EN | Official Journal of the European Union | L 256/5 |
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2.10.2007

EN

Official Journal of the European Union

L 256/5

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COMMISSION REGULATION (EC) No 1137/2007

of 1 October 2007

concerning the authorisation of Bacillus subtilis (O35) as a feed additive

(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) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of the preparation of Bacillus subtilis DSM 17299 (O35) as a feed additive for chickens for fattening to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns the authorisation of the preparation of Bacillus subtilis DSM 17299 (O35) as a feed additive for chickens for fattening to be classified in the additive category ‘zootechnical additives’.

| (4) | The European Food Safety Authority (the Authority) concluded in its opinion of 17 October 2006 that the preparation of Bacillus subtilis DSM 17299 (O35) does not have an adverse effect on animal health, human health or the environment (2). It further concluded that that preparation does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. The opinion of the Authority recommends appropriate measures for user safety. It does not consider that there is a need for specific requirements of post market monitoring. This opinion 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 17 October 2006 that the preparation of Bacillus subtilis DSM 17299 (O35) does not have an adverse effect on animal health, human health or the environment (2). It further concluded that that preparation does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. The opinion of the Authority recommends appropriate measures for user safety. It does not consider that there is a need for specific requirements of post market monitoring. This opinion 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 for authorisation, 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. |
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(5)

The assessment of that preparation shows that the conditions for authorisation, 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) | 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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(6)

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

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 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, 1 October 2007.

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)  Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed and the Scientific Panel on Genetically Modified Organisms on the safety and efficacy of the microbiological product ‘O35’, a preparation of Bacillus subtilis, as a feed additive for chickens for fattening in accordance with Regulation (EC) No 1831/2003. Adopted on 17 October 2006. The EFSA Journal (2006) 406, p. 1-11.

2

Bacillus subtilis

The EFSA Journal

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ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive
  (Trade name) | Composition, chemical formula, description, analytical method | 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 with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: gut flora stabilisers |
| 4b1821 | Chr. Hansen A/S | Bacillus subtilis DSM 17299
  (O35) | | Additive composition:
  Preparation of Bacillus subtilis DSM 17299
  Containing a minimum of 1,6 × 109 CFU/g of additive |

Identification number of the additive

Name of the holder of authorisation

Additive

(Trade name)

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

CFU/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers

4b1821

Chr. Hansen A/S

Bacillus subtilis DSM 17299

(O35)

Additive composition:

Preparation of Bacillus subtilis DSM 17299

Containing a minimum of 1,6 × 109 CFU/g of additive

| | Characterisation of the active substance:

  Bacillus subtilis DSM 17299 spore concentrate |
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Characterisation of the active substance:

Bacillus subtilis DSM 17299 spore concentrate

| | Analytical method (1):
  Enumeration spread plate method using tryptone soya agar with pre-heat treatment of feed samples |
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Analytical method (1):

Enumeration spread plate method using tryptone soya agar with pre-heat treatment of feed samples

Chickens for fattening

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8 × 108

1,6 × 109

| 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. |
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1.

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

| 2. | The use is permitted in feed containing the permitted coccidiostats: diclazuril, halofuginone and robenidine. |
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2.

The use is permitted in feed containing the permitted coccidiostats: diclazuril, halofuginone and robenidine.

22 October 2017

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(1)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives

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