# L_2009256EN.01002601.xml

| 29.9.2009 | EN | Official Journal of the European Union | L 256/26 |
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29.9.2009

EN

Official Journal of the European Union

L 256/26

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COMMISSION REGULATION (EC) No 903/2009

of 28 September 2009

concerning the authorisation of the preparation of Clostridium butyricum MIYAIRI 588 (FERM-P 1467) as a feed additive for chickens for fattening (holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Mitsui & Co. Deutschland GmbH)

(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 Clostridium butyricum MIYAIRI 588 (FERM-P 1467) 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 Clostridium butyricum MIYAIRI 588 (FERM-P 1467) as a feed additive for chickens for fattening, to be classified in the additive category ‘zootechnical additives’.

| (4) | From the opinion of the European Food Safety Authority (the Authority) of 2 April 2009 (2) it results that the preparation of Clostridium butyricum MIYAIRI 588 (FERM-P 1467) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation can have a significant benefit on feed to gain ratio. 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 Community Reference Laboratory set up by Regulation (EC) No 1831/2003. |
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(4)

From the opinion of the European Food Safety Authority (the Authority) of 2 April 2009 (2) it results that the preparation of Clostridium butyricum MIYAIRI 588 (FERM-P 1467) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation can have a significant benefit on feed to gain ratio. 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 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, 28 September 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)  
  The EFSA Journal (2009) 1039, p. 1.

2

The EFSA Journal

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ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | 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 |
| 4b1830 | Miyarisan Pharmaceutical Co. Ltd represented by Mitsui & Co. Deutschland GmbH | Clostridium butyricum MIYAIRI 588 (FERM-P 1467) | | Additive composition:
  Preparation of Clostridium butyricum MIYAIRI 588 (FERM-P 1467) containing a minimum of solid form 5 × 108 CFU/g additive |

Identification number of the additive

Name of the holder of authorisation

Additive

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

4b1830

Miyarisan Pharmaceutical Co. Ltd represented by Mitsui & Co. Deutschland GmbH

Clostridium butyricum MIYAIRI 588 (FERM-P 1467)

Additive composition:

Preparation of Clostridium butyricum MIYAIRI 588 (FERM-P 1467) containing a minimum of solid form 5 × 108 CFU/g additive

| | Characterisation of the active substance:

  Clostridium butyricum MIYAIRI 588 (FERM-P 1467) |
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Characterisation of the active substance:

Clostridium butyricum MIYAIRI 588 (FERM-P 1467)

| | Analytical method (1): | Quantification: iron sulphite agar for the additive and premixtures and selective Clostridium butyricum MIYAIRI 588 agar for feedingstuffs |
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Analytical method (1):

Quantification: iron sulphite agar for the additive and premixtures and selective Clostridium butyricum MIYAIRI 588 agar for feedingstuffs

| | Identification: pulsed-field gel electrophoresis (PFGE) method |
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Identification: pulsed-field gel electrophoresis (PFGE) method

Chickens for fattening

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5 × 108 CFU

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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. |
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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 allowed in feed containing the permitted coccidiostats: monensin sodium, diclazuril, maduramicin ammonium, robenidine, narasin, narasin/nicarbazin, semduramycin, decoquinate. |
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2.

The use is allowed in feed containing the permitted coccidiostats: monensin sodium, diclazuril, maduramicin ammonium, robenidine, narasin, narasin/nicarbazin, semduramycin, decoquinate.

| 3. | For safety reasons: breathing protection shall be used during handling. |
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3.

For safety reasons: breathing protection shall be used during handling.

19 October 2019

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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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