# L_2008050EN.01000601.xml

| 23.2.2008 | EN | Official Journal of the European Union | L 50/6 |
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23.2.2008

EN

Official Journal of the European Union

L 50/6

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COMMISSION REGULATION (EC) No 164/2008

of 22 February 2008

amending Regulation (EC) No 1444/2006 as regards the minimum content of the feed additive Bacillus subtilis C-3102 (Calsporin)

(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 13(3) thereof,

Whereas:

| (1) | The additive Bacillus subtilis C-3102 (Calsporin) was authorised under certain conditions in accordance with Regulation (EC) No 1831/2003. Commission Regulation (EC) No 1444/2006 (2) authorised that additive for ten years for use for chickens for fattening, linking the authorisation to the holder of authorisation for putting that additive into circulation. |
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(1)

The additive Bacillus subtilis C-3102 (Calsporin) was authorised under certain conditions in accordance with Regulation (EC) No 1831/2003. Commission Regulation (EC) No 1444/2006 (2) authorised that additive for ten years for use for chickens for fattening, linking the authorisation to the holder of authorisation for putting that additive into circulation.

| (2) | Regulation (EC) No 1831/2003 provides for the possibility of modifying the authorisation of an additive further to a request from the holder of the authorisation and an opinion of the European Food Safety Authority (‘the Authority’). |
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(2)

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

| (3) | The holder of the authorisation of the feed additive Bacillus subtilis C-3102 (Calsporin) has submitted an application which proposes changing the terms of the authorisation by reducing the minimum content of that additive. |
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(3)

The holder of the authorisation of the feed additive Bacillus subtilis C-3102 (Calsporin) has submitted an application which proposes changing the terms of the authorisation by reducing the minimum content of that additive.

| (4) | In its opinion adopted on 18 September 2007, the Authority has proposed to reduce the minimum content of active substance from 1 × 109 CFU to 5 × 108 CFU because there is evidence of efficacy at the lowest dose proposed (3). |
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(4)

In its opinion adopted on 18 September 2007, the Authority has proposed to reduce the minimum content of active substance from 1 × 109 CFU to 5 × 108 CFU because there is evidence of efficacy at the lowest dose proposed (3).

| (5) | Regulation (EC) No 1444/2006 should therefore be amended accordingly. |
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(5)

Regulation (EC) No 1444/2006 should therefore be amended accordingly.

| (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 Annex to Regulation (EC) No 1444/2006 is replaced by 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, 22 February 2008.

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 271, 30.9.2006, p. 19.

2

(3)  Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on Safety and efficacy of Calsporin, a preparation of Bacillus subtilis, as a feed additive for chickens for fattening in accordance with Regulation (EC) No 1831/2003. The EFSA Journal (2007) 543, 1-8.

3

Bacillus subtilis

The EFSA Journal

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ANNEX

‘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 |
| 4b1820 | Calpis Co., Ltd
  Represented in the Community by Orffa International Holding BV | Bacillus subtilis

  C-3102 DSM 15544
  (Calsporin) | | Additive composition:
  Preparation of Bacillus subtilis C-3102 (DSM 15544) containing a minimum of 1 × 1010 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

4b1820

Calpis Co., Ltd

Represented in the Community by Orffa International Holding BV

Bacillus subtilis

C-3102 DSM 15544

(Calsporin)

Additive composition:

Preparation of Bacillus subtilis C-3102 (DSM 15544) containing a minimum of 1 × 1010 CFU/g of additive

| | Characterisation of the active substance:
  Viable spores of Bacillus subtilis C-3102 (DSM 15544) |
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Characterisation of the active substance:

Viable spores of Bacillus subtilis C-3102 (DSM 15544)

| | Analytical method (1)

  Enumeration spread plate method using tryptone soya agar with preheat treatment of feed samples |
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Analytical method (1)

Enumeration spread plate method using tryptone soya agar with preheat treatment of feed samples

Chickens for fattening

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5 × 108

1 × 109

| 1. | For user safety: breathing protection during handling and safety glasses. |
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1.

For user safety: breathing protection during handling and safety glasses.

| 2. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. |
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2.

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

| 3. | The use is permitted in feed containing the permitted coccidiostats: monensin sodium, salinomycin sodium, semduramycin sodium, lasalocid sodium, maduramycin ammonium, narasin-nicarbazin and diclazuril. |
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3.

The use is permitted in feed containing the permitted coccidiostats: monensin sodium, salinomycin sodium, semduramycin sodium, lasalocid sodium, maduramycin ammonium, narasin-nicarbazin and diclazuril.

20 October 2016

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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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