# L_2006271EN.01002201.xml

| 30.9.2006 | EN | Official Journal of the European Union | L 271/22 |
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30.9.2006

EN

Official Journal of the European Union

L 271/22

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COMMISSION REGULATION (EC) No 1445/2006

of 29 September 2006

amending Regulation (EC) No 1200/2005 as regards the authorisation of the feed additive ‘
  Bacillus cereus var. toyoi
  ’, belonging to the group of micro-organisms

(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 Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012), belonging to the group of ‘micro-organisms’, was authorised in accordance with Council Directive 70/524/EEC (2) without a time-limit as a feed additive for chickens for fattening and rabbits for fattening by Commission Regulation (EC) No 1200/2005 (3). 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 Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012), belonging to the group of ‘micro-organisms’, was authorised in accordance with Council Directive 70/524/EEC (2) without a time-limit as a feed additive for chickens for fattening and rabbits for fattening by Commission Regulation (EC) No 1200/2005 (3). 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 following coccidiostats: diclazuril (Clinacox 0,5 % and Clinacox 0,2 %), narasin-nicarbazina (Maxiban G160) and maduramicin ammonium (Cygro 1 %) for chickens 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 following coccidiostats: diclazuril (Clinacox 0,5 % and Clinacox 0,2 %), narasin-nicarbazina (Maxiban G160) and maduramicin ammonium (Cygro 1 %) for chickens 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 (the Authority) concluded in its opinion of 5 November 2005 that the compatibility of the additive Bacillus var. toyoi (NCIMB 40112/CNCM I-1012) with diclazuril (Clinacox 0,5 % and Clinacox 0,2 %), narasin-nicarbazina (Maxiban G160) and maduramicin ammonium (Cygro 1 %) was established (4). 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 5 November 2005 that the compatibility of the additive Bacillus var. toyoi (NCIMB 40112/CNCM I-1012) with diclazuril (Clinacox 0,5 % and Clinacox 0,2 %), narasin-nicarbazina (Maxiban G160) and maduramicin ammonium (Cygro 1 %) was established (4). 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 1200/2005 should therefore be amended accordingly. |
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(6)

Regulation (EC) No 1200/2005 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 II to Regulation (EC) No 1200/2005 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, 29 September 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 195, 27.7.2005, p. 6.

3

(4)  Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the modification of terms of authorisation of the micro-organism preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) (Toyocerin®) authorised as a feed additive in accordance with Council Directive 70/524/EEC. Adopted on 30 November 2005. The EFSA Journal (2005) 288, pp. 1 to 7.

4

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ANNEX

In Annex II to Regulation (EC) No 1200/2005 the entry for E 1701, Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012), 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 feedingstuff |
| Micro-organisms |
| ‘E 1701 | Bacillus cereus var. toyoi

  NCIMB 40112/CNCM I-1012 | Preparation of Bacillus cereus var. toyoi containing a minimum of: 1 × 1010 CFU/g additive | Rabbits for fattening | — | 0,1 × 109 | 5 × 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: robenidine, salinomycin sodium. | Without a time-limit |
| Chickens for fattening | — | 0,2 × 109 | 1 × 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: monensin sodium, lasalocid sodium, salinomycin sodium, decoquinate, robenidine, narasin, halofuginone, diclazuril, narasin/nicarbazin, maduramicin ammonium. | Without a 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 feedingstuff

Micro-organisms

‘E 1701

Bacillus cereus var. toyoi

NCIMB 40112/CNCM I-1012

Preparation of Bacillus cereus var. toyoi containing a minimum of: 1 × 1010 CFU/g additive

Rabbits for fattening

—

0,1 × 109

5 × 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: robenidine, salinomycin sodium.

Without a time-limit

Chickens for fattening

—

0,2 × 109

1 × 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: monensin sodium, lasalocid sodium, salinomycin sodium, decoquinate, robenidine, narasin, halofuginone, diclazuril, narasin/nicarbazin, maduramicin ammonium.

Without a time-limit’

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