# L_2005195EN.01000601.xml

| 27.7.2005 | EN | Official Journal of the European Union | L 195/6 |
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27.7.2005

EN

Official Journal of the European Union

L 195/6

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COMMISSION REGULATION (EC) No 1200/2005

of 26 July 2005

concerning the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of a new use of an additive already authorised in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), and in particular Articles 3, 9a, and 9d(1) thereof,

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 (2), and in particular Article 25 thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition. |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition.

| (2) | Article 25 of Regulation (EC) No 1831/2003 lays down transitional measures for applications for the authorisation of feed additives submitted in accordance with Directive 70/524/EEC before the date of application of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

Article 25 of Regulation (EC) No 1831/2003 lays down transitional measures for applications for the authorisation of feed additives submitted in accordance with Directive 70/524/EEC before the date of application of Regulation (EC) No 1831/2003.

| (3) | The applications for the authorisation of the additives listed in the Annexes to this Regulation were submitted before the date of application of Regulation (EC) No 1831/2003. |
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(3)

The applications for the authorisation of the additives listed in the Annexes to this Regulation were submitted before the date of application of Regulation (EC) No 1831/2003.

| (4) | Initial comments on those applications, as provided for in Article 4(4) of Directive 70/524/EEC, were forwarded to the Commission before the date of application of Regulation (EC) No 1831/2003. Those applications are therefore to continue to be treated in accordance with Article 4 of Directive 70/524/EEC. |
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(4)

Initial comments on those applications, as provided for in Article 4(4) of Directive 70/524/EEC, were forwarded to the Commission before the date of application of Regulation (EC) No 1831/2003. Those applications are therefore to continue to be treated in accordance with Article 4 of Directive 70/524/EEC.

| (5) | The use of the growth promoter Formi LHS (potassium diformate) was provisionally authorised, for the first time, for piglets and pigs for fattening by Commission Regulation (EC) No 1334/2001 (3). The person responsible for putting into circulation Formi LHS (potassium diformate) submitted an application to obtain a provisional authorisation for extension of use for four years, as a growth promoter for sows, according to Article 4 of that Directive. The European Food Safety Authority (EFSA) has delivered an opinion on the safety of the use of this preparation for humans, animals and environment, under the conditions set out in Annex I to this Regulation. The assessment shows that the conditions laid down in Article 9a(1) of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of this preparation, as specified in Annex I, should be authorised for four years. |
| --- | --- |

(5)

The use of the growth promoter Formi LHS (potassium diformate) was provisionally authorised, for the first time, for piglets and pigs for fattening by Commission Regulation (EC) No 1334/2001 (3). The person responsible for putting into circulation Formi LHS (potassium diformate) submitted an application to obtain a provisional authorisation for extension of use for four years, as a growth promoter for sows, according to Article 4 of that Directive. The European Food Safety Authority (EFSA) has delivered an opinion on the safety of the use of this preparation for humans, animals and environment, under the conditions set out in Annex I to this Regulation. The assessment shows that the conditions laid down in Article 9a(1) of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of this preparation, as specified in Annex I, should be authorised for four years.

| (6) | The use of the micro-organism Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012 was provisionally authorised, for the first time, for chickens for fattening and for rabbits for fattening by Commission Regulation (EC) No 1411/1999 (4). New data were submitted in support of an application for authorisation without time-limit of that micro-organism. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation, as specified in Annex II, should be authorised without a time-limit. |
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(6)

The use of the micro-organism Bacillus cereus var. toyoi NCIMB 40112/CNCM I-1012 was provisionally authorised, for the first time, for chickens for fattening and for rabbits for fattening by Commission Regulation (EC) No 1411/1999 (4). New data were submitted in support of an application for authorisation without time-limit of that micro-organism. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation, as specified in Annex II, should be authorised without a time-limit.

| (7) | The use of the micro-organism Enterococcus faecium NCIMB 10415 was provisionally authorised, for the first time, for sows by Commission Regulation (EC) No 866/1999 (5). New data were submitted in support of an application for authorisation without time-limit of that micro-organism. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation, as specified in Annex II, should be authorised without a time-limit. |
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(7)

The use of the micro-organism Enterococcus faecium NCIMB 10415 was provisionally authorised, for the first time, for sows by Commission Regulation (EC) No 866/1999 (5). New data were submitted in support of an application for authorisation without time-limit of that micro-organism. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation, as specified in Annex II, should be authorised without a time-limit.

| (8) | The use of the micro-organism Enterococcus faecium DSM 10663/NCIMB 10415 was provisionally authorised, for the first time, for piglets by Regulation (EC) No 1411/1999. New data were submitted in support of an application for authorisation without time-limit of that micro-organism. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation, as specified in Annex II, should be authorised without a time-limit. |
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(8)

The use of the micro-organism Enterococcus faecium DSM 10663/NCIMB 10415 was provisionally authorised, for the first time, for piglets by Regulation (EC) No 1411/1999. New data were submitted in support of an application for authorisation without time-limit of that micro-organism. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation, as specified in Annex II, should be authorised without a time-limit.

| (9) | The use of the micro-organism Saccharomyces cerevisiae MUCL 39885 was provisionally authorised, for the first time, for piglets by Regulation (EC) No 1411/1999. New data were submitted in support of an application for authorisation without time-limit of that micro-organism. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation, as specified in Annex II, should be authorised without a time-limit. |
| --- | --- |

(9)

The use of the micro-organism Saccharomyces cerevisiae MUCL 39885 was provisionally authorised, for the first time, for piglets by Regulation (EC) No 1411/1999. New data were submitted in support of an application for authorisation without time-limit of that micro-organism. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation, as specified in Annex II, should be authorised without a time-limit.

| (10) | The use of the micro-organism Saccharomyces cerevisiae CNCM I-1077 was provisionally authorised, for the first time, for dairy cows and cattle for fattening by the Commission Regulation (EC) No 1436/98 (6). New data were submitted in support of an application for authorisation without time-limit of that micro-organism. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation, as specified in Annex II, should be authorised without a time-limit. |
| --- | --- |

(10)

The use of the micro-organism Saccharomyces cerevisiae CNCM I-1077 was provisionally authorised, for the first time, for dairy cows and cattle for fattening by the Commission Regulation (EC) No 1436/98 (6). New data were submitted in support of an application for authorisation without time-limit of that micro-organism. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation, as specified in Annex II, should be authorised without a time-limit.

| (11) | The use of the micro-organism Pediococcus acidilactici CNCM MA 18/5M was provisionally authorised, for the first time, for chickens for fattening by Regulation (EC) No 866/1999. New data were submitted in support of an application for authorisation without time-limit of that micro-organism. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation, as specified in Annex II, should be authorised without a time-limit. |
| --- | --- |

(11)

The use of the micro-organism Pediococcus acidilactici CNCM MA 18/5M was provisionally authorised, for the first time, for chickens for fattening by Regulation (EC) No 866/1999. New data were submitted in support of an application for authorisation without time-limit of that micro-organism. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation, as specified in Annex II, should be authorised without a time-limit.

| (12) | The assessment of these applications shows that certain procedures should be required to protect workers from exposure to the additives set out in the Annexes. Such protection should be assured by the application of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (7). |
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(12)

The assessment of these applications shows that certain procedures should be required to protect workers from exposure to the additives set out in the Annexes. Such protection should be assured by the application of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (7).

| (13) | 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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(13)

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 belonging to the group ‘Growth promoters’, as specified in Annex I, is authorised provisionally for four years for use as an additive in animal nutrition under the conditions laid down in that Annex.

Article 2

The preparations belonging to the group ‘Micro-organisms’, as specified in Annex II, are authorised without a time-limit for use as additives in animal nutrition under the conditions laid down in that Annex.

Article 3

This Regulation shall enter into force on the third 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, 26 July 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 270, 14.12.1970, p. 1. Directive as last amended by Regulation (EC) No 1800/2004 (OJ L 317, 16.10.2004, p. 37).

1

(2)  
  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).

2

(3)  
  OJ L 180, 3.7.2001, p. 18. Regulation as amended by Regulation (EC) No 676/2003 (OJ L 97, 15.4.2003, p. 29).

3

(4)  
  OJ L 164, 30.6.1999, p. 56.

4

(5)  
  OJ L 108, 27.4.1999, p. 21.

5

(6)  
  OJ L 191, 7.7.1998, p. 15.

6

(7)  
  OJ L 183, 29.6.1989, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

7

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ANNEX I

| Registration number of additive | Name and registration number of person responsible for putting the additive into circulation | Additive (trade name) | Composition, chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of active substance/kg of complete feedingstuff |
| Growth promoters |
| 1 | BASF Aktiengesellschaft | Potassium diformate (Formi LHS) | Additive composition: | Potassium diformate, solid min. 98 %, |

Registration number of additive

Name and registration number of person responsible for putting the additive into circulation

Additive (trade name)

Composition, chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of active substance/kg of complete feedingstuff

Growth promoters

1

BASF Aktiengesellschaft

Potassium diformate (Formi LHS)

Additive composition:

Potassium diformate, solid min. 98 %,

| | Silicate max. 1,5 %, |
| --- | --- |

Silicate max. 1,5 %,

| | Water max. 0,5 % |
| --- | --- |

Water max. 0,5 %

Active substance:

| | Potassium diformate, solid |
| --- | --- |

Potassium diformate, solid

| | KH(COOH)2 |
| --- | --- |

KH(COOH)2

| | CAS No 20642-05-1 |
| --- | --- |

CAS No 20642-05-1

Sows

—

8 000

12 000

—

30 July 2009

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ANNEX II

| 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. | Without a time-limit |
| E 1705 | Enterococcus faecium

  NCIMB 10415 | Preparation of Enterococcus faecium containing a minimum of: | Microencapsulated form: | 1,0 × 1010 CFU/g additive |

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.

Without a time-limit

E 1705

Enterococcus faecium

NCIMB 10415

Preparation of Enterococcus faecium containing a minimum of:

Microencapsulated form:

1,0 × 1010 CFU/g additive

| | Granulated form: | 3,5 × 1010 CFU/g additive |
| --- | --- | --- |

Granulated form:

3,5 × 1010 CFU/g additive

Sows

—

0,7 × 109

1,25 × 109

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

Sows 2 weeks before farrowing and during lactation.

Without time-limit

E 1707

Enterococcus faecium

DSM 10663/NCIMB 10415

Preparation of Enterococcus faecium containing a minimum of:

| | Powder and granulated forms: | 3,5 × 1010 CFU/g additive |
| --- | --- | --- |

Powder and granulated forms:

3,5 × 1010 CFU/g additive

| | Coated form: | 2,0 × 1010 CFU/g additive |
| --- | --- | --- |

Coated form:

2,0 × 1010 CFU/g additive

| | Liquid form: | 1 × 1010 CFU/ml additive |
| --- | --- | --- |

Liquid form:

1 × 1010 CFU/ml additive

Piglets

—

1 × 109

1 × 1010

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

For use in piglets until approximately 35 kg.

Without a time-limit

E 1710

Saccharomyces cerevisiae MUCL 39885

Preparation of Saccharomyces cerevisiae containing a minimum of:

| | Powder, spheric and oval granulated forms: | 1 × 109 CFU/g additive |
| --- | --- | --- |

Powder, spheric and oval granulated forms:

1 × 109 CFU/g additive

Piglets (weaned)

—

3 × 109

3 × 109

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

For use in weaned piglets until approximately 35 kg.

Without a time-limit

E 1711

Saccharomyces cerevisiae CNCM I-1077

Preparation of Saccharomyces cerevisiae containing a minimum of:

| | Granulated powder form: | 2 × 1010 CFU/g additive |
| --- | --- | --- |

Granulated powder form:

2 × 1010 CFU/g additive

| | Coated form: | 1 × 1010 CFU/g additive |
| --- | --- | --- |

Coated form:

1 × 1010 CFU/g additive

Dairy cows

—

4 × 108

2 × 109

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

The quantity of Saccharomyces cerevisiae in the daily ration must not exceed 8,4 × 109 CFU for 100 kg body weight. Add 1,8 × 109 CFU for each additional 100 kg body weight.

Without a time-limit

Cattle for fattening

—

5 × 108

1,6 × 109

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

The quantity of Saccharomyces cerevisiae in the daily ration must not exceed 4,6 × 109 CFU for 100 kg body weight. Add 2 × 109 CFU for each additional 100 kg body weight.

Without a time-limit

E 1712

Pediococcus acidilactici CNCM MA 18/5M

Preparation of Pediococcus acidilactici containing a minimum of 1 × 1010 CFU/g additive

Chickens for fattening

—

1 × 109

1 × 1010

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:decoquinate, halofuginone, narasin, salinomycin sodium, maduramicin ammonium, diclazuril.

Without a time-limit

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