# L_2007335EN.01001701.xml

| 20.12.2007 | EN | Official Journal of the European Union | L 335/17 |
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20.12.2007

EN

Official Journal of the European Union

L 335/17

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COMMISSION REGULATION (EC) No 1520/2007

of 19 December 2007

concerning the permanent authorisation of certain additives 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, 9d(1) and 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. |
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(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. |
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(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 microorganism preparation of Saccharomyces cerevisiae (MUCL 39885) was provisionally authorised for the first time for dairy cows by Commission Regulation (EC) No 879/2004 (3). New data were submitted in support of an application for authorisation without a time limit of that microorganism preparation for dairy cows. 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 microorganism preparation, as specified in Annex I to this Regulation, should be authorised without a time limit. |
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(5)

The use of the microorganism preparation of Saccharomyces cerevisiae (MUCL 39885) was provisionally authorised for the first time for dairy cows by Commission Regulation (EC) No 879/2004 (3). New data were submitted in support of an application for authorisation without a time limit of that microorganism preparation for dairy cows. 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 microorganism preparation, as specified in Annex I to this Regulation, should be authorised without a time limit.

| (6) | The use of the microorganism preparation of Enterococcus faecium (DSM 10663/NCIMB 10415) was provisionally authorised for the first time for turkeys for fattening by Commission Regulation (EC) No 1801/2003 (4). New data were submitted in support of an application for authorisation without a time limit of that microorganism preparation. 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 microorganism preparation, as specified in Annex II to this Regulation, should be authorised without a time limit. |
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(6)

The use of the microorganism preparation of Enterococcus faecium (DSM 10663/NCIMB 10415) was provisionally authorised for the first time for turkeys for fattening by Commission Regulation (EC) No 1801/2003 (4). New data were submitted in support of an application for authorisation without a time limit of that microorganism preparation. 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 microorganism preparation, as specified in Annex II to this Regulation, should be authorised without a time limit.

| (7) | The use of the microorganism preparation of Enterococcus faecium (DSM 10663/NCIMB 10415) was provisionally authorised for the first time for dogs by Commission Regulation (EC) No 1288/2004 (5). New data were submitted in support of an application for authorisation without a time limit of that microorganism preparation. 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 microorganism preparation, as specified in Annex III to this Regulation, should be authorised without a time limit. |
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(7)

The use of the microorganism preparation of Enterococcus faecium (DSM 10663/NCIMB 10415) was provisionally authorised for the first time for dogs by Commission Regulation (EC) No 1288/2004 (5). New data were submitted in support of an application for authorisation without a time limit of that microorganism preparation. 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 microorganism preparation, as specified in Annex III to this Regulation, should be authorised without a time limit.

| (8) | The use of the microorganism preparation of Lactobacillus acidophilus (D2/CSL CECT 4529) was provisionally authorised for the first time for laying hens by Commission Regulation (EC) No 2154/2003 (6). New data were submitted in support of an application for authorisation without a time limit of that microorganism preparation. 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 microorganism preparation, as specified in Annex IV to this Regulation, should be authorised without a time limit. |
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(8)

The use of the microorganism preparation of Lactobacillus acidophilus (D2/CSL CECT 4529) was provisionally authorised for the first time for laying hens by Commission Regulation (EC) No 2154/2003 (6). New data were submitted in support of an application for authorisation without a time limit of that microorganism preparation. 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 microorganism preparation, as specified in Annex IV to this Regulation, should be authorised without a time limit.

| (9) | The use of the enzyme preparation of endo-1,4-beta-glucanase, EC 3.2.1.4 produced by Trichoderma longibrachiatum (IMI SD 142) was provisionally authorised for the first time for piglets by Commission Regulation (EC) No 1436/98 (7). New data were submitted in support of an application for authorisation without a time limit of that enzyme preparation. 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 enzyme preparation, as specified in Annex V to this Regulation, should be authorised without a time limit. |
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(9)

The use of the enzyme preparation of endo-1,4-beta-glucanase, EC 3.2.1.4 produced by Trichoderma longibrachiatum (IMI SD 142) was provisionally authorised for the first time for piglets by Commission Regulation (EC) No 1436/98 (7). New data were submitted in support of an application for authorisation without a time limit of that enzyme preparation. 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 enzyme preparation, as specified in Annex V to this Regulation, should be authorised without a time limit.

| (10) | 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 (8). |
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(10)

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 (8).

| (11) | 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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(11)

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 ‘Microorganisms’, as specified in Annex I, is authorised without a time limit as an additive in animal nutrition under the conditions laid down in that Annex.

Article 2

The preparation belonging to the group ‘Microorganisms’, as specified in Annex II, is authorised without a time limit as an additive in animal nutrition under the conditions laid down in that Annex.

Article 3

The preparation belonging to the group ‘Microorganisms’, as specified in Annex III, is authorised without a time limit as an additive in animal nutrition under the conditions laid down in that Annex.

Article 4

The preparation belonging to the group ‘Microorganisms’, as specified in Annex IV, is authorised without a time limit as an additive in animal nutrition under the conditions laid down in that Annex.

Article 5

The preparation belonging to the group ‘Enzymes’, as specified in Annex V, is authorised without a time limit as an additive in animal nutrition under the conditions laid down in that Annex.

Article 6

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, 19 December 2007.

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 Commission 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 162, 30.4.2004, p. 65.

3

(4)  
  OJ L 264, 15.10.2003, p. 16.

4

(5)  
  OJ L 243, 15.7.2004, p. 10. Regulation as amended by Regulation (EC) No 1812/2005 (OJ L 291, 5.11.2005, p. 18).

5

(6)  
  OJ L 324, 11.12.2003, p. 11.

6

(7)  
  OJ L 191, 7.7.1998, p. 15.

7

(8)  
  OJ L 183, 29.6.1989, p. 1. Directive as last amended by Directive 2007/30/EC of the European Parliament and of the Council (OJ L 165, 27.6.2007, p. 21).

8

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ANNEX I

| 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 1710 | Saccharomyces cerevisiae

  MUCL 39885 | Preparation of Saccharomyces cerevisiae containing a minimum of:
  Powder, spheric and oval granulated forms:
  1 × 109 CFU/g additive | Dairy cows | — | 1,23 × 109 | 2,33 × 109 | 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. |

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 1710

Saccharomyces cerevisiae

MUCL 39885

Preparation of Saccharomyces cerevisiae containing a minimum of:

Powder, spheric and oval granulated forms:

1 × 109 CFU/g additive

Dairy cows

—

1,23 × 109

2,33 × 109

1.

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

| 2. | The quantity of Saccharomyces cerevisiae in the daily ration must not exceed 8,4 × 109 CFU per 100 kg. Body weight till 600 kg. Over 600 kg add 0,9 × 109 CFU for each additional 100 kg body weight. |
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2.

The quantity of Saccharomyces cerevisiae in the daily ration must not exceed 8,4 × 109 CFU per 100 kg. Body weight till 600 kg. Over 600 kg add 0,9 × 109 CFU for each additional 100 kg body weight.

Without a time limit

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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 |
| Microorganisms |
| E 1707 | Enterococcus faecium

  DSM 10663/NCIMB 10415 | Preparation of Enterococcus faecium containing a minimum of: | Powder and granulated form:
  3,5 × 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

Microorganisms

E 1707

Enterococcus faecium

DSM 10663/NCIMB 10415

Preparation of Enterococcus faecium containing a minimum of:

Powder and granulated form:

3,5 × 1010 CFU/g additive

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

2,0 × 1010 CFU/g additive

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

Liquid form:

1 × 1010 CFU/ml additive

Turkeys for fattening

—

1 × 107

1,0 × 109

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

1.

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

| 2. | May be used in compound feed containing the permitted coccidiostats: diclazuril, halofuginone, lasalocid sodium, maduramicin ammonium monensin sodium, robenidine. |
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2.

May be used in compound feed containing the permitted coccidiostats: diclazuril, halofuginone, lasalocid sodium, maduramicin ammonium monensin sodium, robenidine.

Without a time limit

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ANNEX III

| 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 |
| Microorganisms |
| E 1707 | Enterococcus faecium

  DSM 10663/NCIMB 10415 | Preparation of Enterococcus faecium containing a minimum of: | Powder and granulated form:
  3,5 × 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

Microorganisms

E 1707

Enterococcus faecium

DSM 10663/NCIMB 10415

Preparation of Enterococcus faecium containing a minimum of:

Powder and granulated form:

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

Dogs

—

1 × 109

3,5 × 1010

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

Without a time limit

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ANNEX IV

| 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 |
| Microorganisms |
| E 1715 | Lactobacillus acidophilus

  D2/CSL
  CECT 4529 | Preparation of Lactobacillus acidophilus containing minimum of:
  50 × 109 CFU/g additive | Laying hens | — | 1 × 109 | 1 × 109 | In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. | Without 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

Microorganisms

E 1715

Lactobacillus acidophilus

D2/CSL

CECT 4529

Preparation of Lactobacillus acidophilus containing minimum of:

50 × 109 CFU/g additive

Laying hens

—

1 × 109

1 × 109

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

Without time limit

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ANNEX V

| EC No | Additive | Chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Units of activity/kg of complete feedingstuff |
| Enzymes |
| E 1616 | Endo-1,4-beta-glucanase
  EC 3.2.1.4 | Preparation of endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (IMI SD 142) having a minimum activity of: | Solid form: 2 000 CU (1)/g |

EC No

Additive

Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Units of activity/kg of complete feedingstuff

Enzymes

E 1616

Endo-1,4-beta-glucanase

EC 3.2.1.4

Preparation of endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (IMI SD 142) having a minimum activity of:

Solid form: 2 000 CU (1)/g

| | Liquid form: 2 000 CU/ml |
| --- | --- |

Liquid form: 2 000 CU/ml

Piglets (weaned)

—

350 CU

—

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

1.

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

| 2. | Recommended dose per kg of complete feedingstuff: 350-1 000 CU. |
| --- | --- |

2.

Recommended dose per kg of complete feedingstuff: 350-1 000 CU.

| 3. | For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans), e.g. containing more than 40 % barley. |
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3.

For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans), e.g. containing more than 40 % barley.

| 4. | For use in weaned piglets up to approximately 35 kg. |
| --- | --- |

4.

For use in weaned piglets up to approximately 35 kg.

Without a time limit

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(1)  1 CU is the amount of enzyme which liberates 0,128 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,5 and 30 °C.

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