# L_2004239EN.01000801.xml

| 9.7.2004 | EN | Official Journal of the European Union | L 239/8 |
| --- | --- | --- | --- |

9.7.2004

EN

Official Journal of the European Union

L 239/8

---

COMMISSION REGULATION (EC) No 1259/2004

of 8 July 2004

concerning the permanent authorisation of certain additives 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), as last amended by Regulation (EC) No 1756/2002 (2), and in particular Articles 3 and 9d(1) thereof,

Whereas:

| (1) | Directive 70/524/EEC provides that no additive may be put into circulation unless a Community authorisation has been granted. |
| --- | --- |

(1)

Directive 70/524/EEC provides that no additive may be put into circulation unless a Community authorisation has been granted.

| (2) | In the case of additives referred to in part II of Annex C to Directive 70/524/EEC, which includes micro-organisms and enzymes, authorisation without a time limit of an additive already authorised may be given if the conditions laid down in Article 3(a) are satisfied. |
| --- | --- |

(2)

In the case of additives referred to in part II of Annex C to Directive 70/524/EEC, which includes micro-organisms and enzymes, authorisation without a time limit of an additive already authorised may be given if the conditions laid down in Article 3(a) are satisfied.

| (3) | The use of the micro-organism preparation of Enterococcus faecium (DSM 10663/NCIMB 10415) was provisionally authorised, for the first time, for chickens for fattening by Commission Regulation (EC) No 1636/1999 (3). |
| --- | --- |

(3)

The use of the micro-organism preparation of Enterococcus faecium (DSM 10663/NCIMB 10415) was provisionally authorised, for the first time, for chickens for fattening by Commission Regulation (EC) No 1636/1999 (3).

| (4) | New data were submitted in support of the application for authorisation without a time limit of this micro-organism. |
| --- | --- |

(4)

New data were submitted in support of the application for authorisation without a time limit of this micro-organism.

| (5) | The assessment of the application for authorisation submitted in respect of this micro-organism, shows that the conditions provided for in Directive 70/524/EEC for authorisation without a time limit are satisfied. |
| --- | --- |

(5)

The assessment of the application for authorisation submitted in respect of this micro-organism, shows that the conditions provided for in Directive 70/524/EEC for authorisation without a time limit are satisfied.

| (6) | The use of this micro-organism for chickens for fattening, specified in Annex I, should therefore be authorised without a time limit. |
| --- | --- |

(6)

The use of this micro-organism for chickens for fattening, specified in Annex I, should therefore be authorised without a time limit.

| (7) | The use of the enzyme preparation of endo-1,4-beta-glucanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 74 252) was provisionally authorised, for the first time, for chickens for fattening in liquid form by Commission Regulation (EC) No 1436/1998 (4), and in granular form by Commission Regulation (EC) No 937/2001 (5). |
| --- | --- |

(7)

The use of the enzyme preparation of endo-1,4-beta-glucanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 74 252) was provisionally authorised, for the first time, for chickens for fattening in liquid form by Commission Regulation (EC) No 1436/1998 (4), and in granular form by Commission Regulation (EC) No 937/2001 (5).

| (8) | The use of the enzyme preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94) was provisionally authorised, for the first time, for chickens for fattening by Commission Regulation (EC) No 654/2000 (6). |
| --- | --- |

(8)

The use of the enzyme preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94) was provisionally authorised, for the first time, for chickens for fattening by Commission Regulation (EC) No 654/2000 (6).

| (9) | The use of the enzyme preparation endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Penicillium funiculosum (IMI SD 101) was provisionally authorised, for the first time, for chickens for fattening by Commission Regulation (EC) No 866/1999 (7). |
| --- | --- |

(9)

The use of the enzyme preparation endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Penicillium funiculosum (IMI SD 101) was provisionally authorised, for the first time, for chickens for fattening by Commission Regulation (EC) No 866/1999 (7).

| (10) | The use of the enzyme preparation endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 520.94) was provisionally authorised, for the first time, for chickens for fattening by Commission Regulation (EC) No 1436/1998 (8). |
| --- | --- |

(10)

The use of the enzyme preparation endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 520.94) was provisionally authorised, for the first time, for chickens for fattening by Commission Regulation (EC) No 1436/1998 (8).

| (11) | The use of the enzyme preparation endo-1,4-beta-xylanase produced by Bacillus subtilis (LMG-S 15136) was provisionally authorised, for the first time, for chickens for fattening in solid form by Commission Regulation (EC) No 1353/2000 (9) and in liquid form by Commission Regulation (EC) No 2188/2002 (10). |
| --- | --- |

(11)

The use of the enzyme preparation endo-1,4-beta-xylanase produced by Bacillus subtilis (LMG-S 15136) was provisionally authorised, for the first time, for chickens for fattening in solid form by Commission Regulation (EC) No 1353/2000 (9) and in liquid form by Commission Regulation (EC) No 2188/2002 (10).

| (12) | New data were submitted in support of the applications for authorisation without a time limit of each of these enzyme preparations. |
| --- | --- |

(12)

New data were submitted in support of the applications for authorisation without a time limit of each of these enzyme preparations.

| (13) | The assessment of the applications for authorisation submitted in respect of each of these enzyme preparations, shows that the conditions provided for in Directive 70/524/EEC for authorisation without time limit are satisfied. |
| --- | --- |

(13)

The assessment of the applications for authorisation submitted in respect of each of these enzyme preparations, shows that the conditions provided for in Directive 70/524/EEC for authorisation without time limit are satisfied.

| (14) | The use of these enzyme preparations for chickens for fattening under the conditions set out in Annexes II, III, IV, V and VI should therefore be authorised without a time limit. |
| --- | --- |

(14)

The use of these enzyme preparations for chickens for fattening under the conditions set out in Annexes II, III, IV, V and VI should therefore be authorised without a time limit.

| (15) | 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 (11), as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (12). |
| --- | --- |

(15)

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 (11), as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (12).

| (16) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(16)

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 ‘micro-organisms’ as set out in Annex I is authorised for use as additive in animal nutrition under the conditions laid down in that Annex.

Article 2

The preparations belonging to the group ‘enzymes’ as set out in Annexes II, III, IV, V and VI are authorised for use as additive in animal nutrition under the conditions laid down in those Annexes.

Article 3

This Regulation shall enter into force on the third 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, 8 July 2004.

For the Commission

David BYRNE

Member of the Commission

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(1)  
  OJ L 270, 14.12.1970, p. 1.

1

(2)  
  OJ L 265, 3.10.2002, p. 1.

2

(3)  
  OJ L 194, 27.7.1999, p. 17.

3

(4)  
  OJ L 191, 7.7.1998, p. 15.

4

(5)  
  OJ L 130, 12.5.2001, p. 25.

5

(6)  
  OJ L 79, 30.3.2000, p. 26.

6

(7)  
  OJ L 108, 27.4.1999, p. 21.

7

(8)  
  OJ L 191, 7.7.1998, p. 15.

8

(9)  
  OJ L 155, 28.6.2000, p. 15.

9

(10)  
  OJ L 333, 10.12.2002, p. 5.

10

(11)  
  OJ L 183, 29.6.1989, p. 1.

11

(12)  
  OJ L 284, 31.10.2003, p. 1.

12

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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 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

Micro-organisms

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

Chickens for fattening

—

1 × 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: diclazuril, halofuginone, lasalocid sodium, maduramicin ammonium, monensin sodium, robenidine

Without a time limit

---

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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Units of activity/kg of complete feedingstuff |
| Enzymes |
| E 1602 | | Endo-1,4-beta-glucanase
  EC 3.2.1.4 |

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 1602

Endo-1,4-beta-glucanase

EC 3.2.1.4

| | Endo-1,3(4)-beta-glucanase
  EC 3.2.1.6 |
| --- | --- |

Endo-1,3(4)-beta-glucanase

EC 3.2.1.6

| | Endo-1,4-beta-xylanase
  EC 3.2.1.8 |
| --- | --- |

Endo-1,4-beta-xylanase

EC 3.2.1.8

Preparation of endo-1,4-beta-glucanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 74 252) having a minimum activity of:

Liquid and granular form:

| | Endo-1,4-beta-glucanase:
  8 000  U (1)/ml or g |
| --- | --- |

Endo-1,4-beta-glucanase:

8 000  U (1)/ml or g

| | Endo-1,3(4)-beta-glucanase:
  18 000  U (2)/ml or g |
| --- | --- |

Endo-1,3(4)-beta-glucanase:

18 000  U (2)/ml or g

| | Endo-1,4-beta-xylanase:
  26 000  U (3)/ml or g |
| --- | --- |

Endo-1,4-beta-xylanase:

26 000  U (3)/ml or g

Chickens for fattening

—

endo-1,4-beta-glucanase:

400 U

—

| 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: | endo-1,4-beta-glucanase:
  400-1 600  U |
| --- | --- | --- |

2.

Recommended dose per kg of complete feedingstuff:

endo-1,4-beta-glucanase:

400-1 600  U

| | endo-1,3(4)-beta-glucanase:
  900-3 600  U |
| --- | --- |

endo-1,3(4)-beta-glucanase:

900-3 600  U

| | endo-1,4-beta-xylanase:
  1 300 -5 200  U |
| --- | --- |

endo-1,4-beta-xylanase:

1 300 -5 200  U

| 3. | For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 30 % wheat or barley and more than 10 % rye |
| --- | --- |

3.

For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 30 % wheat or barley and more than 10 % rye

Without a time limit

endo-1,3(4)-beta-glucanase:

900 U

—

endo-1,4-beta-xylanase:

1 300 U

—

---

(1)  1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from carboxymethylcellulose per minute at pH 5,0 and 40 °C.

(2)  1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from barley beta-glucan per minute at pH 5,0 and 40 °C.

(3)  1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from oat spelt xylan per minute at pH 5,0 and 40 °C.

---

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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Units of activity/kg of complete feedingstuff |
| Enzymes |
| E 1603 | Endo-1,3(4)-beta-glucanase
  EC 3.2.1.6 | Preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94) having a minimum activity of: | coated form:
  50 FBG (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 1603

Endo-1,3(4)-beta-glucanase

EC 3.2.1.6

Preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94) having a minimum activity of:

coated form:

50 FBG (1)/g

| | liquid form:
  120 FBG/ml |
| --- | --- |

liquid form:

120 FBG/ml

Chickens for fattening

—

10 FBG

—

| 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: 15-20 FBG |
| --- | --- |

2.

Recommended dose per kg of complete feedingstuff: 15-20 FBG

| 3. | For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans), e.g. containing more than 60 % vegetable ingredients (maize, lupin, wheat, barley, soya, rice, oilseed rape or peas) |
| --- | --- |

3.

For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans), e.g. containing more than 60 % vegetable ingredients (maize, lupin, wheat, barley, soya, rice, oilseed rape or peas)

Without a time limit

---

(1)  1 FBG is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 5,0 and 30 oC.

---

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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Units of activity/kg of complete feedingstuff |
| Enzymes |
| E 1604 | | Endo-1,3(4)-beta-glucanase
  EC 3.2.1.6 |

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 1604

Endo-1,3(4)-beta-glucanase

EC 3.2.1.6

| | Endo-1,4-beta-xylanase
  EC 3.2.1.8 |
| --- | --- |

Endo-1,4-beta-xylanase

EC 3.2.1.8

Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Penicillium funiculosum (IMI SD 101) having a minimum activity of:

| | powder form: | endo-1,3(4)-beta-glucanase: |
| --- | --- | --- |

powder form:

endo-1,3(4)-beta-glucanase:

| | 2 000 U (1)/g |
| --- | --- |

2 000 U (1)/g

| | endo-1,4-beta-xylanase:
  1 400 U (2)/g |
| --- | --- |

endo-1,4-beta-xylanase:

1 400 U (2)/g

| | liquid form: | endo-1,3(4)-beta-glucanase: |
| --- | --- | --- |

liquid form:

endo-1,3(4)-beta-glucanase:

| | 500 U/ml |
| --- | --- |

500 U/ml

| | endo-1,4-beta-xylanase
  350 U/ml |
| --- | --- |

endo-1,4-beta-xylanase

350 U/ml

Chickens for fattening

—

| | endo-1,3(4)-beta-glucanase: |
| --- | --- |

endo-1,3(4)-beta-glucanase:

| | 100 U |
| --- | --- |

100 U

| | endo-1,4-beta-xylanase:
  70 U |
| --- | --- |

endo-1,4-beta-xylanase:

70 U

—

| 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: | endo-1,3(4)-beta-glucanase: 100 U |
| --- | --- | --- |

2.

Recommended dose per kg of complete feedingstuff:

endo-1,3(4)-beta-glucanase: 100 U

| | endo-1,4-beta-xylanase: 70 U |
| --- | --- |

endo-1,4-beta-xylanase: 70 U

| 3. | For use in compound feed rich in non-starch polysaccharides, (mainly beta-glucan and arabinoxylans), e.g. containing more than 50 % barley or 60 % wheat |
| --- | --- |

3.

For use in compound feed rich in non-starch polysaccharides, (mainly beta-glucan and arabinoxylans), e.g. containing more than 50 % barley or 60 % wheat

Without a time limit

---

(1)  1 U is the amount of enzyme which liberates 5,55 micromoles of reducing sugars (maltose equivalents) from barley beta-glucan per minute at pH 5,0 and 50 °C.

(2)  1 U is the amount of enzyme which liberates 4,00 micromoles of reducing sugars (maltose equivalents) from birchwood xylan per minute at pH 5,5 and 50 °C.

---

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 1605 | Endo-1,4-beta-xylanase
  EC 3.2.1.8 | Preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 520.94) having a minimum activity of: | solid form:
  Endo-1,4-beta-xylanase:
  600 U (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 1605

Endo-1,4-beta-xylanase

EC 3.2.1.8

Preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 520.94) having a minimum activity of:

solid form:

Endo-1,4-beta-xylanase:

600 U (1)/g

| | liquid form:
  Endo-1,4-beta-xylanase:
  300 U/ml |
| --- | --- |

liquid form:

Endo-1,4-beta-xylanase:

300 U/ml

Chickens for fattening

—

300 U

—

| 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: endo-1,4-beta-xylanase: 300-600 U |
| --- | --- |

2.

Recommended dose per kg of complete feedingstuff: endo-1,4-beta-xylanase: 300-600 U

| 3. | For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 50 % wheat |
| --- | --- |

3.

For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 50 % wheat

Without a time limit

---

(1)  1 U is the amount of enzyme which liberates 1 micromole of xylose from birchwood xylan per minute at pH 5,3 and 50 °C.

---

ANNEX VI

| 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 1606 | Endo-1,4-beta-xilanase
  EC 3.2.1.8 | Preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis (LMG-S 15136) having a minimum activity of: | Solid and liquid form:
  100 IU (1)/g or ml |

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 1606

Endo-1,4-beta-xilanase

EC 3.2.1.8

Preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis (LMG-S 15136) having a minimum activity of:

Solid and liquid form:

100 IU (1)/g or ml

Chickens for fattening

—

10 IU

—

| 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: 10 IU |
| --- | --- |

2.

Recommended dose per kg of complete feedingstuff: 10 IU

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

3.

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

Without a time limit

---

(1)  1 IU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 4,5 and 30 °C.

---