Commission Regulation (EC) No 322/2009 of 20 April 2009 concerning the permanent authorisations of certain additives in feedingstuffs (Text with EEA relevance )

• CELEX: Regulation (EC) No 322/2009
• Articles: 7

Article 1

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

Article 2

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

Article 3

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

Article 4

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX I

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

Units of activity/kg of complete feedingstuff

Enzymes

‘E 1606

Endo-1,4-beta-xylanase

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

Laying hens

-

10 IU

-

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

3.

For use in compound feed rich in arabinoxylan, e.g. containing minimum 40 % wheat or barley.

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.’

ANNEX II

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 1617

Endo-1,4-beta-xylanase

EC 3.2.1.8

Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (IMI SD 135) having a minimum activity of:

Solid form: 6 000 EPU  ( 1 ) /g

Liquid form: 6 000 EPU/ml

Laying hens

-

1 050 EPU

-

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: 1 050 – 1 500 EPU.

3.

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

Without a time limit.

Piglets (weaned)

-

1 500 EPU

-

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: 1 500 – 3 000 EPU.

3.

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

4.

For use in weaned piglets until approximately 35 kg

Without a time limit.

( 1 )   1 EPU is the amount of enzyme which liberates 0,0083 micromoles of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 4,7 and 30 °C.’

ANNEX III

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 1604

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

EC 3.2.1.6

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 from Penicillium funiculosum (IMI SD101) having a minimum activity of:

powder form

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

2 000 U  ( 1 ) /g

Endo-1,4-beta-xylanase:

1 400 U  ( 2 ) /g

liquid form

Endo-1,3(4)-beta-glucanase: 500 U/ml

Endo-1,4-beta-xylanase: 350 U/ml

Ducks for fattening

-

Endo-1,3(4)-beta-glucanase: 100 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.

2.

Recommended dose per kg of complete feedingstuff:

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

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

3.

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

Without a time limit.

Piglets (weaned)

-

Endo-1,3(4)-beta-glucanase: 100 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.

2.

Recommended dose per kg of complete feedingstuff:

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

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

3.

For use in compound feed rich in non-starch polysaccharides, (mainly betaglucans and arabinoxylans), e.g. containing more than 30 % barley or 20 % wheat.

4.

For use in weaned piglets until approximately 35 kg.

Without a time limit.

( 1 )   1 U is the amount of enzyme which liberates 5,55 micromoles of reducing sugars (maltose equivalents) from barley betaglucan 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.’