Commission Regulation (EC) No 1284/2006 of 29 August 2006 concerning the permanent authorisations of certain additives in feedingstuffs (Text with EEA relevance)

• CELEX: Regulation (EC) No 1284/2006
• 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 1638

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

EC 3.2.1.6

Endo-1,4-beta-xylanase

EC 3.2.1.8

Alpha-amylase

EC 3.2.1.1

Preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (ATCC 2106), endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105) and alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553) having a minimum activity of:

Endo-1,3(4)-beta-glucanase: 250 U  ( 1 ) /g

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

Alpha-amylase: 1 000 U  ( 3 ) /g

Piglets (weaned)

—

Endo-1,3(4)-beta-glucanase: 250 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: 250 U

—

endo-1,4-beta-xylanase: 400 U

—

alpha-amylase: 1 000 U.

3.

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

4.

For weaned piglets up to approximately 35 kg.

Without a time-limit

Endo-1,4-beta-xylanase: 400 U

—

Alpha-amylase: 1 000 U

—

( 1 )   1 U 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 °C.

( 2 )   1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 5,3 and 50 °C.

( 3 )   1 U is the amount of enzyme which hydrolyses 1 micromole of glucosidic linkages from a water insoluble cross-linked starch polymer substrate per minute at pH 6,5 and 37 °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 1621

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

EC 3.2.1.6

Endo-1,4-beta-glucanase

EC 3.2.1.4

Alpha-amylase

EC 3.2.1.1

Endo-1,4-beta-xylanase

E.C. 3.2.1.8

Preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatus (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma longibrachiatum (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP 4842) having a minimum activity of:

Endo-1,3(4)-beta-glucanase: 10 000 U  ( 1 ) /g

Endo-1,4-beta-glucanase: 120 000 U  ( 2 ) /g

Alpha-amylase: 400 U  ( 3 ) /g

Endo-1,4-beta-xylanase: 210 000 U  ( 4 ) /g

Turkeys for fattening

—

Endo-1,3(4)-beta-glucanase: 500 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: 1 000 -1 500 U

—

endo-1,4-beta-glucanase: 12 000 -18 000 U

—

alpha-amylase: 40-60 U

—

endo-1,4-beta-xylanase: 21 000 -31 500 U

3.

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

Without a time-limit

Endo-1,4-beta-glucanase: 6 000 U

—

Alpha-amylase: 20 U

—

Endo-1,4-beta-xylanase: 10 500 U

—

( 1 )   1 U is the amount of enzyme which liberates 0,0056 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 7,5 and 30 °C.

( 2 )   1 U is the amount of enzyme which liberates 0,0056 micromoles of reducing sugars (glucose equivalents) from carboxymethylcellulose per minute at pH 4,8 and 50 °C.

( 3 )   1 U is the amount of enzyme which liberates 1 micromole of glucose from a cross-linked starch polymer per minute at pH 7,5 and 37 °C.

( 4 )   1 U is the amount of enzyme which liberates 0,0067 micromoles of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 5,3 and 50 °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 1628

Endo-1,4-beta-xylanase

EC 3.2.1.8

Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105) having a minimum activity of:

Powder form:

Endo-1,4-beta-xylanase: 8 000  U  ( 1 ) /g

Liquid form:

Endo-1,4-beta-xylanase: 8 000  U/ml

Pigs for fattening

—

Endo-1,4-beta-xylanase: 1 000  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-1,4-beta-xylanase: 1 000 -4 000  U

3.

For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 35 % wheat.

Without a time-limit

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