Commission Regulation (EC) No 2036/2005 of 14 December 2005 concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisation of a new use of certain additives already authorised in feedingstuffs (Text with EEA relevance)

• CELEX: Regulation (EC) No 2036/2005
• Articles: 7

Article 1

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

Article 2

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

Article 3

The preparations belonging to the group ‘Enzymes’, as specified in Annex III, are authorised for use for four years as additives 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

CFU/kg of complete feedingstuff

Micro-organisms

E 1703

Saccharomyces cerevisiae

CNCM I-1079

Preparation of Saccharomyces cerevisiae containing a minimum of:

2 × 10 10  CFU/g additive

Sows

—

1 × 10 9

6 × 10 9

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

Without a time limit

E 1712

Pediococcus acidilactici

CNCM MA 18/5M

Preparation of Pediococcus acidilactici containing a minimum of:

1 × 10 10 CFU/g additive

Pigs for fattening

—

1 × 10 9

1 × 10 9

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

Without a time limit

E 1713

Enterococcus faecium

CECT 4515

Preparation of Enterococcus faecium containing a minimum of:

1 × 10 9 CFU/g additive

Piglets (weaned)

—

1 × 10 9

1 × 10 9

1.

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

2.

For use in weaned piglets until approximately 35 kg.

Without a time limit

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 1636

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

EC 3.2.1.6

Preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (CBS 526.94) having a minimum activity of:

Solid form: 700 000 BU  ( 1 ) /g

Liquid form: 300 000 BU/g

Chickens for fattening

—

17 500 BU

—

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: 17 500 -50 000 BU.

3.

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

Without a time limit

E 1637

Endo-1,4-beta-xylanase

EC 3.2.1.8

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

EC 3.2.1.6

Subtilisin

EC 3.4.21.62

Alpha-amylase

EC 3.2.1.1

Polygalacturonase

EC 3.2.1.15

Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105), endo-1,3(4)-beta-glucanase and alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), subtilisin produced by Bacillus subtilis (ATCC 2107), polygalacturonase produced by Aspergillus aculeatus (CBS 589.94) having a mimimum activity of:

Endo-1,4-beta-xylanase: 300 U  ( 2 ) /g

Endo-1,3(4)-beta-glucanase: 150 U  ( 3 ) /g

Subtilisin: 4 000 U  ( 4 ) /g

Alpha-amylase: 400 U  ( 5 ) /g

Polygalacturonase: 25 U  ( 6 ) /g

Chickens for fattening

—

endo-1,4-beta-xylanase:

300 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: 300 U

endo-1,3(4)-beta-glucanase: 150 U

subtilisin: 4 000 U

alpha-amylase: 400 U

polygalacturonase: 25 U.

3.

For use in compound feed rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40 % maize or 60 % wheat.

Without a time limit

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

150 U

—

subtilisin:

4 000 U

—

alpha-amylase:

400 U

—

polygalacturonase:

25 U

—

( 1 )   1 BU is the amount of enzyme which liberates 0,06 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,8 and 50 °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 liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 5,0 and 30 °C.

( 4 )   1 U is the amount of enzyme which liberates 1 microgram of phenolic compound (tyrosine equivalents) from a casein substrate per minute at pH 7,5 and 40 °C.

( 5 )   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.

( 6 )   1 U is the amount of enzyme which liberates 1 micromole of reducing material (galacturonic acid equivalents) from a poly D-galacturonic substrate per minute at pH 5,0 and 40 °C.

ANNEX III

ANNEX III

EC No or 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

5

Endo-1,4-beta-xylanase

EC 3.2.1.8

Preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10287) having a minimum activity of:

Coated form:

1 000 FXU  ( 1 ) /g

Liquid form:

650 FXU/ml

Pigs for fattening

—

200 FXU

—

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: 200-400 FXU.

3.

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

4.1.2010

Ducks

—

100 FXU

—

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: 100-200 FXU.

3.

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

4.1.2010

37

Endo-1,4-beta-xylanase

EC 3.2.1.8

Subtilisin

EC 3.4.21.62

Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105) and subtilisin produced by Bacillus subtilis (ATCC 2107) having a minimum activity of:

Endo-1,4-beta-xylanase: 5 000 U  ( 2 ) /g

Subtilisin: 1 600 U  ( 3 ) /g

Ducks

—

endo-1,4-beta-xylanase:

2 500 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-1,4-beta-xylanase: 2 500 U

subtilisin: 800 U.

3.

For use in compound feed e.g. containing more than 65 % wheat.

4.1.2010

subtilisin:

800 U

—

59

Endo-1,4-beta-xylanase

EC 3.2.1.8

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

EC 3.2.1.6

Subtilisin

EC 3.4.21.62

Alpha-amylase

EC 3.2.1.1

Polygalacturonase

EC 3.2.1.15

Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105), endo-1,3(4)-beta-glucanase and alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), subtilisin produced by Bacillus subtilis (ATCC 2107), polygalacturonase produced by Aspergillus aculeatus (CBS 589.94) having a mimimum activity of:

Endo-1,4-beta-xylanase: 300 U  ( 2 ) /g

Endo-1,3(4)-beta-glucanase: 150 U  ( 4 ) /g

Subtilisin: 4 000 U  ( 3 ) /g

Alpha-amylase: 400 U  ( 5 ) /g

Polygalacturonase: 25 U  ( 6 ) /g

Ducks

—

endo-1,4-beta-xylanase:

300 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: 300 U

endo-1,3(4)-beta-glucanase: 150 U

subtilisin: 4 000 U

alpha-amylase: 400 U

polygalacturonase: 25 U.

3.

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

4.1.2010

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

150 U

—

subtilisin:

4 000 U

—

alpha-amylase:

400 U

—

polygalacturonase:

25 U

—

Laying hens

—

endo-1,4-beta-xylanase:

225 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: 225 U

endo-1,3(4)-beta-glucanase: 112 U

subtilisin: 3 000 U

alpha-amylase: 300 U

polygalacturonase: 18 U.

3.

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

4.1.2010

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

112 U

—

subtilisin:

3 000 U

—

alpha-amylase:

300 U

—

polygalac-turonase:

18 U

—

( 1 )   1 FXU is the amount of enzyme which liberates 7,8 micromoles of reducing sugars (xylose equivalents) from azo-wheat arabinoxylan per minute at pH 6,0 and 50 °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 liberates 1 microgram of phenolic compound (tyrosine equivalents) from a casein substrate per minute at pH 7,5 and 40 °C.

( 4 )   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.

( 5 )   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.

( 6 )   1 U is the amount of enzyme which liberates 1 micromole of reducing material (galacturonic acid equivalents) from a poly D-galacturonic substrate per minute at pH 5,0 and 40 °C.