Commission Regulation (EC) No 358/2005 of 2 March 2005 concerning the authorisations without a time limit of certain additives and the authorisation of new uses of additives already authorised in feedingstuffsText with EEA relevance

• CELEX: Regulation (EC) No 358/2005
• Articles: 9

Article 1

The preparations belonging to the group ‘Enzymes’ as set out 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 substances belonging to the group ‘Colourants, including pigments, other colourants’ as set out 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 set out in Annex III are authorised provisionally for four years as additives in animal nutrition under the conditions laid down in that Annex.

Article 4

The preparation belonging to the group ‘Micro-organisms’, as set out in Annex IV is authorised provisionally for four years as additive in animal nutrition under the conditions laid down in that Annex.

Article 5

This Regulation shall enter into force on the third 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 1619

Alpha-amylase EC 3.2.1.1

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

Preparation of alpha-amylase and endo-1,3(4)-beta-glucanase produced by Bacillus amyloliquefaciens (DSM 9553) having minimum activities of:

Coated form:

Alpha-amylase: 200 KNU  ( 1 ) /g

Endo-1,3(4)-beta-glucanase: 350 FBG  ( 2 ) /g

Liquid form:

Alpha-amylase: 130 KNU/ml

Endo-1,3(4)-beta-glucanase: 225 FBG/ml

Chickens for fattening

––

alpha-amylase: 10 KNU

––

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:

alpha-amylase: 20–40 KNU

endo-1,3(4)-beta-glucanase: 35–70 FBG

3.

For use in compound feed rich in starch and beta glucans, e.g. containing more than 40 % cereals (e.g. barley, oats, wheat, rye, triticale, or maize).

Without a time limit

endo-1,3(4)-beta –glucanase: 17 FBG

––

E 1620

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

Bacillolysin EC 3.4.24.28

Endo-1,4-beta-xylanase EC 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), bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) 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: 2 350  U  ( 3 ) /g

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

Alpha-amylase: 400 U  ( 5 ) /g

Bacillolysin: 450 U  ( 6 ) /g

Endo-1,4-beta-xylanase: 20 000  U  ( 7 ) /g

Chickens for fattening

––

Endo-1,3(4)-beta-glucanase: 587 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: 1 175 –2 350  U

endo-1,4-beta-glucanase: 2 000 –4 000  U

alpha-amylase: 200–400 U

bacillolysin: 225–450 U

endo-1,4-beta-xylanase: 10 000 –20 000  U

3.

For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 45 % wheat.

Without a time limit

Endo-1,4-beta-glucanase: 1 000  U

––

Alpha-amylase: 100 U

––

Bacillolysin: 112 U

––

Endo-1,4-beta-xylanase: 5 000  U

––

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 EC 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  ( 3 ) /g

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

Alpha-amylase: 400 U  ( 5 ) /g

Endo-1,4-beta-xylanase: 210 000  U  ( 7 ) /g

Chickens 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 –2 000  U

endo-1,4-beta-glucanase: 12 000 –24 000  U

alpha-amylase: 40–80 U

endo-1,4-beta-xylanase: 21 000 –42 000  U

3.

For use in compound feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 45 % 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

––

E 1622

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 by Trichoderma longibrachiatum (CBS 357.94) having a minimum activity of:

Granulated form:

6 000  BGU  ( 8 ) /g

8 250  EXU  ( 9 ) /g

Liquid form:

2 000  BGU/ml

2 750  EXU/ml

Chickens for fattening

––

endo-1,3(4)-beta-glucanase: 500 BGU

––

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: 500 BGU

endo-1,4-beta-xylanase: 680 EXU

3.

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

Without a time limit

endo-1,4-beta-xylanase: 680 EXU

––

( 1 )   1 KNU is the amount of enzyme which liberates 672 micromoles of reducing sugars (glucose equivalent) from soluble starch per minute at pH 5,6 and 37 °C.

( 2 )   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 °C.

( 3 )   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.

( 4 )   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.

( 5 )   1 U is the amount of enzyme which hydrolyses 1 micromole of glucosidic linkages from water insoluble cross-linked starch polymer per minute at pH 7,5 and 37 °C.

( 6 )   1 U is the amount of enzyme which makes 1 microgram of azo-casein soluble in trichloracetic acid per minute at pH 7,5 and 37 °C.

( 7 )   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.

( 8 )   1 BGU is the amount of enzyme which liberates 0,278 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 3,5 and 40 °C.

( 9 )   1 EXU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH 3,5 and 55 °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

mg/kg of complete feedingstuff

Colourants, including pigments

2.    Other colourants

E 102

Tartrazine

C 16 H 9 N 4 O 9 S 2 Na 3

Grain-eating ornamental birds

—

—

150

—

Without a time limit

Small rodents

—

—

150

—

Without a time limit

E 110

Sunset yellow FCF

C 16 H 10 N 2 O 7 S 2 Na 2

Grain-eating ornamental birds

—

—

150

—

Without a time limit

Small rodents

—

—

150

—

Without a time limit

E 131

Patent blue V

Calcium salt of 5-Hydroxy-4′,4″-bis (diethylamino)-triphenyl-carbinol-2,4-disulfonic acid

Grain-eating ornamental birds

—

—

150

—

Without a time limit

Small rodents

—

—

150

—

Without a time limit

E 141

Chlorophyll copper complex

—

Grain-eating ornamental birds

—

—

150

—

Without a time limit

Small rodents

—

—

150

—

Without a time limit

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

51

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.

6 March 2009

28

3-Phytase EC 3.1.3.8

Preparation of 3-phytase produced by Trichoderma reesei (CBS 528.94) having a minimum activity of:

Solid form: 5 000 PPU  ( 2 ) /g

Liquid form: 1 000 PPU/g

Turkeys for fattening

—

250 PPU

—

1.

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

2.

Recommended dose per kg of complete feedingstuff: 250-1 000 PPU

3.

For use in compound feed containing more than 0,22 % phytin bound phosphorus.

6 March 2009

Sows

—

250 PPU

—

1.

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

2.

Recommended dose per kg of complete feedingstuff: 500-1 000 PPU

3.

For use in compound feed containing more than 0,22 % phytin bound phosphorus.

6 March 2009

( 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.

( 2 )   1 PPU is the amount of enzyme which liberates 1 micromole of inorganic phosphate from sodium phytate per minute at pH 5 and 37 °C.

ANNEX IV

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

Micro-organisms

10

Enterococcus faecium NCIMB 10415

Preparation of Enterococcus faecium containing a minimum of microencapsulated form: 5 × 10 9 CFU/g

Dogs

—

4,5 × 10 6

2 × 10 9

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

6 March 2009

Cats

—

5 × 10 6

8 × 10 9

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

6 March 2009