02004R1453 — EN — 04.04.2017 — 002.001

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►B

COMMISSION REGULATION (EC) No 1453/2004

of 16 August 2004

concerning the permanent authorisation of certain additives in feedingstuffs

(Text with EEA relevance)

(OJ L 269 17.8.2004, p. 3)

Amended by:

 

 

Official Journal

  No

page

date

 M1

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1399 of 17 August 2015

  L 217

1

18.8.2015

►M2

COMMISSION IMPLEMENTING REGULATION (EU) 2017/447 of 14 March 2017

  L 69

18

15.3.2017



▼B

COMMISSION REGULATION (EC) No 1453/2004

of 16 August 2004

concerning the permanent authorisation of certain additives in feedingstuffs

(Text with EEA relevance)



Article 1

The preparations belonging to the groups ‘Micro-organisms’ and ‘Enzymes’, as set out in Annexes I and II are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in those Annexes.

Article 2

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.

▼M2 —————

▼B



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 1609

Endo-1,4-beta-xylanase

EC 3.2.1.8

Endo-1,4-beta-glucanase

EC 3.2.1.4

Preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 600.94) having minimum activities of:

Coated form:

Endo-1,4-beta-xylanase: 36 000 FXU (1)/g

Endo-1,4-beta-glucanase: 15 000 BGU (2)/g

Liquid form:

Endo-1,4-beta-xylanase: 36 000 FXU/ml

Endo-1,4-beta-glucanase: 15 000 BGU/ml

Solid form:

Endo-1,4-beta-xylanase: 36 000 FXU/g

Endo-1,4-beta-glucanase: 15 000 BGU/g

Chickens for fattening

—

4 860 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:

4 860 –6 000 FXU

2 025 –2 500 BGU.

3.  For use in compound feed rich in non-starch polysaccharides (mainly arabino-xylans and beta-glucans), e.g. containing more than 35 % barley and 20 % wheat.

Without a time limit

2 025 BGU

—

Turkeys for fattening

—

6 000 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:

6 000 FXU

2 500 BGU.

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

Without a time limit

2 500 BGU

—

Piglets (weaned)

—

6 000 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:

6 000 FXU

2 500 BGU.

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

4.  For use in weaned piglets until approximately 35 kg.

Without a time limit

2 500 BGU

—

E 1610

Endo-1,4-beta-glucanase

EC 3.2.1.4

Endo-1,4-beta-xylanase

EC 3.2.1.8

Preparation of endo-1,4-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 600.94) having minimum activities of:

Coated form:

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

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

Liquid form:

Endo-1,4-beta-glucanase: 20 000 BGU/ml

Endo-1,4-beta-xylanase: 8 000 FXU/ml

Solid form:

Endo-1,4-beta-glucanase: 20 000 BGU/g

Endo-1,4-beta-xylanase: 8 000 FXU/g

Chickens for fattening

—

5 000 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:

5 000 –10 000 BGU

2 000 –4 000 FXU.

3.  For use in compound feed rich in non-starch polysaccharides (mainly arabino-xylans and beta-glucans), e.g. containing more than 60 % barley.

Without a time limit

2 000 FXU

—

E 1611

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

EC 3.2.1.6

Endo-1,4-beta-xylanase

EC 3.2.1.8

Polygalacturonase

EC 3.2.1.15

Preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (ATCC 2106) and endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (IMI SD 135) and polygalacturonase produced by Aspergillus aculeatus (CBS 589.94) having a minimum activity of:

Endo-1,3(4)-beta-glucanase: 400 U (5)/g

Endo-1,4-beta-xylanase: 400 U (6)/g

Polygalacturonase: 50 U (7)/g

Pigs for fattening

—

endo-1,3(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.

2.  Recommended dose per kg of complete feedingstuff:

endo-1,3(4)-beta-glucanase: 400 U

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

polygalacturonase: 50 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 40 % barley.

Without a time limit

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

—

polygalacturonase: 50 U

—

E 1612

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 and endo-1,4-beta-xylanase produced by Aspergillus niger (phoenicis) (NRRL 25541) and of alpha-amylase produced by Aspergillus oryzae (ATCC 66222) having a minimum activity of:

Endo-1,3(4)-beta-glucanase: 275 U (8)/g

Endo-1,4-beta-xylanase: 400 U (9)/g

Alpha-amylase: 3 100 U (10)/g

Piglets (weaned)

—

endo-1,3(4)-beta-glucanase: 138 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: 138 U

endo-1,4-beta-xylanase: 200 U

alpha-amylase: 1 550 U

3.  For use in compound feeds rich in starch and non-starch polysaccharides, for example mixed diets containing barley, maize, wheat.

4.  For use in weaned piglets until approximately 35 kg.

Without a time limit

endo-1,4-beta-xylanase: 200 U

—

alpha-amylase: 1 550 U

—

E 1613

Endo-1,4-beta-xylanase

EC 3.2.1.8

Preparation of endo-1,4-beta-xylanase, produced from Trichoderma longibrachiatum (CNCM MA 6 - 10W), having a minimum activity of:

Powder form:

70 000 IFP (11)/g

Liquid form:

7 000 IFP/ml

Chickens for fattening

—

1 050 IFP

—

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:

1 400 IFP.

3.  For use in compound feeds rich in non-starch polysaccharides (mainly arabinoxylans), for example more than 40 % wheat.

Without a time limit

(1)   1 FXU is the amount of enzyme which liberates 0,15 micromoles of xylose from azurine-cross-linked xylan per minute at pH 5,0 and 40 °C.

(2)   1 BGU is the amount of enzyme which liberates 0,15 micromoles of xylose from azurine-cross-linked beta-glucan per minute at pH 5,0 and 40 °C.

(3)   1 BGU is the amount of enzyme which liberates 0,15 micromoles of xylose from azurine-cross-linked beta-glucan per minute at pH 5,0 and 40 °C.

(4)   1 FXU is the amount of enzyme which liberates 0,15 micromoles of xylose from azurine-cross-linked xylan per minute at pH 5,0 and 40 °C.

(5)   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.

(6)   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.

(7)   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.

(8)   1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from oat beta-glucan per minute at pH 5,0 and 40 °C.

(9)   1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from oat xylan per minute at pH 4,0 and 30 °C.

(10)   1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from wheat starch per minute at pH 4,0 and 30 °C.

(11)   1 IFP is the quantity of enzyme which liberates 1 micromole of reducing sugars (measured as xylose equivalent) from oat xylan per minute at pH 4,8 and 50 °C.