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Document 02005R2036-20180329

Consolidated text: 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)

ELI: http://data.europa.eu/eli/reg/2005/2036/2018-03-29

02005R2036 — EN — 29.03.2018 — 006.001


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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)

(OJ L 328 15.12.2005, p. 13)

Amended by:

 

 

Official Journal

  No

page

date

 M1

COMMISSION IMPLEMENTING REGULATION (EU) No 1018/2012 of 5 November 2012

  L 307

56

7.11.2012

►M2

COMMISSION IMPLEMENTING REGULATION (EU) No 1206/2012 of 14 December 2012

  L 347

12

15.12.2012

►M3

COMMISSION IMPLEMENTING REGULATION (EU) 2017/961 of 7 June 2017

  L 145

7

8.6.2017

►M4

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1145 of 8 June 2017

  L 166

1

29.6.2017

►M5

COMMISSION IMPLEMENTING REGULATION (EU) 2017/2299 of 12 December 2017

  L 329

33

13.12.2017

►M6

COMMISSION IMPLEMENTING REGULATION (EU) 2018/347 of 5 March 2018

  L 67

21

9.3.2018




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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)



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.

▼M4 —————

▼B

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.




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

▼M6 —————

▼M5 —————

▼M3 —————

▼M4 —————

▼B




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

▼M2 —————

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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 (1)/g

Subtilisin: 1 600 U (2)/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 (1)/g

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

Subtilisin: 4 000 U (2)/g

Alpha-amylase: 400 U (4)/g

Polygalacturonase: 25 U (5)/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 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.

(2)   

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.

(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 hydrolyses 1 micromole of glucosidic linkages from a water insoluble cross-linked starch polymer substrate per minute at pH 6,5 and 37 °C.

(5)   

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.

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