Commission Implementing Regulation (EU) No 403/2013 of 2 May 2013 concerning the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase produced by Trichoderma reesei (ATCC 74444) as a feed additive for poultry for fattening and for laying and for weaned piglets and amending Regulations (EC) No 1259/2004, (EC) No 1206/2005 and (EC) No 1876/2006 (holder of authorisation DSM Nutritional Products) Text with EEA relevance

• CELEX: Implementing Regulation (EU) No 403/2013
• Articles: 7

Article 1 Authorisation

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Amendments to Regulation (EC) No 1259/2004

Regulation (EC) No 1259/2004 is amended as follows:

1.

Article 2 is replaced by the following:

‘Article 2

The preparations belonging to the group “Enzymes”, as set out in Annexes III, IV, V and VI are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in those Annexes.’;

2.

Annex II is deleted.

Article 3 Amendment to Regulation (EC) No 1206/2005

In the Annex to Regulation (EC) No 1206/2005 all the data contained in the entry E1602 are deleted.

Article 4 Amendments to Regulation (EC) No 1876/2006

Regulation (EC) No 1876/2006 is amended as follows:

1.

Article 3 is deleted;

2.

Annex III is deleted.

Article 5 Transitional measures

The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 23 November 2013 in accordance with the rules applicable before 23 May 2013, may continue to be placed on the market and used until the existing stocks are exhausted.

Article 6

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

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 with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a1602i

DSM Nutritional Products

Endo-1,4-beta-xylanase

EC 3.2.1.8

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

EC 3.2.1.6

Endo-1,4-beta-glucanase

EC 3.2.1.4

Additive composition

Preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase, produced by Trichoderma reesei (ATCC 74444) having a minimum activity of:

endo-1,4-beta-xylanase 2 700  U  ( 1 ) /ml or g additive

endo-1,3(4)-beta-glucanase 700 U  ( 2 ) /ml or g additive

endo-1,4-beta-glucanase 800 U  ( 3 ) /ml or g additive

(Liquid and solid form)

Characterisation of the active substance

endo-1,4-betaxylanase, endo-1,4-betaglucanase and endo-1,3(4)-betaglucanase, produced by Trichoderma reesei (ATCC 74444)

Analytical method

( 4 )

Characterisation of the active substances in the feedingstuff:

—

Colorimetric method measuring water soluble dye released by the action of endo-1,4-beta-xylanase from cross-linked birchwood azoxylan substrate

—

Colorimetric method measuring water soluble dye released by the action of endo-1,3(4)-beta-glucanase from cross-linked azobarley glucan substrate

—

Colorimetric method measuring water soluble dye released by the action of endo-1,4-beta-glucanase from cross-linked azocarboxymethylcellulose substrate.

Poultry for fattening other than turkeys for fattening

—

endo-1,4-beta-xylanase: 135 U

endo-1,3(4)-beta-glucanase: 35 U

endo-1,4-beta-glucanase: 40 U

—

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 feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans).

3.

For use in weaned piglets up to 35 kg.

4.

For safety: breathing protection and gloves shall be used during handling.

23 May 2023

Poultry for laying

endo-1,4-beta-xylanase: 216 U

endo-1,3(4)-beta-glucanase: 56 U

endo-1,4-beta-glucanase: 64 U

Turkeys for fattening

Piglets

(weaned)

endo-1,4-beta-xylanase: 270 U

endo-1,3(4)-beta-glucanase: 70 U

endo-1,4-beta-glucanase: 80 U

( 1 )   1 U is the amount of enzyme which liberates 1 micromoles of glucose from wheat arabinoxylan per minute at pH 5,0 and 40 °C.

( 2 )   1 U is the amount of enzyme which liberates 1 micromoles of glucose from barley beta-glucan per minute at pH 5,0 and 40 °C.

( 3 )   1 U is the amount of enzyme which liberates 1 micromoles of glucose from carboxymethylcellulose per minute at pH 5,0 and 40 °C.

( 4 )   Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx