Commission Implementing Regulation (EU) 2024/221 of 12 January 2024 concerning the renewal of 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 all poultry species for fattening, all poultry species for laying and weaned piglets (holder of authorisation: DSM Nutritional Products) and amending Implementing Regulation (EU) No 403/2013

• CELEX: Implementing Regulation (EU) 2024/221
• Articles: 5

Article 1 Renewal of authorisation

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is renewed subject to the conditions laid down in that Annex.

Article 2 Amendment to Implementing Regulation (EU) No 403/2013

Implementing Regulation (EU) No 403/2013 is amended as follows:

(1)

Article 1 is deleted;

(2)

the Annex is deleted.

Article 3 Transitional measures

1.   The preparation specified in the Annex and premixtures containing that preparation, which are produced and labelled before 4 August 2024 in accordance with the rules applicable before 4 February 2024 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the preparation specified in the Annex, which are produced and labelled before 4 February 2025 in accordance with the rules applicable before 4 February 2024 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4 Entry into force

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 or solid form.

Characterisation of the active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8), endo-1,4-beta-glucanase (EC 3.2.1.6) and endo-1,3(4)-beta-glucanase (EC 3.2.1.4), produced by Trichoderma reesei ATCC 74444

Analytical method

( 4 )

—

For the determination of endo-1,4-beta-xylanase in the feed additive: colorimetric (DNS) method based on the enzymatic hydrolysis of the wheat arabinoxylan substrate.

—

For the determination of endo-1,3(4)-beta-glucanase in the feed additive: colorimetric (DNS) method based on the enzymatic hydrolysis of the barley betaglucan substrate.

—

For the determination of endo-1,4-beta-glucanase in the feed additive: colorimetric (DNS) method based on the enzymatic hydrolysis of the carboxy-methyl-cellulose substrate.

—

For the determination of endo-1,4-beta-xylanase in premixtures and compound feed: colorimetric method based on the enzymatic reaction on the azo-xylan (birchwood) substrate.

—

For the determination of endo-1,3(4)-beta-glucanase in premixtures and compound feed: colorimetric method based on the enzymatic reaction on the azo-barley-glucan substrate.

—

For the determination of endo-1,4-beta-glucanase in premixtures and compound feed: colorimetric method based on the enzymatic reaction on the azo-carboxy-methyl-cellulose substrate.

All poultry species 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, the storage conditions and stability to heat treatment shall be indicated.

2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

4 February 2034

All poultry species 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 )   One endo-1,4-beta-xylanase unit (U) is the amount of enzyme which releases 1 micromole of reducing sugar (xylose equivalent) per minute from wheat arabinoxylan at 40 °C and pH 5,0.

( 2 )   One endo-1,3(4)-beta-glucanase unit (U) is the amount of enzyme which releases 1 micromole of reducing sugar (glucose equivalent) per minute from barley beta-glucan at 40 °C and pH 5,0.

( 3 )   One endo-1,4-beta-glucanase unit (U) is the amount of enzyme which releases 1 micromole of reducing sugar (glucose equivalent) per minute from carboxy-methyl-cellulose at 40 °C and pH 5,0.

( 4 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en.