Commission Implementing Regulation (EU) 2025/193 of 31 January 2025 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei CBS 143953, subtilisin produced with Bacillus subtilis CBS 143946 and alpha-amylase produced with Bacillus amyloliquefaciens CBS 143954 as a feed additive for chickens for fattening, turkeys for fattening, ducks, and laying hens, and the authorisation of new uses of that preparation as a feed additive for all other poultry species and categories (holder of authorisation: Genencor International B.V.) and repealing Regulation (EC) No 1087/2009 and Implementing Regulation (EU) No 389/2011

• CELEX: Implementing Regulation (EU) 2025/193
• Articles: 6

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 for chickens for fattening, turkeys for fattening, ducks and laying hens, subject to the conditions laid down in that Annex.

Article 2 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 for all poultry species (except ducks) for laying other than laying hens, for fattening other than chickens and turkeys, reared for breeding and reared for laying, subject to the conditions laid down in that Annex.

Article 3 Repeals

Regulation (EC) No 1087/2009 and Implementing Regulation (EU) No 389/2011 are repealed.

Article 4 Transitional measures

1.   The preparation specified in the Annex and premixtures containing that preparation, which are intended for chickens for fattening, turkeys for fattening, ducks and laying hens, and which are produced and labelled before 23 August 2025 in accordance with the rules applicable before 23 February 2025 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 intended for chickens for fattening, turkeys for fattening, ducks and laying hens, and which are produced and labelled before 23 February 2026 in accordance with the rules applicable before 23 February 2025 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 5 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 feed 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: zootechnical additives. Functional group: digestibility enhancers

4a10

Genencor

International B.V.

Endo-1,4-beta-xylanase

(EC 3.2.1.8), Subtilisin (EC 3.4.21.62) and Alpha-amylase

(EC 3.2.1.1)

Additive composition

Preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei CBS 143953, subtilisin produced with Bacillus subtilis CBS 143946 and alpha-amylase produced with Bacillus amyloliquefaciens CBS 143954 having a minimum activity of:

Endo-1,4-beta-xylanase: 1 500 U  ( 1 ) /g,

Subtilisin: 20 000 U  ( 2 ) /g,

Alpha-amylase: 2 000 U  ( 3 ) /g.

Solid form.

Characterisation of the active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Trichoderma reesei CBS 143953, Subtilisin (EC 3.4.21.62) produced with Bacillus subtilis CBS 143946 and Alpha-amylase (EC 3.2.1.1) produced with Bacillus amyloliquefaciens CBS 143954

Analytical method

( 4 )

For the determination of the active substance in the feed additive, premixtures and compound feed:

Endo-1,4-beta-xylanase: colorimetric method based on the quantification of water-soluble dyed fragments produced by the action of endo-1,4-beta-xylanase on commercially available azurine crosslinked wheat arabinoxylan substrates.

Subtilisin: colorimetric method based on the quantification of water-soluble dyed fragments (azurine) produced by the action of subtilisin on commercially available cross-linked casein substrates.

Alpha-amylase: colorimetric method based on the quantification of water-soluble dyed fragments produced by the action of alpha-amylase on commercially available azurine cross-linked starch polymer substrates.

Ducks

—

Endo-1,4-beta-Xylanase 75 U Subtilisin 1 000 U

Alpha-amylase 100 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 the 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.

23 February 2035

Poultry species for fattening, reared for breeding or reared for laying (except ducks)

Endo-1,4-beta-Xylanase 187,5 U

Subtilisin 2 500 U

Alpha-amylase 250 U

Poultry species for laying (except ducks)

Endo-1,4-beta-Xylanase 300 U Subtilisin 4 000 U

Alpha-amylase 400 U

( 1 )   1 U of endo-1,4-beta-xylanase is the amount of enzyme which releases 0,48 μmol of reducing sugar (xylose equivalent) per minute from wheat arabinoxylan at pH 4,2 and 50 °C.

( 2 )   1 U subtilisin (protease) is defined as the amount of enzyme that liberates 1 μmol of phenolic compound (tyrosine equivalents) per minute from a casein substrate at pH 7,5 and 40 °C.

( 3 )   1 U alpha-amylase is defined as the amount of enzyme, which liberates 1 micromole of glucosidic linkages, per minute from a water insoluble cross-linked starch polymer substrate at pH 6,5 and 37 °C.

( 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