Commission Implementing Regulation (EU) 2025/2556 of 17 December 2025 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 as a feed additive for chickens for laying or breeding, turkeys for breeding, minor poultry species for fattening and minor poultry species for laying or breeding (holder of authorisation: Kaesler Nutrition GmbH) and amending Implementing Regulation (EU) 2018/1090 as regards the terms of the authorisation of the preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 as a feed additive for chickens for fattening and chickens reared for laying
Authorisation
The preparation specified in Annex I, 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.
Amendment to Implementing Regulation (EU) 2018/1090
The Annex to Implementing Regulation (EU) 2018/1090 is replaced by the Annex II to this Regulation.
Transitional measures
1. The feed additive endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469, as authorised by Implementing Regulation (EU) 2018/1090 and premixtures containing that additive, which are intended for chickens for fattening and chickens reared for laying, and which are produced and labelled before 7 July 2026 in accordance with the rules applicable before 7 January 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.
2. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for chickens for fattening and chickens reared for laying, and which are produced and labelled before 7 January 2027 in accordance with the rules applicable before 7 January 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.
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.
Supplementary provisions
ANNEX ISupplementary provisions
ANNEX I
Identification number of the feed additive
Name of the holder of authorisation
Name of the 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 feed with a moisture content of 12 %
Category of zootechnical additives. Functional group: digestibility enhancers
4a28
Kaesler Nutrition GmbH
Endo-1,4- beta-xylanase
(EC 3.2.1.8)
Endo-1,3(4)- beta-glucanase
(EC 3.2.1.6)
Additive composition
Preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 having a minimum activity of:
25 000 LXU ( 1 ) and 2 200 LGU ( 2 ) /g.
Solid and liquid form.
Characterisation of the active substance
Endo-1,4- beta-xylanase (EC 3.2.1.8) produced with Komagataella phaffii DSM 25376 and endo-1,3(4)- beta-glucanase (EC 3.2.1.6) produced with Komagataella phaffii DSM 26469
Analytical method
( 3 )
For the determination of xylanase in the feed additive, premixtures and compound feed:
—
colorimetric method based on the quantification of water soluble dyed fragments produced by the action of endo-1,4-β-xylanase on cross-linked wheat arabinoxylan.
For the determination of β-glucanase in the feed additive, premixtures and compound feed:
—
colorimetric method based on the quantification of water soluble dyed fragments produced by the action of 1,4-β-β-gluconases on cross-linked azo-barley-glucan.
Hens
Turkeys for breeding
Minor poultry species for fattening
Minor poultry species for laying or breeding
-
1 400 LXU
120 LGU
-
1.
In the directions for use of the additive and premixtures, 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 protective equipment.
7 January 2036
( 1 ) 1 LXU is the amount of enzyme that releases one μmole of reducing sugar equivalents per minute (as xylose from birch xylan) at pH 5,5 and 50 °C.
( 2 ) 1 LGU is the amount of enzyme which liberates one μmole of reducing sugar equivalents per minute (as glucose from barley glucan) at pH 5,5 and 50 °C.
( 3 ) 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
ANNEX IISupplementary provisions
ANNEX II
Identification number of the feed additive
Name of the holder of authorisation
Name of the 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 feed with a moisture content of 12 %
Category of zootechnical additives. Functional group: digestibility enhancers
4a28
Kaesler Nutrition GmbH
Endo-1,4- beta-xylanase
(EC 3.2.1.8)
Endo-1,3(4)- beta-glucanase
(EC 3.2.1.6)
Additive composition
Preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 having a minimum activity of:
25 000 LXU ( 1 ) and 2 200 LGU ( 2 ) /g.
Solid and liquid form.
Characterisation of the active substance
Endo-1,4- beta-xylanase (EC 3.2.1.8) produced with Komagataella phaffii DSM 25376 and endo-1,3(4)- beta-glucanase (EC 3.2.1.6) produced with Komagataella phaffii DSM 26469
Analytical method
( 3 )
For the determination of xylanase in the feed additive, premixtures and compound feed:
—
colorimetric method based on the quantification of water soluble dyed fragments produced by the action of endo-1,4-β-xylanase on cross-linked wheat arabinoxylan.
For the determination of β-glucanase in the feed additive, premixtures and compound feed:
—
colorimetric method based on the quantification of water soluble dyed fragments produced by the action of 1,4-β-β-gluconases on cross-linked azo-barley-glucan.
Chickens for fattening
Turkeys for fattening
All avian species reared for laying or for breeding purposes
-
1 400 LXU
120 LGU
-
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 from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment.
21.8.2028
Piglets (weaned)
Minor porcine species (weaned)
700 LXU
60 LGU
( 1 ) 1 LXU is the amount of enzyme that releases one μmole of reducing sugar equivalents per minute (as xylose from birch xylan) at pH 5,5 and 50 °C.
( 2 ) 1 LGU is the amount of enzyme which liberates one μmole of reducing sugar equivalents per minute (as glucose from barley glucan) at pH 5,5 and 50 °C.
( 3 ) 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
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.