Commission Implementing Regulation (EU) 2024/781 of 5 March 2024 concerning the renewal of the authorisation of a preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604 as a feed additive for chickens for fattening, minor poultry species for fattening and chickens reared for laying (holder of authorisation: Kerry Ingredients & Flavours Ltd.) and repealing Implementing Regulations (EU) No 237/2012 and (EU) No 1365/2013
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
Repeals
Implementing Regulations (EU) No 237/2012 and (EU) No 1365/2013 are repealed.
Transitional measures
1. The preparation specified in the Annex and premixtures containing that preparation, which are produced and labelled before 26 September 2024 in accordance with the rules applicable before 26 March 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 26 March 2025 in accordance with the rules applicable before 26 March 2024 may continue to be placed on the market and used until the existing stocks 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.
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 4a17 Kerry Ingredients and Flavours Ltd. Alpha-galactosidase (EC 3.2.1.22) Endo-1,4-beta-glucanase (EC 3.2.1.4) Additive composition Preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604 having a minimum activity of: — 1 000 U ( 1 ) alpha-galactosidase/g, — 5 700 U ( 2 ) endo-1,4-beta-glucanase/g. Solid form. Characterisation of the active substance Alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger CBS 120604. Analytical method ( 3 ) For the determination of alpha-galactosidase: in the feed additive, premixtures and compound feed: colorimetric method measuring p-nitrophenol released by action of alpha-galactosidase from p-nitrophenyl-alpha-galactopyranoside substrate. For the determination of endo-1,4-beta-glucanase in the feed additive, premixtures and compound feed: colorimetric method measuring water soluble dye released by action of endo-1,4-beta-glucanase from azurine-crosslinked barley glucan substrate. Chickens for fattening Minor poultry species for fattening Chickens reared for laying — 50 U alpha-galactosidase 285 U endo-1,4-beta-glucanase — 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. Indicate in the directions for use: ‘Maximum recommended dose: — 100 U alpha-galactosidase/kg complete feed — 570 U endo-1,4-beta-glucanase/kg complete feed’ 3. 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. 26 March 2034 Category of zootechnical additives. Functional group: digestibility enhancers 4a17 Kerry Ingredients and Flavours Ltd. Alpha-galactosidase (EC 3.2.1.22) Endo-1,4-beta-glucanase (EC 3.2.1.4) Additive composition Preparation of alpha-galactosidase produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase produced by Aspergillus niger CBS 120604 having a minimum activity of: — 500 U alpha-galactosidase/g, — 2 850 U endo-1,4-beta-glucanase/g. Liquid form. Characterisation of the active substance Alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae CBS 615.94 and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger CBS 120604. Analytical method For the determination of alpha-galactosidase: in the feed additive, premixtures and compound feed: colorimetric method measuring p-nitrophenol released by action of alpha- galactosidase from p-nitrophenyl-alpha-galactopyranoside substrate. For the determination of endo-1,4-beta-glucanase in the feed additive, premixtures and compound feed: colorimetric method measuring water soluble dye released by action of endo-1,4-beta-glucanase from azurine-crosslinked barley glucan substrate. Chickens for fattening — 50 U alpha-galactosidase 285 U endo-1,4-beta-glucanase — 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. Indicate in the directions for use: ‘Maximum recommended dose: — 100 U alpha-galactosidase/kg complete feed — 570 U endo-1,4-beta-glucanase/kg complete feed’ 3. 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. 26 March 2034 ( 1 ) One alpha-galactosidase unit (U) is the amount of enzyme that will produce one micromole of para-nitrophenol per minute from p-nitrophenyl-alpha-galactopyranoside (pNPG) under the specified conditions (pH = 5,0; temperature 37 °C). ( 2 ) One endo-1,4-beta-glucanase unit (U) is the amount of enzyme that will produce one milligram of reducing sugar (glucose equivalent) per minute from hydrolyses of beta-D-glucans under the specified conditions (pH = 5,0; temperature 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
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