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

Article 1Renewal 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 2Repeals

Implementing Regulations (EU) No 237/2012 and (EU) No 1365/2013 are repealed.

Article 3Transitional 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.

Article 4Entry 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

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

Schedules & Appendices

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