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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 5 March 2024.

For the Commission

The President

Ursula VON DER LEYEN

( 1 ) OJ L 268, 18.10.2003, p. 29 , ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

( 2 ) Commission Implementing Regulation (EU) No 237/2012 of 19 March 2012 concerning the authorisation of 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 n iger (CBS 120604) as a feed additive for chickens for fattening (holder of authorisation Kerry Ingredients and Flavours) ( OJ L 80, 20.3.2012, p. 1 , ELI: http://data.europa.eu/eli/reg_impl/2012/237/oj).

( 3 ) Commission Implementing Regulation (EU) No 1365/2013 of 18 December 2013 concerning the authorisation of a preparation of alpha-galactosidase produced by Saccharomyces cerevisiae (CBS615.94) and endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 120604) as a feed additive for minor poultry species for fattening and for chickens reared for laying (holder of authorisation Kerry Ingredients and Flavours) ( OJ L 343, 19.12.2013, p. 31 , ELI: http://data.europa.eu/eli/reg_impl/2013/1365/oj).

( 4 ) EFSA Journal 2023;21(8):8175.

( 5 ) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives ( OJ L 59, 5.3.2005, p. 8 , ELI: http://data.europa.eu/eli/reg/2005/378/oj).

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

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

In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

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’

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

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

In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

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’

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

ELI: http://data.europa.eu/eli/reg_impl/2024/781/oj

ISSN 1977-0677 (electronic edition)

COMMISSION IMPLEMENTING REGULATION (EU) 2024/781 of 5 March 2024 concerning the renewal of the authorisation of a preparation of alpha-galactosidase produced by