Commission Implementing Regulation (EU) 2023/61 of 5 January 2023 concerning the authorisation of a preparation of endo-1,4-beta-glucanase from Aspergillus niger CBS 120604, a preparation of endo-1,3(4)-beta-glucanase from Aspergillus neoniger MUCL 39199, a preparation of endo-1,4-beta-xylanase from Trichoderma citrinoviride MUCL 39203 and a preparation of endo-1,4-beta-xylanase from Trichoderma citrinoviride CBS 614.94 as feed additives for all animal species (Text with EEA relevance)

Article 1Authorisation

The preparations specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2Transitional measures

   The preparations specified in the Annex and premixtures containing these preparations, which are produced and labelled before 26 July 2023 in accordance with the rules applicable before 26 January 2023 may continue to be placed on the market and used until the existing stocks are exhausted.
   Compound feed and feed materials containing the preparations specified in the Annex which are produced and labelled before 26 January 2024 in accordance with the rules applicable before 26 January 2023 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
   Compound feed and feed materials containing the preparations specified in the Annex which are produced and labelled before 26 January 2025 in accordance with the rules applicable before 26 January 2023 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food producing animals.

Article 3Entry 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
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 of additive/kg of fresh material
Category: technological additives. Functional group: silage additives.
1k105
Endo-1,4-beta-glucanase (EC 3.2.1.4)
Additive composition
Preparation of endo-1,4-beta-glucanase produced by:
Aspergillus niger CBS 120604, having a minimum activity of 25 650 DNS  ( 1 ) /g additive
Solid form
Characterisation of the active substance
Endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger CBS 120604
Analytical method
( 2 )
For the determination of endo-1,4-beta-glucanase in the feed additive:
—
colorimetric (DNS) method based on the enzymatic hydrolysis of the carboxymethyl cellulose (CMC) at pH 4,5 and 37 °C
All animal species
-
-
-
1.
In the directions for use of the additive and premixtures, the storage conditions shall be indicated.
2.
Minimum content of the additive when used without combination with other enzymes or micro-organisms as silage additives: 3 DNS/kg of fresh material.
3.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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, including skin, eye, and breathing protection.
26 January 2033
Identification number of the additive
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 of additive/kg of fresh material
Category: technological additives. Functional group: silage additives.
1k106
Endo-1,3(4)-beta-glucanase
(EC 3.2.1.6)
Additive composition
Preparation of endo-1,3(4)-β-glucanase produced by:
Aspergillus neoniger MUCL 39199, having a minimum activity of 10 000 DNS  ( 3 ) /g additive
Solid form
Characterisation of the active substance
Endo-1,3(4)-beta-glucanase (EC 3.2.1.6) produced by Aspergillus neoniger MUCL 39199
Analytical method
( 4 )
For the determination of endo-1,3(4)-beta-glucanase in the feed additive:
—
colorimetric (DNS) method based on the enzymatic hydrolysis of the carboxymethyl cellulose (CMC) at pH 4,5 and 37 °C
All animal species
-
-
-
1.
In the directions for use of the additive and premixtures, the storage conditions shall be indicated.
2.
Minimum content of the additive when used without combination with other enzymes or micro-organisms as silage additives: 3,4 DNS/kg of fresh material.
3.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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, including skin, eye and breathing protection.
26 January 2033
Identification number of the additive
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 of additive/kg of fresh material
Category: technological additives. Functional group: silage additives.
1k107
Endo-1,4-beta-xylanase
(EC 3.2.1.8)
Additive composition
Preparation of endo-1,4-beta-xylanase produced by:
Trichoderma citrinoviride MUCL
39203, having a minimum activity of 51 600 DNS  ( 5 ) /g additive
Solid form
Characterisation of the active substance
Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride MUCL 39203
Analytical method
( 6 )
For the determination of endo-1,4-beta-xylanase in the feed additive:
—
colorimetric (DNS) method based on the enzymatic hydrolysis of the xylan at pH 4,5 and 37 °C
All animal species
-
-
-
1.
In the directions for use of the additive and premixtures, the storage conditions shall be indicated.
2.
Minimum content of the additive when used without combination with other enzymes or micro-organisms as silage additives: 3,2 DNS/kg of fresh material.
3.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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, including skin, eye and breathing protection.
26 January 2033
Identification number of the additive
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 of additive/kg of fresh material
Category: technological additives. Functional group: silage additives.
1k108
Endo-1,4-beta-xylanase
(EC 3.2.1.8)
Additive composition
Preparation of endo-1,4-beta-xylanase produced by:
Trichoderma citrinoviride CBS 614.94, having a minimum activity of 70 000 DNS  ( 7 ) /g additive
Solid form
Characterisation of the active substance
Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride CBS 614.94
Analytical method
( 8 )
For the determination of endo-1,4-beta-xylanase in the feed additive:
—
colorimetric (DNS) method based on the enzymatic hydrolysis of the xylan at pH 4,5 and 37 °C
All animal species
-
-
-
1.
In the directions for use of the additive and premixtures, the storage conditions shall be indicated.
2.
Minimum content of the additive when used without combination with other enzymes or micro-organisms as silage additives: 15 DNS/kg of fresh material.
3.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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, including skin, eye and breathing protection.
26 January 2033
( 1 )   1 DNS (3,5-dinitrosalicylic acid) unit is the amount of reducing sugar released as glucose equivalents in μmol per g per min at pH 4,5 and 37 °C from starch.
( 2 )   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
( 3 )   1 DNS (3,5-dinitrosalicylic acid) unit is the amount of reducing sugar released as glucose equivalents in μmol per g per min at pH 4,5 and 37 °C from starch.
( 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
( 5 )   1 DNS (3,5-dinitrosalicylic acid) unit is the amount of reducing sugar released as xylose equivalents in μmol per g per min at pH 4,5 and 37 °C from birchwood xylan.
( 6 )   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
( 7 )   1 DNS (3,5-dinitrosalicylic acid) unit is the amount of reducing sugar released as xylose equivalents in μmol per g per min at pH 4,5 and 37 °C from birchwood xylan.
( 8 )   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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