COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/61 
of 5 Januar y 2023
concer ning the author isation of a preparation of endo-1,4-bet a-glucanase from Aspergillus niger CBS 
120604, a preparation of endo-1,3(4)-bet a-glucanase from Aspergillus neonig er MUCL 39199, a 
preparation of endo-1,4-bet a-xylanase from Trichoder ma citrinovir ide MUCL 39203 and a preparation 
of endo-1,4-bet a-xylanase from Trichoder ma citrinoviride CBS 614.94 as feed additiv es for all animal 
species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provid es for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such an author isation. Article 10(2) of that Regulation provides for the 
re-evaluation of additives author ised pursuant to Council Directive 70/524/EEC (2). Article 10(7) of Regulation (EC) 
No 1831/2003 sets out specif ic provisions for the placing on the mark et and use of products used in the Union as 
silage additives.
(2) The preparations of endo-1,4-beta-g lucanase from Aspergillus niger CBS 120604, endo-1,3(4)-beta-g lucanase from 
Aspergillus neonig er MUCL 39199, endo-1,4-beta-xylanase from Trichoder ma citrinovir ide MUCL 39203 and 
endo-1,4-beta-xylanase from Trichoder ma citrinov iride CBS 614.94 were entered in the Regist er of feed additives as 
existing products (3)for all animal species belonging to the functional group of silage additives, in accordance with 
Article 10(1), point (b), of Regulation (EC) No 1831/2003.
(3) In accordance with Article 10(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(2) and Article 7 
thereof, an application was submitte d for the author isation of the preparations of endo-1,4-beta-g lucanase from 
Aspergillus niger CBS 120604, endo-1,3(4)-beta-g lucanase from Aspergillus neonig er MUCL 39199, endo-1,4-beta- 
xylanase from Trichoder ma citrinov iride MUCL 39203 and endo-1,4-beta-xylanase from Trichoder ma citrinovi ride CBS 
614.94 as feed additives for all animal species. The applicant requeste d the preparations to be classified in the 
additive cate gory ‘technological additives’ and the functional group ‘silage additives ’. The application was 
accompan ied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Author ity (‘the Auth ority’) concluded in its opinions of 7 March 2018 (4)and 29 June 
2022 (5), that, under the proposed conditions of use, the preparations concer ned do not have adverse effects on 
animal health, consumer health or the environment. The Author ity also concluded that in the absence of data, no 
conclusion could be drawn on the skin and eye irritancy of the additives and on their skin sensitisation potential. 
Owing to the prote inaceous nature of the active substances, these preparations should be considered to be potential 
(1)OJ L 268, 18.10.2003, p. 29.
(2)Council Directive 70/524/EEC of 23 November 1970 concer ning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
(3)In the Register of feed additives: endo-1,4-beta-g lucanase from Aspergillus niger CBS 120604 was identified as cellulase from Aspergillus 
niger CBS 120604; endo-1,3(4)-beta-g lucanase from Aspergillus neonige r MUCL 39199 was identif ied as beta-g lucanase from Aspergillus 
niger MUCL 39199 or Aspergillus tubingen sis MUCL 39199; endo-1,4-beta-xylanase from Trichoder ma citrinovir ide MUCL 39203 was 
identified as xylanase from Trichoder ma longibr achiatum MUCL 39203 or Trichoder ma koningii MUCL 39203; endo-1,4-beta-xylanase 
from Trichoder ma citrinoviride CBS 614.94 was identified as xylanase from Trichoder ma longibrachiatum CBS 614.94.
(4)EFSA Journal 2018;16(4):5224.
(5)EFSA Journal 2022;20(7):7425.EN Offi cial Jour nal of the European Union L 5/24 6.1.2023  respirato ry sensitisers. The Author ity further concluded in its opinion of 29 June 2022 that the preparations 
concer ned have the pote ntial to improve the production of silage from easy , moderate and difficult to ensile forag e 
mater ials. It also verified the repor t on the methods of analysis of the feed additives in feed submitted by the 
Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) The assessment of the preparations of endo-1,4-beta-g lucanase from Aspergillus niger CBS 120604, endo-1,3(4)-beta- 
glucanase from Aspergillus neonig er MUCL 39199, endo-1,4-beta-xylanase from Trichoder ma citrinov iride MUCL 
39203 and endo-1,4-beta-xylanase from Trichoder ma citrinov iride CBS 614.94 shows that the conditions for 
author isation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. According ly, the use of 
those preparations should be author ised. The Commission considers that appropr iate protect ive measures should 
be taken to prevent adverse effects on human health, in particular as regar ds the users of the additive.
(6) Since safet y reasons do not require the immediate application of the modifications to the conditions of author isation 
of the preparations concer ned, it is appropr iate to provide for a transitional period for inter ested parties to prepare 
themselves to meet the new requirements resulting from the author isation.
(7) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
Author isation
The preparations specifi ed in the Annex, belonging to the additive catego ry ‘techn ological additives ’ and to the functional 
group ‘silag e additives’, are author ised as additives in animal nutr ition, subject to the conditions laid down in that Annex.
Article 2
Transitional measures
1. The preparations specifi ed in the Annex and premixtures containing these preparations, whic h are produced and 
labelled before 26 July 2023 in accordance with the rules applicable before 26 Januar y 2023 may continue to be placed on 
the mark et and used until the existing stoc ks are exhaust ed.
2. Com pound feed and feed mater ials containing the preparations specifi ed in the Annex whic h are produced and 
labelled before 26 Januar y 2024 in accordance with the rules applicable before 26 Januar y 2023 may continue to be 
placed on the market and used until the existing stoc ks are exhaust ed if they are intended for food-producing animals.
3. Com pound feed and feed mater ials containing the preparations specifi ed in the Annex whic h are produced and 
labelled before 26 Januar y 2025 in accordance with the rules applicable before 26 Januar y 2023 may continue to be 
placed on the market and used until the existing stoc ks are exhaust ed if they are intended for non-f ood producing animals.
Article 3
Entr y into force
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.EN Offi cial Jour nal of the European Union 6.1.2023 L 5/25  This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 Januar y 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 5/26 6.1.2023  ANNEX 
Identification 
number of the 
additiveAdditiveCompo sition, chem ical formula, 
descr iption, analytical methodSpecies or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isation Units of activity of  
additive/kg of fresh 
material
Categor y: technological additiv es. Functional group: silage additiv es.
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
Char acter isation of the active 
substance
Endo-1,4-beta-g lucanase (EC 
3.2.1.4) produced by Aspergillus 
niger CBS 120604
Analytical method (2)
For the determination of 
endo-1,4-beta-g lucanase in the 
feed additive:
— color imetr ic (DNS) method 
based on the enzymatic 
hydrolysis of the carbo xy­
meth yl cellulose (CMC) at 
pH 4,5 and 37 °CAll animal 
species- - - 1.In the directions for use of the additive and pre­
mixtures, the storage conditions shall be indi ­
cated .
2.Minimum content of the additive when used 
without combination with other enzymes or mi­
cro-org anisms as silage additives: 3 DNS/kg of 
fresh mate rial.
3.For users of the additive and premixtures, feed 
business operat ors shall establish operational 
procedures and organisational measures to ad­
dress poten tial 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 per­
sonal protective equipment, including skin, eye, 
and breathing protection.26 Januar y 
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 Laborato ry: https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_enEN Offi cial Jour nal of the European Union 6.1.2023 L 5/27  Identification 
number of the 
additiveAdditiveCompo sition, chem ical formula, 
descr iption, analytical methodSpecies or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isation Units of activity of  
additive/kg of fresh 
material
Categor y: technological additiv es. Functional group: silage additiv es.
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 neonig er MUCL 
39199, having a minimum 
activity of 10 000 DNS (1)/g 
additive
Solid form
Char acter isation of the active 
substance
Endo-1,3(4)-beta-g lucanase (EC 
3.2.1.6) produced by Aspergillus 
neonig er MUCL 39199
Analytical method (2)
For the determination of 
endo-1,3(4)-beta-g lucanase in 
the feed additive:
— color imetr ic (DNS) method 
based on the enzymatic 
hydrolysis of the carbo xy­
meth yl cellulose (CMC) at 
pH 4,5 and 37 °CAll animal 
species- - - 1.In the directions for use of the additive and pre­
mixtures, the storage conditions shall be indi ­
cated .
2.Minimum content of the additive when used 
without combination with other enzymes or mi­
cro-org anisms as silage additives: 3,4 DNS/kg of 
fresh mate rial.
3.For users of the additive and premixtures, feed 
business operat ors shall establish operational 
procedures and organisational measures to ad­
dress poten tial 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 per­
sonal prote ctive equipment, including skin, eye 
and breathing protection.26 Januar y 
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 Laborato ry: https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_enEN Offi cial Jour nal of the European Union L 5/28 6.1.2023  Identification 
number of the 
additiveAdditiveCompo sition, chem ical formula, 
descr iption, analytical methodSpecies or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isation Units of activity of  
additive/kg of fresh 
material
Categor y: technological additiv es. Functional group: silage additiv es.
1k107 Endo-1,4-beta- 
xylanase
(EC 3.2.1.8)Additive composition
Preparation of endo-1,4-beta- 
xylanase produced by:
Trichoder ma citrinovi ride MUCL
39203, having a minimum 
activity of 51 600 DNS (1)/g 
additive
Solid form
Char acter isation of the active 
substance
Endo-1,4-beta-xylanase (EC 
3.2.1.8) produced by Trichoder ma 
citrinovir ide MUCL 39203
Analytical method (2)
For the determination of 
endo-1,4-beta-xylanase in the 
feed additive:
— color imetr ic (DNS) method 
based on the enzymatic 
hydrolysis of the xylan at 
pH 4,5 and 37 °CAll animal 
species- - - 1.In the directions for use of the additive and pre­
mixtures, the storage conditions shall be indi ­
cated .
2.Minimum content of the additive when used 
without combination with other enzymes or mi­
cro-org anisms as silage additives: 3,2 DNS/kg of 
fresh mate rial.
3.For users of the additive and premixtures, feed 
business operat ors shall establish operational 
procedures and organisational measures to ad­
dress poten tial 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 per­
sonal prote ctive equipment, including skin, eye 
and breathing protection.26 Januar y 
2033
(1)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 birchw ood xylan.
(2)Details of the analytical methods are available at the following address of the Reference Laborato ry: https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_enEN Offi cial Jour nal of the European Union 6.1.2023 L 5/29  Identification 
number of the 
additiveAdditiveCompo sition, chem ical formula, 
descr iption, analytical methodSpecies or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isation Units of activity of  
additive/kg of fresh 
material
Categor y: technological additiv es. Functional group: silage additiv es.
1k108 Endo-1,4-beta- 
xylanase
(EC 3.2.1.8)Additive composition
Preparation of endo-1,4-beta- 
xylanase produced by:
Trichoder ma citrinovi ride CBS 
614.94, having a minimum 
activity of 70 000 DNS (1)/g 
additive
Solid form
Char acter isation of the active 
substance
Endo-1,4-beta-xylanase (EC 
3.2.1.8) produced by Trichoder ma 
citrinovir ide CBS 614.94
Analytical method (2)
For the determination of 
endo-1,4-beta-xylanase in the 
feed additive:
— color imetr ic (DNS) method 
based on the enzymatic 
hydrolysis of the xylan at 
pH 4,5 and 37 °CAll animal 
species- - - 1.In the directions for use of the additive and pre­
mixtures, the storage conditions shall be indi ­
cated .
2.Minimum content of the additive when used 
without combination with other enzymes or mi­
cro-org anisms as silage additives: 15 DNS/kg of 
fresh mate rial.
3.For users of the additive and premixtures, feed 
business operat ors shall establish operational 
procedures and organisational measures to ad­
dress poten tial 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 per­
sonal prote ctive equipment, including skin, eye 
and breathing protection.26 Januar y 
2033
(1)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 birchw ood xylan.
(2)Details of the analytical methods are available at the following address of the Reference Laborato ry: https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_enEN Offi cial Jour nal of the European Union L 5/30 6.1.2023