REGUL ATIONS 
COMMI SSION IMPLEMENTING REGUL ATION (EU) 2019/454 
of 20 March 2019 
concer ning the author isation of preparations of alpha-amylase from Bacillus amylol iquef aciens 
DSM 9553, Bacillus amyl oliquef aciens NCIMB 30251, or Aspergillus oryzae ATCC SD-5374, as well 
as a preparation of endo-1,4-beta-gluca nase from Trichoder ma reesei ATCC PTA-10001 as silage 
additiv es for all animal species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutr ition (1), and in particular Article 9(2) thereof, 
Whereas: 
(1)  Regulation (EC) No 1831/2003 provi des for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such author isation. Article 10(7) of Regulation (EC) No 1831/2003 in 
conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in 
the Union as silage additives. 
(2)  In accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003, the preparations of alpha-amyl ase 
(EC 3.2.1.1) produced by the follo wing strains of Bacillus amyl oliquef aciens DSM 9553, Bacillus amyloliquef aciens 
NCIMB 30251 or by Aspergillus oryzae ATCC SD-5374 as well as a preparation of endo-1,4-beta-g lucanase 
(EC 3.2.1.4) produced by Trichoder ma reesei ATCC PTA-10001 were entered in the Regist er of feed additives as 
existing products belonging to the functional group of silage additives, for all animal species. 
(3)  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an 
application was submitte d for the author isation of the three preparations of alpha-amyl ase (EC 3.2.1.1) and 
a preparation of endo-1,4-beta-g lucanase (EC 3.2.1.4) as feed additives for all animal species. 
(4)  The application concer ns the author isation of preparations of alpha-amyl ase (EC 3.2.1.1) produced by Bacillus 
amyl oliquef aciens DSM 9553, Bacillus amyloliquef aciens NCIMB 30251 or by Aspergillus oryzae ATCC SD-5374 as 
well as the preparation of endo-1,4-beta-g lucanase (EC 3.2.1.4) produced by Trichoder ma reesei ATCC PTA-10001 
as feed additives for all animal species, to be classif ied in the additive categor y ‘techn ological additives ’. The 
application was accompan ied by the particulars and documents required under Article 7(3) of Regulation (EC) 
No 1831/2003. 
(5)  The European Food Safety Auth ority (‘the Author ity’) concluded in its opinion of 7 Marc h 2018 (2) that, under 
the proposed conditions of use, the preparations concer ned do not have an adverse effect on animal health, 
human health or the environment. The Author ity also concluded that the preparations concer ned have the 
poten tial to impro ve the production of silage from easy , moderate and difficult to ensile forag e mat erials. The 
Author ity does not consider that there is a need for specifi c requirements of post-market monitori ng. It also 
verified the repor t on the method of analysis of the feed additive in feed submitted by the Reference Laborat ory 
set up by Regulation (EC) No 1831/2003. 
(6)  The assessment of the preparations of alpha-amylase (EC 3.2.1.1) produced by Bacillus amyloliquef aciens 
DSM 9553, Bacillus amyloliquef aciens NCIMB 30251 or by Aspergillus oryzae ATCC SD-5374 as well as the 
preparation of endo-1,4-beta-g lucanase (EC 3.2.1.4) produced by Trichoder ma reesei ATCC PTA-10001 show that 
the conditions for author isation, as provid ed for in Article 5 of Regulation (EC) No 1831/2003, are satisfi ed. 
According ly, the use of those preparations should be author ised as specified in the Annex to this Regulation. 21.3.2019 L 79/4 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Jour nal 2018; 16(4):5224. (7)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
The preparations specified in the Annex, belonging to the additive categor y ‘technological 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 
This Regulation shall enter into force on the twentieth day followi ng 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 State s. 
Done at Brussels, 20 Marc h 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  21.3.2019 L 79/5 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the additive Additive Com position, chemi cal formula, 
descr iption, analytical method Species or cat­
egor y of animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of period 
of author isa­
tion Units of activity of addi ­
tive/kg of fresh material 
Technological additiv es: silage additiv es 
1k101 Alpha-am ylase 
(EC 3.2.1.1) Additive composition 
Preparation of alpha-amyl ase pro­
duced by: 
Bacillus amyl oliquef aciens DSM 
9553, having a minimum activity 
of 129 800 DNS (1)/g additive 
Solid form 
Char acter isation of the active sub­
stance 
Alpha-am ylase produced by Bacil ­
lus amyloliquef aciens DSM 9553 
Analytical method (2) 
For the deter mination of alpha- 
amy lase in the feed additive: col­
orimetr ic (DNS) method based on 
the enzymatic hydrolysis of the 
starch at pH 4,5 and 37 °C All animal 
species — — — 1.  In the directions for use of the additive 
and premixture, the storage conditions 
and stability to heat treatment shall be 
indicated . 
2.  Minimum dose of alpha-amylase when 
used without combination with other en­
zymes or microorganisms as silage addi ­
tives 40 DNS/kg of fresh mater ial. 
3.For users of the additive and premix ­
tures, feed business operators shall estab ­
lish operational procedures and organisa ­
tional measures to address pote ntial risks 
resulting from its use. Where those risks 
cannot be eliminate d or reduced to 
a minimum by such procedures and 
measures, the additive and premixtures 
shall be used with personal prot ective 
equipment, including breathing prot ec­
tion. 11 Apr il 
2029 
1k102 Alpha-am ylase 
(EC 3.2.1.1) Additive composition 
Preparation of alpha-amyl ase pro­
duced by Bacillus amyl oliquef aciens 
NCIMB 30251, having a minimum 
activity of 101 050 DNS/g addi ­
tive 
Solid form  All animal 
species — — — 1.  In the directions for use of the additive 
and premixture, the storage conditions 
and stability to heat treatment shall be 
indicated . 
2.  Minimum dose of alpha-amylase when 
used without combination with other en­
zymes or microorganisms as silage addi ­
tives 10 DNS/kg of fresh mater ial.  11 Apr il 
2029 21.3.2019 L 79/6 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Additive Com position, chemi cal formula, 
descr iption, analytical method Species or cat­
egor y of animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of period 
of author isa­
tion Units of activity of addi ­
tive/kg of fresh material 
Char acter isation of the active sub­
stance 
Alpha-am ylase produced by Bacil ­
lus amyloliquef aciens NCIMB 30251 
Analytical method (2) 
For the deter mination of alpha- 
amy lase in the feed additive: col­
orimetr ic (DNS) method based on 
the enzymatic hydrolysis of the 
starch at pH 4,5 and 37 °C 3.For users of the additive and premix ­
tures, feed business operators shall estab ­
lish operational procedures and organisa ­
tional measures to address pote ntial risks 
resulting from its use. Where those risks 
cannot be eliminate d or reduced to 
a minimum by such procedures and 
measures, the additive and premixtures 
shall be used with personal prot ective 
equipment, including breathing prot ec­
tion. 
1k103 Alpha-am ylase 
(EC 3.2.1.1) Additive composition 
Preparation of alpha-amyl ase pro­
duced by Aspergillus oryzae ATCC 
SD-5374 having a minimum ac­
tivity of 235 850 DNS/g additive 
Solid forms 
Char acter isation of the active sub­
stance 
Alpha-am ylase produced by Asper ­
gillus oryzae ATTC SD-5374 
Analytical method (2) 
For the deter mination of alpha- 
amy lase in the feed additive: col­
orimetr ic (DNS) method based on 
the enzymatic hydrolysis of the 
starch at pH 4,5 and 37 °C All animal 
species — — — 1.  In the directions for use of the additive 
and premixture, the storage conditions 
and stability to heat treatment shall be 
indicated . 
2.  Minimum dose of alpha-amylase when 
used without combination with other en­
zymes or microorganisms as silage addi ­
tives 23 DNS/kg of fresh mater ial. 
3.For users of the additive and premix ­
tures, feed business operators shall estab ­
lish operational procedures and organisa ­
tional measures to address pote ntial risks 
resulting from its use. Where those risks 
cannot be eliminate d or reduced to 
a minimum by such procedures and 
measures, the additive and premixtures 
shall be used with personal prot ective 
equipment, including breathing prot ec­
tion. 11 Apr il 
2029 21.3.2019 L 79/7 Official Jour nal of the European Union EN     Identifica ­
tion 
number of 
the additive Additive Com position, chemi cal formula, 
descr iption, analytical method Species or cat­
egor y of animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of period 
of author isa­
tion Units of activity of addi ­
tive/kg of fresh material 
1k104 Endo-1,4-beta- 
glucanase 
(EC 3.2.1.4) Additive composition 
Preparation of endo-1,4-beta-g lu­
canase produced by Trichoder ma 
reese i ATCC PTA-10001 having 
a minimum activity of 
2 750 DNS (3)/g additive 
Solid form 
Char acter isation of the active sub­
stance 
Endo-1,4-beta-g lucanase produced 
by Trichoder ma reesei ATCC 
PTA-10001 
Analytical method (2) 
For the deter mination of endo- 
1,4-beta-g lucanase in the feed ad­
ditive: color imetr ic (DNS) method 
based on the enzymatic hydrolysis 
of the carbo xymethyl cellulose 
(CMC) at pH 4,5 and 37 °C All animal 
species — — — 1.  In the directions for use of the additive 
and premixture, the storage conditions 
and stability to heat treatment shall be 
indicated . 
2.Minimum dose of endo-1,4-beta-g luca ­
nase when used without combination 
with other enzymes or microorg anisms 
as silage additives 7 DNS/kg of fresh ma­
terial. 
3.For users of the additive and premix ­
tures, feed business operators shall estab ­
lish operational procedures and organisa ­
tional measures to address pote ntial risks 
resulting from its use. Where those risks 
cannot be eliminate d or reduced to 
a minimum by such procedures and 
measures, the additive and premixtures 
shall be used with personal prot ective 
equipment, including breathing prot ec­
tion. 11 Apr il 
2029 
(1)  1 DNS (3,5-dinitrosalicylic acid) unit is the amount of reducing sugar released as maltose equivalents in μmol per g per min at pH 4,5 and 37 °C from starch under specified conditions of the assa y. 
(2)  Details of the analytical methods are available at the following address of the Reference Laborato ry: https://ec.europa.eu/jrc/en/eurl/feed-addi tives/evaluation-repor ts 
(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 carbo xymethyl cellulose (CMC) under specified condit ­
ions of the assa y.   21.3.2019 L 79/8 Official Jour nal of the European Union EN