
Article 1 
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 2 
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, 20 March 2019.
For the Commission
The President
Jean-Claude JUNCKER
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
Technological additives: silage additives
1k101 Alpha-amylase(EC 3.2.1.1) 
Preparation of alpha-amylase produced by:

Bacillus amyloliquefaciens DSM 9553, having a minimum activity of 129 800 DNS/g additive

Solid form

Alpha-amylase produced by Bacillus amyloliquefaciens DSM 9553

For the determination of alpha-amylase in the feed additive: colorimetric (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 enzymes or microorganisms as silage additives 40 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 breathing protection.
 11 April 2029
1k102 Alpha-amylase(EC 3.2.1.1) 
Preparation of alpha-amylase produced by Bacillus amyloliquefaciens NCIMB 30251, having a minimum activity of 101 050 DNS/g additive

Solid form

Alpha-amylase produced by Bacillus amyloliquefaciens NCIMB 30251

For the determination of alpha-amylase in the feed additive: colorimetric (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 enzymes or microorganisms as silage additives 10 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 breathing protection.
 11 April 2029
1k103 Alpha-amylase(EC 3.2.1.1) 
Preparation of alpha-amylase produced by Aspergillus oryzae ATCC SD-5374 having a minimum activity of 235 850 DNS/g additive

Solid forms

Alpha-amylase produced by Aspergillus oryzae ATTC SD-5374

For the determination of alpha-amylase in the feed additive: colorimetric (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 enzymes or microorganisms as silage additives 23 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 breathing protection.
 11 April 2029
1k104 Endo-1,4-beta-glucanase(EC 3.2.1.4) 
Preparation of endo-1,4-beta-glucanase produced by Trichoderma reesei ATCC PTA-10001 having a minimum activity of 2 750 DNS/g additive

Solid form

Endo-1,4-beta-glucanase produced by Trichoderma reesei ATCC PTA-10001

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 premixture, the storage conditions and stability to heat treatment shall be indicated.

2. Minimum dose of endo-1,4-beta-glucanase when used without combination with other enzymes or microorganisms as silage additives 7 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 breathing protection.
 11 April 2029


