Commission Implementing Regulation (EU) 2019/454 of 20 March 2019 concerning the authorisation of preparations of alpha-amylase from Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251, or Aspergillus oryzae ATCC SD-5374, as well as a preparation of endo-1,4-beta-glucanase from Trichoderma reesei ATCC PTA-10001 as silage additives for all animal species (Text with EEA relevance.)

• CELEX: Implementing Regulation (EU) 2019/454
• Articles: 3

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 .

Schedules & Appendices

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

Technological additives: silage additives

1k101

Alpha-amylase

(EC 3.2.1.1)

Additive composition

Preparation of alpha-amylase produced by:

Bacillus amyloliquefaciens DSM 9553, having a minimum activity of 129 800 DNS  ( 1 ) /g additive

Solid form

Characterisation of the active substance

Alpha-amylase produced by Bacillus amyloliquefaciens DSM 9553

Analytical method

( 2 )

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)

Additive composition

Preparation of alpha-amylase produced by Bacillus amyloliquefaciens NCIMB 30251, having a minimum activity of 101 050 DNS/g additive

Solid form

Characterisation of the active substance

Alpha-amylase produced by Bacillus amyloliquefaciens NCIMB 30251

Analytical method

( 2 )

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)

Additive composition

Preparation of alpha-amylase produced by Aspergillus oryzae ATCC SD-5374 having a minimum activity of 235 850 DNS/g additive

Solid forms

Characterisation of the active substance

Alpha-amylase produced by Aspergillus oryzae ATTC SD-5374

Analytical method

( 2 )

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)

Additive composition

Preparation of endo-1,4-beta-glucanase produced by Trichoderma reesei  ATCC PTA-10001 having a minimum activity of 2 750  DNS  ( 3 ) /g additive

Solid form

Characterisation of the active substance

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

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 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

( 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 assay.

( 2 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

( 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 carboxymethyl cellulose (CMC) under specified conditions of the assay.