Commission Implementing Regulation (EU) 2017/963 of 7 June 2017 concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatinus (formerly classified as Aspergillus aculeatus) (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma reesei (formerly classified as Trichoderma longibrachiatum) (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP4842) and bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) as a feed additive for all avian species and weaned piglets and amending Regulations (EC) No 358/2005 and (EU) No 1270/2009 (holder of the authorisation Kemin Europa NV) (Text with EEA relevance. )

• CELEX: Implementing Regulation (EU) 2017/963
• Articles: 6

Article 1 Authorisation

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Amendments to Regulation (EC) No 358/2005

In Annex I to Regulation (EC) No 358/2005 entry E 1620 on endo-1,3(4)-beta-glucanase EC 3.2.1.6, endo-1,4-beta-glucanase EC 3.2.1.4, alpha-amylase EC 3.2.1.1, bacillolysin EC 3.4.24.28 and endo-1,4-beta-xylanase EC 3.2.1.8 is deleted.

Article 3 Amendment to Regulation (EU) No 1270/2009

Regulation (EC) No 1270/2009 is amended as follows:

(1)

Article 2 is deleted.

(2)

Annex II is deleted.

Article 4 Transitional measures

The preparation specified in the Annex, and feed containing that preparation, which are produced and labelled before 28 December 2017 in accordance with the rules applicable before 28 June 2017 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 5 Entry 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.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the additive

Name of the holder of authorisation

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/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a1620i

Kemin Europa NV

Endo-1,3(4)-beta-glucanase

EC 3.2.1.6

Endo-1,4-beta-glucanase

EC 3.2.1.4

Alpha-amylase

EC 3.2.1.1

Endo-1,4-beta-xylanase EC 3.2.1.8

Bacillolysin

EC 3.4.24.28

Additive composition

Preparation of:

—

endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatinus (formerly classified as Aspergillus aculeatus ) (CBS 589.94),

—

endo-1,4-beta-glucanase produced by Trichoderma reesei (formerly classified as Trichoderma longibrachiatum ) (CBS 592.94),

—

alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553),

—

endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP4842),

—

bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) having a minimum activity of:

—

Endo-1,3(4)-beta-glucanase: 2 350 U  ( 1 ) /g,

—

Endo-1,4-beta-glucanase: 18 000 U  ( 2 ) /g,

—

alpha-amylase: 400 U  ( 3 ) /g,

—

Endo-1,4-beta-xylanase: 35 000 U  ( 4 ) /g,

—

bacillolysin 1 700 U  ( 5 ) /g

Solid form

Characterisation of the active substance

—

endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatinus (CBS 589.94),

—

endo-1,4-beta-glucanase produced by Trichoderma reesei (CBS 592.94),

—

alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553),

—

endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP4842),

—

bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554).

Chickens for fattening

Chickens reared for laying

Minor avian species for laying

Minor avian species reared for laying

Ornamental birds

Piglets (weaned)

—

Endo-1,3(4)-beta-glucanase

1 175 U

Endo-1,4-beta-glucanase

9 000 U

Alpha-amylase

200 U

Endo-1,4-beta-xylanase

17 500 U

Bacillolysin

850 U

—

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2.

For use in weaned piglets up to 35 kg of body weight.

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 and skin protection.

4.

Recommended use level in laying hens: endo-1,3(4)- beta glucanase: 1 175 U; endo-1,4-beta-glucanase: 9 000 U; alpha-amylase: 200 U; endo-1,4-beta-xylanase: 17 500 U; bacillolysin: 850 U/kg of complete feed.

28 June 2027

Analytical method

( 6 )

For the determination in feed additive of:

—

endo-1,3(4)-beta-glucanase in the feed additives: colorimetric method based on the enzymatic hydrolysis of glucanase on the barley beta-glucan substrate at pH 7,5 and 30 °C,

—

endo-1,4-beta-glucanase in the feed additives: colorimetric method based on the enzymatic hydrolysis of cellulase on the carboxymethylcellulose at pH 4,8 and 50 °C,

—

alpha-amylase in the feed additives: colorimetric method based on the formation of water soluble dyed fragments produced by the action of amylase on azurine cross-linked starch polymer substrates at pH 7,5 and 37 °C,

—

endo-1,4-beta-xylanase in the feed additives: colorimetric method based on the enzymatic hydrolysis of xylanase on the birchwood xylane substrate at pH 5,3 and 50 °C,

—

bacillolysin: colorimetric method based on the release of azo-dye resulting from the action of protease on the azo-casein substrate at pH 7,5 and 37 °C.

For the determination in premixtures and feedingstuffs of:

—

endo-1,3(4)-beta-glucanase: plate test method based on the glucanase diffusion and the subsequent decolouring of the red agar medium due to the beta-glucan hydrolysis,

—

endo-1,4-beta-glucanase: colorimetric method based on the quantification of the water soluble dye fragments produced by the action of cellulase on azurine cross-linked water insoluble HE-cellulose substrate,

—

alpha-amylase: colorimetric method based on the formation of water soluble blue fragments produced by the action of amylase on azurine cross-linked insoluble blue-coloured starch polymer substrates,

—

endo-1,4-beta-xylanase: colorimetric method based on the quantification of water soluble dyed fragments produced by the action of xylanase on azurine cross-linked wheat arabinoxylan,

—

bacillolysin: test plate method based on the diffusion of protease in the azo-casein agar medium and the subsequent hydrolysis of casein.

All Turkeys

Laying hens

Minor avian species for fattening

Endo-1,3(4)beta-glucanase

588 U

Endo-1,4-beta-glucanase

4 500 U

Alpha-amylase

100 U

Endo-1,4-beta-xylanase

8 750 U

Bacillolysin

425 U

( 1 )   1 U is the amount of enzyme which liberates 0,0056 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 7,5 and 30 °C.

( 2 )   1 U is the amount of enzyme which liberates 0,0056 micromoles of reducing sugars (glucose equivalents) from carboxymethylcellulose per minute at pH 4,8 and 50 °C.

( 3 )   1 U is the amount of enzyme which hydrolyses 1 micromole of glycosidic linkages from water insoluble cross-linked starch polymer per minute at pH 7,5 and 37 °C.

( 4 )   1 U is the amount of enzyme which liberates 0,0067 micromoles of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 5,3 and 50 °C.

( 5 )   1 U is the amount of enzyme which solubilises one microgram of azo-casein substrate per minute at pH 7,5 and 37 °C.

( 6 )   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