Commission Implementing Regulation (EU) 2017/429 of 10 March 2017 concerning the authorisation of a 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) and endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP4842) as a feed additive for all avian species and amending Regulations (EC) No 358/2005 and (EC) No 1284/2006 and repealing Regulation (EU) No 516/2010 (holder of the authorisation Kemin Europa NV) (Text with EEA relevance. )

• CELEX: Implementing Regulation (EU) 2017/429
• Articles: 7

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 E1621 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 and endo-1,4-beta-xylanase EC 3.2.1.8 is deleted.

Article 3 Amendments to Regulation (EC) No 1284/2006

Regulation (EC) No 1284/2006 is amended as follows:

(1)

Article 2 is deleted.

(2)

Annex II is deleted.

Article 4 Repeal

Regulation (EU) No 516/2010 is repealed.

Article 5 Transitional measures

The preparation specified in the Annex, and feed containing that preparation, which are produced and labelled before 30 September 2017 in accordance with the rules applicable before 31 March 2017 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 6 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

4a1621i

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

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) having a minimum activity of:

—

endo-1,3(4)-beta-glucanase: 10 000 U  ( 1 ) /g,

—

endo-1,4-beta-glucanase: 310 000 U  ( 2 ) /g,

—

alpha-amylase: 400 U  ( 3 ) /g,

—

endo-1,4-beta-xylanase: 210 000 U  ( 4 ) /g.

Liquid 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).

Analytical method

( 5 )

For the determination in feed additive of:

—

endo-1,3(4)-beta-glucanase in the feed additive: 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 additive: colorimetric method based on the enzymatic hydrolysis of cellulase on the carboxylmethylcellulose at pH 4,8 and 50 °C,

—

alpha-amylase in the feed additive: 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 additive: colorimetric method based on the enzymatic hydrolysis of xylanase on the birchwood xylane substrate at pH 5,3 and 50 °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.

All avian species

—

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

500 U

Endo-1,4-beta-glucanase

15 500 U

Alpha-amylase

20 U

Endo-1,4-beta-xylanase

10 500 U

—

1.

In the directions for use of the additive and premixture the storage conditions and stability to pelleting shall be indicated.

2.

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.

31 March 2027

( 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 liberates 1 micromole of glucose from a 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 )   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