
Article 1 
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 
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 
Regulation (EC) No 1284/2006 is amended as follows:

((1)) Article 2 is deleted.
((2)) Annex II is deleted.
Article 4 
Regulation (EU) No 516/2010 is repealed.
Article 5 
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 
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, 10 March 2017.
For the Commission
The President
Jean-Claude JUNCKER
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 3.2.1.6Endo-1,4-beta-glucanase EC 3.2.1.4Alpha-amylase EC 3.2.1.1Endo-1,4-beta-xylanase EC 3.2.1.8 
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/g,
— endo-1,4-beta-glucanase: 310 000 U/g,
— alpha-amylase: 400 U/g,
— endo-1,4-beta-xylanase: 210 000 U/g.

Liquid form


— 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).

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-glucanase500 UEndo-1,4-beta-glucanase15 500 UAlpha-amylase20 UEndo-1,4-beta-xylanase10 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




