Commission Implementing Regulation (EU) 2017/1896 of 17 October 2017 concerning the authorisation of a preparation o endo-1,3(4)-beta-glucanase (EC 3.2.1.6) and endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger (NRRL 25541) as a feed additive for chickens for fattening, laying hens, pigs for fattening, minor poultry species and minor porcine species for fattening and amending Regulation (EC) No 255/2005 and repealing Regulation (EC) No 668/2003 (holder of the authorisation Andrés Pintaluba S.A.) (Text with EEA relevance. )

• CELEX: Implementing Regulation (EU) 2017/1896
• 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 255/2005

In Annex II to Regulation (EC) No 255/2005, entry E 1601 on endo-1,3(4)-beta-glucanase EC 3.2.1.6 and endo-1,4-beta-xylanase EC 3.2.1.8 is deleted.

Article 3 Repeal

Regulation (EC) No 668/2003 is repealed.

Article 4 Transitional measures

The preparation specified in the Annex, and feed containing that preparation, which are produced and labelled before 7 May 2018 in accordance with the rules applicable before 7 November 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.

4a1601

Andrés Pintaluba S.A.

Endo-1,3(4)-beta-glucanase EC 3.2.1.6

and endo-1,4-beta-xylanase EC 3.2.1.8

Additive composition:

Preparation of endo-1,3(4)-beta-glucanase (EC 3.2.1.6) and endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger (NRRL 25541) having a minimum activity of: endo-1,3(4)-beta-glucanase 1 100 U  ( 1 ) /g and endo-1,4-beta-xylanase 1 600 U  ( 2 ) /g.

(solid form)

Characterisation of the active substance:

Endo-1,3(4)-beta-glucanase (EC 3.2.1.6) and endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger (NRRL 25541).

Analytical method

( 3 )

For the characterisation in the feed additive and premixtures of:

—

endo-1,3(4)-beta-glucanase activity: colorimetric method measuring reducing sugar (glucose equivalents) released by the action of endo-1,3(4)-beta-glucanase on barley beta-glucan substrate in presence of 3,5-dinitrosalicil acid (DNS);

—

endo-1,4-beta-xylanase activity: colorimetric method measuring reducing sugar (glucose equivalents) released by the action of endo-1,4-beta-xylanase on oat xylan substrate in presence of 3,5-dinitrosalicil acid (DNS).

For the characterisation in the feed of:

—

endo-1,3(4)-beta-glucanase activity: colorimetric method measuring depolymerised soluble fragments released by the action of endo-1,3(4)-beta-glucanase on azo-barley-glucan;

—

endo-1,4-beta-xylanase activity: colorimetric method measuring depolymerised soluble fragments released by the action of endo-1,4-beta-xylanase on azo-xylan.

Chickens for fattening

Laying hens

Pigs for fattening

Minor poultry species

Minor porcine species for fattening

—

Endo-1,3(4)-beta-glucanase 138 U

Endo-1,4-beta-xylanase

200 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 users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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 skin, eyes and breathing protections.

7.11.2027

( 1 )   1 U (unit) endo-1,3(4)-beta-glucanase is the amount of enzyme which liberates 1 μmole of reducing sugar (glucose equivalents) from oat beta-glucan per minute at 30 °C and pH 4.

( 2 )   1 U (unit) endo-1,4-beta-xylanase is the amount of enzyme which liberates 1 μmole of reducing sugar (xylose equivalents) from oat xylan per minute at 30 °C and pH 4.

( 3 )   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