Commission Implementing Regulation (EU) 2015/2305 of 10 December 2015 concerning the authorisation of a preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142) as a feed additive for chickens for fattening, minor poultry species for fattening and weaned piglets, and amending Regulations (EC) No 2148/2004 and (EC) No 1520/2007 (holder of authorisation Huvepharma NV) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2015/2305
• 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 Amendment to Regulation (EC) No 2148/2004

In Annex IV to Regulation (EC) No 2148/2004 the entry on E 1616, endo-1,4-beta-glucanase, is deleted.

Article 3 Amendment to Regulation (EC) No 1520/2007

Regulation (EC) No 1520/2007 is amended as follows:

(1)

Article 5 is deleted;

(2)

Annex V is deleted.

Article 4 Transitional measures

The preparation specified in the Annex, and feed containing that preparation, which is produced and labelled before 30 June 2016 in accordance with the rules applicable before 31 December 2015 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.

4a1616

Huvepharma NV

Endo-1,4-beta-glucanase

EC 3.2.1.4

Additive composition:

Preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142) with a minimum activity of 2 000 CU  ( 1 ) /g (solid and liquid form).

Characterisation of the active substance:

Endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma citrinoviride Bisset (IM SD142).

Analytical method

( 2 ) :

For the determination of endo-1,4-beta-glucanase in feed additive, premixtures and feedingstuffs:

—

colorimetric method based on the quantification of water soluble dyed fragments (azurine) produced by the action of endo-1,4-beta-glucanase on azurine-crosslinked cellulose.

Chickens for fattening and minor poultry species for fattening

—

500 CU

—

1.

In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.

2.

For safety: breathing protection, glasses and gloves shall be used during handling.

3.

For use in weaned piglets until approximately 35 kg.

31 December 2025

Weaned piglets

350 CU

( 1 )   1 CU is the amount of enzyme that liberates 0,128 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,5 and 30 °C.

( 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