Commission Implementing Regulation (EU) 2023/1332 of 29 June 2023 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 114044 as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and weaned piglets (holder of the authorisation: Roal Oy), and repealing Regulation (EC) No 902/2009 (Text with EEA relevance)
Renewal of the authorisation
The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is renewed subject to the conditions laid down in that Annex.
Transitional measures
1. The preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 114044 and premixtures containing it, which are produced and labelled before 20 January 2024 in accordance with the rules applicable before 20 July 2023 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Feed materials and compound feed containing the preparation referred to in paragraph 1, which are produced and labelled before 20 July 2024 in accordance with the rules applicable before 20 July 2023 may continue to be placed on the market and used until the existing stocks are exhausted, where they are intended for food-producing animals.
Repeal of Regulation (EC) No 902/2009
Regulation (EC) No 902/2009 repealed.
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 .
Supplementary provisions
ANNEXSupplementary provisions
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 feed with a moisture content of 12 %
Category of zootechnical additives. Functional group: digestibility enhancers.
4a8i
Roal Oy
Endo-1,4-beta-xylanase (EC 3.2.1.8)
Additive composition
Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 114044 having a minimum activity of:
solid form: 160 000 BXU ( 1 ) /g
liquid form: 160 000 BXU/g
Characterisation of the active substance
Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei CBS 114044
Analytical method
( 2 )
Characterisation of the active substance in the additive and the premixture: reducing sugar assay for endo-1,4- beta-xylanase by colorimetric reaction of dinitrosalicylic acid reagent on reducing sugar yield at pH 5,3 and 50 °C;
Characterisation of the active substance in the compound feed: colorimetric method measuring water soluble dye released by the enzyme from azurine crosslinked wheat arabinoxylan substrate.
Chickens for fattening and chickens reared for laying
-
8 000 BXU
-
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 by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing, skin and eye protection for solid forms, and breathing protection for liquid forms.
20 July 2033
Turkeys for fattening and turkeys reared for breeding
16 000 BXU
Piglets (weaned)
24 000 BXU
( 1 ) 1 BXU is the amount of enzyme which liberates 1 nmol reducing sugars as xylose from birch xylan per second at pH 5,3 and 50 °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
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.