ANNEXSupplementary provisions
ANNEX Identification number of the additive Name of the holder of authorisation Name of the 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 4a22 Adisseo France S.A.S. Endo-1,4-beta-xylanase (EC 3.2.1.8) and Endo-1,3(4)-beta-glucanase (EC 3.2.1.6) Additive composition Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) and endo-1,3(4)-beta-glucanase (EC 3.2.1.6) produced with Talaromyces versatilis IMI 378536 and Talaromyces versatilis DSM 26702 having a minimum activity of: — solid form: endo-1,4-beta-xylanase 22 000 VU ( 1 ) /g and endo-1,3(4)-beta-glucanase 15 200 VU/g; — liquid form: endo-1,4-beta-xylanase activity of 5 500 VU/ml and endo-1,3(4)-beta-glucanase 3 800 VU/ml. Characterisation of the active substance Endo-1,4-beta-xylanase (EC 3.2.1.8) and endo-1,3 (4)-beta-glucanase (EC 3.2.1.6) produced with Talaromyces versatilis IMI 378536 and Talaromyces versatilis DSM 26702. Analytical method ( 2 ) For the determination of endo- 1,4-beta-xylanase activity: — viscosimetric method based on decrease in viscosity produced by action of endo-1,4- beta-xylanase on the xylan containing substrate (wheat arabinoxylan). For the determination of endo- 1,3(4)-beta-glucanase activity: — viscosimetric method based on decrease in viscosity produced by action of endo-1,3 (4)-beta-glucanase on the glucan containing substrate (barley beta-glucan). Poultry - Endo-1,4- beta-xylanase 1 100 VU Endo-1,3(4)-beta-glucanase 760 VU - 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 the 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 breathing and skin protections. 28 May 2036 ( 1 ) 1 VU (viscosimetric unit) of the xylanase or glucanase activity is the amount of the enzyme which hydrolyses the substrate (wheat arabinoxylan or barley betaglucan, respectively), reducing the viscosity of the solution, to give a change in relative fluidity of 1 (dimensionless unit)/min at 30 °C and pH 5,5. ( 2 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en