Xylanase and glucanase from Trichoderma reesei MUCL 49755/49754 (4a9) renewed for pigs, poultry and turkeys and authorised for suckling piglets; EFSA: no data on compliance of the formulation with calcium carbonate + sepiolite carrier, dusting potential up to 14 325 mg/m³
Commission Implementing Regulation (EU) 2025/711, published on 11 April 2025, renews the authorisation of the preparation of endo-1,4-beta-xylanase (T. reesei MUCL 49755) and endo-1,3(4)-beta-glucanase (T. reesei MUCL 49754) as a zootechnical digestibility enhancer for weaned piglets, laying hens and minor poultry species, fattening pigs of all Suidae and turkeys for fattening, authorises it for suckling piglets and repeals three earlier regulations. It is based on three EFSA opinions of 2024.
- Specification and doses (annex, holder AVEVE BV, 4a9): activity of at least 40 000 XU and 9 000 BGU per gram, solid and liquid forms; minimum content 4 000 XU and 900 BGU/kg complete feed for piglets (weaned and suckling), fattening pigs of all Suidae, turkeys for fattening, laying hens and minor poultry species for laying, and 3 000 XU and 675 BGU/kg for minor poultry species for fattening. 1 XU releases 1 μmol of reducing sugar from oat spelt xylan per minute at pH 4.8 and 50 °C, 1 BGU — from barley beta-glucan at pH 5.0 and 50 °C. Authorisation until 1 May 2035.
- Methods: in the additive — colorimetric methods based on reducing sugars reacting with dinitrosalicylic acid (DNS); in compound feed — colorimetric methods measuring the water-soluble dye released from dye-crosslinked wheat arabinoxylan (xylanase) and barley beta-glucan (glucanase). The reference laboratory considered the earlier method evaluations still valid, so no new report was required. Protective equipment: respiratory and skin, and eyes only for the powder with calcium carbonate and wheat flour.
- EFSA data (e8852, e8853, e8951): the carrier of the powder form was changed from soybean meal to calcium carbonate with wheat flour or calcium carbonate with sepiolite; the powder contains 27–32 % spray-dried enzyme concentrate and 68–73 % carriers. In five batches of powder on average 47 458 XU/g (42 535–55 490) and 9664 BGU/g (9185–10 395), in the liquid form 51 595 XU/g and 9534 BGU/g. Dusting potential of the powder with wheat flour (Stauber–Heubach method, three batches) 13 779–14 325 mg/m³. EFSA noted that no data were submitted to support compliance of the formulation with calcium carbonate and sepiolite with the conditions of authorisation — the act does not mention this.
- Safety: the additive is safe for the target animals, consumers and the environment; the sepiolite formulation and the liquid form are not irritant to skin and eyes, no conclusion for the powder with wheat flour; all forms are respiratory and skin sensitisers. Efficacy in suckling piglets at 4 000 XU and 900 BGU/kg. Version discrepancy: Polish recital 3 states that for suckling piglets the category „dodatki technologiczne” (technological additives) was requested, the English — “zootechnical additives”; Article 2 in both versions authorises the preparation as a zootechnical additive.