Xylanase from Bacillus subtilis LMG S-15136 (Belfeed) renewed and extended to all pigs — EFSA flags the microbial contamination of the solid form
Commission Implementing Regulation (EU) 2026/2130 of 18 September 2026, published on 21 September, renews until 11 October 2036 the authorisation of endo-1,4-beta-xylanase (Puratos NV) as a digestibility enhancer for poultry and pigs and extends it to all porcine species; the minimum content is 10 IU/kg feed. It repeals four earlier regulations: 2017/211, 2020/1377, 2021/1413 and 2026/356.
- Activity is defined on birchwood xylan: 1 IU releases one micromole of reducing sugars (xylose equivalents) per minute at pH 4.5 and 30 °C; the preparation has at least 400 IU/g. In the additive it is measured colorimetrically with 3,5-dinitrosalicylic acid (DNS), in premixtures and feed by measuring the dye released from azurine-cross-linked wheat arabinoxylan.
- In five batches the activity was 408 IU/g (405–411) in the solid Belfeed B MP and 405 IU/ml (402–408) in the liquid Belfeed B ML. In batches of the solid form Enterobacteriaceae reached 1800 CFU/g, total coliforms 3000 CFU/g and moulds 400 CFU/g — EFSA considered that this deserves attention and monitoring in production.
- No viable cells of the production strain were found in three batches of the liquid enzyme concentrate after sterile filtration (1 g each, in triplicate); the presence of its DNA was checked by PCR. An agar disc-diffusion test with six reference strains, including Staphylococcus aureus ATCC 6538 and Escherichia coli ATCC 11229, showed no antimicrobial activity of the intermediate product.
- Both forms are considered skin and eye irritants and respiratory sensitisers. The dusting potential of the solid form was 575–628 mg/m³; the liquid form has a pH of 4.2 and a viscosity of 44.2–45.0 cP. Stocks labelled before 11 April 2027 (feed before 11 October 2027) may be used up.