Safety Assessment on the Safety and Efficacy of an Endo‐1,4‐beta‐xylanase (ECONASE® XT) as a Feed Additive for Use in Laying Hens, Minor Poultry Species Other Than Laying Birds, Laying Birds of Minor Poultry Species and Pigs for Fattening (RP1366)

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in November 2021 from Roal Oy (‘the applicant’) for the new authorisation of an additive containing an endo‐1,4‐beta‐xylanase produced by Trichoderma reesei CBS 114044 (ECONASE® XT), under the category of ‘zootechnical additives’ and functional group ‘digestibility enhancers’. The additive is proposed to be used at an inclusion rate of 12,000 – 24,000 BXU/kg complete feed for laying hens, 8,000 – 24,000 BXU/kg feed for minor poultry species other than laying birds, 24,000 BXU/kg feed for laying birds of minor poultry species and 20,000 – 24,000 BXU/kg feed for pigs for fattening. To support the FSA and Food Standards Scotland (FSS) in evaluating the dossier, the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to review the dossier and the supplementary information from the applicant. The FSA/FSS concluded, based on the ACAF’s advice, that all five forms of the additive and the production strain were correctly characterised. The liquid and solid forms of the additive are stable for 24 months at 25 °C and 20-23 °C, respectively. The solid forms are stable for pelleting to 95 °C for 32-33 seconds and in a premixture for 6 months. All forms of the additive are stable in pelleted and mash feed for 3 months and capable of homogenous distribution in feed. ECONASE® XT can be considered safe for the target species, consumers and the environment. All forms of the additive are considered non-irritating to skin and eyes and are not skin sensitisers but are potential respiratory sensitisers. The additive is efficacious in laying hens, minor poultry species other than laying birds, laying birds of minor poultry species and pigs for fattening. The views of ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.