Assessment of the feed additive consisting of endo-1,4-β-xylanase produced by Trichoderma reesei CBS 143953 and endo-1,3(4)-β-glucanase produced by T. reesei CBS 143945 (Axtra® XB 201 TPT/L) for poultry and pigs for renewal of its authorisation (Danisco (UK) Ltd)

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the renewal of the authorisation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 143953 and endo-1,3 (4)-beta-glucanase produced by T. reesei CBS 143945 (Axtra (R) XB 201 TPT/L) as a zootechnical feed additive (digestibility enhancers) for poultry and pigs. The endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase are produced by a genetically modified strain of T. reesei and a non-genetically modified strain of T. reesei, respectively. The applicant also requested a reduction of the minimum recommended level for turkeys for fattening and the extension of use to other species/categories. The Panel concluded that the additive complies with the conditions of the current authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider previous conclusions on the safety of the additive. These conclusions apply also to the new target species/categories for which a request of use was made, suckling piglets. The Panel concluded that the additive should be considered irritant to eyes and a respiratory sensitiser. However, no conclusions could be drawn on the skin irritancy/sensitisation potential of the additive. No change in the authorisation conditions were requested for poultry species (other than turkeys), weaned piglets, pigs for fattening, sows and minor porcine species; therefore there was no need for an assessment on the efficacy of the additive for those species/categories. The Panel concluded that the additive has the potential to be efficacious in turkeys for fattening/reared for breeding and in suckling piglets (for the period in which solid feed is administered) at an intended level of 610 xylanase U/kg and 76 glucanase U/kg feed. However, the Panel noted that the actual effective level used in the studies supporting this conclusion was approximately 50% higher than the intended level. (C) 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.

Automated summary

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) provided a scientific opinion on the renewal of the authorization of two enzyme additives produced by Trichoderma reesei for poultry and pigs. The Panel concluded that the additives comply with the current authorization conditions and have the potential to be efficacious, but may cause eye irritation and respiratory sensitization. However, no conclusions could be drawn on the skin irritancy/sensitization potential of the additives.