Safety Assessment RP416 Axtra XB

An application was submitted to the Food Standards Agency in February 2021 by Genencor International B.V. (“the applicant”) for the authorisation of an additive (endo-1,4-betaxylanase and endo-1,3(4)-beta-glucanase - Axtra® XB), under retained regulation No 1831/20031 . The application seeks authorisation under the category ‘zootechnical additives’, functional group ‘digestibility enhancers’ for two conditions: • A renewal of authorisation for use in all avian species reared for fattening, reared for breeding, and reared for laying, laying hens, weaned piglets and pigs for fattening, lactating sows, and minor porcine species. • A modification of authorisation for the reduction of the minimum dose for turkeys for fattening and breeding (610 U xylanase /kg of complete feed and 76 U glucanase /kg of complete feed), by extrapolation of safety and efficacy data from chickens for fattening. To support the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in evaluating the dossier, the Animal Feed and Feed Additives Joint Expert Group (AFFAJEG) and the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to review the dossier and the supplementary information from the applicant. The Animal Feed and Feed Additives Joint Expert Group (AFFAJEG) and the Advisory Committee on Animal Feedingstuffs (ACAF) concluded that the additive was correctly identified and characterised, and that the additive can be considered safe for the target species, the consumer and the environment. The product should be considered a respiratory sensitiser and a potential eye and skin irritant. The product is not a skin sensitiser. Based on data from a new trial in turkeys, the ACAF concluded that Axtra® XB, in both formulations (TPT/L), has the potential to be efficacious in turkeys for fattening and breeding at the proposed reduced minimum dose of 610 U/kg of complete feed (xylanase) and 76 U/kg of complete feed (glucanase). The views of AFFAJEG and ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.