Safety Assessment RP309 Hostazym X

An application was submitted to the Food Standards Agency in February 2021 from Huvepharma NV (“the applicant”) for the authorisation of an additive (endo-1,4-betaxylanase - Hostazym® X), under the category ‘zootechnical additives’, functional group ‘digestibility enhancers’ for two uses: • A renewal of authorisation for its use in chickens for fattening, laying hens, turkeys for fattening, minor poultry species for fattening, minor poultry species for laying, weaned piglets, pigs for fattening, chickens reared for laying and carp. • A new use in breeding hens, turkeys reared for breeding, ornamental birds, suckling piglets, minor pig species for fattening and minor poultry species reared for breeding. 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 Joint Expert Group on Animal Feed and Feed Additives (AFFAJEG) concluded that both solid formulations of the additive had a considerable percentage of respirable particles to which workers could be exposed by inhalation. The additive can be considered safe for the target species, consumers and the environment, based on the literature review presented by the applicant. Regarding user safety, the Group agreed with the applicant that the additive should be considered a potential skin and eye irritant, and a potential skin and respiratory sensitiser. The data that demonstrated efficacy in the target species covered by the existing authorisation could be used as evidence of efficacy also in the new species proposed for the extension of authorisation. The views of AFFAJEG and ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.