Safety Assessment RP593 Hostazym C

An application was submitted to the Food Standards Agency in November from Huvepharma NV (“the applicant”) for the authorisation of an additive (endo-1,4-betaglucanase - Hostazym® C) under the category ‘zootechnical additives’, functional group ‘digestibility enhancers’ for two uses: • A renewal of authorisation for chickens for fattening, minor poultry species for fattening, weaned piglets. • A new authorisation for turkeys for fattening, turkeys reared for breeding, chickens reared for laying, minor poultry species reared for laying or breeding, ornamental birds and suckling piglets To support the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in evaluating the dossier, the Advisory Committee on Animal Feedingstuffs (ACAF) was asked to review the dossier and the supplementary information from the applicant. The safety and efficacy sections of the dossier were evaluated by the ACAF, and no new concerns were raised. Taking account of the literature review provided by the applicant, it was concluded that previous conclusions drawn by The European Food Safety Authority (EFSA) could be accepted and the additive could, therefore, be considered safe for the target species, the consumer and the environment. It was also concluded that the product should be considered a potential skin and eye irritant, and a potential skin and respiratory sensitiser. It was concluded the additive remains efficacious and that these conclusions can be extrapolated to the new uses proposed. The views of ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.