Safety Assessment on the Safety and Efficacy of an Additive of Endo-1,4-Beta-Xylanase, Alpha-Amylase and Subtilisin Protease (Avizyme® 1505) as a Feed Additive for All Avian species. (RP1341)

An application was submitted to the Food Standards Agency in November 2021 from Genencor International B.V (‘the applicant’) for the modification and new authorisation of an additive (Avizyme® 1505) containing endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588), subtilisin protease produced by Bacillus subtilis (ATCC 2107) and alpha-amylase produced by Bacillus amyloliquefaciens (ATCC 3978), under the category ‘zootechnical’ additive, functional group ‘digestibility enhancer’. The additive is proposed to be used in all avian species for fattening, reared for laying, and reared for breeding (except ducks) at an inclusion rate of 0.125 kg/tonne, in all avian species for laying (except ducks) at an inclusion rate of 0.2 kg/tonne, and for all ducks at an inclusion rate of 0.05 kg/tonne. To support the Food Standards Agency (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 the additive was correctly characterised, and that the additive is stable in premixtures and feedingstuffs for 16 months at 20 °C. The additive is stable during pelleting at 90 °C for 30 seconds. Homogeneity in feed was also demonstrated. The additive can be considered safe for the target animal, the consumer and the environment. The additive is a mild irritant to the skin and eyes and is not a dermal sensitiser. The additive contains enzymes that are potential respiratory sensitisers, and measures should be taken to avoid contact through inhalation. It was concluded that Avizyme® 1505 is efficacious for all avian species for fattening, reared for breeding and reared for laying (except ducks), and for all avian species for laying (except ducks) at the proposed inclusion rates detailed under the conditions of use of the additive. Efficacy in ducks at the proposed inclusion rate was only demonstrated for the first 42 days. The views of ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.