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Safety Assessment RP420 Axtra Phy Gold

Objective

An application was submitted to the Food Standards Agency in February 2021 from Genencor International B.V. (“the applicant”) for the authorisation of an additive (6- phytase - Axtra® Phy Gold), under the category of ‘zootechnical additives’, functional group ‘digestibility enhancers’ for its use in all poultry and pigs. 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 additive should be considered a respiratory sensitiser. The additive is non-irritant to eyes and skin, and it is not a skin sensitiser. Based on data from 12 efficacy trials in broilers, laying hens, sows and piglets, the Committee concluded that Axtra® Phy Gold, in its three formulations (30L, 30T and 65G), can be considered efficacious in all poultry and pigs at the proposed minimum dose of 300 phytase units (FTU)/kg of complete feed (laying birds) and 500 FTU/kg of complete feed (other target species). The views of AFFAJEG and ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.

Institution
Regulated Products Risk Assessment Unit FSA and Risk Assessment Team FSS.
Project number
RP420