Safety Assessment on the Safety and Efficacy of an Additive Consisting of 6-Phytase Produced by <i>Trichoderma Reesei</i> (Quantum® Blue) as a Feed Additive for Use in Fin Fish (RP1275)

An application was submitted to the Food Standards Agency (FSA) in September 2021 from Roal Oy (‘the applicant’) for the new use (extension of species) of an additive consisting of 6-phytase produced by Trichoderma reesei (Quantum® Blue) under the category ‘zootechnical’, functional group ‘digestibility enhancer’. The additive is proposed to be used in feed for fin fish at a minimum recommended enzyme activity of 500 FTU/kg feed and at a recommended level ranging between 500 – 2,500 FTU/kg complete feed. To support the 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 identified and characterised, and that it is stable at room temperature for 12 months and in animal feed for 2 months. The ACAF concluded that the additive is safe for the target animals, the consumers, and the environment. The additive is not irritant to skin or eyes but should be treated as a potential respiratory sensitiser. The additive is not a skin-sensitiser. The ACAF concluded that Quantum® Blue is efficacious in salmonids at an inclusion of 2,500 FTU/kg; however, they could not conclude on efficacy in other species of fin fish at a lower inclusion of 500 FTU/kg. Regarding species of fin fish other than salmonids, the Committee concluded that the additive has the potential to be efficacious at levels of 2,500 FTU/kg of Quantum® Blue. The views of ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.