Safety Assessment on the Safety and Efficacy of a Feed Additive Containing Muramidase Produced by <i>T. Reesei</i> DSM 32338 for Its Use in Laying Hens (RP1499)

An application was submitted to the Food Standards Agency and Food Standards Scotland in March 2022 from DSM Nutritional Products (‘the applicant’) for the new use (extension of species) of an additive containing muramidase produced by Trichoderma reesei DSM 32338, under the category of ‘zootechnical additives’ and functional group ‘other zootechnical additives’. The additive is proposed to be used at a minimum inclusion rate of 30,000 LSU(F)/kg of complete feed (12% moisture) for laying hens. Under Assimilated Regulations (EU) No 2019/805 and No 2020/163, the additive is authorised for use in feed for chicken and minor poultry species for fattening, turkeys for fattening, and chickens, turkeys and other poultry species reared for breeding. In addition, the additive is authorised in the EU under the Commission Implementing Regulation No 2021/1431 for use in feed for weaned piglets. This application requested a new use (extension of species) in feed for laying hens. The FSA/FSS concluded that the additive was correctly identified and characterised as there were no changes from the previous assessment. No significant concerns were raised for the Identity, characterisation and condition of use section of the dossier. The additive can be considered safe for the target species (laying hens) up to a dose of 60,000 LSU(F)/kg of complete feed. The additive is safe for consumers and the environment. The active substances are presumed to be respiratory sensitisers due to their proteinaceous nature. The liquid formulation of the additive is not considered an irritant to the eyes or skin. The solid formulation of the additive is not an irritant to the skin but should be considered a potential eye irritant. Based on the three trials provided, the FSA/FSS concluded that muramidase has the potential to be efficacious as a zootechnical additive in laying hens when used at the minimum inclusion rate of 30,000 LSU(F)/kg complete feed.