Safety Assessment of the Safety and Efficacy of an Additive Consisting of Endo-1,4-Beta-Xylanase (Produced by <i>Aspergillus Oryzae</i> DSM 33700) for All Poultry Species and All Pigs (Suidae) (DSM Nutritional Products Ltd). (RP1393)

An application was submitted to the Food Standards Agency in December 2021 from DSM nutritional products Ltd (‘the applicant’) for the renewal, extension of use and new use of an additive (RONOZYME® WX) containing endo-1,4-beta-xylanase (produced by Aspergillus oryzae DSM 33700), under the category ‘zootechnical’ additive, functional group ‘digestibility enhancer’. The applicant seeks renewal of the additive for use in poultry for fattening, piglets (weaned), pigs for fattening, lactating sows and laying hens, as well as an extension of use of the additive in all poultry species and all pigs (Suidae). In addition, the applicant seeks authorisation for the new use concerning use of an improved production strain, substituting strain A. oryzae DSM 26372 with A. oryzae DSM 33700. 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 fully identified and characterised. It was concluded that RONOZYME® WX (CT and L), manufactured with the A. oryzae DSM 33700 strain, did not raise any safety concerns regarding the genetic modification of the production strain. Members concluded positively on the stability and homogeneity of the additive. However, the pelleting stability for RONOZYME® WX (CT) was only tested for 20 seconds, and therefore this should be made clear on the label as some of the uses may require longer conditioning times. The additive is considered safe for the target species, the consumer and the environment. The additive RONOZYME® WX (CT and L) is not a skin irritant and RONOZYME® WX (L) is not an eye irritant. RONOZYME® WX (CT) is a potential eye irritant. No information on skin sensitisation was provided; therefore, the additive is regarded as a potential skin sensitiser. The additive should be classified as a respiratory sensitiser due to the proteinaceous nature of its active ingredient (enzyme). It was concluded that the additive is efficacious in all poultry species and in all pigs (Suidae) at a minimum recommended level of 100 Fungal Xylanase Units (FXU)/kg and 200 FXU/kg complete feed, respectively, with the exception to gestating sows, as no data was provided. The views of ACAF have been considered in the safety assessment, which represents the opinion of the FSA and FSS.