Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii DSM 33574 (Xylamax) for chickens and turkeys for fattening, chickens reared for laying/breeding, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay (BioResource international, Inc.)

Abstract

Following a request from the European Commission, the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the product containing endo‐1,4‐β‐xylanase produced by Komagataella phaffii DSM 33574 (Xylamax) as a zootechnical additive in chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay. The production strain is genetically modified. No viable cells nor recombinant DNA of the production strain were detected in the final product. Therefore, the Panel concluded that the additive does not pose any safety concern regarding the production strain. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats, the Panel concluded that Xylamax is safe for all poultry species for fattening or reared to the point of lay. Considering the production strain and the results obtained in the genotoxicity studies, the Panel concluded that the additive is safe for the consumers. The Panel also concluded that Xylamax is not irritant to the skin but should be considered a potential eye irritant and a respiratory sensitiser. No conclusions could be drawn on the potential of the additive to cause skin sensitisation. The use of the product as a feed additive is of no concern for the environment. The FEEDAP Panel concluded that the additive has the potential to be efficacious at 10,000 XU/kg feed in chickens for fattening. This conclusion was extended/extrapolated to chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay.

Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii DSM 33574, and viable spores of Bacillus velezensis DSM 21836 and Bacillus licheniformis ATCC 53757 (EnzaPro) for chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and growing minor poultry species (BioResource International (BRI), Inc.)

“…The identity of the production strain and the characterisation of its genetic modification were established in a previous assessment (EFSA FEEDAP Panel, 2022 ). ■■■■■…”

“…16 ■■■■■. The manufacturing process of the xylanase is the same as the one assessed in a previous assessment (EFSA FEEDAP Panel, 2022 ).…”

“…The production strain of the xylanase present in the product belongs to K. phaffii , a species considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment when used for enzyme production (EFSA BIOHAZ Panel, 2007 ; EFSA BIOHAZ Panel, 2020 ). The safety aspects of its genetic modification were evaluated in a previous assessment (EFSA FEEDAP Panel, 2022 ). In the context of the current assessment, the applicant provided data excluding the presence of viable cells and recombinant DNA of K. phaffii DSM 33574 in EnzaPro final product.…”

“…The applicant submitted a bacterial reverse mutation test, 35 an in vitro mammalian micronucleus assay 36 and a sub‐chronic oral toxicity study 37 performed with the intermediate concentrate form of xylanase to support the safety of the xylanase contained in EnzaPro. Those studies were assessed in a previous opinion (EFSA FEEDAP Panel, 2022 ) and the results showed that the xylanase intermediate product used for the formulation of EnzaPro did not show any genotoxicity potential. Moreover, the results obtained in the sub‐chronic oral toxicity study raised no concerns regarding the product and allowed to derive a no observed adverse effect level (NOAEL) of 1,292,410 XU/kg body weight (bw) per day (highest dose tested).…”

“…EFSA issued an opinion on the safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by K. phaffii DSM 33574 for chickens and turkeys for fattening, chickens reared for laying/breeding, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay (EFSA FEEDAP Panel, 2022 ) and another opinion on the safety and efficacy of a preparation of B. licheniformis ATCC 53757 and its protease (Cibenza® EP150) as a feed additive for chickens for fattening, chickens reared for laying and minor avian species for fattening and to point of lay and ornamental birds (EFSA FEEDAP Panel, 2015 ).…”