Italia
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.
