Safety and efficacy of fumonisin esterase (FUMzyme®) as a technological feed additive for all avian species
FUMzyme® is an enzyme-based feed additive intended to degrade fumonisin mycotoxins found as contaminants in feeds for avian species. It is produced from a genetically modified strain of Komagataella pastoris. The additive is already authorised for use with pigs. During the course of this assessment, it was shown that the production strain and its recombinant genes are not present in the final product. Safety for the consumer, the user and the environment were also established. The extension of its use to all avian species is not expected to alter these conclusions. Chickens and turkeys for fattening and laying hens showed no adverse effect when given feed containing 100 times the maximum recommended dose. Consequently, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the additive is safe for poultry when used within the dose range proposed (15–300 U/kg feed) and extends this conclusion to all other avian species. Five shortterm feeding studies were made in which poultry were given feed contaminated with fumonisins with or without the additive. Each included a measure of the concentration of fumonisin B1 and its breakdown products and showed that the enzyme was able to significantly reduce the concentration of fumonisin in faeces and various points in the digestive tract and increase the concentration of the degradation products. In addition, ratio of sphinganine/sphingosine, considered the most sensitive endpoint for fumonisin toxicosis, was significantly reduced by the addition of FUMzyme® at the minimum proposed dose, when added to diets contaminated with fumonisins. FUMzyme® has the capacity to degrade fumonisins in feed, at concentrations below the Guidance limits operating in the EU in chickens and turkeys for fattening and laying hens at the minimum recommended dose of 15 U/kg complete feed. This conclusion can be extrapolated to all avian species.