Scientific Opinion on the safety and efficacy of fumonisin esterase (FUMzyme®) as a technological feed additive for pigs

FUMzyme® is an enzyme-based feed additive intended to degrade fumonisin mycotoxins found as contaminants in feeds for growing pigs. It is produced from a genetically modified strain of Komagataella pastoris. The viable production strain and its recombinant genes are not present in the final product. Piglets showed no adverse effect when given feed containing 15-times the maximum recommended dose. Consequently the FEEDAP Panel concludes that the additive is safe for pigs when used within the dose range proposed (15 – 300 units/kg feed). In studies with the additive, no evidence of mutagenicity or genotoxicity was detected and no evidence of toxicity found in a subchronic oral toxicity study. Metabolites of fumonisin B1 produced by the action of the active agent have a lower toxicity than the parent compound. Consequently use of the additive in feed for pigs is considered safe for consumers of pork products. The additive is non-irritant and is not a skin sensitiser but presents a hazard for respiratory sensitisation. The active substance of FUMzyme® is a protein and as such is largely degraded/inactivated during passage through the digestive tract of animals. In addition, any hydrolysis of fumonisins in the digestive tract would anticipate that which would occur naturally in soils. Therefore, no risks for the environment are expected. A number of short and long-term feeding studies were made in which pigs were given feed contaminated with fumonisins with or without the additive. Each included a measure of the ratio of sphinganine/sphingosine, considered the most sensitive endpoint for fumonisin toxicosis. This ratio was significantly reduced in piglets by the addition of FUMzyme® at the minimum proposed dose when added to diets contaminated with fuminosins above and below the guidance limits operating in the EU. Sphinganine/sphingosine values generally returned to those seen in animals fed corresponding diets free from fumonisins.