Safety and efficacy of a feed additive consisting of fumonisin esterase produced with Komagataella phaffiiNCAIM (P) Y001485 for all terrestrial species (Dr. Bata Ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of fumonisin esterase produced with the genetically modified strain Komagataella phaffii NCAIM (P) Y001485 as a technological feed additive (functional group: substances for reduction of the contamination of feed by mycotoxins) for all terrestrial species. Based on the data provided by the applicant in this and previous applications, the FEEDAP Panel concluded that the additive does not pose any safety concern regarding the genetically modified production strain, is safe for all terrestrial species at 360 U/kg complete feed, and its use in animal nutrition is of no concern for consumers or the environment. The additive is not irritant to skin or eyes. Due to the proteinaceous nature of the additive and the fact that the carrier is an inactivated microorganism, the additive is considered a dermal and respiratory sensitiser. Exposure by any route is considered a risk. The additive has the potential to be efficacious in all terrestrial species when added to feed at the proposed conditions of use.