EFSA Evaluates Paecilomyces variotii Biomass as a Novel Food Ingredient

EniferBio Oy has submitted an application for the authorization of a novel food ingredient: the dry biomass of *Paecilomyces variotii* KCL-24. This non-genetically modified fungal biomass is produced through controlled fermentation, resulting in non-viable cells that are dried and milled. Comprehensive analyses confirm its consistent composition, primarily comprising protein and dietary fiber, with no safety concerns regarding chemical or microbiological contaminants. Historically used as a feed ingredient, *P. variotii* KCL-24 has demonstrated safety in numerous feeding trials, including a three-generation study on pigs. The novel food is intended for incorporation into various products such as baked goods, cereals, dairy substitutes, and meat and fish analogs, targeting the general population. Nutritional assessments indicate it is not disadvantageous to consumers, lacking antinutritional factors and posing no risk of excessive nutrient intake. Genotoxicity tests, including the Ames test and mammalian cell micronucleus test, showed no genotoxic effects. Allergenicity assessments, based on literature reviews and genomic analyses, suggest minimal allergenic potential. Overall, the dry biomass of *P. variotii* KCL-24 is considered safe under the proposed conditions of use.