Toxicological evaluation of a recombinant inulosucrase (Convero®) produced by precision fermentation: In vitro genotoxicity studies and 28-day oral toxicity study in rats.

Convero® is an inulosucrase powder preparation produced via precision fermentation using a genetically modified strain of Komagataella phaffii as the production organism. It is intended for use in food applications due to its ability to catalyse the conversion of sucrose into inulin-type fructooligosaccharides. To support the safety of Convero®, a bacterial reverse mutation assay, an in vitro micronucleus assay in mammalian cells, and a 28-day repeated-dose oral toxicity study were performed. All experimental procedures were performed in compliance with Good Laboratory Practice (GLP) and adhered to the Organisation for Economic Co-operation and Development (OECD) test guidelines for chemicals. No evidence of mutagenicity, aneugenicity or clastogenicity was detected. No evidence of oral toxicity was observed and no treatment-related adverse effects were observed in the 28-day repeated-dose oral toxicity study in rats at doses up to 2000 mg TOS/kg bw/day, the highest dose tested. Isolated minor, non-adverse changes in clinical pathology, urinalysis, and organ weights were considered incidental and within physiological variability. Overall, the combined in vitro and in vivo data indicate no toxicologically relevant effects of Convero® under the conditions tested.