Toxicological Evaluation of the Sweet Protein Brazzein Derived From Komagataella phaffii for Use as a Sweetener in Foods and Beverages

ABSTRACT Brazzein is a promising new protein sweetener that has gained significant attention by the food and beverage industry in recent years. Brazzein has a sweetness intensity significantly greater than that of other low‐ and no‐calorie sweeteners currently on the global market and can provide a comparable sweetness at lower use levels within food and beverage products. In this study, a safety assessment of the sweet protein brazzein, produced from the fermentation of Komagataella phaffii , was undertaken in an in vitro digestibility study, an in silico allergenicity assessment, an in vitro reverse mutation assay, an in vitro mammalian micronucleus assay, and a 90‐day oral toxicity study in rats. The results of the in silico and in vitro studies indicate that brazzein is not readily digestible, does not have allergenic potential, and does not have genotoxic or mutagenic potential. In the 90‐day toxicity study, brazzein was not associated with any adverse systemic effects at up to 2000 mg/kg body weight/day, the highest dose tested. The dose of 2000 mg/kg body weight/day was concluded to be the no observed adverse effect level. The findings from the current safety assessment demonstrate that brazzein is safe for use as a sweetener in foods and beverages for human consumption.