Advantame

Summary

Abstract

The Food Safety Commission of Japan (FSCJ) conducted a risk assessment of advantame (CAS number: 714229-20-6), a food additive used as a sweetener, based on results from various studies. FSCJ concluded that advantame and its degraded-products are of no concern in terms of their genotoxicity. In a prenatal developmental toxicity study in rabbits, dams administered advantame exhibited digestive disorders accompanied by deterioration of general conditions at doses of 1,000 mg/kg body weight/day or higher. FSCJ considered this effect attributable to the administration of advantame, and regarded 500 mg/kg body weight/day (a dose lower than that causing the above-mentioned effect) as the lowest no-observed-adverse-effect level (NOAEL) of advantame. In addition, advantame showed no carcinogenicity. Taking the observed toxicological effects and the estimated intake of advantame (3.57 mg/person/day (0.0714 mg/kg body weight/day)) after its approval in Japan into account, FSCJ considered that it is necessary to specify an acceptable daily intake (ADI) for advantame. FSCJ specified the ADI of 5.0 mg/kg body weight/day, based on the NOAEL in the prenatal developmental toxicity study in rabbits (500 mg/kg body weight/day) and applying a safety factor of 100.