The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the safety of advantame as a sweetener for use in the food categories specified in the dossier. Advantame is stable under normal storage conditions. The Panel noted that there is an indication of advantame instability in acidic beverages and thermally treated foods. Metabolism and toxicokinetics of advantame and its main metabolite, ANS9801-acid, have been studied in mice, rats, rabbits, dogs and humans. Advantame is rapidly but poorly absorbed and the main excretion route is via faeces. The Panel concluded that advantame does not raised concern with regards to genotoxicity and carcinogenicity. The critical effect observed in animal studies was maternal toxicity (gastrointestinal disturbances) in the prenatal developmental toxicity study in rabbits. The NOAEL for this effect was 500 mg advantame/kg bw/day. Advantame was well tolerated in single or repeated doses up to 0.5 mg/kg bw/day by normo-glycemic or diabetic subjects. The Panel established an ADI of 5 mg/kg bw/day based on the application of a 100-fold uncertainty factor to the NOAEL of 500 mg/kg bw/day for maternal toxicity from the prenatal developmental toxicity study in the rabbit. Conservative estimates of advantame exposure for high level adults and children consumers were below the ADI for the proposed use levels.
After considering all the data on stability, degradation products, toxicology and exposure, EFSA ANS Panel concludes that advantame and its metabolites pose no safety concern for consumers at the proposed uses and use levels as a sweetener.
Advantame is a derivative of aspartame reported to be approximately 37 000 times sweeter than sucrose and could be used in very small quantities in food and beverages. After considering all the available data, the Panel concluded that advantame does not raise concern with regards to genotoxicity and carcinogenicity, and established an ADI of 5 mg/kg bw/day. Conservative estimates of advantame exposure for high level adults and children consumers were below the ADI for the proposed use levels.