Scientific Opinion on the safety of advantame for the proposed uses as a food additive

Abstract

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

Comprehensive Assessment of Functional Effects of Commonly Used Sugar Substitute Sweeteners on Ex Vivo Human Gut Microbiome

“…For sweeteners without defined ADI, in the case of all sugar alcohols the concentration used was standardized to 2 mg/mL, which would represent consumption levels lower than those in the general public ( 34 – 36 ). Since the cADI of advantame exceeded its solubility and the ADI would represent a consumption level much higher than that in the general public ( 37 ), advantame was tested at 2 mg/mL, about one-fifth of the cADI. In addition, aspartame (ASP), THA, and salt of aspartame-acesulfame (SAA) are known to be completely metabolized before reaching the colon ( 38 , 39 ), resulting in cADI values of 0.…”

Alternative søtningsmidler: Egenskaper, bruksområder, sikkerhetsaspekter og helseeffekter – Del 2: Intense søtstoff

“…De dipeptidbaserte søtstoffene er svakt løselige i vann og svaert lite løselige i etanol (16,17,23,24). Saltet av aspartam-acesulfam er mer løselig i vann enn aspartam alene (17).…”

“…Bruksområdet for disse søtstoffene er meget bredt, og de tilsettes de aller fleste typer naeringsmidler og produkter hvor intense søtstoff anvendes (tabell 3). I løsning varierer dipeptidenes stabilitet med temperatur og pH (16,17,23,24). Aspartam er mest stabilt ved lave temperaturer og pH ca.…”

Research of Rational Concentration of Oilseed Crops Meals in the Sandy Dough Semi-Finished Product

“…There are distinguished flax, sesame, walnut, sunflower meals. Their use provides the daily need of the organism in proteins, mineral substances and macro-and microelements [6,7].…”