Brussels, 01/08/2013 (Agence Europe) - Advantame (ANS 9801), a very powerful food sweetener derived from aspartame, does not raise concerns with regard to genotoxicity and carcinogenicity in humans as long as the acceptable daily intake (ADI) is not exceeded, states the European Food Safety Authority (EFSA) in a scientific opinion establishing the ADI published on 31 July.
Furthermore, although advantame is stable in normal storage conditions, it is unstable in acid drinks and foodstuffs that have undergone thermal treatment, and this must be duly taken into account. This is the second important lesson to be drawn from the opinion drafted by the EFSA scientific panel on food additives and nutrient sources added to food (ANS).
At the European Commission's request, EFSA was asked to provide a scientific opinion on the safety of advantame as a high-intensity sweetener. The final advantame product is described as having a minimum purity of 97% and sweetening power 37,000 times greater than sucrose.
After consideration of all the data on advantame and its metabolites and major and minor degradation products available for this evaluation, the EFSA panel concluded that there were insufficient data with which to establish an acceptable daily intake at 5 mg/kg/body weight. The ADI was established by application of a 100-fold uncertainty factor to the ADI of 500 mg/kg/bw established for maternal toxicity from the prenatal developmental toxicity study, carried out on laboratory rabbits.
In certain non-consecutive batches of the final product, experts noted that the levels of platinum and palladium, residues from the catalysts used in the catalytic hydrogenation process, could amount to 1.7 and 5.3 mg/kg respectively and therefore the panel recommends that limit values be fixed for these two residues.
The metabolism and toxicokinetics of advantame and ANS9801-acid which is its main metabolite, were studied in mice, rats, rabbits, dogs and humans. Advantame is rapidly but ill absorbed. The critical effects observed in the studies on animals were maternal toxicity (gastro-intestinal troubles) in the study on the toxicity on prenatal development carried out on rabbits. (AN/transl.jl)