*Geek Box: Artificial Sweeteners Regulatory Framework

*Geek Box: Artificial Sweeteners Regulatory Framework

The main artificial sweeteners [AS] currently in use are aspartame, acesulfame-K, saccharin, and sucralose. Each compound is structurally unique, meaning the individual compounds all vary in sweetness potency, duration of sweetness, aftertaste, and mouth feel.

These are approved for use in the European Union [EU] through the European Food Standards Agency [EFSA] and in the U.S. by the Food and Drug Administration [FDA], through a process involving submission of both scientific safety evaluation and technical data.

‘Technical data’ includes the chemical composition of the compound, its source and manufacturing methods, its stability across a range of food matrices, and its sensory properties. ‘Safety data’ includes the full range of studies on safety, derived from animal toxicology studies, and includes the anticipated daily intake in the population from all dietary sources, within different ages groups.

The animal toxicology studies have specific criteria for the design and type of the studies required based on a system of “Concern Levels”; due to their potential high exposure in the population, AS are considered a “high concern” level. Thus, the animal studies [rodents mostly] must assess both absolute toxicity thresholds and also sub-chronic long-term toxicity for potential effects on reproduction, development, carcinogenicity, genotoxicity, and immunotoxicity.

These studies are used to establish the “No Observable Adverse Effect Level” [NOAEL]; the Acceptable Daily Intake [ADI] is then established by dividing the NOAEL by an “uncertainty factor” of 100. The potential health impacts from exposure to the compound in the food supply is assessed by combining data on anticipated intake on the concentrations of the AS anticipated for use in food and beverages together with the quantity of those foods/drinks typically consumed. The requirement for this calculation is to combine the maximum permitted level of the compound in foods together with the maximum level of consumption of food/drink. Thus, these processes are highly conservative assessments, particularly for children and the elderly.