EFSA Reevaluates Safety of Artificial Sweetener Acesulfame K, Raises Acceptable Daily Intake
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The European Food Safety Authority (EFSA) recently published the conclusions of its safety reevaluation of acesulfame potassium, also known as acesulfame K, and registered as additive E 950 in the EU.
EFSA raised the acceptable daily intake (ADI) for the chemical to 15 milligrams per kilogram of bodyweight per day (mg/kg BW/day), replacing the previous ADI of 9 mg/kg BW/day. The last time E 950 was reviewed in the EU was in 2000 by the Scientific Committee on Food (SCF). Additionally, the Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Joint Expert Committee on Food Additives (JECFA) conducted its most recent evaluation of acesulfame K 1991, at which point it set an ADI of 0–15 mg/kg BW/day.
The new ADI was based on the no observed adverse effect level (NOAEL) in rats of 1,500 mg/kg BW/day (3 percent acesulfame K in the diet), which was the highest dose tested.
EFSA also considered data gathered through a call for information, and a literature review of studies published between January 1999 and November 2024. The data comprised evidence from in vitro tests, toxicological studies in experimental animals, and interventional and epidemiological studies in humans. All data were integrated using a weight of evidence approach.
Based on the available data, EFSA concluded that, in the EU, the highest exposure estimate of E 950 was generally below the ADI for all population groups, indicating no safety concern.
However, EU limits for lead and mercury in E 950 were exceeded in commercial samples of the food additive. EFSA recommended lowering the maximum limits for lead and mercury in E 950.
Additionally, a limit value was reported for acetylacetamide—an organic impurity and degradation product of the food additive—in analyses of commercial samples of E 950. At present, no EU limit exists for acetylacetamide in acesulfame potassium. EFSA recommended amending EU specifications for E 950 to include a maximum limit of 1 mg/kg for acetylacetamide.
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EFSA also noted the potential presence of 5-chloro-acesulfame in E 950, an impurity that is lacking experimental data regarding its genotoxicity. Therefore, EFSA recommended specifying a maximum limit of 0.1 mg/kg for 5-chloro-acesulfame in E 950 or, alternatively, requesting appropriate genotoxicity data for 5-chloro-acesulfame.
The full scientific opinion on acesulfame K can be read here.
