Lack of potential carcinogenicity for acesulfame potassium - Systematic evaluation and integration of mechanistic data into the totality of the evidence

Food Chem Toxicol. 2020 Jul:141:111375. doi: 10.1016/j.fct.2020.111375. Epub 2020 Apr 28.


The safety of low- and no-calorie sweeteners remains a topic of general interest. Substantial evidence exists demonstrating a lack of carcinogenicity of the no-calorie sweetener acesulfame potassium (Ace K). The objective of this evaluation was to conduct a systematic assessment of available mechanistic data using a framework that quantitatively integrates proposed key characteristics of carcinogens (KCCs) into the totality of the evidence. Over 800 KCC-relevant endpoints from a variety of in vitro and in vivo assays were assessed for quality, relevance, and activity, and integrated to determine the overall strength of the evidence for plausibility that Ace K acts through the KCC. Overall, there was a lack of activity across the KCCs (overall integrated score <0 and no "strong" categorization for evidence of activity) in which data were identified. Together with the absence of treatment-related tumor effects in rodent bioassays, these results support the conclusion that Ace K is unlikely to induce a carcinogenic response. This assessment employed a weight of the evidence analysis that includes the consideration of factors such as reliability, strength of the model system, activity, and dose in a complex and heterogeneous dataset, and the ultimate integration of multiple data streams in the cancer hazard evaluation.

Keywords: Ace K; Acesulfame potassium; Carcinogenicity; Key characteristic of carcinogens; Mechanisms; Sweetener.

Publication types

  • Systematic Review

MeSH terms

  • Animals
  • Carcinogenicity Tests
  • High-Throughput Screening Assays
  • Humans
  • Sweetening Agents / toxicity*
  • Thiazines / toxicity*


  • Sweetening Agents
  • Thiazines
  • acetosulfame