Sucralose non-carcinogenicity: A review of the scientific and regulatory rationale

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Author(s): Colin Berry, David Brusick, Samuel M. Cohen, Jerry F. Hardisty, V. Lee Grotz & Gary M. Williams
Publication name: Nutrition and Cancer 2016; DOI: 10.1080/01635581.2016.1224366
Publication year: 2016


Regulatory authorities worldwide have found the nonnutritive sweetener, sucralose, to be noncarcinogenic, based on a range of studies. A review of these and other studies found through a comprehensive search of electronic databases, using appropriate key terms, was conducted and results of that review are reported here. An overview of the types of studies relied upon by regulatory agencies to assess carcinogenicity potential is also provided as context. Physiochemical and pharmacokinetic/toxicokinetic studies confirm stability under conditions of use and reveal no metabolites of carcinogenic potential. In vitro and in vivo assays reveal no confirmed genotoxic activity. Long-term carcinogenicity studies in animal models provide no evidence of carcinogenic potential for sucralose. In studies in healthy adults, sucralose was well-tolerated and without evidence of toxicity or other changes that might suggest a potential for carcinogenic effects. In summary, sucralose does not demonstrate carcinogenic activity even when exposure levels are several orders of magnitude greater than the range of anticipated daily ingestion levels.


This comprehensive systematic review examined all the available evidence and studies testing the safety and carcinogenicity of sucralose and confirmed that the sweetener is safe to consume and does not cause cancer. Sucralose does not demonstrate carcinogenic activity even when exposure levels are several orders of magnitude greater that the range of anticipated daily ingestion levels. Reviewing the scientific literature in this area through a systematic search of the available studies, including both independently conducted and industry-supported research on sucralose safety, the authors concluded that:

  • There is no evidence of chemical concerns or toxicity;
  • No metabolites in sucralose were found to be carcinogenic;
  • No changes to genes were observed to indicate cancer-causing effects;
  • At doses thousands of times the maximum expected daily intake in humans, toxicity and long-term carcinogenicity studies “showed no evidence of sucralose having carcinogenic potential”.

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