Background:
Non-nutritive consumption has been repeatedly evaluated for its possible cancerogenic and mutagenic activity in the humans as well as animal models. The safety of sucralose has been reviewed regularly by authoritative bodies like FAO, WHO within the ADI, even after their approval for their intended use in human consumption. Epidemiological studies in this area are limited in humans, especially in single use of sweeteners (eg. sucralose) but are more on overall exposure to low-calories sweeteners.
Objective:
The present study systematically identifies and integrated all available mechanistic data in context of carcinogenicity and mutagenicity for Sucralose alone.
Methodology:
Inclusion criteria: Studies that evaluated the relationship between sucralose and endpoints relevant to one or more of the KCCs (or lack there of), Animal cancer bioassays for sucralose, Human epidemiological studies of cancer outcomes and sucralose consumption.
Exclusion criteria: Studies that were not available in English, Studies that did not report original data (e.g., reviews), Studies in which exposure to sucralose was not differentiated (e.g., various sweeteners evaluated simultaneously)
Results:
The authoritative review of several studies in humans has concluded that sucralose is non-carcinogenic as the data were consistent with findings from animal cancer bioassays. The systematic assessment of the mechanistic data of the potential carcinogenicity of sucralose demonstrated a lack of any overall activity of sucralose across the characteristics of carcinogens (KCCs). In few instances, the activity across the KCCs was observed but the studies were accompanied by limitations in dosage, quality study design and heightened upon integration of the totality of the evidence.
Conclusions:
The study findings from this comprehensive and integrative evaluation of mechanistic data support prior conclusions that sucralose is unlikely to be carcinogenic in humans.
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