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. 2018 Aug 8;104(3):446–457. doi: 10.1002/cpt.1132

Table 1.

Comparison between significant history of use and traditional use

Significant history of use Traditional use
A concept used to describe the qualified presumption of safety, where there is evidence for safety from compositional data and from experience as an ongoing part of the diet (and possibly from other relevant routes of exposure) for a number of generations in a large, genetically diverse population. Is based upon knowledge and experience in a population/culture but may have limited scientific documentation.
Includes a scientific evaluation of the information, which should include conclusions about safe use. Traditional use in this regard may provide information on acute toxicity but it is unlikely to provide information on chronic toxicity and those effects that are delayed and, thus, less likely to be detected, such as cancer, developmental toxicity (including teratogenicity) and reproductive toxicity.
A description of history of use covers the use in different defined geographic areas with information on intake levels, intake patterns, years of use, preparation, handling methods, and impact on human health as well as addressing any potential adverse effect issues. Information from traditional use will be influenced by the general health of the particular population and the available health care and health monitoring facilities.