Safety evaluation of certain food additives - ipcs inchem

STEVIOL GLYCOSIDES (addendum) 213
shown some evidence of pharmacological effects in patients with hypertension or
with type 2 diabetes at doses corresponding to about 12.5–25.0 mg/kg bw per day
(5–10 mg/kg bw per day expressed as steviol).
The results of the new studies presented to the Committee at its present
meeting have shown no adverse effects of steviol glycosides when taken at doses
of about 4 mg/kg bw per day, expressed as steviol, for up to 16 weeks by individuals
with type 2 diabetes mellitus and individuals with normal or low-normal blood
pressure for 4 weeks. The Committee concluded that the new data were sufficient
to allow the additional safety factor of 2 and the temporary designation to be
removed and established an ADI for steviol glycosides of 0–4 mg/kg bw expressed
as steviol.
The Committee noted that some estimates of high-percentile dietary
exposure to steviol glycosides exceeded the ADI, particularly when assuming
complete replacement of caloric sweeteners with steviol glycosides, but recognized
that these estimates were highly conservative and that actual intakes were likely to
be within the ADI range.
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