Safety evaluation of certain food additives - ipcs inchem

210 STEVIOL GLYCOSIDES (addendum)
Table 7. Predicted dietary exposures of steviol glycosides (expressed as
steviol equivalents) based on sweetener surveys
Population group Mean exposure
(mg/kg bw per day)
Non-diabetic adults 0.4 1.1
Diabetic adults 0.5 1.5
Non-diabetic children 0.8 1.7
Diabetic children 1.1 1.5
3.5 Summary of dietary exposures
High-percentile consumer
(mg/kg bw per day)
Table 8 contains a summary of the dietary exposures to steviol glycosides
evaluated or derived by the Committee at the sixty-third and present meetings. The
present Committee concurred with the conclusion of the sixty-third meeting that the
replacement estimates were highly conservative and that dietary exposure to steviol
glycosides (as steviol) would likely be 20–30% of these values (i.e. 1–2 mg/kg bw
per day). This range is consistent with the survey-derived estimates submitted to
the current meeting.
Table 8. Estimates of dietary exposure to steviol glycosides, expressed as
steviol
Estimate Exposure (mg/kg bw per day)
GEMS/Food (international per capita) 0.9–5
Japan (per capita disappearance) 0.04
Japan (per capita replacement estimate) 3
USA (per capita replacement estimate) 5.8
Diabetic adult (high-percentile estimate) 1.5
Diabetic child (high-percentile estimate) 1.5
Non-diabetic child (high-percentile estimate) 1.7
4. COMMENTS
4.1 Toxicological data
The toxicokinetic studies confirmed that intact stevioside and rebaudioside
A are poorly absorbed, but they are hydrolysed by the intestinal microflora to steviol,
which is well absorbed. After absorption, steviol is metabolized mainly to steviol
glucuronide, which is excreted in the urine of humans. In rats, steviol glucuronide
is excreted in the bile and deconjugated in the lower intestine, before elimination as
steviol in the faeces. Pharmacokinetic parameters indicate that systemic exposure