Joint FAO/WHO Expert Committee on Food Additives (JECFA)
2010 At its seventy-third meeting, JECFA concluded that rebaudioside D and rebaudioside F are not genotoxic. JECFA had previously noted that stevioside and rebaudioside A are not genotoxic in vitro or in vivo and that the genotoxicity of steviol and some of its oxidative derivatives in vitro is not expressed in vivo at its sixty-third meeting. In June 2010 JECFA added rebaudioside D and rebaudioside F to their list of non-genotoxic food additives.73rd Meeting Summary
2009 In a report titled, Safety evaluation of certain food additives (Food additives series 60), JECFA notes the results of the new studies presented to the Committee have shown no adverse effects of steviol glycosides when taken at doses of about 4 mg/kg bw/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 content.List of Substances Scheduled for Evaluation
2008 In its sixty-ninth meeting report titled, Evaluation of certain food additives, JECFA concluded that toxicokinetic studies confirmed intact stevioside and rebaudioside A are poorly absorbed, but they are hydrolyzed 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. The new studies in humans were designed to address the issues that the Committee raised at its sixty-third meeting concerning evidence to demonstrate that the putative pharmacological effects of steviol glycosides would not be found at the exposure levels resulting from the proposed use as a food additive. 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 so they established an ADI for steviol glycosides of 0– 4 mg/kg of bw/day expressed as steviol content.69th Meeting Summary
2004 At its sixty-third meeting, JECFA concluded that stevioside and rebaudioside A are not genotoxic in vitro or in vivo and that the genotoxicity of steviol and some of its oxidative derivatives in vitro is not expressed in vivo. The NOEL for stevioside was 970 mg/kg per bw/day in a long-term study evaluated by the Committee at its fifty-first meeting.63rd Meeting Summary