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http://whqlibdoc.who.int/trs/WHO_TRS_928.pdf
See this link for the full report. The Committee 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 970mg/kgbw per day in a long-term study evaluated by the Committee at its fifty-first meeting. The Committee noted that stevioside has shown some evidence of pharmacological effects in patients with hypertension or with type-2 diabetes at doses corresponding to about 12.5–25mg/kgbw per day (equivalent to 5–10mg/kgbw per day expressed as steviol). The evidence available at present was inadequate to assess whether these pharmacological effects would also occur at lower levels of dietary exposure, which could lead to adverse effects in some individuals (e.g. those with hypotension or diabetes). The Committee therefore decided to allocate a temporary ADI, pending submission of further data on the pharmacological effects of steviol glycosides in humans. A temporary ADI of 0–2mg/kgbw was established for steviol glycosides, expressed as steviol, on the basis of the NOEL for stevioside of 970mg/kgbw per day (or 383mg/kgbw per day, expressed as steviol) in the 2-year study in rats and a safety factor of 200. This safety factor incorporates a factor of 100 for inter- and intra-species differences and an additional factor of 2 because of the need for further information. The Committee noted that this temporary ADI only applies to products complying with the specifications. The Committee required additional information, to be provided by 2007, on the pharmacological effects of steviol glycosides in humans. These studies should involve repeated exposure to dietary and therapeutic doses, in normotensive and hypotensive individuals and in insulin-dependent and insulin-independent diabetics.
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Dr. Seetharam Annadana, STEVIA FORUM MODERATOR ASR HERBALS 71/2, 21st A main, Marenahalli, JP Nagar II Phase, Bangalore 78 PH: 080-26493204, Mobile: 9845006451 FAX: 080-26651157 e-mail: stevier@asrherbals.com URL: www.asrherbals.com |
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