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Regulatory Issues

General situation
Sweeteners derived from stevia are permitted in food in South America and in several countries in Asia including China, Japan, and South Korea since many years. Steviol glycosides are used as a dietary supplement in the United States since 1995 and since 2008,high-purity steviol glycosides and high-purity Reb A compositions are permitted in food in the U.S. (Status GRAS)..
The European Food Safety Authority (EFSA) examined the safety information of steviol glycosides in light of JECFA’s findings published 2008 and in response to a request by the European Commission to deliver a scientific opinion on the safety of the steviol glycosides as a sweetener for use in several designated food categories.
Based on the assessment, steviol-glycosides are permitted in food by the end of 2011.
The Joint Expert Committee on Food Additives (JECFA) reviewed the safety of steviol glycosides for more than a decade. In 2000, JECFA published the original safety review on steviol glycosides, and JECFA established a temporary acceptable daily intake (ADI ) of 0-2 mg/kg body weight (bw)/day (calculated for steviol) at its 63rd meeting. JECFA continued its review and deliberations on the safety of steviol glycosides over the next few years, making the temporary status of the ADI permanent while raising the ADI to 0–4 mg/kg bw/day (calculated for steviol) following JECFA’s favorable review of additional clinical studies on steviol glycosides. In 2009, JECFA published a final monograph addendum on steviol glycosides. In early 2009, a number of interested parties-including the Australian government-submitted a request to the Codex Committee on Food Additives in which they proposed that the JECFA specifications for steviol glycosides should be expanded beyond the initial seven named steviol glycosides to include Reb D and Reb
F. This proposed modification was endorsed by the Codex Alimentarius Committee, and JECFA approved the modified steviol glycosides specifications with inclusion of Reb D and Reb F as part of the steviol-glycosides.. Original document (Refer to appendix 1): Compendium of food additive specifications, Joint FAO/WHO Expert Committee on Food Additives,73rd Meeting 2010
On December 17th, 2008 the U.S. Food and Drug Administration (FDA) sent a “No Objection Letter” to Merisant’s Whole Earth Sweetener company and to Cargill, Inc., responding to their long awaited request to market a highly purified form of stevia sweetener known as Reb A. This letter means FDA has given the green light for Reb A, the sweetener made from the stevia leaf, to be used in food and beverages - opening the flood gates for new product launches.
Reb A with a purity of 95% or was included into the Food Chemical Codex (FCC) with a monograph in March 2009. Reb A is used as a food ingredient in a variety of food products in the United States, such as cereals and energy bars, and beverages such as diet soft drinks, fruit juice drinks, and iced teas at levels consistent with the ADI of 0-4 mg/kg body weight/day (as steviol equivalents) established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) for steviol glycosides (WHO, 2008). In US, it can be labeled as “Stevia extract” or “Reb A (stevia extract)” or “Stevia extract (Stevia rebaudiana)” ,” Stevia Leaf Extract” or similar style.
The European Union (EU) Commission published a final approval to authorize the use of steviol glycosides in food and beverages. The corresponding regulation permitting the sale and use of steviol glycosides had been published in the Official Journal of the European Union as of Nov. 12th, 2011. The regulation came into force on Dec. 2nd, 2011.
As of today, the legislation for steviol-glycosides consists of 2 documents specifying the conditions of use and the product specifications (refer to 3.6). The EU commission is obliged to monitor the development and will publish a post-marketing surveillance report not earlier than end of 2014. This date is therefore the earliest time-point for a potential amendment of the regulation (in terms of application categories and maximum allowed limits).

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