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QUALITY
Stevia Regulatory Environment

U.S. FDA Approves Stevia.

Worldwide there has been much movement across scientific bodies for the approval of the use of stevia in food and beverage applications as a new all natural sugar substitute. This positive movement has resulted in the removal of restrictions on the ingredient in many countries, which heretofore had only allowed stevia to be consumed as a dietary supplement or not at all. Today, many people around the world are able to enjoy the benefits of stevia as a healthy sweetening solution.

U.S. Food and Drug Administration

On December 17, 2008 the U.S. Food and Drug Administration (FDA) approved the use of high quality stevia extract in food and beverages. The decision was made after leading industry players Cargill in partnership with The Coca Cola Company and Pepsi in partnership with Merisant submitted applications for its approval for use in food and beverages as generally recognized as safe (GRAS).

 

In May of this year, Cargill, the world's leading agricultural and food products provider, published studies in the peer-reviewed scientific journal Food and Chemical Toxicology that established the safety of rebiana, a sweetener made with 97% Rebaudioside A, and sourced from stevia extract supplied by GLG. These studies were submitted to the FDA among a host of other scientific data that included years of in-depth study and clinical trials that supported the use of rebiana high grade stevia extract as a safe and healthy food ingredient. The studies were accompanied by an application for approval under GRAS status and were reviewed by the FDA extensively before it recently issued its letter of "No Objection" for rebiana's use in food and beverages.

Pepsi and Merisant also received a letter of no objection from the FDA.

 

FAO/WHO Joint Expert Committee on Food Additives (JECFA) Approval

In June of this year the Joint Expert Committee on Food Additives, administered jointly by the World Health Organization and the Food and Agricultural Organization of the United Nations, raised the Acceptable Daily Intake (ADI) level for stevia.

 

JECFA is an international scientific committee established in 1956 to evaluate food additives. Leading the global scientific community in research and in establishing the principles and guidelines of safety assessment for chemicals in food, the committee has evaluated more than 1500 food additives, approximately 40 contaminants and naturally occurring toxicants, and residues of approximately 90 veterinary drugs.

After over a decade of study, JECFA published approval of stevia stating that "95 percent steviol glycosides are safe for human use in the range of four milligrams per kilogram of body weight per day". This doubled the ADI level previously set by

JECFA from earlier studies.

 

These findings added to its previous releases in 2006 which established that "stevioside and rebaudioside A are not genotoxic in vitro or in vivo". JECFA has been instrumental in paving the way for the establishment of safe and healthy food additives for over 50 years.

 

 

Australia and New Zealand Approval

In July, the Australian and New Zealand food and safety regulatory body FSANZ also approved stevia for use in food and beverages as an ingredient. The approval was based on research and data published by JECFA as well as 10-year studies

conducted by the Plant Science Group at Central Queensland University and Australian Stevia Mills. The petition and subsequent approval of stevia are part of a movement towards the development of healthier products in the food and beverage industry which are driven by both consumer and regulatory demand.

 

Other Governments

In addition to governments such as Australia and New Zealand, announcements have been made for the allowance of stevia to be sold in Switzerland. Europe has traditionally been the most strict regulatory community for stevia but interest from industry players in the European region remains strong as the developments and studies published by JECFA are followed.

 

Currently, stevia is approved as a food additive in many countries such as China, Japan, Paraguay, Korea, Brazil, Israel and Malaysia. In Paraguay, it has been used for over 200 years to sweeten food and beverages. In other parts of the world, stevia is very widely used and even now accounts for over 40% of the sweetener market in Japan. Korea and Japan are currently the largest markets for stevia.

 

Summary of Regulatory History of Stevia and Stevia-Derived Sweeteners

 

Stevia derived-sweeteners are permitted as a food additive in South America and in several countries in Asia, including China, Japan, and Korea. As discussed more fully below, over the past few months, the subject sweeteners have received approvals in Australia, New Zealand, and Switzerland, and the US FDA has issued two “no objection letters” in response to the GRAS notifications filed on behalf of Reb A food uses.

 

In the US, steviol glycosides have been used as a dietary supplement since 1995 (Geuns, 2003).

 

The Food Standards Australia New Zealand (FSANZ) has completed evaluation of an application for use of steviol glycosides in foods and has recommended to the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) to amend the Australia New Zealand Food Standards Code to allow its use in food (FSANZ, 2008).

 

At the 69th  meeting, the temporary status of the AD1 was removed and the AD1 was raised to 0-4 mg/kg bw/day (on a steviol basis) as a result of the JECFA review of recently completed clinical studies with steviol glycosides (JECFA, 2008).

 

In August 2008, Switzerland’s Federal Office for Public Health cited the favorable actions of JECFA in issuing its approval for the use of stevia as a sweetener (Switzerland Office of Public Health, 2008).

 

EFSA’s Food Additives & Nutrient Sources (ANS) Finally As per EFSA Journal 2010;8(4):1537, European Food Safety Authority EFSA  gives Scientific Opinion on the safety of steviol glycosides for the proposed uses as a food additive.

 

The Panel establishes an ADI for steviol glycosides, expressed as steviol equivalents, of 4 mg/kg bw/day based on application of a 100-fold uncertainty factor to the NOAEL for stevioside of 2.5% in the diet, equal to 967 mg stevioside/kg bw/day (approximately 388 mg steviol equivalents/kg bw/day), from a 2-year carcinogenicity study in the rat.

 

Conservative estimates of steviol glycosides exposure both in adults and in children suggest that it is likely that the ADI would be exceeded at the maximum proposed use levels.

 

 

 

KEY APPROVALS:

 

69th report of the Joint FAO / WHO Expert Committee on Food Additives

Refer Point 3.1.8 of the index and notes published on page 50 to 55 , where

In conclusion

 

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.

 

After considering all the data on stability, degradation products, metabolism and toxicology, the Panel establishes an Acceptable Daily Intake (ADI) for steviol glycosides, expressed as steviol equivalents, of 4 mg/kg bw/day based on application of a 100-fold uncertainty factor to the NOAEL for stevioside of 967 mg stevioside/kg bw/day (corresponding to approximately 388 mg steviol equivalents/kg bw/day) from a 2-year carcinogenicity study in the rat.

 

Conservative estimates of steviol glycosides exposures both in adults and in children suggest that it is likely that the ADI would be exceeded at the maximum use levels.

 

 

European Food Safety Authority ( EFSA ) As per EFSA Journal 2010;8(4):1537

 

SCIENTIFIC OPINION:  Scientific Opinion on the safety of steviol glycosides for the uses as a food additive, FSA Panel on Food Additives and Nutrient Sources added to Food (ANS), Parma, Italy

 

CONCLUSIONS

There are extensive in vitro and in vivo animal studies and some human tolerance studies on the steviol glycosides rebaudioside A and stevioside and their metabolite steviol. After considering all the data available, the Panel concludes that steviol glycosides covered by the proposed specifications are not carcinogenic, genotoxic or associated with any reproductive/developmental toxicity. The Panel considers a carcinogenicity study with stevioside of high purity meeting the specifications proposed by the petitioners, as pivotal for the present evaluation. The NOAEL in this study was 2.5% stevioside in the diet, equal to 967 mg stevioside/kg bw/day (approximately 388 mg steviol equivalents/kg bw/day), the highest dose tested.

 

Studies in humans demonstrated that daily doses of the steviol glycosides up to 1000 mg/person/day, equivalent to 16.6 mg/kg bw/day for a 60 kg person (corresponding to approximately 330 mg steviol equivalents/person/day or to 5.5 mg steviol equivalents/kg bw/day) were well-tolerated by individuals with normal glucose metabolism or type-2 diabetes mellitus.

 

The Panel establishes an ADI for steviol glycosides, expressed as steviol equivalents, of 4 mg/kg bw/day based on application of a 100-fold uncertainty factor to the NOAEL for stevioside of 2.5% in the diet, equal to 967 mg stevioside/kg bw/day (approximately 388 mg steviol equivalents/kg bw/day), from a 2-year carcinogenicity study in the rat.

Conservative estimates of steviol glycosides exposure both in adults and in children suggest that it is likely that the ADI would be exceeded at the maximum proposed use levels.

 

 

 

Complete quality control, including qualitative and quantitative analysis, is performed at manufacturing facilities before the ingredients are released for distribution. Laboratories are equipped with HPLC, UV, GC and TLC systems in order to ensure the quality of our ingredients. Certificates of analysis are based on assay results from our own laboratories as well as third party certification. Ingredients are also screened for contaminants and even radiation levels, in order to ensure the safety, integrity and purity of our raw materials.

 

Certifications:

• Awarded GMP Certification

• ISO-9001:2000

• Kosher Certification

ISO-9001: 2000