Question

What are the safety aspects and toxicology of stevia?

ANSWER

Safety and Toxicology of Stevia

Stevia sweeteners are a natural, zero calorie source of sweetness. They are extracted from the sweetest part of the stevia plant and are composed of highly purified steviol glycosides.

In December 2008, the FDA stated it had no questions regarding the conclusion of an expert panel that steviol glycosides are generally recognized as safe (GRAS) for use as general purpose sweeteners. Prior for use as sweeteners, stevia was only permitted for use as a dietary supplement in the U.S. At present, stevia sweeteners can be found in many foods and beverages, including some juices and tea beverages, as well as some tabletop sweeteners (International Stevia Council, n.d.).

The term Stevia typically refers to a crude preparation (powder or liquid) of dried stevia leaves. It may contain a mixture of many substances, only some of which are sweet. Steviol glycosides can be isolated and purified from the leaves of the stevia plant and can be used to sweeten foods and beverages and used as tabletop sweeteners. Rebaudioside A is one of the steviol glycosides purified from the leaf of the stevia plant. Other steviol glycosides include stevioside, rebaudiosides B, C, D, F, steviolbioside, rubusoside, and dulcoside A (International Stevia Council, n.d.).

Applications

No. Application Maximum Level
1. Breakfast Cereal 350 mg/kg
2. Chewing Gum 3500 mg/kg
3. Confectionery 700 mg/kg
4. Dairy based dessert 330 mg/kg
5. Dietetic Formula 270 mg/kg
6. Food Supplement 2500 mg/kg
7. Seasoning and Condiments 30 mg/kg
8. Dairy Drink 200 mg/kg

(Codex Alimentarius Commission, 2014).

Regulations

FDA

In December 2008, the FDA stated it has no questions regarding the conclusion of expert panels that Rebaudioside A is Generally Recognized as Safe (GRAS) for use as a general purpose sweetener (International Stevia Council, n.d.).

Safety and toxicology

JECFA

JEFCA committee concluded that a ADI of 4 mg/kg bw expressed as steviol, based on a NOEL of 970 mg/kg bw per day from a long-term experimental study with stevioside (383 mg/kg bw per day expressed as steviol) and a safety factor of 100. The results of the new studies presented to the Committee showed no adverse effects of steviol glycosides when taken at doses of about 4 mg/kg bw per 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 (JECFA , 2008).

FSANZ

The risk assessments undertaken by FSANZ concluded that steviol glycosides are well-tolerated and unlikely to have adverse effects on blood pressure, blood glucose or other parameters in normal, hypotensive or diabetic subjects at doses up to 11 mg/kg bw/day (FDA, 2015).

Acceptable Daily Intake (ADI)

EFSA established an ADI for steviol glycosides, expressed as steviol equivalents of 4 mg per kg of body weight per day (the same ADI established by Joint FAO/WHO Expert Committee on Food Additives) (EFSA, 2015).

 

References

Codex Alimentarius Commission. (2014). Steviol glycosides.

EFSA. (2015). Scientific opinion on the safety of the extension of use of steviol glycosides (E960) as a food additive. EFSA Journal, 13(6), 4146. https://doi.org/10.2903/j.efsa.2015.4146

FDA. (2015). GRAS Notification for Purified steviol glycosides with rebaudioside A and stevioside as the principal components (GRN No. 287).

International Stevia Council. (n.d.). The new sweetener from natural origins…made from the leaves of the stevia plant. Brussels, Belgium: Author.

JECFA (Joint FAO/WHO Expert Committee on Food Additives). (2008). Safety evaluation of certain food additives.

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