Frequently Asked Questions "FAQs" on Stevia

General:

1) Is stevia approved for use in Canada?

In foods:

Stevia leaves (fresh, dried or powdered) without health claims CAN be sold in Canada to a consumer wishing to use this product for personal culinary use only.

Foods containing stevia leaves (fresh, dried or powdered) have not been accepted for sale in Canada.

Stevia extracts are not currently approved for use in foods sold in Canada.

In natural health products:

To date, Health Canada has approved the use of stevia and its extracts as a non-medicinal ingredient (sweetener) in 108 natural health products, and as a medicinal ingredient in three natural health products (NHPs).

Stevia in Foods:

2) Why are stevia extracts not approved as a sweetening ingredient for use in foods in Canada?

Non-nutritive sweetening agents such as stevia extracts are regulated under the Food and Drug Regulations as food additives. Food additives must undergo a full safety evaluation before they can be listed as an approved additive in Division 16 of the Regulations. Health Canada needs to be provided with sufficient safety information to support listing stevia extracts as approved additives in the Regulations.

3) What would it take for stevia extracts to be approved for use in Canada as sweetening ingredients?

The approval of the use of stevia extracts as food additives must be triggered by a petitioner, typically a member of the food industry, making a formal request to Health Canada's Food Directorate to permit its use in specified foods. The petitioner must provide all scientific data necessary to demonstrate the safety of their proposal, as outlined in section B.16.002, Division 16, Part B of the Regulations

To better understand these requirements, please visit Food Additives - Submission Preparation on the Health Canada website.

4) What is the current status of stevia extracts as food additives in Canada?

Stevia extracts are not currently permitted as food additives in Canada. However, Health Canada is prepared to examine any food additive submissions requesting such use provided the required information and data on safety in use has been provided.

Stevia in Natural Health Products:

5) What are the guidelines in Canada for the use of stevia and its extracts in natural health products?

The Natural Health Products Directorate (NHPD) of Health Canada has adopted new guidelines for the use of stevia and its extracts in natural health products. The new guidelines are based on Health Canada's review of international regulation and scientific evidence for their safety and efficacy.

NHPD's new guidelines are in accordance with the recommendations established by the Joint Expert Committee on Food Additives (JECFA) of the Food and Agriculture Organization and the World Health Organization in June, 2008.

As a non-medicinal ingredient:

As a sweetener or flavour enhancer, the quantity of stevia used should be in accordance with the conditions of the Good Manufacturing Practices and should not exceed 4 mg steviol/kg of body weight per day.

As a medicinal ingredient:

Natural health products containing stevia and its extracts as a medicinal ingredient in excess of 4 mg steviol/kg of body weight per day will have to provide evidence that the product is safe and effective, and will require cautionary statements for consumers who have high blood pressure, diabetes or are pregnant or breastfeeding.

6) What medicinal claims are allowed in Canada for stevia?

Health Canada does not have a list of pre-approved health claims specific to stevia.

Manufacturers/importers wishing to market a stevia product with a specific health claim must supply the necessary evidence/data demonstrating the safety and efficacy of that claim. Health Canada will assess any and all evidence provided to determine whether the claim is valid or not.

7) What health claims were made for the three approved stevia-containing natural health products?

Of the three approved stevia-containing NHPs, two were authorized with the claim of "maintaining good health," while the third was authorized for "the promotion of bowel movement."

None of the three approved products are single ingredient stevia products. Rather, they are all multi-ingredient products of which stevia is but one or many medicinal ingredients.

Stevia in Food vs. Stevia in Natural Health Products:

8) Why has stevia been approved as a sweetener in 108 natural health products, but has not been authorized for use as a sweetening ingredient in food?

Non-nutritive sweetening agents such as stevia extracts which are intended for use in foods are regulated as food additives under the Food and Drug Regulations. As such, they are subject to regulatory requirements which are different from those specific to natural health products. Stevia leaves (fresh, dried or powdered) are not regulated as food additives but are considered ingredients. However, Health Canada has not been in a position to provide an opinion on the safety of foods containing stevia leaves. Foods are consumed ad libitum, in other words at an individual's own discretion. Health Canada needs to be provided with sufficient toxicological data to support the safety of stevia extracts used in food products.

Because food and natural health products have different patterns of use, it is possible for a substance to be approved for use in therapeutic products such as natural health products but not for more widespread use that would be typical in foods. The nature of the product and how it would be used by consumers has an impact on exposure, and therefore can affect the risk assessment conducted for a substance.