It seems the outcry from the food industry and consumers to allow the use of stevia in food products in Canada is finally being heard by Health Canada. The public consultation period on a proposal by Health Canada’s Food Directorate to allow the use of steviol gylcosides as a food additive and as a sweetener in certain food categories has just recently closed (on October 14, 2012)1. This signals an important step towards the long awaited approval of the use of stevia in food products in Canada.
Stevia is a genus of species of the Asteraceae (sunflower) plant family. Commonly, the use of the name “stevia” refers to the particular species of plant, Stevia rebaudiana, which is widely grown for its sweet leaves. The concentrated and extracted steviol glycosides derived from the leaves of the plant Stevia rebaudiana can be used for the purpose of a sweetening agent. Steviol glycosides have a sweet taste with a slight bitter aftertaste, and are considered to be approximately 200 to 300 times the sweetness of sucrose.
Stevia, along with its extracts, are currently allowed in natural health products (NHPs) in Canada for use both as non-medicinal and medicinal ingredients (if used in accordance with the Natural Health Products Directorate (NHPD) of Health Canada’s Revised Guidelines )2. These Guidelines are based on Health Canada’s review of international regulation and scientific evidence for their safety and efficacy. Further, stevia leaves without health claims can be sold in Canada to a consumer wishing to use this product for personal culinary use only3.
However, to date, we have yet to receive official approval from Health Canada for the use of stevia, or its extracts, in foods – arguably the more desirable market given that it is associated with enhancing taste, flavour and sweetness.
The dichotomy between the regulatory status of stevia in NHPs and foods in Canada has created a significant amount of confusion, and general unease, in the food and NHP industry. This is especially so for those wanting to import food products containing stevia that are compliant foods in many other jurisdictions, or for NHPs containing stevia that are being transitioned to the food regulatory scheme under the new “food-like NHP” transition.
For instance, stevia is approved for use in foods in a number of international jurisdictions, including Australia, European Union, and the United States. And, the Codex Committee of Food Additives (GSFA) now has provisions for the use steviol glycosides in a wide variety of food categories at various levels of use, and is considering new provisions for additional food categories4.
Health Canada has justified the lack of approval for use of stevia in foods up until this point on the following rationale:
“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.”
In addition, steviol glycosides’ proposed use as a sweetening agent in foods is considered by Health Canada to be a food additive function. In Canada, all food additives are regulated and subject to rigorous controls under the Food and Drugs Act and the Food and Drug Regulations (FDR). Before a new food additive can legally be used, Health Canada requires a thorough safety evaluation of the proposed use(s) of the additive.
But, there is good news on the horizon.
Several food additive petitions were put forward from industry to Health Canada to approve the use of steviol glycosides in foods. Health Canada’s evaluation of the submissions it received focused on safety and efficacy, a chemical assessment, and a nutritional assessment based on proposed uses and typical food consumption patterns.
Following this review, on July 31, 2012 the Information and Consultation Document on Health Canada’s Proposal to Allow the Use of the Food Additive Steviol Glycosides as a Table-Top Sweetener and as a Sweetener in Certain Food Categories was released, indicating that Health Canada determined “there are no health or safety concerns associated with the use of [stevia] in the prescribed applications”, and proposed the approval of use of certain stevia extracts as a table-top sweetener and as a sweetener in certain food categories.
The Health Canada proposal suggests a wide variety of food categories where steviol glycosides will be approved for use as a food additive. They include:
Following this public consultation, Health Canada intends to review and summarize the commentary received from all stakeholders during the consultation period.
In order to continue along with the proposed action to allow the use of steviol glycosides, Health Canada is awaiting approval of Bill C-38 regarding amendments to the FDA for food. Under the proposed changes to the FDA for food, there are two targeted changes that are important for this process: 1. The first is a new authority called a Marketing Authorization (MA). This allows the Minister of Health to act on certain safety decisions such as permitting the use of specific substances in food (like food additives), and set specific conditions of these approvals.
2. The second change is to allow broader referencing of public documents as part of regulations – termed “incorporation by reference”5.
It has been communicated by the Food Directorate that once these new authorities are set in place, steviol glycosides will be the first food additive through the door utilizing the new MA and “incorporation by reference” procedure. This will allow the use of steviol glycosides as a food additive in Canada – finally!
Health Canada has mentioned (but not committed to) the approval of steviol glycosides through this new MA tool before the end of year.
So, as the plethora of uses of stevia in food products in other jurisdictions grow, industry stakeholders in Canada anxiously await the next step in the stevia approval process.
If you are looking to market your stevia containing food in Canada and want to know more, our team of experts can assist you with up to date regulatory information and advice about the compliant use of stevia in foods and the status of Health Canada’s approval process. If you have any questions, please contact us. We can be reached at 1-866-647-3279 or info@dicentra.com
References: