Consultation Document on Health Canada's Proposal to Enable the Use of Saccharin, Calcium Saccharin, Potassium Saccharin and Sodium Saccharin as Sweeteners in Various Unstandardized Foods

Notice of Proposal - Lists of Permitted Food Additives
October 7, 2013

Summary

Food additives are regulated in Canada under Marketing Authorizations (MAs) issued by the Minister of Health and the Food and Drug Regulations. Approved food additives and their permitted conditions of use are set out in the Lists of Permitted Food Additives that are incorporated by reference in the MAs. A petitioner can request that Health Canada approve a new additive or a new condition of use for an already approved food additive by filing a food additive submission with the Department's Food Directorate. Health Canada uses this premarket approval process to determine whether the scientific data support the safety of food additives when used under specified conditions in foods sold in Canada.

Health Canada received a food additive submission seeking approval for the use of saccharin as a sweetener in various unstandardized foods. Saccharin and its salts, specifically calcium saccharin, potassium saccharin and sodium saccharin are permitted for sale, as saccharin sweeteners, under specific conditions prescribed in Part E of the Food and Drug Regulations.  These conditions allow pharmacies to sell saccharin and its salts as sweeteners that can be used by consumers. Saccharin and its salts are currently not permitted for use as sweeteners in foods sold in Canada.

The results of Health Canada's evaluation of available scientific data support the safety of saccharin, calcium saccharin, potassium saccharin and sodium saccharin when used as described below. Therefore, it is the intention of Health Canada to modify the List of Permitted Sweeteners by adding the following entries to the list.

Health Canada's evaluation of the available scientific data also supports the safety of saccharin, calcium saccharin, potassium saccharin and sodium saccharin for use in table-top sweeteners. However, this particular use is not included in this proposal. Rather, Health Canada intends to propose to modify the List of Permitted Sweeteners and amend Part E of the Food and Drug Regulations in order to enable the use of saccharin, calcium saccharin, potassium saccharin and sodium saccharin as food additives in table-top sweeteners.

Rationale

Health Canada's Food Directorate has completed a pre-market safety assessment of saccharin, calcium saccharin, potassium saccharin and sodium saccharin when used as described above. The assessment focused on toxicological aspects of the proposal.

In 2007, Health Canada published an information document on the safety assessment of saccharin, calcium saccharin, potassium saccharin and sodium saccharin and the proposal to enable these food additives as sweeteners in various foods. This document, entitled Information Document on the Proposal to Reinstate Saccharin for Use as a Sweetener in Foods in Canada, is available on Health Canada's website and provides a summary of the evidence used by Health Canada in support of the proposal to reinstate saccharin as a sweetener in foods in Canada. No new scientific safety information has become available since that time that would alter the conclusions of the safety assessment.

As described in the Summary of Input Received on Health Canada's Consultation to Reinstate Saccharin as a Food Additive, Health Canada announced in late 2009 that the Department would proceed with drafting regulatory amendments to enable the use of saccharin as a food additive which would lead to additional consultation through publication in Canada Gazette, Part I.  Since that time, the regulatory framework for food additives has changed. Food additives are now enabled for use through the Lists of Permitted Food Additives, which are incorporated by reference using Marketing Authorizations. Modifications to the Lists of Permitted Food Additives are publically announced using notifications that are posted on Health Canada's website. More information in this regard is found in the Transition Guide: Understanding and Using the Lists of Permitted Food Additives.

Health Canada's information document on the proposal to reinstate saccharin included a proposal that would require the labeling of foods containing saccharin to follow a similar labelling regime, as set out in Division 1 of the Food and Drug Regulations, for certain other high intensity sweeteners including sucralose, acesulfame-potassium and neotame. This regime sets out additional labelling requirements, such as a requirement for the declaration of the sweetener's presence on the principal display panel. For saccharin, this requirement for additional labelling was being proposed for consistency. However, upon further consideration, it was determined that there is no health-based rationale to require this additional labelling for saccharin. Like all other food additives, saccharin will be required to be shown in the list of ingredients on pre-packaged foods.

Based on the results of the safety assessment, described in the 2007 information document available on Health Canada's website, and the fact that no new scientific safety information has become available that would alter the conclusions of the safety assessment, Health Canada considers that the data demonstrate the safety of saccharin, calcium saccharin, potassium saccharin and sodium saccharin as sweeteners under the requested conditions of use. The Department is therefore proposing to enable the use of saccharin as described in the above table.

Other Relevant Information

The Codex General Standard for Food Additives (GSFA) provides for the use of saccharin, calcium saccharin, potassium saccharin and sodium saccharin in numerous foods including: canned fruit (maximum level 200 p.p.m. or 0.02%); chewing gum (2500 p.p.m. or 0.25%); various types of desserts (100 p.p.m. or 0.01%); fruit toppings (200 p.p.m. or 0.02%); aromatized alcoholic beverages (80 p.p.m. or 0.008%); jams, jellies and marmalade (200 p.p.m. or 0.02%); and table-top sweeteners (GMP).

Implementation and Enforcement

The proposed changes will be effective the day on which they are published in the List of Permitted Sweeteners. This will be announced via a Notice of Modification which will be published on the Health Canada's Website.
 
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods.

Contact Information

For additional information or to submit comments related to this proposal, please contact:

Bureau of Chemical Safety, Food Directorate

If communicating by e-mail, please use the words "Saccharin Notification" in the subject line of your e-mail.  Health Canada is able to consider information received by December 20, 2013, 75 days from the date of this posting.