Summary of Input Received on Health Canada-s Consultation to Reinstate Saccharin as a Food Additive


In November 2006, Health Canada sent a letter to stakeholders to inform them of the department’s intention to reinstate saccharin as a food additive after the completion of a safety evaluation by Health Canada’s scientists. Information on this proposal was also made available on Health Canada’s website in July 2007, providing the larger stakeholder community and the public with information supporting Health Canada’s evaluation of this food additive and it recommendation to reinstate its use in foods available for sale in Canada.

Further Information

Summary of Stakeholder Input

Health Canada received input from several stakeholders representing the food industry and professional organizations including:

  • Refreshments Canada
  • Centre for Science in the Public Interest (CSPI)
  • Canadian Diabetes Association (CDA)
  • Dietitians of Canada (DC)
  • International Chewing Gum Association (ICGA)
  • Calorie Control Council
  • Pepsi Cola Company

Most stakeholders expressed their support to Health Canada’s recommendation to reinstate saccharin as a food additive. Supportive stakeholders included the Canadian Diabetes Association, Dietitians of Canada, Refreshments Canada, Calorie Council of Canada, Pepsi Cola Company, and the International Chewing Gum Association.

Some stakeholders requested additional information on Health Canada’s evaluation, in particular the various studies used by Health Canada’s scientists to review the safety of saccharin. The Bureau of Chemical Safety in Health Canada’s Food Directorate provided these stakeholders with an extensive list of studies that had been reviewed during this assessment and the relevant references.

Some other stakeholders requested clarification pertaining to the use of saccharin during pregnancy and the labelling requirements associated with the use of this additive. Health Canada responded to these questions by providing an overview of the animal studies that were conducted to examine possible effects of saccharin on the fetus. These studies provided the scientific evidence to support the conclusion that saccharin can be safely consumed by humans, including pregnant and breastfeeding women. However, for nutritional reasons, Health Canada cautions pregnant women against excessive consumption of products containing artificial sweeteners since such foods could be replacing nutrient-dense, energy yielding foods.

In addition, the present labelling requirements for high intensity sweeteners as established in Division 1 of the Food and Drug Regulations were cited and it was stated that a similar labelling regime for saccharin would also be developed in Division 1 of the Food and Drug Regulations.

Conclusion and Next Steps

In view of the results of Health Canada’s evaluation concluding to the safe use of saccharin as a food additive in certain food commodities, and of the input received from stakeholders, Health Canada’s Food Directorate will proceed with the drafting of regulatory amendments to reinstate saccharin in Table IX, Division 16 of Part B of the Food and Drug Regulations as follows:

Table 1: Proposed Addition to Table IX, Section B.16.100
Item No. Column I Additive Column II Permitted in or Upon Column III Maximum Level of Use
S.1 Saccharin and its calcium, potassium and sodium salts (1) Breath freshener products (1) 1500 ppm, calculated as saccharin
    (2) Canned fruits, except those for standardized in this Part (2) 100 ppm, calculated as saccharin
    (3) Chewing gum (3) 2500 ppm, calculated as saccharin
    (4) Frozen desserts (4) 25 ppm, calculated as saccharin
    (5) Fruit, whipped or dessert toppings (5) 900 ppm, calculated as saccharin
    (6) Liqueurs, except those standardized in this Part (6) 1200 ppm, calculated as saccharin
    (7) Soft drinks (7) 300 ppm, calculated as saccharin
    (8) Jams, jellies and marmalades, except those standardized in this Part (8) 200 ppm, calculated as saccharin
    (9) Table-top sweeteners (9) Good Manufacturing Practice

In doing so, Health Canada’s Food Directorate would fulfill the department’s obligation under section B.16.003 of the Food and Drug Regulations to enable the use of this food additive given that the requirements set out in Section B.16.002 of the Food and Drug Regulations are met.

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