Saccharin is a non-nutritive sweetener that is used in products in many countries. It has not been allowed in Canada as a food additive since the 1970s.
In the 1970s, studies raised concerns that saccharin could be carcinogenic in laboratory rats. On this basis, saccharin was de-listed as a food additive in Canada, although restricted access to saccharin as a table-top sweetener was maintained.
More recent studies have revealed that the carcinogenic effect of saccharin in rats is not relevant to humans.
Internationally, after a complete evaluation of this more recent data, the International Agency for Research on Cancer (IARC) has concluded that saccharin can no longer be considered a "possible carcinogen in humans." In May 2000, the U.S. National Toxicology Program also removed saccharin from its list of suspected cancer-causing chemicals.
In addition, the Joint Expert Committee on Food Additives of the World Health Organization and the Food and Agriculture Organization of the United Nations (JECFA) has established an acceptable daily intake level for saccharin, as has the European Union Scientific Committee on Food.
As a result of food industry requests to use saccharin in foods sold in Canada, Health Canada has completed an exhaustive evaluation of sodium saccharin toxicological data. The evaluation concluded that results of the previous studies on rats are not applicable to humans. This is in accord with the conclusions of other regulatory agencies world-wide.
In 2006, a letter was sent to stakeholders informing them of the results of Health Canada's evaluation and the intention to propose regulatory changes to allow saccharin to be used as a food additive.
Health Canada sets national standards and regulations for food safety based on the latest scientific information available. The department regularly reviews new information as it becomes available to ensure that its policies, standards and regulations are up to date and effective in protecting the health of Canadians.
In Canada, food additives such as saccharin are subjected to rigorous controls under the Food and Drugs Act and Regulations. Before any food additive is permitted for use, manufacturers are required to file a food additive submission. A submission must contain detailed information, including the results of safety tests, as well as information on the usefulness and potential benefits to the consumer of the additive in question.
Before Health Canada formally proposes to permit broader use of saccharin in Canada, a regulatory amendment must be developed. Stakeholders and the public will have an opportunity to comment on the proposed relisting of saccharin once a proposed regulatory amendment is published in the Canada Gazette, Part I.
If saccharin is relisted as an approved food additive, commercial products will have to include saccharin in their ingredient list. This will allow consumers to make informed choices about the products they consume