Aspartame, a low-calorie artificial sweetener, has been permitted for use as a food additive in Canada since 1981 in a number of foods including soft drinks, desserts, breakfast cereals and chewing gum and is also available as a table-top sweetener. It is made by the bonding together of the amino acids aspartic acid and phenylalanine, which are normal constituents of proteins, to form a dipeptide which is further esterified with methanol.
In Canada, food additives such as aspartame 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 in accordance with Section B.16.002 of the Regulations. A submission must contain detailed information, including the results of safety tests, as well as information respecting the utility of the additive in question.
Before consideration was given to permitting aspartame for use in foods in Canada, officials of Health Canada evaluated an extensive array of toxicological tests in laboratory animals and, since its listing for use, they have examined the results of a number of clinical studies in humans. There is no evidence to suggest that the consumption of foods containing this sweetener, according to the provisions of the Food and Drug Regulations and as part of a well-balanced diet, would pose a health risk to consumers. In addition, other scientific advisory bodies such as the Scientific Committee for Food of the European Community, and the Joint Expert Committee on Food Additives (JECFA) of the United Nations Food and Agriculture Organization and World Health Organization have reviewed all the available safety studies and have found aspartame to be safe. More than ninety countries world-wide, including the United States Footnote 1, countries of the European Union Footnote 2, and Australia and New Zealand Footnote 3, have also reviewed aspartame and found it to be safe for human consumption and allow its use in various foods.
Although aspartame can be safely consumed by most healthy individuals, it has long been recognized that excessive intake of phenylalanine, one of the constituent amino acids of aspartame, can pose a hazard to individuals suffering from an inherited metabolic disorder called phenylketonuria. For this reason, all foods sweetened with aspartame have a statement in bold font at the end of the list of ingredients that aspartame contains phenylalanine.
An acceptable daily intake (ADI) of 40 milligrams/kilogram of body weight/day was established by Health Canada before aspartame was permitted for use as a food additive in Canada. An ADI is an estimate of the amount of a substance in food that can be consumed daily over a lifetime without presenting an appreciable risk to health. This ADI is recognized internationally and is the same as that established and recently re-affirmed by the Joint Expert Committee on Food Additives (JECFA) of the Food and Agriculture Organization/World Health Organization (FAO/WHO).
Health Canada is reviewing the summary assessments by the WHO’s International Agency for Research on Cancer (IARC) and JECFA published on July 13, 2023, and will review the full reports for each assessment once they are released. The department will determine whether action on aspartame is needed to protect Canadians, taking into consideration the scientific details from the full reports and information specific to the Canadian context for aspartame. Action Health Canada could take, if necessary, includes reducing one or more maximum levels of use for aspartame, further restricting which foods it may be used in, or no longer permitting it to be used as a food additive.
Health Canada has additional information about sugar substitutes and healthy eating.
- Footnote 1
See 21 CFR 172.804, U.S. Code of Federal Regulations.
- Footnote 2
See Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives Text with EEA relevance [EUR-Lex - 02008R1333-20230322 - EN - EUR-Lex (europa.eu)]
- Footnote 3
See Schedule 15 - Substances that may be used as food additives (Australia New Zealand Food Standards Code – Schedule 15 – Substances that may be used as food additives (legislation.gov.au))
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