Aspartame
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 and potential benefits to the consumer 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 hazard 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, countries
of the European Union, and Australia and New Zealand, 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 containing aspartame must indicate on
the label the presence of phenylalanine.
An acceptable daily intake (ADI) of 40 milligrams/kilogram of
body weight/day was established by scientists in the Food
Directorate of Health Canada. This ADI is recognized
internationally and is the same as that established by the
Joint Expert Committee on Food Additives (JECFA) of the Food
and Agriculture Organization/World Health Organization
(FAO/WHO).
As part of a post-market surveillance program, a study was
conducted in 1987 to monitor the actual consumption of
aspartame in Canada. This study which involved 5200 Canadian
households and 7500 individuals, demonstrated that the actual
consumption of aspartame was well below the recommended ADI
even during the warmest period of the year when soft drink
consumption would be expected to be high. Furthermore,
follow-up studies on human subjects revealed that no adverse
effects were observed even when humans were exposed to higher
intakes than the established ADI.
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