Aspartame

What is aspartame?

Aspartame is an intense sweetener used to replace sugar in foods and drinks.   It is a natural product that consists of two amino acids (aspartic acid and phenylalanine), which are basic building blocks of proteins in the human body, joined together by a special chemical link.   Aspartame breaks down following digestion in the human body to products that are found in many foods humans currently eat (e.g.   meat, milk, fruit and vegetables) and to products, which are also produced within the cells of humans.

Food Standards Australia New Zealand (FSANZ) and other international regulatory agencies have approved aspartame for general use in a range of foods including tabletop sweeteners, carbonated soft drinks, yoghurt and confectionery.

Is aspartame safe?

Yes.   FSANZ and other international regulatory agencies have concluded that aspartame is safe.

Studies have been conducted that have assessed the potential for aspartame to produce both short-term (acute) and long-term adverse effects in animals and humans.   In particular, the ability of aspartame in the diet to produce structural changes or genetic mutations in the deoxyribonucleic acid (DNA) of cells (genotoxicity) and/or cancer causing abilities in animals has been studied in rats and mice.   Genotoxicity tests and long-term cancer causing studies have showed no evidence of a genotoxic or cancer causing potential when administered at very high doses in the diets of rats and mice.   A number of studies in human volunteers, including individuals with diabetes, have demonstrated that aspartame is a safe food additive.

In 1994, FSANZ (when it was the National Food Authority) commissioned research to investigate consumption patterns in the general Australian population of eight food groups containing intense sweeteners.   For a selected subgroup of consumers of these products, estimated intakes of the four most commonly available intense sweeteners (aspartame, saccharin, cyclamate and acesulphame-K) were compared with the relevant acceptable daily intake (ADI).   For average consumers of aspartame, intakes were low compared to its ADI (7% of the ADI).   At a higher range of intakes (90th percentile intake for high consumer subgroup), reported aspartame intakes were less than 30% of the ADI.

A more recent survey in September 2003 was undertaken which looked in detail at current intake levels of aspartame for average and high consumers.   The survey found that for average consumers of aspartame the intakes were low (6% of the ADI) as per the previous survey; however, for high consumers the exposure had decreased to 15% of the ADI.

In summary, FSANZ has concluded that, in Australia, aspartame levels are well below those at which adverse health effects might be observed.

Has the safety of aspartame been considered by other regulatory agencies or expert Committees?

Yes.   Aspartame has been a very extensively studied food additive.   International regulatory bodies charged with reviewing safety data on food additives have evaluated numerous studies performed with aspartame in both experimental animals and humans and concluded that it was a safe food additive.

The Joint (FAO/WHO) Expert Committee on Food Additives evaluated aspartame in 1980, establishing an ADI for aspartame.   The ADI is the amount of a food additive that can be consumed over an entire lifetime without any appreciable health risks.   The ADI for aspartame is 40 milligrams per kilogram of body weight per day (40 mg/kg bw/day) based on the highest level causing no effect in a long-term rat study.

The European Commission’s Scientific Committee on Food (SCF) published an updated opinion on the safety of the sweetener aspartame in December 2002.   After an extensive review of more than 500 pieces of research, the Committee concluded on the basis of its review of all the data available that there was no need to revise its earlier risk assessment, which concluded that aspartame is safe.   The SCF also concluded that there is no need to revise the previously established ADI calculation for aspartame of 40 mg/kg bw/day, which is consistent with the ADI established by JECFA.

A study in the USA in 2006 by the National Cancer Institute involving 340,045 men and 226, 945 women (aged 50 to 69) found no statistically significant link between aspartame consumption and cancer.

A recent review carried out by a panel of internationally recognised scientists evaluated more than 500 studies, articles and reports conducted over the last 25 years on aspartame, including unpublished works submitted to the US Food and Drug Administration for approval of aspartame [1] .   It was concluded that aspartame is safe at current levels of consumption.   No credible evidence was found that aspartame could cause cancer, affect the nervous system function, learning or behaviour or has any adverse effect on health when consumed at quantities many times the established ADI.

Is aspartame labelled?

Yes.   Food additives are required to be identified by their class name (e.g. sweetener) and by an individual name or code number.   Aspartame’s additive number is 951.

While aspartame is safe for the general population, people with the rare genetic disorder phenylketonuria need to avoid consuming food that contains phenylalanine which is in aspartame.   This is why any food containing aspartame must state on the label ‘contains phenylalanine’.

September 2007