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Food Standards Australia New Zealand Logo


(September 2017)

Sweeteners are food additives that have a relative sweetness many times that of sugar which means they can be used in much smaller amounts. They are added to foods to replace the sweetness normally provided by sugars.

FSANZ does a thorough safety assessment of all food additives, including sweeteners, before they are approved for use in food. FSANZ checks whether:
  • the food additive is safe at the use levels being proposed and
  • that there is a good technological reason for its use.
FSANZ’s safety assessment process follows an internationally accepted model involving a hazard (safety) assessment of the chemical, a dietary exposure (consumption levels) assessment and consideration of risk management options.
Food additives are approved only if it can be shown no harmful effects are likely to result from their use.
To assess their safety, extensive testing of food additives is required, including animal studies and human studies if they are available. For sweeteners human studies are sometimes conducted on diabetic patients to establish whether the specific sweetener will be tolerated by this population group.
Animal studies are designed to determine whether a substance can cause any adverse effects. They are usually conducted using very high concentrations in the diet—far greater than the level people are likely to consume if the substance was present in food. An uncertainty or safety factor is then applied to establish an acceptable daily intake (ADI) and a maximum permitted level if needed in the Code.


The safety of aspartame has been the subject of comprehensive reviews by:

  • the Food and Agricultural Organization/World Health Organization
  • Joint Expert Committee on Food Additives (JECFA)
  • the European Food Safety Authority (EFSA)
  •  the US Food and Drug Administration (USFDA).
All scientific evidence to date supports the safety of aspartame for use as a sweetener.
In 1980 JECFA established an Acceptable Daily Intake (ADI) for aspartame of 40mg/kg of body weight, for aspartame. The ADI is the amount of a food additive that can be consumed each day, over an entire lifetime, without any appreciable health risks.
In 2007, a study by the European Ramazzini Foundation (ERF) suggested that aspartame can cause cancer in rats at levels close to the human acceptable daily intake. EFSA reviewed this study and released an updated scientific opinion in March 2009. EFSA concluded that based on all the evidence available, including the ERF study, aspartame did not produce cancer and there was no reason to revise the ADI for aspartame. After examining the study FSANZ agreed with EFSA.
In 2010, two more studies were released. The first, by Soffritti et al., (2010) from the ERF, shows that life expectancy in mice remains unchanged following a lifetime of daily exposure to aspartame. But the study also claimed the incidence of some cancer types at death is slightly increased among mice fed aspartame. The second is an epidemiological study by Halldorsson et al., (2010) which examines an association between the consumption of sugar-sweetened and artificially-sweetened soft drinks and the risk of pre-term delivery in Danish pregnant women.
EFSA evaluated these studies and in a statement on 28 February 2011, said they did not give cause to reconsider previous safety assessments of aspartame or of other sweeteners currently authorised in the European Union.
In December 2013 EFSA announced it had completed a full risk assessment on aspartame and concluded it is safe at current levels of exposure. The risk assessment involved a review of all scientific research on aspartame and its breakdown products.


To find out if there is an sweetener is in your food look at the ingredient list on the food label for the food additive’s name or Code number, for example, Sweetener Aspartame or Sweetener (951).
Labelling is particularly important for consumers with the rare genetic disorder called Phenylketonuria (PKU). PKU is characterised by a deficiency in an enzyme needed to breakdown the amino acid phenylalanine (a product of aspartame) in the human body to another amino acid named tyrosine. When this enzyme is deficient phenylalanine accumulates.



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