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How FSANZ ensures the safety of food additives

(July 2013)

Food Standards Australia New Zealand carries out safety assessments on food additives before they can be used. FSANZ checks whether:

  • the food additive is safe (at the use levels being proposed)
  • there is a good technological reason for using the additive.
FSANZ’s safety assessment process follows an internationally accepted (Codex Alimentarius) model involving a hazard (safety) assessment of the chemical and dietary exposure (consumption levels) assessment.
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. Animal studies are designed to determine whether a substance can cause any adverse effects. They are usually conducted using very high concentrations in the dietfar 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 a maximum permitted level. For example, this would mean that a safe concentration determined from animal studies would be usually divided by a safety (or uncertainty) factor of 100 to provide a health based guidance value that would be applicable to humans, e.g. the acceptable daily intake (ADI), which is the amount of a food additive that can be eaten every day for an entire lifetime without adverse effect.
The exposure assessment predicts the likely amount of the additive that would be consumed if it was permitted. This estimate is then compared with the ADI. FSANZ recommends a maximum level of the food additive, providing the estimate based on this level is well within the range of the ADI based on this comparison. The permitted level also takes account of the level of use that is required for the additive to perform its function.
For example, the food colour tartrazine has an ADI of 0-7.5 mg/kg bodyweight. A dietary exposure assessment predicted that tartrazine consumption for children aged between 2 and 16 years in Australia, even at the highest daily consumption, would be between 0.21 and 0.38 mg/kg bodyweight (which corresponds to between 3 and 5% of the ADI).
Another example is the intense sweetener aspartame where the dietary exposure assessment based on a survey of intense sweetener use in Australian and New Zealand foods showed that consumption of the intense sweetener for Australian and New Zealand consumers would be in the range of 9% and 20% of the ADI for the population groups with the highest daily consumption.
Permitted food additives are listed in Standard 1.3.1 of the Food Standards Code.  Schedule 1 to the Standard details permitted uses and restrictions of food additives by food type.
FSANZ is constantly monitoring the scientific literature relevant to the safety of food additives, as are other international agencies such as the European Food Safety Authority, the United States Food and Drug Administration and the Joint Expert Committee on Food Additives (JECFA), an international scientific expert committee administered jointly by the Food and Agriculture Organization of the United Nations and the World Health Organization. If any new information becomes available that is likely to affect the ADI value FSANZ will evaluate the data and amend permissions as required.








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