The FSANZ received an application from the Ajinomoto Company in August 2009 asking an amendment of Standard 1.3.1, relating to the permissible use of additives in the Australia New Zealand Food Standards Code, to approve the sweetener for use in the two countries.
After consideration, the FSANZ concluded that Advantame was safe to use in a range of foodstuffs proposed by Ajinomoto: powdered table-top sugar substitutes, powdered beverages such as fruit-flavoured drinks, milks, flavoured milk drinks, instant tea and coffee and protein drinks.
No risk to public health
In April 2009 Ajinomoto submitted a dossier (still under consideration) to the US Food and Drug Administration (FDA) for approval of Advantame, which is derived from the same amino acids as aspartame and vanillin.
At the time, a company spokesperson told FoodNavigator-USA.com that, while aspartame is 200 times sweeter than sugar, Advantame is “thousands of times sweeter”, which means less would be used in formulations, although actual food sweetness levels would depend upon specific applications.
The FSANZ assessment report considered whether the stated purpose for Advantame had been made clear, the appropriateness of intake levels and form suggested by the Ajinomto, the need for a reference health standard relating to the sweetener and any potential risks to it entering the food chain.
It concluded:“The FSANZ concludes that approval of Advantame for use…poses no risk to public health and safety for Australian or New Zealand consumers.
“The ADI for Advantame is set at 0-5 mg/kg for all groups of Australian and New Zealand consumers assessed (including children), estimated dietary exposures were well below the ADI (acceptable daily intake).
“Furthermore, Advantame is technologically justified as it provides the function of sweetening these foods at the use levels proposed by the applicant.”
As part of the submission Ajinomoto submitted “extensive toxicological data”, said the FSANZ, including the results of over 50 studies – “many unpublished” – which are still subject to external peer review by FSANZ. Nonetheless, the agency said that the toxicology of Advantame was well characterised.
The stated weight management purpose of using Advantame as part of a “weight management or weight loss regime” was considered in some detail by the FSANZ, given its characterisation of Advantame under Standard 1.3.1.
According to Schedule 5, Advantame is an intense sweetener that, “replaces the sweetness normally provided by sugars in foods without contributing significantly to the available energy of the food.”
Since the purpose of adding Advantame to food under FSANZ policy principles fell under this “technological function”, the body cited potential “inconsistency” with a provision in the existing food standard prohibiting “health or related claims” to be made regarding its addition to food.
But the FSANZ did not consider this an insurmountable problem: “The FSANZ considers that as long as the claims made are in accordance with the requirements and conditions set out in Standards 1.1A.2 – Transitional Standard – Health Claims, and 1.2.8 – Nutrition Information Requirements, there are no reasons to prohibit such claims.
The FSANZ is now seeking written submissions from industry, consumers and government before an October 16 deadline, on the safety and potential costs/benefits of approving Advantame. In the meantime a second assessment report will now be produced that proposes a draft variation of Standard 1.3.1.