FSANZ issues preferred option for Advantame approval

Advantame is a high intensity sweetener derived from the same amino acids as aspartame, and vanillin. While aspartame is around 200 times sweeter than sugar, Advantame is said to be “thousands of times” ​sweeter. In general this means less would be required in formulations, although actual food sweetness levels would depend upon specific applications.

The Ajinomoto Company filed a petition in August 2009 for 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.

The food agency issued its first assessment report in September 2010, in which it concluded that the high intensity sweetener is safe for use in the 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.

The second assessment, which makes the formal recommendation for the code to be amended, takes into consideration the 11 responses received in consultation on the first assessment.

FSANZ bases its conclusions on its finding that Advantame as an intense sweetener “does not pose a significant human health risk for Australian or New Zealand consumers”​ and that “Advantame is technologically justified as it provides the function of an intense sweetener in foods at the use levels proposed by the applicant”. ​

Responses​

The responses to the first assessment were positive in tone, with the exception of one response from an individual who would prefer no artificial sweeteners to be used in products.

However Ajinomoto’s response was that the ADI should be established on the basis of the long-term rat study – and given that the NOEL was at the highest dietary concentration of 50,000 ppm, the data support an ADI of ‘not specified’, it says.

In the second assessment, however, FSANZ sets out its reasons for sticking by its ADI of 0-5 mg/kg bw/day. These centre on some adverse effects observed in a study on rabbits, which the agency says cannot be discounted: discoloured urine suggesting systemic exposure to a metabolite or metabolites either not present in rats and dogs, or present at much lower levels; and an observed maternotoxicity effect.

NSW Food Authority (New South Wales) sought clarification of come of the toxicological studies referred to in the risk assessment report, in particular relating to pharmacokinetics and comparison with other sweeteners.

Queensland Health pointed out that while the analytical approach described may be appropriate for some food matrices like soft drinks and table top sweeteners, an extra extraction and purification step may be required for more complex matrices like meal replacements and dairy foods.

Consultation on the second assessment report will be open until 15 March 2011. More details are available here​.