by Joe Lederman and John Gao © Lawmedia Pty Ltd, April 2008
FSANZ recently completed a review of cyclamate permissions in a range of foods including beverages and tabletop sweeteners. The result seems to be a compromise by FSANZ but does it really benefit anyone? On 21 February 2008 changes to the Australia New Zealand Food Standards Code were gazetted to reduce the level of cyclamate permissible in certain types of food. The Final Assessment Report was published on 12 December 2007. What is cyclamate? Sodium Cyclamate is an artificial sweetener used as a replacement for sugar in some low energy beverages. Sodium Cyclamate is permitted in many countries around the world but has been banned in the USA since the 1970’s. The US FDA banned the substance in the 1970’s due to concerns caused by evidence showing that cyclamate when mixed with saccharin (another artificial sweetener) could cause bladder cancer. The FSANZ Review The FSANZ review was conducted in response to a survey conducted by Roy Morgan Research in 2004 on “Consumption of Intense Sweeteners in Australia and New Zealand”. The survey had suggested that some consumers who regularly consume foods containing cyclamate were consuming the substance at levels above the level of Acceptable Daily Intake (ADI). FSANZ undertook its own assessment of the level of cyclamate consumption and found that while the majority of people aged 12 years and over consumed cyclamate at levels under the ADI, the majority of people aged 11 years and under consumed excessive amounts of cyclamate. However, FSANZ did not conduct a full independent assessment of the RISK of toxicity or adverse reactions to cyclamate. While FSANZ recognised that an excessive amount of cyclamate was a health concern, FSANZ did not assess what these health concerns were and the level of risk involved. The Final Assessment Report merely mentioned that there is a possibility of testicular atrophy when cyclamate is consumed at excessive levels. FSANZ mentioned that cyclamate is banned in the USA but has failed to consider or even mention the US FDA’s reasons for imposing such a ban. The problem with not conducting a separate risk assessment is that although FSANZ has a recommended ADI level, FSANZ may not have sufficient data to be able to model the reduction in the likelihood or severity of adverse reactions where intake has been reduced. FSANZ is only able to model the proportion of the population that will likely consume less than the ADI of the substance based on limited data. FSANZ concluded that the risk can be sufficiently reduced by lowering the permissible amount of cyclamate in water based flavoured drinks from 600 mg/kg to 350 mg/kg. What does reducing cyclamate permissions achieve? FSANZ has therefore chosen a position which provides a compromise between protecting public health by reducing the permissible amount of cyclamate while still allowing manufacturers to use cyclamate at a reduced level. However, as mentioned above, FSANZ does not have data to determine how much the reduction in cyclamate levels is likely to affect the level of health risk. FSANZ can only conclude that the likely level of consumption for the majority of the population will be under an ADI recommended by an independent body. Therefore, whether or not FSANZ’s conclusion will really reduce the risk of adverse health reactions is unknown. Further, FSANZ did not consider whether a reduction in the level of cyclamate in a product is practical for industry. Because cyclamate is a sweetener, reducing the amount of cyclamate in a food is likely, in many cases, to reduce the sweetness of the food in half. To compensate for the reduction in sweetness, manufacturers would need to replace the cyclamate with another sweetener. Liability for harm Even if your product complies with the requirements under the Australia New Zealand Food Standards Code, there is still a legal risk of liability if a consumer in fact suffers harm from the consumption of the product. In fact, we believe this may explain why some manufacturers have already announced that cyclamate will soon be removed from some major product lines.
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