Industry awaits regulator's review of aspartame
week of an EU regulatory review either confirming or rejecting the
results of a scientific study claiming that aspartame poses a
The European Food Safety Authority (EFSA) announced yesterday it will release its review on 5 May of study by the Ramazzini Foundation, based in Bologna.
What ever the conclusion, the study has heightened public concerns over the artificial sweetener. Since the study's publication last year, some suppliers have exited the market and some food and beverage companies have stopped using it for their diet products.
The EFSA review started last year after researchers at the institute's cancer research centre in Italy caused a stir by claiming that their study indicates that aspartame consumption by rats leads to increase in lymphomas and leukaemias in females at dose levels "very near those to which humans can be exposed".
A more recent study by the foundation, published last month in Environmental Health Perspectives, found a link between life-long aspartame consumption in the rats and cancer of the kidney and peripheral nerves.
The EHP report concluded: "The results of this mega-experiment indicate that APM (aspartame) is a multipotential carcinogenic agent, even at a daily dose of 20 mg/kg body weight, much less than the current acceptable daily intake. On the basis of these results, a reevaluation of the present guidelines on the use and consumption of APM is urgent and cannot be delayed."
Kathryn Knowles, a spokesperson for Ramazzini, told FoodProductionDaily.com today that the researchers stand by the data collected by the long term study that is the subject of the EFSA review.
"We maintain that it is our job to provide the data and we leave it is up to EFSA to give an opinion," she said. "We are as curious as you as to what their opinion will be."
Since its discovery in 1965 aspartame has be the source of controversy within the scientific community and industry over whether it causes health problems. Some studies have indicated a health risk, some have indicated that it does not cause harm to humans. Industry has consistently denied that the artificial sweetener poses a health risk, claiming that the numerous scientific studies were faulty.
They also point to four previous long term studies sponsored by G.D. Searle, a chemical company that held the patent to aspartame, which were the basis for regulatory acceptance worldwide. Searle was later bought by Monsanto and became NutraSweet Co.. The US Food and Drug Administration approved aspartame for consumption in 1981.
"The overwhelming body of scientific evidence clearly demonstrates that aspartame, even in amounts many times what people typically consume, is safe and not associated with adverse health effects," claims the Aspartame Information Center, an industry funded body.
The organisation cited 200 studies showing the sweetener's safety, including a recent one sponsored by the National Cancer Institute. The NCI study involved 340,045 men and 226,945 women, ages 50 to 69, and found no statistically significant link between aspartame consumption and leukemias, lymphomas or brain tumors.
However Knowles noted that the Ramazzini study was the first long term independent study relating to cancer. The results of the seven-year study into the long-term effects of eating aspartame in rats were released in July 2005.
Knowles said the study should be a valuable lesson for industry, which can learn from the experience, no matter if it turns out to be painful.
"There should be a quality assurance partnership between researchers and the food additive industry," she said. "There should be independent evaluations using long term studies."
Since the study, Holland Sweetener Co., the largest supplier of aspartame in the European market, said it will stop production of the sweetener by the fourth quarter of 2006.
"The global aspartame markets are facing structural oversupply, which has caused worldwide strong price erosion over the last five years," the Netherlands-based company stated in announcing the decision.
The US patent on aspartame expired in 1992. NutraSweet, Ajinomoto, Merisant and Holland Sweetener were the main players in the market. Holland Sweetener is a joint venture between Royal DSM of the Netherlands and Tosoh Corporation in Japan.
After saccharin, aspartame is the second most used artificial sweetener in the world. In terms of world consumption, the artificial sweetener represents 62 per cent of the value of the intense sweetener market.
Aspartame is found in about 6,000 products worldwide, including carbonated and powdered soft drinks, hot chocolate, chewing gum, candy, desserts, yogurt, tabletop sweeteners, and some pharmaceutical products, such as vitamins and sugarfree cough drops. The Aspartame Information Center estimates the sweetener is consumed by about 200 million people a year worldwide.
Aspartame was first authorised for use by several EU member states in the 1980s. European legislation harmonising its use in foodstuffs was introduced in 1994 following safety evaluations in 1984, 1987, 1988. A further review of all the original and more recent data on aspartame was carried out in 2002 by the bloc's food regulator.
Both published and unpublished data, including all the information on genotoxicity and carcinogenicity in animals and humans, were considered at that time and the SCF re-confirmed the previously established acceptable daily intake (ADI) for aspartame.
Various food associations have dismissed the Ramazzini study, saying it did not follow established scientific procedures.
According to market analysts Freedonia, the sweetener market is set to grow at around 8.3 per cent year on year until 2008: considerably higher than growth in the ingredients industry currently at about 3 to 4 per cent