European Food Safety Authority Reconfirms Safety of Aspartame; EFSA Releases Opinion on Ramazzini Study

ATLANTA (April 21, 2009) — The European Food Safety Authority (EFSA) has once again confirmed the safety of aspartame.  After a comprehensive review of data, EFSA’s Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) stated, “Overall, the Panel concluded on the basis of all the evidence currently available including the last published ERF [European Ramazzini Foundation] study that there is no indication of any genotoxic or carcinogenic potential of aspartame and that there is no reason to revise the previously established ADI for aspartame of 40 mg/kg bw/day.”  This statement further confirms EFSA’s 2006 statement regarding an earlier Ramazzini study, which alleged that aspartame consumption may cause cancer.

Although EFSA found many problems with the Ramazzini study, the panel stated that one of the reasons for the confounding conclusions by Ramazzini may be due, in part, to the fact that the rats already suffered from chronic respiratory disease.  The Panel went on to note that there is no information as to whether the Ramazzini study was performed under “Good Laboratory Practices” and the study design is not reflective of currently accepted toxicological methodologies.

The allegations made by Ramazzini are at complete odds with the wealth of scientific literature demonstrating that aspartame is safe and does not cause cancer.  A recent epidemiology study from the National Cancer Institute confirms previous study conclusions that there is no link between aspartame consumption and leukemias, lymphomas and brain tumors.  The study evaluated over 500,000 men and women between the ages of 50 and 69 over a five-year period.  A comprehensive review of more than 500 studies and recently published in Critical Reviews in Toxicology also found that aspartame is safe and not associated with cancer.  The review was conducted by a panel of eight leading experts in the areas of toxicology, epidemiology, metabolism, pathology, biostatistics etc., and conclusively determined that aspartame is safe.

The U.S. Food & Drug Administration (FDA) also supports the fact that aspartame is a safe low-calorie sweetener.  According to the FDA, “Based on the large body of evidence we have reviewed, including several studies on carcinogenicity which showed no adverse effects and data on how aspartame is metabolized by humans, we have no reason to believe that aspartame would cause cancer. Thus, it remains FDA’s position that use [of aspartame] is safe.”

Aspartame is one of the most thoroughly studied food ingredients with more than 200 studies supporting its safety.  In addition to the FDA, the Joint Expert Committee on Food Additives (JECFA) of the World Health Organization and Food and Agriculture Organization, the Scientific Committee on Food of the European Union and regulatory agencies in more than 100 countries have reviewed aspartame and found it to be safe for use.  For additional information on the safety and benefits of aspartame and other low-calorie sweeteners, please visit: and

For EFSA’s full report please visit here.

Items of Interest

April 21, 2009 Research Summaries