Assessment of aspartame study and its safety

The AFC panel of the European Food Safety Authority (EFSA) has evaluated a long-term study on the carcinogenicity of aspartame conducted by the European Ramazzini Foundation in Bologna, Italy.

The panel concluded, on the basis of all the evidence currently available, that there is no need to further review the safety of aspartame nor to revise the previously established Acceptable Daily Intake (ADI) for aspartame (40 mg/kg body weight).

The panel also noted that intakes of aspartame in Europe, with levels up to 10 mg/kg body weight per day, are well below the ADI.

Aspartame, an intense sweetener, has been authorised for use in foods and as a table-top sweetener for more than 20 years in many countries throughout the world. Extensive investigations have been carried out on aspartame and its breakdown products through experimental animal and human studies, intake studies and post-marketing surveillance.

In addition to a number of safety evaluations conducted in the past, the Scientific Committee on Food (SCF) carried out a review of all original and more recent studies on aspartame in 2002 and reconfirmed that aspartame is safe for human consumption.

However, since it was introduced onto the market, the safety of aspartame has been a controversial issue.

In 2005, the European Ramazzini Foundation published findings of a long-term study on aspartame conducted in rats.

The scientists from the European Ramazzini Foundation concluded that the results of their study indicate that aspartame can cause cancer and that the current guidelines on the use and consumption of the sweetener should be re-evaluated.

EFSA undertook the evaluation of the findings and requested that the European Ramazzini Foundation provide all study details necessary for the assessment. The European Commission confirmed the need to assess the study and supported the high priority given to this work.