European Food Safety Authority (EFSA)

Aspartame

Aspartame is a low-calorie, intense sweetener. It is a white, odourless powder, approximately 200 times sweeter than sugar.

Aspartame is used in a number of foodstuffs such as drinks, desserts, sweets, dairy, chewing gums, energy-reduces and weight control products and as a table-top sweetener throughout the world. The sweetener has been authorised for many years in many countries following thorough safety assessments.

EFSA's role and activities

The sweetener and its breakdown products have been a matter of extensive investigation for more than 20 years including experimental animal studies, clinical research, intake and epidemiological studies and post-marketing surveillance. Aspartame was found to be safe for human consumption, a conclusion which was reconfirmed in the review carried out by the Scientific Committee on Food (SCF) in 2002.  

In 2007 the European Ramazzini Foundation in Bologna, Italy, published findings of a new study on the carcinogenicity of aspartame in rats. EFSA’s ANS Panel adopted an opinion on this study in January 2009. The ANS Panel subsequently updated its opinion in March 2009 taking into consideration data submitted by the Ramazzini Foundation in February 2009. The Panel concluded that on the basis of all the evidence currently available, including the ERF study published in 2007, there is no indication of any genotoxic or carcinogenic potential of aspartame and no reason to revise the previously established Acceptable Daily Intake for aspartame of 40 mg/kg body weight. An earlier opinion, following the first study on aspartame by the European Ramazzini Foundation, was adopted by the former AFC Panel in 2006.

Initiative in cooperation with the Advisory Forum

Even though aspartame has been authorised for many years in many countries following thorough safety assessments, a degree of public concern about the safety of aspartame has continued. EFSA, together with its Advisory Forum made up of representatives of the risk assessment bodies in the EU Member States, is now working to address this public concern.

EFSA adopted an opinion in 2006 reconfirming the safety of aspartame. This work is not being undertaken because of new concerns about the current safety assessments. However, both EFSA and its Advisory Forum recognize that public concern continues despite the risk assessments that have been undertaken. The aim of this initiative is to ensure that every effort has been made to address these concerns.

In April 2009 EFSA held a meeting of national experts with relevant scientific knowledge in relation to aspartame, nominated by their Member States. They looked at all the published literature and other data made available, with the aim of addressing in a comprehensive manner the public concern that remained. Experts also took into consideration additional evidence and literature that EFSA had gathered through a call for data issued in 2008.

Next steps will include the further preparation of a draft report for consideration at the meeting of national experts in Porto on 10-11 November. It was also agreed that there will then be a public consultation, so that interested parties will have the opportunity to see and comment on the report and any conclusions and recommendations. The experts’ report, together with a summary of the consultation feedback, will then be presented to the EFSA Advisory Forum in early 2010.

EU regulatory framework

• EU legislation on food additives – European Commission, DG Health and Consumers