Aspartame

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 aspartame 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. It was found to be safe for human consumption, a conclusion which was reconfirmed in the review carried out by the Scientific Committee on Food in 2002. 

In 2007 the European Ramazzini Foundation (ERF) in Bologna, Italy, published findings of a new study on the carcinogenicity of aspartame in rats. EFSA requested the data related to this study in 2007 and 2008. EFSA’s Panel on additives and nutrient sources added to food (ANS) adopted an opinionon the study in January 2009, which was subsequently updatedin March 2009, taking into consideration additional data submitted by ERF in February 2009. The Panel concluded that on the basis of all the currently available evidence, 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 (ADI) for aspartame of 40 mg/kg body weight. An earlier opinion, following the first study on aspartame by the ERF, had been adopted by the former AFC Panel in 2006 and had also reconfirmed the safety of this sweetener. 

Recent activities – 2011   

In May 2011, the European Food Safety Authority (EFSA) was asked by the European Commission to bring forward the full re-evaluation of the safety of aspartame (E 951) to 2012. Previously planned for completion by 2020, the review of this individual sweetener is part of the systematic re-evaluation of all food additives authorised in the European Union prior to 20 January 2009, foreseen by Regulation (EU) No 257/2010. 

EFSA accepted the mandate for the re-evaluation of aspartame, stipulating the need for a public call for scientific data, which was launched on 1 June 2011, as well as a thorough literature review. Additionally, the Authority will liaise closely with the French Agency for Food, Environmental and Occupational Health Safety (ANSES) on their nutritional risk/benefit assessment of sweeteners.

In 2010, two studies on possible health risks related to the consumption of artificial sweeteners were published, namely a carcinogenicity study in mice exposed to aspartame through feed conducted by the ERF (Soffritti et al., 2010[1]), and an epidemiological study on the association between intakes of artificially sweetened soft drinks and increased incidence of preterm delivery (Halldorsson et al., 2010[2]). In a February 2011 statement, EFSA concluded that the two studies do not give reason to reconsider previous safety assessments of aspartame or of other sweeteners currently authorised in the European Union. EFSA’s review of these studies was carried out in co-operation with France’s Agency for Food, Environment and Occupational Health Safety, which is also undertaking work in this area (Anses[3]). 

[1] Soffritti M. et al., Aspartame administered in feed, beginning prenatally through life span, induces cancers of the liver and lung in male Swiss mice, Am. J. Ind. Med. 2010, 53, 1197-1206.

[2] Halldorsson T.I. et al., Intake of artificially sweetened soft drinks and risk of preterm delivery: a prospective cohort study in 59334 Danish pregnant women. Am. J. Clin. Nutr. 2010, 92: 626-633.

[3] Further information on the work initiated by Anses can be found at: http://www.anses.fr/PM910058I0.htm

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 recognise 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.

EFSA held a series of meetings 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 information 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.

At the 36th Advisory Forum meeting in May 2010 a report of the meetings on aspartame with national experts was presented along with comments from stakeholders received through the consultation on the report.

The national experts concluded that no new evidence was identified to suggest that the previous opinions of EFSA and the Scientific Committee on Food need to be reconsidered, but also recognised that the public concern relating to aspartame does not go away. Much of the concern expressed relates to the anecdotal reports of adverse effects. Whilst EFSA and the national experts have made considerable efforts and invested time and resources to assess the anecdotal information, this information has proved to have severe limitations preventing effective analysis.

The UK Food Standards Agency has launched a pilot study to test individual sensitivity to aspartame through a double-blind placebo-controlled study. This study aims to record any effects from eating a food that may or may not contain aspartame, in a safe controlled clinical environment. It will be carried out both amongst individuals who report reactions following consumption of foods containing aspartame and individuals who normally consume foods containing aspartame without problems. This objective evidence base could provide further insights into the issue of possible sensitivity to aspartame and may be useful in providing pointers for any further study or additional work.

The Advisory Forum agreed that it would be inappropriate to pre-judge the findings of the pilot study and to await its conclusions before reconsidering what further activity, if any, may be useful. It was therefore agreed that no further consideration of the issue would be undertaken in the meantime.

Last updated: 29 June 2011