FAQ on aspartame

What is aspartame?

Aspartame is a low-calorie, intense sweetener which is approximately 200 times sweeter than sucrose (table sugar).

In which products is aspartame used?

Aspartame is used to sweeten a variety of foods and beverages such as drinks, desserts, sweets, chewing gum, yogurt, energy-reduced and weight control products and as a table-top sweetener. It has been authorised for use in foods and as a table-top sweetener for over 20 years in many countries throughout the world following thorough safety evaluations. Consumers can identify those foodstuffs containing aspartame by looking at the ingredients lists on product labelling. Like all food additives, aspartame has been assigned an “E-number” following authorisation. Its presence in foods can be indicated either by name (i.e. “aspartame”) or by its number E 951.

Is it safe to eat products containing aspartame?

EFSA considers that aspartame is safe for human consumption and that there is no scientific evidence to date which gives reason to reconsider previous safety assessments of aspartame. EFSA keeps the safety of aspartame under regular review and its scientific panels have issued several opinions on this sweetener.

Why have questions been raised about aspartame in the past?

Prior to its authorisation and since its market introduction, the safety of aspartame has sparked interest and controversy. Questions have primarily been raised about some of the early experimental animal studies utilised to evaluate the safety of aspartame. Extensive reviews on aspartame have been carried out by many national and international regulatory and advisory bodies. All have concluded that the scientific evidence is sufficient to confirm that aspartame is safe for human consumption.

Why have new questions been raised about aspartame?

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 European Ramazzini Foundation (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].

Has EFSA assessed the safety of aspartame?

The first safety assessment of aspartame carried out in Europe was published by the Scientific Committee on Food (SCF)[4] in 1984 and reconfirmed in 2002. Since then EFSA has kept the safety of aspartame under regular review and its scientific panels have issued several opinions on this sweetener.

In 2009, the ANS Panel concluded that on the basis of all the then available evidence, including the study by the European Ramazzini Foundation (ERF) published in 2007, there was no indication of any genotoxic or carcinogenic potential of aspartame and no reason to revise the previously established Acceptable Daily Intake (ADI)[5] for aspartame of 40 mg/kg body weight. An earlier opinion, following the first study on aspartame by the ERF, was adopted by the former AFC Panel in 2006 and had also reconfirmed the safety of this sweetener.

What happens to aspartame in the body once it is ingested?

Following ingestion, aspartame breaks down in the gut into its three constituent parts: aspartic acid, phenylalanine and methanol. All of these substances occur normally in the body. Aspartame itself does not enter the bloodstream nor does it accumulate in the body.

The three breakdown products from aspartame are also present naturally in other foods and are used by the body in the same way as those derived from common foods. Compared to common foods, the amounts of these components that we ingest from aspartame are small. For example, a serving of non-fat milk provides about six times more phenylalanine and 13 times more aspartic acid compared to an equivalent amount of a diet beverage sweetened only with aspartame.

Extensive investigations have been carried out on aspartame and its breakdown products through experimental animal and human studies, intake studies and post-market surveillance. In addition to a number of thorough safety evaluations in the past, the SCF[6] carried out a review of all original and more recent data on aspartame in 2002 and concluded that aspartame is safe for human consumption.

What about the recent study on the association between intakes of artificially sweetened soft drinks and increased incidence of preterm delivery?

In February 2011 EFSA also assessed the Halldorsson et al. (2010)[7] publication that reports findings suggesting that the daily intake of artificially sweetened soft drinks may be associated with an increased risk of preterm delivery.

EFSA concluded that there is no evidence available in this study to support a causal relationship between the consumption of artificially sweetened soft drinks and preterm delivery and that additional studies would be required either to confirm or reject such an association, as indicated by the authors. Given that the association found by the authors appears to be primarily related to medically induced (rather than spontaneous) preterm deliveries, EFSA stressed that medical history and criteria on which medical decisions to induce delivery were based are factors which should be investigated further. EFSA recommended that future studies should also investigate other important confounding factors such as exposure to other substances in the diet which might have an effect on pregnancy.

The independence of scientific advice given on aspartame has at time been questioned. How does EFSA guarantee the independence of its scientific advice?

EFSA is constantly vigilant to potential conflicts of interest whilst recognising that the top scientific experts in Europe can only gain their expertise by being active in their fields. The independence of scientific experts and all those involved in the activities of EFSA is ensured by one of the most rigorous Declaration of Interest policies in force in the world. The robust set of internal mechanisms and working processes EFSA applies include a mandatory declaration of commitment of independence and a declaration of interests. These declarations are done annually and are public documents on the EFSA website. In addition to these annual declarations, members of the Scientific Committee, the Scientific Panels, external experts participating in working groups and EFSA staff declare at each meeting any interests which might be considered prejudicial to their independence in relation to the items on the agenda. When a potential conflict is identified, EFSA limits or excludes experts from taking part in its scientific activities. More information on EFSA’s policy of independence is available at: http://www.efsa.europa.eu/en/values/independence.htm

Who regulates the use of aspartame within the EU? What is EFSA’s role?

EFSA’s role is to provide independent scientific advice on questions from risk managers related to food and feed safety and to communicate its advice to the public at large. It is in this context that EFSA and its scientific panels carry out safety assessments and review new evidence such as the recent study carried out by the European Ramazzini Foundation on the carcinogenicity of aspartame in mice.

The Authority neither authorises nor bans the use of substances in foods. It is the responsibility of risk managers in the European Commission, the European Parliament and the EU Member States to define and agree measures as and where required, taking into account scientific advice and other considerations.

Why has EFSA been asked to review the safety of aspartame as an artificial sweetener?

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

• Topic: Food additives – EU framework
• Request from the European Commission for a full re-evaluation of aspartame
   

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[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

[4] The Scientific Committee on Food (SCF) was the former scientific committee of the European Union before EFSA was established in 2002.

[5] Acceptable Daily Intake (ADI) is an estimate of the amount of a food additive, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable health risk (JECFA – The Joint FAO/WHO Expert Committee on Food Additives).

[6] The Scientific Committee on Food (SCF) was the former scientific committee of the European Union before EFSA was established in 2002

[7] 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.