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 (ie “aspartame”) or by its number E-951.

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 6 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 Scientific Committee on Food (SCF)[1] has carried out a review of all original and more recent data on aspartame in 2002 and concluded that aspartame is safe for human consumption.

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 raised about aspartame?
In July 2005 the European Ramazzini Foundation in Bologna (Italy) informed the public about a large life-time study on aspartame conducted in rats between 1997 and 1999. Based on the results from their study, the scientists from the European Ramazzini Foundation considered that aspartame may cause cancer and that its use in foods should be reconsidered. EFSA took these findings seriously and urged the European Ramazzini Foundation to make the full data available to enable EFSA’s AFC Panel[2] to review them.

What has EFSA done?
EFSA immediately undertook the evaluation of the new findings and requested additional unpublished data required to carry out this work following discussions with the European Ramazzini Foundation in June 2005. EFSA received the study report in December 2005 and further additional data in April 2006. In carrying out its risk assessment, the Panel took into account the previous extensive safety data available on aspartame. The AFC Panel adopted its opinion on 3 May 2006 which is published on the EFSA website at: http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620765743.htm .

What were EFSA’s conclusions?
The Panel concluded that based on all the evidence currently available from the European Ramazzini Foundation’s study, other recent studies and previous evaluations that there is no reason to further review the previous scientific opinion on the safety of aspartame nor to revise the Acceptable Daily Intake (ADI)[3] for aspartame of 40 mg/kg body weight.

Only one finding from the study was considered to require further investigation. This concerned the low incidence of malignant tumours in peripheral nerves found in animals fed with aspartame. Whilst the numbers of tumours were very low, their diagnosis is uncertain and no clear dose relationship with aspartame was found, the Panel indicated that this finding could only be fully evaluated by an independent peer review of the relevant tissues.

Is it safe to eat products containing aspartame?
Based on the previous thorough evaluations and the new opinion from the AFC Panel, EFSA considers that aspartame remains safe for human consumption and that there is no scientific basis for reconsidering its use in foods. Based on the Panel’s assessment, EFSA does not see a need for consumers who choose to eat products containing aspartame to modify their dietary habits.

The safety of aspartame has been questioned in the past. How does EFSA guarantee the independence of its scientific advice?
The independence of the scientific experts and all those involved in the activities of EFSA is ensured by 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. EFSA is constantly vigilant to potential conflicts whilst recognising that the top scientific experts in Europe can only gain their expertise where they are active in their fields.

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 the AFC Panel has carried out an assessment of the study carried out by the European Ramazzini Foundation on the carcinogenicity of aspartame.

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.

For media enquiries, please contact:

E-mail: Press@efsa.europa.eu

Press Office Hotline
Tel: + 39 0521 036 149

or

Anne-Laure Gassin, EFSA Communications Director
Mobile: + 39 348 640 34 34

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

[2] Scientific Panel on food additives, flavourings, processing aids and materials in contact with food [AFC]

[3] 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)