Aspartame is an intense, low-calorie, artificial sweetener. It is a white, odourless powder, approximately 200 times sweeter than sugar. In Europe, it is authorised to be used as a food additive in foodstuffs such as drinks, desserts, sweets, dairy, chewing gums, energy-reducing and weight control products and as a table-top sweetener.
Aspartame and its breakdown products have been the subject of extensive investigation for more than 30 years including experimental animal studies, clinical research, intake and epidemiological studies and post-marketing surveillance. It has been found to be safe and authorised for human consumption for many years and in many countries following thorough safety assessments.
In the EU the label on foodstuffs containing aspartame must state its presence, indicating either its name or its E number (E 951).
EFSA publishes its first full risk assessment of aspartame. The opinion concludes that aspartame and its breakdown products are safe for the general population (including infants, children and pregnant women).
The acceptable daily intake (ADI) of 40mg/kg bw/day is considered protective for the general population and consumer exposure to aspartame is estimated to be well below this ADI. For patients suffering from the medical condition phenylketonuria, the ADI is not applicable, as they require strict adherence to a diet low in phenylalanine (an amino acid making up proteins found in many foods).
During its risk assessment of aspartame EFSA launches a call for data on 5-benzyl-3,6-dioxo-2-piperazine acetic acid (DKP) and other degradation products of aspartame, after experts find that there were insufficient data available on these substances that can form from aspartame in food and beverages when stored under certain conditions.
Reaffirming its commitment to openness and transparency, EFSA publishes the full list of scientific studies received following a call for data and makes publicly available previously unpublished scientific data, including the 112 original documents on aspartame which were submitted to support the request for authorisation of aspartame in Europe in the early 1980s.
The European Commission asks EFSA to bring forward the full re-evaluation of aspartame, originally planned for completion by 2020 as part of the systematic re-evaluation of all food additives authorised in the EU prior to 20 January 2009.
EFSA concludes that two recent publications on artificial sweeteners do not give reason to reconsider previous safety assessments of aspartame or of other sweeteners currently authorised in the EU.
EFSA’s experts assess new findings on the carcinogenicity of aspartame in rats and conclude that there is no indication that aspartame is genotoxic or carcinogenic and no reason to revise the ADI for aspartame of 40 mg/kg bw/day.
After assessing a long-term carcinogenicity study on aspartame EFSA’s experts conclude that there is no reason to revise the ADI for aspartame of 40 mg/kg bw/day.
EFSA’s main task in relation to the safety assessment of aspartame is to respond to requests from risk managers for scientific advice and to monitor scientific literature that may affect evaluation of the safety of this substance.
Under the programme for the re-evaluation by 2020 of all food additives authorised prior to 20 January 2009, EFSA is required to re-evaluate the safety of aspartame. This re-evaluation, originally scheduled to be finalised at the latest by 2020, was brought forward to 2013 following a request from the European Commission.
As part of its safety evaluations of food additives EFSA establishes, when possible (i.e. when sufficient scientific information is available), an acceptable daily intake (ADI) for each substance. The ADI is the amount of a substance that people can consume on a daily basis during their whole life without any appreciable risk to health. ADIs are usually expressed in mg per kg of body weight per day (mg/kg bw/day). The ADI can apply to a specific additive or a group of additives with similar properties. When re-evaluating previously authorised additives, EFSA may either confirm, amend or withdraw an existing ADI following review of all available evidence.
Since 2002, EFSA has kept the safety of aspartame under regular review and its scientific panels have issued several opinions on studies related to this sweetener.
Aspartame is a food additive. The relevant EU legislation is detailed in the Topic: Food additives (see ‘EU framework’).
During the 1980s, aspartame was authorised for use in foods and as a table-top sweetener by several EU Member States. European legislation harmonising its use in foodstuffs was introduced in 1994 following thorough safety evaluations by the Scientific Committee on Food (SCF) in 1984 and 1988. Further reviews of aspartame data were carried out by the SCF in 1997 and 2002.
Background on aspartame:
1. What is aspartame?
2. In which food products is aspartame used?
3. Is it safe to eat products containing aspartame?
EFSA’s Panel on Food Additives and Nutrient Sources Added to Food (ANS Panel) has carried out a full re-evaluation of the safety of aspartame and has concluded that aspartame does not pose a safety concern at current levels of exposure. The Panel considers that the ADI for aspartame set by the SCF is safe for the general population (including infants, children and pregnant women) and consumer exposure to aspartame is below this ADI. It is not applicable to people who suffer from PKU – see Question 4.
[*] The Scientific Committee on Food (SCF) was the former scientific committee of the European Union before EFSA was established in 2002.
4. What is PKU?
5. How much aspartame is it safe to consume?
6. Has EFSA ever evaluated the safety of aspartame?
7. So if aspartame is safe, why has EFSA carried out a full re-evaluation?
8. Has EFSA finished its new safety review of aspartame?
- Press release: EFSA wraps up aspartame consultation with public meeting
- Public consultation on the Draft scientific opinion on the re-evaluation of aspartame as a food additive
The re-evaluation of aspartame was carried out by EFSA’s Panel on Food Additives and Nutrient Sources Added to Food (ANS).
9. Why did EFSA have a public consultation for its scientific opinion on aspartame?
EFSA regularly consults the scientific community and other stakeholders on its guidance documents and, when compatible with the procedures and deadlines laid down in the relevant EU legislation, also on important scientific outputs of keen public interest such as its opinion on aspartame. This ensures that EFSA considers the widest possible range of views and scientific information. Feedback from the public consultation is then compiled in a report and, where appropriate, incorporated into the final scientific output.
10. What were the main results of the public consultation?
11. Why have questions been raised about aspartame in the past?
12. What information did EFSA look at? Has it reviewed the studies submitted with the original application for the authorisation of aspartame in Europe?
The ANS Panel’s comprehensive review was made possible following two public calls for data. As part of its re-evaluation, EFSA launched a public call for scientific data as well as a thorough literature review. The Authority received access to over 600 both published and unpublished scientific studies and datasets following the call for data. Reaffirming its commitment to openness and transparency, EFSA published the full list of these scientific studies and also made publicly available on the EFSA website previously unpublished scientific data including the 112 original documents on aspartame which were submitted to support the request for authorisation of aspartame in Europe in the early 1980s. These studies have been critically evaluated and underpin the discussion points addressed in the opinion.
In the course of its scientific deliberations, the Panel found that there were too little data available on 5-benzyl-3,6-dioxo-2-piperazine acetic acid (DKP) and other potential degradation products that can be formed from aspartame in food and beverages when stored under certain conditions. EFSA therefore launched an additional call for data on DKP and other degradation products of aspartame. The Authority received over 140 studies and datasets as a result of this call.
The ANS Panel considered close to 2,000 studies and datasets during its risk assessment; some 800 of these were received as a result of its two calls for data. The Panel’s opinion references 365 published studies and 147 additional studies received during the calls for data.
Lists of published and unpublished studies and data files available for download:
13. Does EFSA only consider studies funded by industry? Can these studies be trusted?
14. The independence of scientific advice given on aspartame has at times been questioned. How does EFSA guarantee the independence of its scientific advice?
- Topic: Independence
15. What are EFSA’s scientists doing to make their decision-making as transparent as possible?
16. Who regulates the use of aspartame within the EU? What is EFSA’s role?
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.
Questions on EFSA’s 2013 opinion:
17. What are the main conclusions of the opinion?
18. Given EFSA is not proposing any change to the ADI, what is different about this scientific opinion?
19. Does the scientific opinion specifically address all aspects relating to the safety of aspartame?
The Panel also confirmed that the ADI, while protective of the general population (including infants, children and pregnant women), is not applicable to people who suffer from PKU, as they require strict adherence to a diet low in phenylalanine (PKU is an inherited disorder which increases blood phenylalanine concentrations to levels toxic to the developing brain).
20. What are the Panel’s conclusions regarding specific safety concerns?
- Studies do not suggest an increased risk associated with aspartame consumption for pre-term delivery in pregnant women, leukaemia, brain tumours or a variety of cancers, including brain, lymphatic and haematopoietic (blood) cancers.
- The weight of evidence suggests that aspartame ingestion has no effect on behaviour or cognitive function.
- There is no evidence that consuming aspartame causes seizures.
- There is no convincing evidence that consuming aspartame causes headaches.
- The weight of evidence shows that aspartame is not associated with allergic type reactions.
- Methanol derived from aspartame is a small portion of total exposure to methanol from all sources.
- The contribution of breakdown products of aspartame (phenylalanine, methanol and aspartic acid) to the overall dietary exposure to these substances is low.
21. Do these conclusions also take into consideration EFSA’s recent scientific work on aspartame?
For EFSA’s 2013 risk assessment, the ANS Panel has re-examined these studies in full.
22. Is there scientific evidence that pregnant women should not consume products containing aspartame?
Furthermore, in relation to EFSA’s previous work the Panel’s new assessment of the Halldorsson et al. (2010) publication 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. In an additional study conducted in Norway by Englund-Ögge et al. (2012), there was a barely discernible association of pre-term delivery with artificially sweetened soft drinks. In fact, this was not as strong as the association with sugar-sweetened soft drinks.
23. What about the second study that looked at long-term carcinogenic effects?
24. What happens to aspartame in the body once it is ingested?
Aspartic acid, phenylalanine and methanol are also present naturally in other foods including fruit and vegetables and, for foods containing aspartame, are processed by the body in the same way as those derived from other dietary sources. By comparison, the amounts of these components ingested from foods and drinks containing 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.
25. Are there any safety concerns related to aspartic acid?
26. Is methanol from aspartame a safety concern?
Based on the available scientific evidence, EFSA’s experts concluded that dietary exposure to methanol from aspartame does not pose a safety concern. The same applies to formaldehyde, a metabolite of methanol.
27. What about the safety of phenylalanine?
Phenylketonuria (PKU) is a hereditary human disorder that causes high levels of phenylalanine and low levels of tyrosine in the blood. High phenylalanine concentrations in blood are toxic to the brain and can, if left untreated, affect brain development and cause mental retardation, mood disorders and behavioural problems. This is especially critical to the developing foetus in women suffering from PKU. Most PKU treatment aims to keep blood phenylalanine at acceptable levels by restriction of foods rich in protein (meat, fish, eggs, bread, dairy products, nuts and seeds), as well as foods and drinks containing aspartame.
The Panel confirmed that the ADI, while protective of the general population, is not applicable to people who suffer from PKU, as they require strict adherence to a diet low in phenylalanine. In regulating the use of aspartame in foods, EU risk managers have recognised the need to ensure that PKU sufferers are made aware of the presence of aspartame in foods so that they can avoid exposure to this substance. In the European Union, because they are a source of phenylalanine, all products containing aspartame must be labelled “Contains a source of phenylalanine”.
28. How did EFSA use human studies in its review of the current ADI for aspartame?
The Panel compared blood phenylalanine levels in humans following consumption of aspartame, with blood phenylalanine levels associated with developmental effects in children born from PKU mothers. Current clinical guidelines recommend that levels of phenylalanine in blood are maintained below 6 mg/dl. By comparison, for PKU patients, mild effects have been associated with levels of 10-13mg/dl, whilst significant detrimental effects have been associated with levels exceeding 20mg/dl of phenylalanine in the blood. In calculating a safe level of aspartame exposure (based on blood phenylalanine concentrations), the ANS Panel assumed a worst-case scenario that intake of aspartame occurs in combination with an everyday meal (containing naturally occurring sources of phenylalanine). The Panel estimated that even an hourly dose of aspartame equal to the current ADI would result in peak blood phenylalanine concentrations of 240 µM, well below the current clinical guidelines. This implies that an adult weighing 60kg would have to drink 12 (330ml) cans of a diet soft drink (containing aspartame at the maximum permitted levels of use), every hour to reach this blood phenylalanine concentration.
29. Is Di-ketopiperazine (DKP) from aspartame a safety concern?
The EU has set an Acceptable Daily Intake for DKP of 7.5 milligrams per kilogram body weight per day (mg/kg bw/day) to protect consumers against possible harmful effects of this substance in food. Based on exposure levels for aspartame, exposure to DKP from all food and drink using the sweetener would on average be approximately 0.1 to 1.9 mg/kg bw/day for all population groups.
Given these findings, EFSA’s experts concluded that consumer safety is not at risk from exposure to DKP from aspartame in foods and drinks.
30. Does the opinion highlight any uncertainties?
In addition, the opinion discusses potential uncertainties related mainly to the difficulties associated with using different sources of data, both on consumption and on the levels of aspartame in foods. In many cases, these are the result of national differences in terms of reporting methodologies and standards, or other technical difficulties experienced in adequately assessing exposure. For example, data may refer to acute (one-off) exposure when chronic (long-term) information is needed. Food and drink categories and portion sizes may also differ. Overall, most of these uncertainties are likely to have led to an overestimation of consumer exposure, however in some cases there could be an underestimation (mainly on consumption data and actual use levels of aspartame in foods). (See Table 18 of the opinion for an overview.)