WHAT IS ASPARTAME?
Aspartame is a low-calorie sweetener that is considered to be a safe and effective alternative to sugar by public health authorities around the world.
Aspartame has been used for decades in a wide variety of food and beverage products including soft drinks, yoghurts and chewing gum. Aspartame is also frequently used as a tabletop sweetener to replace sugar, for example in tea and coffee.
For more information on aspartame and low- and no-calorie sweeteners, the International Sweeteners Association (ISA) is an authoritative source providing science-based information on these ingredients to support public understanding of their safety and benefits. Read more about the lSA news and scientific analyses of the latest research on aspartame here.
WHAT ARE THE SAFE LEVELS OF CONSUMPTION FOR ASPARTAME?
In Europe, the European Food Safety Authority (EFSA) sets the ‘Acceptable Daily Intake’ (ADI), which is the amount of aspartame, like any other food additive, that can be consumed daily in the diet, over a whole lifetime, without risk to health.
The ADI is expressed on a body weight basis –milligrams (mg) per kilogram (kg) of body weight (bw) per day.
The ADI has a huge safety margin – it is usually 100 times lower than the amount known NOT to have any adverse effects.
As an example, for an adult, the equivalent of consuming the upper level of the ADI on any given day for aspartame, through consuming soft drinks alone (and if sweetened at the EU maximum permitted level), would equate approximately to 4 litres of soft drink.
ASPARTAME IS SAFE
Aspartame has a long track record of scientific studies confirming it to be a safe.
More than 100 scientific studies conducted by more than 200 independent researchers over 40 years confirm aspartame is safe.
Food safety agencies from over 90 countries, including EFSA, the U.S. FDA, Health Canada, UK Food Standards Agency, Food Safety Commission of Japan, and Food Standards Australia and New Zealand say aspartame is safe. Nothing has changed to undermine that.
EFSA and WHO re-affirm the safety of aspartame
GLOBAL REACTIONS FROM FOOD SAFETY AUTHORITIES AND REGULATORS TO THE PUBLICATION OF THE IARC AND JECFA ASSESSMENTS
EUROPE
AUSTRIA
Austrian Agency for Health and Food Safety (AGES)
WHO/JECFA findings that “there is no convincing evidence that aspartame has adverse effects” […] are in line with the conclusions of [the European Food Safety Authority] 2013 assessment on aspartame.” Moreover, “daily intake of aspartame in [Austrian] children, adolescents, adults and pregnant women was between max. 0.16- 1.38 mg/kg bw/day. This means that their intake is only about 3.5% of the Acceptable Daily Intake.”
BELGIUM
Belgian Federal Public Service (FPS) Health, Food Chain Safety and Environment
“There is … no reason for JECFA to change the acceptable daily intake of 40 mg of aspartame per kilogram of body weight per day. The consumption of aspartame within this limit is… still considered safe.”
CROATIA
Croatian Agency for Agriculture and Food (HAPIH)
“Aspartame has been approved for human consumption for many years after thorough safety assessments, and the European Food Safety Authority (EFSA), which is in charge of assessing the safety of food additives in the EU, conducted the last aspartame risk assessment in 2013. New findings from IARC and JECFA confirmed the conclusions of EFSA’s assessment of
CZECHIA
Vlastimil Valk, Minister of Health of Czechia
“It’s not even that there is a huge risk, but it’s that even a minimal risk doesn’t occur, that’s why we’re always much more careful and strict. In practical terms, it will mean absolutely nothing for the Czech citizen.”
ESTONIA
Mari Reinik, Deputy Director of the National Centre for Laboratory Research and Risk Assessment
“Since the acceptable dose has not been changed based on current research, it does not give a direct signal to change people’s behavior.”
Estonian Food Safety Authority “The risk of possible health hazards to consumers was evaluated by the expert committee of additives, which found that the current safe daily amount, or ADI, remains valid. “Daily intake of aspartame in both children and adults is below the current ADI. “An adult should drink almost five liters of aspartame-containing sugar-free soft drinks a day, so that we can talk about the risk to health,” said Reinik… In the European Union (including Estonia), the European Food Safety Authority (EFSA) assesses the safety of additives. EFSA updated the availability estimates for aspartame, and data currently do not indicate that aspartame intake exceeds the safe daily intake in any age group.”
GREECE
Hellenic Food Authority (EFET)
“It is emphasized that IARC does not have the authority to make health-related recommendations. Therefore, IARC does not recommend legislation or other public health interventions, which are the responsibility of other international organizations and national bodies. JEFCA concluded that there is no convincing evidence from animal or human studies that aspartame has adverse health effects after its consumption.
Regarding epidemiological studies, the JEFCA committee concluded that a consistent (clear) association between aspartame consumption and any specific type of cancer has not been demonstrated.
Evaluating all of the above, JEFCA does not change the value of the Acceptable Daily Intake for aspartame, which remains 40 mg/kg of body weight per day.
For aspartame, this value, based on today’s opinion of JEFCA, does not change and remains the same as that of the European Food Safety Authority (EFSA) which is set as 40 mg/kg of body weight per day.’’
HUNGARY
National Food Chain Safety Office (NEBIH)
Comments from György Pleva, director of food and feed safety at Nébih
“This means that the carcinogenic effect of aspartame itself has not been directly confirmed, but it may happen that under certain circumstances, above a certain amount, the possibility of cancer increases.” For this reason, it was judged that the current average daily intake value does not need to be reduced, since the results of the research were not considered to be well-founded, and further investigation is needed to assess a more serious tightening. This means that, as in the world, in the European Union as well, 40 mg per kilogram of body weight is the permissible value in the future.”
IRELAND
Food Safety Authority of Ireland
“JECFA concluded that there was no convincing evidence from experimental animal or human data that aspartame has adverse effects after ingestion. […] The findings of JECFA are in line with the conclusions of the European Food Safety Authority’s (EFSA) latest assessment on aspartame in 2013. Aspartame has also been evaluated by numerous scientific committees internationally over many years and has been found to be safe. It is authorised for human consumption in many countries following thorough safety assessments.”
PORTUGAL
Portuguese Food Safety Authority (ASAE)
“ASAE’s Scientific Council considers that there is no new data to change the EFSA recommendations regarding the use of aspartame as a sweetener. The admissible daily dose of 40 mg/kg bw/d does not pose an increased health risk. […] The epidemiological studies carried out to date do not show a direct relationship between the consumption of aspartame and the incidence of cancer or other disease caused by aspartame.”
SWEDEN
The Swedish Food Agency
“… there are no known risks of consuming aspartame. The Swedish Food Agency therefore has no special recommendations regarding the consumption of aspartame.
JECFA considers the evidence for a link between the consumption of aspartame and human cancer to be inconclusive. JECFA’s conclusion is that the data evaluated do not provide sufficient reason to change the previously established maximum daily intake for consumers (ADI value).’’
UNITED KINGDOM
United Kingdom Food Standards Agency
“JECFA’s report supports the Food Standards Agency’s view that aspartame is safe to consume at current permitted use levels.”
GLOBAL
UNITED STATES
United States Food and Drug Administration
“The FDA disagrees with IARC’s conclusion that these studies support classifying aspartame as a possible carcinogen to humans. FDA scientists reviewed the scientific information included in IARC’s review in 2021 when it was first made available and identified significant shortcomings in the studies on which IARC relied. We note that JECFA did not raise safety concerns for aspartame under the current levels of use and did not change the Acceptable Daily Intake (ADI). Aspartame is one of the most studied food additives in the human food supply. FDA scientists do not have safety concerns when aspartame is used under the approved conditions. The sweetener is approved in many countries. Regulatory and scientific authorities, such as Health Canada and the European Food Safety Authority have evaluated aspartame and also consider it safe at current permitted use levels.”
CANADA
Health Canada
“…scientific advisory bodies such as the Scientific Committee for Food of the European Community, and the Joint Expert Committee on Food Additives (JECFA) of the United Nations Food and Agriculture Organization and World Health Organization have reviewed all the available safety studies and have found aspartame to be safe. More than ninety countries world-wide, including the United States, countries of the European Union, and Australia and New Zealand, have also reviewed aspartame and found it to be safe for human consumption and allow its use in various foods.”
BRAZIL
Brazil Health Regulatory Agency (ANVISA)
“In Brazil, the use of sweeteners must be authorized by Anvisa, which carries out safety assessments, including the definition of maximum limits. This assessment is carried out based on the FAO and WHO guidelines, which have remained the same. Aspartame has been the subject of extensive investigation, including experimental studies, clinical trials, epidemiological and exposure studies, and post-market
surveillance. […] There is a consensus among several international committees considering aspartame safe, when consumed within the acceptable daily intake. […] So far, there is no change in the safety profile for the consumption of aspartame […] Furthermore, it is important to bear in mind that there are no new recommendations approved by the WHO.”
CHILE
Chile Diego Varela, Executive Secretary of the Chilean Agency for Food Safety and
Quality (ACHIPIA), Vice-Chair of the WHO/FAO Codex Alimentarius Commission
“JECFA notes that there is insufficient evidence to change the previously established
Acceptable Daily Intake (ADI) from 0 to 40 mg/kg of body weight for aspartame.
Therefore, the Committee reaffirmed that the consumption of a daily amount that is
within this limit is safe. […] I highlight the need to be informed responsibly, seeking the
primary sources of information and avoiding the dissemination of incomplete,
superficial, sensationalist and irresponsible information. Call goes also to the press to
be responsible when communicating food issues.”
NIGERIA
National Agency for Food and Drug Administration and Control (NAFDAC) Nigeria
“Aspartame is safe to consume in food products within established limit of 40mg/kg body
weight.”
JORDAN
Jordan Food and Drug Administration (JFDA)
“JFDA clarified that the classification of aspartame as a potential carcinogen indicates a lack of definitive scientific evidence proving its link to cancer. He noted that aspartame use is allowed under applicable legislations and the Codex Alimentarius Commission. He emphasized the importance of reading the label of any food product, paying attention to warnings, and adhering to the daily intake of sweeteners without overconsuming them.”
SAUDI ARABIA
Kingdom of Saudi Arabia Saudi Food and Drug Authority (SFDA):
“SFDA explains that it has conducted many scientific evaluations on the safety of the
substance during the past years, which included reviewing all scientific evaluations
from international organizations and international bodies concerned with food safety
control and sharing information and research with those bodies, which proved that
there are no concerns associated with aspartame.
The Authority also pointed out that aspartame has been used for more than 40 years
and is found in more than six thousand products in various countries of the world,
and there is no evidence or scientific evidence proving the danger of its
consumption.”
ISRAEL
Ministry of Health of Israel
“There is currently no warning not to consume beverages containing aspartame.”
OMAN
Oman Food Safety and Quality Center
Oman authorities reaffirmed the conclusion from JECFA that aspartame is safe, saying of the acceptable daily limit established by JECFA that “it is not easy to reach this quantity per one day.”
CHINA
China National Food Safety Risk Assessment Center
“The National Food Safety Risk Assessment Center (CFSA) and the National Cancer Center reviewed the latest assessment results of JECFA and the consumption of Chinese residents to conduct safety assessment, and confirm that aspartame can be used in accordance with China’s current standards and specifications to ensure
safety.”
INDIA
Food Safety and Standards Authority of India
“FSSAI has taken cognizance on the WHO’s report in the Indian context. All the major highlights of the report and the related Scientific facts about the non-Sugar sweeteners were
discussed. It was found that country specific studies are needed to explore the NSS/Aspartame’s impact on metabolic processes, as well as its links to other diseases. FSSAI is in agreement with JECFA IARC conclusions accord the response of other global regulatory bodies. In the absence of substantive established evidence on the safety of NSS/ Aspartame,
FSSAI is retaining the existing limits.”
INDONESIA
Indonesian Food and Drug Authority – BPOM
“Until now, Codex Alimentarius Commission (CAC) as an international food standard organization under FAO / WHO still recommends the use of aspartame in processed foods and based on this, aspartame is still categorized as safe.
Regulations in Indonesia refer to the Codex General Standard for Food Additives (Codex GSFA) and currently still allow aspartame as an artificial sweetener in food products.
Based on the points above, regulations for aspartame artificial sweetener food additives still remain in accordance with the maximum limit set in BPOM Regulation Number 11 of 2019 concerning Food Additives. BPOM does not need to make changes to the regulation of the use of aspartame in processed foods. However, it continues to monitor further developments regarding aspartame safety studies by IARC and JECFA.”
AUSTRALIA/NEW ZEALAND
Food Standards Australia/New Zealand
“This is good news for consumers in Australia and New Zealand who can be assured our food standards for aspartame align with international benchmarks. The JECFA conclusion is in line with numerous international studies which have found aspartame to be safe at current permitted levels of use with exposures below the ADI. The JECFA work confirms the standards for aspartame in the Australia New Zealand Food Standards Code are appropriate and current.”
JAPAN
Japan Food Safety Commission
‘’The Japanese Food Safety Commission referenced long-standing positive research from agencies including the European Food Safety Authority, which said there are no safety concerns and there is no need to change the ADI, as well as the FDA, which concluded there is no reason to change the ADI of 50 mg/kg body weight per day for aspartame as a general sweetener in foods.’’
REPUBLIC OF KOREA
Republic of Korea Ministry of Food and Drug Safety
“South Korea’s Ministry of Food and Drug Safety said it has decided to retain the country’s daily intake level of 40 mg/kg, considering the JECFA’s recommendation and the aspartame consumption of South Korean people.”
TAIWAN
Taiwan Food and Drug Administration
“Lin Jinfu, deputy director of the Food and Drug Administration, pointed out that aspartame is an artificial sweetener, which is about 200 times sweeter than sucrose. At present, the food safety law is nuclear and can be used […] Internationally, it is roughly the same as the food safety law of the same as that of China, such as the European Union, Japan, etc.”
THAILAND
Thai Food and Drug Administration
“Pharmacist Lertchai Lertwut, Deputy Secretary-General of the [Thai] Food and Drug Administration revealed that the FDA there is an inspection and assessment of the safety of the use of aspartame […] consumers are requested to be confident that the sweeteners that are approved by the [Thai] FDA and supervise their use in accordance with the Ministry of Public Health’s announcement are safe.”
WHAT SCIENTISTS SAY
“In short, the evidence that aspartame causes primary liver cancer or any other cancer in humans is very weak… Group 2b is a very conservative classification in that almost any evidence of carcinogenicity, however flawed, will put a chemical in that category or above.”
“If the ADI is maintained by JECFA and other agencies and food safety authorities worldwide due to lack of scientific evidence, alarmism should not be generated. I don’t imagine that an institution like the WHO says that a drug poses a risk and the medicines agencies or authorities say otherwise, who are the ones that really evaluate the safety and efficacy of medicines.’’
“Classification alone is, at most, useless and in several cases—like in this case—is dangerous. It’s the dose that matters. Almost anything can be toxic if you have enough of it—even water.‘’
“These IARC reports are getting a bit farcical. In spite of the IARC’s conclusion that aspartame was ‘possibly carcinogenic to humans’, which got lots of media attention, another expert committee (JECFA), which actually investigates the magnitude of any risk, found ‘no convincing evidence from experimental animal or human data that aspartame has adverse effects’. “As they have said for 40 years, average people are safe to drink up to 14 cans of diet drink a day, which is about an old gallon — about half a large bucketful. And even this ‘acceptable daily intake’ has a large built-in safety factor.”
‘’The [WHO committee’s] decision puts aspartame in the same category as things like aloe vera and bracken ferns. There is no convincing evidence that it causes cancer in humans and people shouldn’t be worried about getting cancer from aspartame in food and drink. Your overall diet is more important than individual foods or ingredients for reducing cancer risk. So, aim to eat a healthy, balanced diet, with more fruit, veg and wholegrains, and cut back on red and processed meats and foods high in fat, sugar and salt.”
“Importantly, the same evidence that IARC considered and their report have been examined by JECFA, the WHO/FAO committee responsible for estimating whether there are any risks or likelihood of cancer developing associated with aspartame consumption. The committee saw no new reasons to change its longstanding recommendation of an acceptable daily intake 0-40 mg per kg of bodyweight without appreciable health risk.”
“Aspartame has not previously been classified by IARC, so its classification cannot yet have changed. It is in group 2B, not group 3, but the issue of the lack of good enough evidence does seem to apply to aspartame too.” “But for now IARC have put aspartame in group 2, so they are saying it could possibly cause cancer under some circumstances, but that this is far from certain. So it remains perfectly possible that it cannot cause human cancers at all.” “JECFA say that high estimates of actual consumption were 20 mg/kg bodyweight for children and 12 mg/kg of bodyweight for adults, which are well below the 40mg/kg ADI.”
“The Joint FAO/WHO Expert Committee on Food Additives committee has not changed its safety rating on Aspartame which they set at 40mg/kg body weight which for a 70 kg adult would mean drinking roughly 14 cans of Diet Coke a day, over a long period. This is consistent will all the major food safety agencies around the world who regularly conduct their own assessments and all classify aspartame as safe at the levels it is used at.” “We are all exposed to carcinogens every day. Even things that the IARC classifies as class one carcinogens, such as UV light and alcohol, do not cause cancer just because you are exposed to them once. For example, if you get too much sun on the beach in summer you might get sunburn but you’ll recover. If you continually sunbathe with no sun protection then your risk of skin cancer goes up.”
“It is somewhat difficult to judge this report as, at this stage all that IARC is publishing only a summary with a brief description of the interpretation of the available evidence by the expert working group, but, the full report with details of all the evidence considered will be published later. In short there is weak epidemiological evidence that aspartame is associated with an increased risk of primary liver cancer (that is cancer that arises in the liver rather than a cancer that started elsewhere and spread to the liver, or secondary liver cancer). This evidence comes from three studies that have reported an association but there is not much evidence to suggest that the association is ‘causal’ (association/correlation does not necessarily mean causation). In addition there was limited evidence that aspartame is carcinogenic in experimental animals, but this evidence was thought to have serious flaws. Finally, aspartame has some chemical properties that might be cancer associated.” “In short the evidence that aspartame causes primary liver cancer, or any other cancer in humans is very weak. This is why it is classified as Group2B. Other examples of classified as Group2B are extract of aloe vera, diesel oil, caffeic acid found in tea and coffee. Group 2B is a very conservative classification in that almost any evidence of carcinogenicity, however flawed will put a chemical in that category or above.” “This is reflected in the view of the Joint FAO/WHO Expert Committee on Food Additives who concluded that there was no convincing evidence from experimental animal or human data that aspartame has adverse effects after ingestion. They noted that aspartame is rapidly metabolised into chemicals found in many common foods. Thus the JECFA had no reason to alter their current recommendation on an acceptable daily intake of aspartame.” “The general public should not be worried about the risk of cancer associated with a chemical classed as Group 2B by IARC.”
“The conclusions of IARC and JECFA on aspartame reflect the respective approaches taken by the two committees. IARC has classified aspartame as 2b, which reflects a lack of confidence that the data from experimental animals or from humans is sufficiently convincing to reach a clear conclusion that aspartame is carcinogenic. But IARC did conclude that any carcinogenicity was most likely through an indirect effect and not through direct interaction with DNA (genotoxicity). JECFA reviewed all of the toxicological effects of aspartame including carcinogenicity and genotoxicity. The weight of evidence did not support any carcinogenic effect and JECFA found no basis to change its previously established acceptable daily intake. Hence, exposure at current levels would not be anticipated to have any detrimental effects.”
“The new data in the IARC report suggests a possible link between liver cancer and aspartame in some observational studies. There has been a marked increase in liver cancer related to obesity in several Western countries, notably in the USA, that is associated with non-alcoholic fatty liver disease. Type 2 diabetes and obesity are major cause of fatty liver disease. Sugar intake has been previously linked to fatty liver disease as it encourages the synthesis of fat in the liver. There is no evidence that aspartame increases fat accumulation in the liver. People with diabetes or who are obese are more likely to use artificial sweeteners compared with those who are not obese. Consequently, this association while consistent may not be causal.” “IARC noted the evidence is limited because they cannot rule out confounding factors and because the data from animal studies is inconsistent, aspartame was classified 2b – a possible cancer hazard. JECFA, however, does not believe the risks posed by aspartame are anything to be concerned about providing the amounts of aspartame consumed are below the acceptable daily intake, which are unlikely to be exceeded in practice.”
“The publication of the IARC and JECFA opinion is very welcome as it ends the speculation about the safety of Aspartame. The two WHO agencies have done what they are supposed to do: IARC has reviewed the data and found some very limited evidence that Aspartame could cause cancer – and based on the same data JECFA has concluded that a consumption up to 40 mg per kg of body weight per day is safe and there is no need to change current recommendations.” “It is unfortunate that leaking some information might have created unnecessary uncertainty and concern as consumers might be rightfully worried if they are told that something that is in many foods could cause cancer. The published opinion puts this into perspective and makes it very clear that there is no cause for concern when consumed at the current amounts. Scientific advisory bodies are often unable to react quickly and respond to an emerging story so it’s good they will now have both the IARC and JECFA assessments to digest and respond to.” “This illustrates also the importance of distinguishing between hazard and risk and highlights the difficulty in communicating hazards: sunlight is a hazard as it can cause cancer, but the risk depends on the amount of sun light and whether we use protection. Likewise, even if Aspartame causes cancer at very high amounts, there is no risk when consuming it at the amounts that are permitted in foods.”
KEY RESOURCES
- Critical role of JECFA expert risk assessment body reinforced as report on aspartame published by CODEX Alimentarius (international food safety standards)
- A critical appraisal of the WHO reviews of aspartame by the International Sweeteners Association (ISA)
- In the news: does aspartame increase our risk of cancer? by European Food Information Council (EUFIC)
- Belgian website on sweeteners – Edulcorants
- Dutch website on sweeteners – Zoetstoffen
Media statements on the release of the WHO reviews