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    Questions on Aspartame

    ome > Studies > Aspartame

    Scientific Facts on Aspartame

    This study is a faithful summary of the " Update on the Safety of Aspartame ",

    a leading scientific consensus report produced in 2002

    by the EC-SCF (European Commission Scientific Committee on Food).

    The study is written in a language for non-specialistsand structured in 3 levels of increasing detail.

    More info on our 3-level structure

    Questions on Aspartame

    1. What is aspartame ?

    2. How much aspartame do people consume ?

    3. What happens to aspartame once it is ingested ?

    4. Can aspartame affect human health ?

    5. Conclusion6. Other views on aspartame

    GreenFacts 3-Levels Structure

    Our Aspartame study is structured into 3 levels of increasing detail:the SUMMARY, the DETAILS and the SOURCE.

    Click below on the level you want to access.

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    http://www.greenfacts.org/index.htmhttp://www.greenfacts.org/studies/index.htmhttp://europa.eu.int/comm/food/fs/sc/scf/out155_en.pdfhttp://www.greenfacts.org/glossary/abc/consensus.htmhttp://www.greenfacts.org/links/site-boxes/ec_scf.htmhttp://www.greenfacts.org/studies/navigation.htmhttp://www.greenfacts.org/studies/navigation.htmhttp://www.greenfacts.org/links/site-boxes/ec_scf.htmhttp://www.greenfacts.org/glossary/abc/consensus.htmhttp://europa.eu.int/comm/food/fs/sc/scf/out155_en.pdfhttp://europa.eu.int/comm/food/fs/sc/scf/out155_en.pdfhttp://www.greenfacts.org/fr/aspartame/index.htmhttp://www.greenfacts.org/es/aspartamo/index.htmhttp://www.greenfacts.org/studies/index.htmhttp://www.greenfacts.org/index.htmhttp://www.greenfacts.org/about/index.htmhttp://www.greenfacts.org/search/index.htmhttp://www.greenfacts.org/links/index.htmhttp://www.greenfacts.org/studies/index.htmhttp://www.greenfacts.org/index.htmhttp://www.greenfacts.org/about/toolboxes/subscribe.htmhttp://www.greenfacts.org/index.htm
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    Questions on Aspartame

    More info on our 3-level structure

    Click above on the level you want to access.

    Send this page Subscribe to our newsletter Download this study

    Contact | Copyright | Glossary | Sitemap | Link to us | Feedback | About Top

    27-Jul-2004

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    http://www.greenfacts.org/studies/navigation.htmhttp://www.greenfacts.org/about/toolboxes/tellafriend.phphttp://www.greenfacts.org/about/toolboxes/subscribe.htmhttp://www.greenfacts.org/aspartame/download.htmhttp://www.greenfacts.org/about/toolboxes/contact.htmhttp://www.greenfacts.org/about/toolboxes/copyright.htmhttp://www.greenfacts.org/glossary/index.htmhttp://www.greenfacts.org/sitemap.htmhttp://www.greenfacts.org/about/webmaster/index.htmhttp://www.greenfacts.org/about/feedback.phphttp://www.greenfacts.org/about/index.htmhttp://www.greenfacts.org/about/index.htmhttp://www.greenfacts.org/about/feedback.phphttp://www.greenfacts.org/about/webmaster/index.htmhttp://www.greenfacts.org/sitemap.htmhttp://www.greenfacts.org/glossary/index.htmhttp://www.greenfacts.org/about/toolboxes/copyright.htmhttp://www.greenfacts.org/about/toolboxes/contact.htmhttp://www.greenfacts.org/aspartame/download.htmhttp://www.greenfacts.org/aspartame/download.htmhttp://www.greenfacts.org/about/toolboxes/subscribe.htmhttp://www.greenfacts.org/about/toolboxes/subscribe.htmhttp://www.greenfacts.org/about/toolboxes/tellafriend.phphttp://www.greenfacts.org/about/toolboxes/tellafriend.phphttp://www.greenfacts.org/studies/navigation.htmhttp://-/?-
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    Questions on Aspartame

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    Aspartame : Level 1 - Summary on Aspartame

    ome > Studies > Aspartame > Level 1

    Scientific Facts on Aspartame

    Info on our studies structure

    Level 1 - Summary on Aspartame

    1. What is aspartame ?

    2. How much aspartame do people consume ?3. What happens to aspartame once it is ingested ?

    4. Can aspartame affect human health ?

    5. Conclusion

    6. Other views advocated on aspartame

    Level 1 Questions More in Details

    Next Question Top

    . What is aspartame ?

    1.1. Aspartame is a non caloric sweetener. It was discovered in 1965 and entered the market in the 80s. A numberof national and international organizations have assessed the safety of aspartame and an international committee oexperts established an Acceptable Daily Intake value. However, some allegations of health risks have launched a

    debate. More...

    1.2. Aspartame is a white, odourless powder, approximately 200 times sweeter than sugar, used in a number offoodstuffs throughout the world. It is marketed under several brand names, including Canderel and NutraSweetand is labelled E951 in Europe. Aspartame is stable when dry or frozen but it breaks down and loses its sweetnessover time when stored in liquids at temperatures above 30C. More...

    1.3. Some concerns have been raised about aspartame and its breakdown products. For example, it has beensuggested that aspartame may cause headaches, epilepsy and brain tumors. More...

    Conclusion Level 1 Questions More in Details

    Next Question Top

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    http://www.greenfacts.org/index.htmhttp://www.greenfacts.org/studies/index.htmhttp://www.greenfacts.org/studies/navigation.htmhttp://www.greenfacts.org/glossary/abc/ADI-acceptable-daily-intake.htmhttp://www.greenfacts.org/glossary/pqrs/risk.htmhttp://-/?-http://-/?-http://-/?-http://-/?-http://-/?-http://-/?-http://www.greenfacts.org/glossary/pqrs/risk.htmhttp://www.greenfacts.org/glossary/abc/ADI-acceptable-daily-intake.htmhttp://www.greenfacts.org/studies/navigation.htmhttp://www.greenfacts.org/fr/aspartame/index.htmhttp://www.greenfacts.org/es/aspartamo/index.htmhttp://www.greenfacts.org/studies/index.htmhttp://www.greenfacts.org/index.htmhttp://www.greenfacts.org/about/index.htmhttp://www.greenfacts.org/search/index.htmhttp://www.greenfacts.org/links/index.htmhttp://www.greenfacts.org/studies/index.htmhttp://www.greenfacts.org/index.htmhttp://www.greenfacts.org/about/toolboxes/subscribe.htmhttp://www.greenfacts.org/index.htm
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    Aspartame : Level 1 - Summary on Aspartame

    2. How much aspartame do people consume ?

    The consumption of aspartame in Europe is between 2.8 and 10.1 mg/kg body weight per day. It is estimated to bewell below the Acceptable Daily Intake (ADI) set by the international committee of experts of the Food and

    Agriculture Organization (FAO) and the World Health Organization (WHO), even for children and high consumers su

    as diabetics. More...

    Conclusion Level 1 Questions More in Details

    Next Question Top

    3. What happens to aspartame once it is ingested ?

    Following ingestion, aspartame itself does not enter the bloodstream, but instead breaks down in the intestine intothree components: aspartic acid, phenylalanine and methanol. Following this, the blood concentration of

    phenylalanine may increase after high doses surpassing the Acceptable Daily Intake (ADI), while those of aspartic

    acid and methanol do not. More...

    Conclusion Level 1 Questions More in Details

    Next Question Top

    4. Can aspartame affect human health ?

    Many studies have been conducted on aspartame and its breakdown products in experimental animals and inhumans. To date, they conclude that:

    4.1. There is no link between aspartame and damage to the genes or cancer. More...

    4.2. Aspartame does not affect reproduction and development, apart from marginal effects at a very high dose morthan 100 times greater than the Acceptable Daily Intake (ADI). More...

    4.3. Aspartame does not produce nervous system disorders. More...

    4.4. Aspartame does not affect behaviour, cognition and mood, except possibly in depressed individuals. More...

    4.5. Aspartame has not been found to trigger headaches. More...

    4.6. A large number of scientists have refuted a suggested link between aspartame and epileptic seizures. More...

    4.7. Aspartame does not cause allergies and has not been shown to increase body weight. More...

    Conclusion Level 1 Questions More in Details

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    Aspartame : Level 1 - Summary on Aspartame

    Top

    5. Conclusion

    Several scientific committees have reviewed the health risks of aspartame and its breakdown products: aspartic aci

    phenylalanine and methanol.

    Their conclusions are:

    q People get far less aspartic acid, phenylalanine and methanol from aspartame than from normal consumptioof natural foods.

    q Aspartame intakes are unlikely to exceed the current Acceptable Daily Intake (ADI), even for children and

    diabetics.q While some minor effects on health may occur at very high doses, no effects are expected at or below the

    ADI. More...

    Conclusion Level 1 Questions More in Details

    Top

    6. Some of the views advocated on aspartame

    This summary is based on the latest European Commission Scientific Committee on Food (EC-SCF) Update on the

    Safety of Aspartame. It is considered by most scientists as a consensus document and other assessments reach

    rather similar conclusions- click here for some links.

    Some people and organizations believe that aspartame does pose risks to consumers.

    Conclusion Level 1 Questions

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    http://www.greenfacts.org/glossary/pqrs/risk.htmhttp://www.greenfacts.org/glossary/abc/aspartic-acid.htmhttp://www.greenfacts.org/glossary/pqrs/phenylalanine.htmhttp://www.greenfacts.org/glossary/mno/methanol-methyl-alcohol.htmhttp://www.greenfacts.org/glossary/abc/ADI-acceptable-daily-intake.htmhttp://www.greenfacts.org/links/site-boxes/ec_scf.htmhttp://www.greenfacts.org/glossary/abc/consensus.htmhttp://www.greenfacts.org/about/toolboxes/tellafriend.phphttp://www.greenfacts.org/about/toolboxes/subscribe.htmhttp://www.greenfacts.org/aspartame/download.htmhttp://www.greenfacts.org/about/toolboxes/contact.htmhttp://www.greenfacts.org/about/toolboxes/copyright.htmhttp://www.greenfacts.org/glossary/index.htmhttp://www.greenfacts.org/sitemap.htmhttp://www.greenfacts.org/about/webmaster/index.htmhttp://www.greenfacts.org/about/feedback.phphttp://www.greenfacts.org/about/index.htmhttp://www.greenfacts.org/about/index.htmhttp://www.greenfacts.org/about/feedback.phphttp://www.greenfacts.org/about/webmaster/index.htmhttp://www.greenfacts.org/sitemap.htmhttp://www.greenfacts.org/glossary/index.htmhttp://www.greenfacts.org/about/toolboxes/copyright.htmhttp://www.greenfacts.org/about/toolboxes/contact.htmhttp://www.greenfacts.org/aspartame/download.htmhttp://www.greenfacts.org/aspartame/download.htmhttp://www.greenfacts.org/about/toolboxes/subscribe.htmhttp://www.greenfacts.org/about/toolboxes/subscribe.htmhttp://www.greenfacts.org/about/toolboxes/tellafriend.phphttp://www.greenfacts.org/about/toolboxes/tellafriend.phphttp://www.greenfacts.org/glossary/abc/consensus.htmhttp://www.greenfacts.org/links/site-boxes/ec_scf.htmhttp://www.greenfacts.org/glossary/abc/ADI-acceptable-daily-intake.htmhttp://www.greenfacts.org/glossary/mno/methanol-methyl-alcohol.htmhttp://www.greenfacts.org/glossary/pqrs/phenylalanine.htmhttp://www.greenfacts.org/glossary/abc/aspartic-acid.htmhttp://www.greenfacts.org/glossary/pqrs/risk.htm
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    Aspartame : Level 1 - Summary on Aspartame

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    Other views on Aspartame

    About the Toolbox | Back | Print | Forward

    Other Views onAspartame

    This list of links is only a sample and neither pretends to be complete nor fully representative of all the views available.

    GreenFacts Foundation takes no position concerning the views expressed in these linked documents.

    the EC-SCF report a consensus one?

    ost scientists globally agree with the EC-SCF conclusions contained in its 2002 "

    Update on the safety of Aspartame"

    other recent assessment by the French Food Safety Agency (AFSSA, 2002) reaches a similar conclusion:..) the current state of scientific knowledge does not enable a relationship to be established between theposition to the aspartame and brain tumours in humans or animals."

    www.afssa.fr/ftp/basedoc/aspartamgb.pdf

    he pseudo-scientific hoax

    e e-mail hoax that has been circulating is posted at: urbanlegends.about.com/library/blasp.htm

    e answer from the Multiple Sclerosis Foundation (MSF) at: www.msfocus.org/publications/

    b_articles_aspart.html

    e answer from the American Council on Science and Health (ACSH) at:

    www.acsh.org/press/editorials/HealthHoax012899.html

    Click on "Aspartame Links" on top of each main page to find some Factual Links, approved by our Scientific Board.

    This list of links is only a sample and neither pretends to be complete nor fully representative of all the views available.

    GreenFacts Foundation takes no position concerning the views expressed in these linked documents.

    Back | Print | Forward Top

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    Other views on Aspartame

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    Aspartame : Level 2 - Details on Aspartame

    ome > Studies > Aspartame > Level 2 > Questions

    Scientific Facts on Aspartame

    Info on our studies structure

    Level 2 - Details on Aspartame

    q 1. What is aspartame ?

    r 1.1 What is the history of aspartame ?r 1.2 What are the uses and properties of aspartame ?

    r 1.3 Why is there concern about aspartame ?

    q 2. How much aspartame do people consume ?

    q 3 . What happens to aspartame once it is ingested ?

    q 4. Can aspartame affect human health ?

    r 4.1 Can aspartame cause cancer or induce genetic damage ?

    r 4.2 Can aspartame affect reproduction and development ?

    r

    4.3 Can aspartame produce neurological disorders ?r 4.4 Can aspartame affect behaviour, cognition or mood ?

    r 4.5 Does aspartame cause headaches ?

    r 4.6 Does aspartame trigger epileptic seizures ?

    r 4.7 Can aspartame cause other health effects ?

    q 5. Conclusion

    q 6. Other views on aspartame

    Back to Summary Level 2 Questions More in the Source Document

    Send this page Subscribe to our newsletter Download this study

    Contact | Copyright | Glossary | Sitemap | Link to us | Feedback | About Top

    27-Jul-2004

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    Aspartame : Level 2 - Details on Aspartame

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    Aspartame : 1. What is aspartame ?

    ome > Studies > Aspartame > Level 2 > Question 1

    Scientific Facts on Aspartame

    Level 1 Questions Next Question

    . What is aspartame ?

    1.1 What is the history of aspartame ?

    1.2 What are the uses and properties of aspartame ?

    1.3 Why is there concern about aspartame ?

    Back to Summary Level 2 Questions More in the Source Document

    Next Sub-Question Top

    .1 What is the history of aspartame ?

    Aspartame was discovered as a novel sweetener in 1965. It was first authorized to enter the market in the UnitedStates in 1974. This authorization was suspended a few months later on the grounds that the first studies had notproperly evaluated if aspartame could be toxic to the brain or cause brain cancer. A new assessment of those studie

    and the examination of new data, led to a marketing authorization for solid food in 1981 and for soft drinks in 1983Aspartame was finally authorized as general sweetener in 1996. Up to now, the safety of aspartame has beenassessed by a number of national and international organisations. An Acceptable Daily Intake (ADI) of aspartame fo

    humans has been set at 40 mg/kg body weight per day by an international committee of experts.

    A debate on the risks to human health posed by the consumption of aspartame was relaunched, notably on the

    Internet, following an article published in 1996 which suggested there was a link between brain tumours and

    aspartame. Allegations claim that aspartame is responsible for a large number ofadverse health effects such as

    multiple sclerosis, lupus erythematous , Gulf War Syndrome, brain tumours, epileptic seizures, complications of

    diabetes, etc. More...

    Back to Summary Level 2 Questions More in the Source Document

    Next Sub-Question Top

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    Aspartame : 1. What is aspartame ?

    .2 What are the uses and properties of aspartame ?

    Aspartame is marketed as table sweetener (for example, Canderel, NutraSweet). It is also incorporated in anumber of foodstuffs throughout the world, including drinks, desserts and sweets (European code E951). It is awhite, odourless powder, approximately 200 times sweeter than sugar, manufactured by combining phenylalanine

    and aspartic acid. Its main impurity is diketopiperazine that has no sweetening properties.

    Aspartame is stable in the dry state and in frozen products. However, when stored in liquids at more than 30C, it

    progressively converts into diketopiperazine, which is partially degraded into methanol, aspartic acid andphenylalanine. These transformations result in the loss of sweetness. Therefore, aspartame can not be used incooked or sterilized foods. More...

    Back to Summary Level 2 Questions More in the Source Document

    Top

    .3 Why is there concern about aspartame ?

    Some concerns have been raised about aspartame and its breakdown products (methanol, phenylalanine and aspar

    acid). These concerns include epilepsy, brain tumours and effects on the nervous system.

    Another concern is related to possible effect of aspartame breakdown products on specific people, including healthyinfants, children, adolescents, adults, obese individuals, diabetics, lactating women, and people suffering fromphenylketonuria (PKU) disease. More...

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    Aspartame : 1. What is aspartame ?

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    Aspartame : 2. How much aspartame do people consume ?

    ome > Studies > Aspartame > Level 2 > Question 2

    Scientific Facts on Aspartame

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    2. How much aspartame do people consume ?

    The Acceptable Daily Intake (ADI) of 40 mg/kg body weight per day set by the committee of experts of the Food an

    Agriculture Organization (FAO) and the World Health Organization (WHO) is not likely to be exceeded, even by

    children and diabetics.

    A European Commission (EC) report gives a theoretical maximum estimate for adults consumption of 21.3 mg/kg

    body weight per day of aspartame. However, the actual consumption is likely to be lower, even for high consumers aspartame. The report also gives refined estimates for children which show that they consume 1 to 40% of theAcceptable Daily Intake.

    Other reports in Europe use actual food consumption data and actual sweetener levels in foods to estimate that higlevel intakes for the general population vary between 2.8 and 7.5 mg/kg body weight per day. People with diabetesare high consumers of foods containing aspartame; their highest reported intake varies between 7.8 and 10.1 mg/kbody weight per day. More...

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    Aspartame : 2. How much aspartame do people consume ?

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    Aspartame : 3. What happens to aspartame once it is ingested ?

    ome > Studies > Aspartame > Level 2 > Question 3

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    3. What happens to aspartame once it is ingested ?

    Following ingestion, aspartame is broken down in the digestive tract to form aspartic acid, phenylalanine and

    methanol. Therefore, hardly any aspartame gets in the blood.

    The body rapidly metabolises both aspartic acid and methanol, without significantly increasing their concentration in

    the bloodstream, even for aspartame taken as a single dose equivalent to the entire Acceptable Daily Intake (ADI).

    At high doses usually surpassing the ADI, the level of phenylalanine in blood may increase with the dose ofaspartame given. However, high doses generally do not increase the blood level more than a normal meal - exceptfor individuals affected by phenylketonuria disease (homozygous PKU). More...

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    Aspartame : 3. What happens to aspartame once it is ingested ?

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    Aspartame : 4. Can aspartame affect human health ?

    ome > Studies > Aspartame > Level 2 > Question 4

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    4. Can aspartame affect human health ?

    4.1 Can aspartame cause cancer or induce genetic damage ?

    4.2 Can aspartame affect reproduction and development ?

    4.3 Can aspartame produce neurological disorders ?

    4.4 Can aspartame affect behaviour, cognition or mood ?

    4.5 Does aspartame cause headaches ?4.6 Does aspartame trigger epileptic seizures ?

    4.7 Can aspartame cause other health effects ?

    4.1 Can aspartame cause cancer or induce genetic damage ?

    4.1.1. In laboratory studies:

    q Aspartame did not induce genetic mutations.

    q A study on mice showed no cancer effects. A first study on rats fed with very high doses of aspartame (1000

    to 6000 mg/kg body weight per day) found a higher incidence of brain tumours. This study was contradicted

    by two subsequent ones. Therefore, it was concluded that aspartame does not cause brain cancer inlaboratory animals.

    q Diketopiperazine does not cause cancer or genetic mutation in rats or mice. More...

    4.1.2. In 1996, Olney published an article linking the consumption of aspartame and the occurrence of brain tumouin the United States, which has been criticized by a number of scientists. Subsequent studies did not find such a linkIn France, the sale of aspartame did not increase the frequency of brain tumours. More...

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    Aspartame : 4. Can aspartame affect human health ?

    4.2 Can aspartame affect reproduction and development ?

    In laboratory animal tests, no effect on reproduction and development was observed below 4.000 mg/kg body weigper day. At higher doses, some pups grew marginally slower and weighed slightly less than normal because they atless. No other effects of aspartame and its breakdown products were observed on reproduction and development(including neurodevelopment). More...

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    4.3 Can aspartame produce neurological disorders ?

    Following the marketing of aspartame, some consumers complained ofneurological or behavioural effects. These

    complaints received special consideration because some experiments in rats had shown that very high doses ofaspartame (1000 mg/kg body weight per day) could alter the concentrations of some important substances(neurotransmitters) in the central nervous system. However, it appears that these effects on neurotransmitters are

    not consistent and could not be reproduced in later studies.

    About 10% of aspartame breaks down into methanol, which is known to be toxic. However, toxic effects on vision

    and the central nervous system only occur at doses of methanol 100 times higher than could be produced from theamount of aspartame in one litre of "diet" soft drink. More...

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    4.4 Can aspartame affect behaviour, cognition or mood ?

    Some years ago, it was suggested that aspartame could have an effect on human behaviour and cognition. Howeve

    studies on laboratory animals showed no adverse effects on behaviour and cognition, even at very high doses (up to2000 mg/kg body weight per day).

    Also, studies in healthy adults and children and in people heterozygous for phenylketonuria (PKU) disease failed to

    show effects of aspartame on behaviour, mood or learning. But a study suggested that aspartame increased thefrequency and severity of adverse effects in depressed individuals; this study must however be taken with caution athere were criticisms regarding the authors interpretation and because too few subjects were evaluated. More...

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    Aspartame : 4. Can aspartame affect human health ?

    4.5 Does aspartame cause headaches ?

    Headaches are one of the most commonly reported symptoms. Three studies on humans indicate a possibleassociation between aspartame intake and headaches. However, it is not possible to draw conclusions. A more recestudy in a controlled environment on individuals complaining of aspartame-related headaches concluded thataspartame was no more likely to trigger headaches than placebo. More...

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    4.6 Does aspartame trigger epileptic seizures ?

    Some websites report testimonies of people who identify aspartame as the cause of their health problems andepileptic seizures. A few studies have linked the consumption of large amounts of aspartame and the triggering ofepileptic seizures. They suggest that aspartame could cause seizures by affecting the synthesis ofneurotransmitter

    in the brain. Also, some animal studies indicate that aspartame reduces the threshold of sensitivity to chemicallyinduced seizures.

    Another study reported that aspartame could increase the duration of certain types of epileptic seizure in children.Effects ofphenylalanine, aspartic acid and methanol on seizures have been reported, but under unusual conditions,

    such as high doses, particular sensitivities or rare types of seizures. This relationship has been refuted by a largenumber of scientists, who base their opinions on many animals and humans studies.

    The Epilepsy Institute in the USA has also concluded that aspartame is not the cause of epileptic seizures. More...

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    4.7 Can aspartame cause other health effects ?

    Some individuals have attributed their allergic reactions to aspartame. However, two studies on such individualsindicated that their allergies were no more likely to be caused by aspartame than by placebo.

    Other studies focusing on the effects of aspartame on hunger and food intake, reported that aspartame did not causan increase in calorie consumption or body weight. More...

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    Aspartame : 5. Conclusion

    ome > Studies > Aspartame > Level 2 > Question 5

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    5. Conclusion

    Several national and international scientific committees have reviewed the health risks of aspartame consumption.

    They conclude:

    q Compared to normal consumption of natural foods, aspartame consumption is only a minor source ofaspart

    acid, phenylalanine and methanol. Furthermore, aspartame intakes in adults, children and diabetics of all

    ages are unlikely to exceed the current Acceptable Daily Intake (ADI) (see question 2).

    q Aspartame and its main impurity, diketopiperazine (DKP), do not cause cancer. Neither the tests on rodents

    nor the human epidemiological studies demonstrate that the consumption of aspartame causes brain tumou

    (see question 4.1).

    q Overall, current studies do not bring evidence that aspartame induces changes in behaviour, cognition, moo

    or learning, even in individuals claiming to be sensitive and individuals heterozygous for phenylketonuria

    disease (PKU) (see question 4.3 & 4.4).

    q Studies do not show that aspartame causes headaches (see question 4.5).

    q There is no conclusive evidence that aspartame causes epileptic seizures (see question 4.6).

    q Studies on individuals claiming to be allergic to aspartame do not confirm the claims (see question 4.7).

    In its most recent evaluation (EC-SCF 2002) the European Commission Scientific Committee on Food concluded tha

    there is no need to revise the Acceptable Daily Intake (ADI) of 40 mg/kg body weight per day previously establishe

    for aspartame. More...

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    Aspartame : 5. Conclusion

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    Aspartame : Level 3 - Source on Aspartame

    ome > Studies > Aspartame > Level 3 > Questions

    Scientific Facts on Aspartame

    Info on our studies structure

    Level 3 - Source on Aspartame

    q 1. What is aspartame ?

    r 1.1 What is the history of aspartame ?r 1.2 What are the uses and properties of aspartame ?

    r 1.3 Why is there concern about aspartame ?

    q 2. How much aspartame do people consume ?

    q 3. What happens to aspartame once it is ingested ?

    q 4. Can aspartame affect human health ?

    r 4.1 Can aspartame cause cancer or induce genetic damage ?

    r 4.2 Can aspartame affect reproduction and development ?

    r

    4.3 Can aspartame produce neurological disorders ?r 4.4 Can aspartame affect behaviour, cognition or mood ?

    r 4.5 Does aspartame cause headaches ?

    r 4.6 Does aspartame trigger epileptic seizures ?

    r 4.7 Can aspartame cause other health effects ?

    q 5. Conclusion

    q 6. Other views on aspartame

    Back to Details Level 3 Questions More in Experts Links

    Send this page Subscribe to our newsletter Download this study

    Contact | Copyright | Glossary | Sitemap | Link to us | Feedback | About Top

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    Aspartame : Level 3 - Source on Aspartame

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    Aspartame : 1. What is aspartame ?

    ome > Studies > Aspartame > Level 3 > Question 1

    Scientific Facts on Aspartame

    Source & : EC-SCF Update on the Safety of Aspartame

    Also: AFSSA Aspartame Assessment Report

    Level 1 Questions Next Question

    . What is aspartame ?

    1.1 What is the history of aspartame ?1.2 What are the uses and properties of aspartame ?

    1.3 Why is there concern about aspartame ?

    .1 What is the history of aspartame ?

    "Aspartame was discovered in 1965 by a chemist working for the American company Searle and an initial marketingauthorisation (MA) was granted in the United States by the Food and Drug Administration (FDA) in 1974. This MAwas suspended a few months later following an appeal against the authorisation on the grounds that the toxic and

    carcinogenic effects on the brain of this compound and its metabolites had not been properly evaluated during theexperimental studies. Following a reassessment of the studies on experimental animals and an examination of newdata (including a study of carcinogenicity in the rat), the FDA granted this product a new MA in 1981 (FDA, FR 1981for use in solid food. This authorisation was extended to soft drinks in 1983 (FDA, FR 1983) and for its use as ageneral sweetener in 1996. The safety of aspartame has been assessed and recognised by a number of other nationand international organisations including the FAO/WHO Committee of Experts on Food Additives (JECFA) and, at EUlevel, by the Scientific Committee on Food. It was authorised by Directive 94/35/EC of the European Parliament andof the Council on sweeteners for use in foodstuffs (adopted on 30 June 1994) and its use is permitted in more than90 countries. In France, aspartame has been permitted since 1988. The Acceptable DailyIntake (ADI) of aspartame for humans was fixed at 40 mg/kg body weight/day by the JECFA (1980).

    In 1996, an article by J.W. Olney suggesting a link between an increased incidence of brain tumours in the United

    States and the marketing of aspartame relaunched the debate on the risks to human health posed by its

    consumption. The debate has been covered by the media, notably on the Internet where several thousand websitesare devoted to the effects of aspartame. These contain allegations claiming that this additive is responsible for alarge number of adverse effects (more than fifty), some of which are very serious, such as: multiple sclerosis, lupus

    erythematosus, Gulf War Syndrome, brain tumours, epileptic seizures, complications of diabetes, etc. At the same

    time, the health authorities in a number of countries have reacted by informing the public on the studies available ounderway and on the data based on scientific evidence.

    Following a recap of the physical and chemical properties of aspartame, this report will review, firstly, the availabletoxicological and epidemiological data on the effects of this additive on the nervous system (cancer and seizures) an

    secondly, the estimates of the consumption of this sweetener by the general population and by specific populationssuch as children and diabetic adolescents. For these specific populations, there may be a potential risk arising fromheavy consumption, low body mass or finally, a special metabolic susceptibility."

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    Aspartame : 1. What is aspartame ?

    Source & : AFSSA Aspartame Assessment Report chap. 2: Introduction.

    Back to Details Level 3 Questions Level 1 Conclusions

    Next Sub-Question Top

    .2 What are the uses and properties of aspartame ?

    "The E number of aspartame in France and Europe is E 951. It was first marketed by NutraSweet AG and morerecently by Ajinomoto and Holland Sweetener Company. This sweetener is incorporated into a number of foodstuffs(drinks, desserts, sweets, etc.) and in table sweeteners, under the name Canderel, Pouss-suc and into some 600medicines; this report does not consider the possible intake (very limited compared with dietary intake) of aspartamfrom this later source. Its sweetening power is 180 to 200 times greater than that of saccharose.

    Aspartame is a dipeptide methyl ester of L-aspartyl-L-phenylalanine. It is a white, odourless, crystalline powder. Itsmolecular weight is 294.3 Daltons and its rotatory power [a]D22 = 2.3 in 1M HCl.

    Its main impurity (approximately 2%) is diketopiperazine, a degradation product of aspartame which has no

    sweetening properties.

    The solubility of aspartame in water is dependent on pH and temperature, the maximum solubility is reached at pH2.2 (20 mg/ml at 25C) and the minimum solubility at pH 5.2 (pHi) is 13.5 mg/ml at 25C.

    The stability of aspartame is dependent on time, temperature, pH and water activity (Dziezak, 1986; Bell et al.,1991; Tsoubeli et al., 1991; Homler, 1984; Graves et al., 1987; Huang et al., 1987; Neiderauer, 1998).

    Aspartame is very stable in the dry state: at 105C a loss of approximately 5% (formation ofdiketopiperazine) is

    observed after 100 hours of treatment. At 120C, a 50% loss is obtained after 80 hours of treatment.

    In solution, when stored at temperatures ranging from 30 to 80C, aspartame is progressively degraded intodiketopiperazine (Pattanaargson et al., 2000). It is therefore not usable in foods heated at higher temperature(cooking, sterilisation, etc.). At room temperature its stability is good at pH values of between 3.4 and 5 and it ismaximum at pH 4.3. At pH below 3.4 the dipeptide is hydrolysed and at a pH greater than 5, cyclisation occurs with

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    Aspartame : 1. What is aspartame ?

    the formation ofdiketopiperazine. In both cases, this transformation results in the loss of sweetness.

    In foods with a low or moderate water content (water activities between 0.34 and 0.66), the maximum stability isobserved at pH 5.0.

    Aspartame has good stability in deep frozen products. "

    Source & : AFSSA Aspartame Assessment Report

    chap. 3: Identity, physical and chemical properties and stability of aspartame.

    Back to Details Level 3 Questions Level 1 Conclusions

    Top

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    .3 Why is there concern about aspartame ?

    "The Scientific Committee for Food (SCF) initially evaluated aspartame (L-aspartyl- L-phenylalanine methyl ester)during 1984 (SCF, 1985) and subsequently during 1988 (SCF, 1989). At its 107th meeting in June 1997, the SCFalso examined the issue of an alleged connection between aspartame and increase in incidence of brain tumours inthe USA (SCF, 1997).

    Aspartame has also been considered by other bodies including the Joint FAO/WHO Expert Committee on FoodAdditives (JECFA, 1980) the US Food and Drug Administration (FDA, 1984), and the UK Committee on Toxicity (COT1992). The toxicity data on aspartame were used by the JECFA, SCF and COT to establish an Acceptable Daily Intak

    (ADI) of 40 mg/kg body weight/day and an ADI of 50 mg/kg bw/d was established by the FDA. An ADI of 7.5 mg/kbw/d was also established for a minor cyclic dipeptide derivative of aspartame, a diketopiperazine (DKP), which is

    formed in some aqueous solutions (JECFA, 1980; SCF, 1985).

    The safety issues that have been raised in the past about aspartame have included: (1) the possibility of toxicityfrom methanol, one of the breakdown products of aspartame; (2) elevations in plasma concentrations of

    phenylalanine (Phe) and aspartic acid, which could result in increased transport of these amino acids into the brain,

    altering the brain's neurochemical composition; (3) the possibility of neuroendocrine changes, particularly increasedconcentrations in the brain, synaptic ganglia and adrenal medulla of catecholamines derived from Phe and itshydroxylation product, tyrosine; and (4) a postulated link with epilepsy and brain tumours. All these areas have bee

    addressed in the pre-1988 literature and in more recent reviews (Meldrum, 1993; Lajtha et al., 1994; Tschanz et al

    1996).

    The safety of aspartame and its metabolic breakdown products (phenylalanine, aspartic acid and methanol) has bee

    assessed in humans generally and in several subgroups, including healthy infants, children, adolescents, adults,obese individuals, diabetics, lactating women, and individuals heterozygous for the genetic disease, phenylketonuria(PKU), who have a compromised ability to metabolise the essential amino acid, Phe.

    Since its approval, aspartame has undergone further investigation through clinical and laboratory research, intakestudies and postmarketing surveillance of anecdotal reports ofadverse health effects.

    The present review updates the previous SCF opinions in the light of new reports on the consumption of aspartame relation to the onset of brain tumours and seizures, headaches, allergies, and changes in behaviour and cognitive

    function. Information on the safety of aspartame was available from a variety of sources including scientific papers,conference proceedings, abstracts and magazine articles. This review focuses on papers published in the openscientific literature from 1988 to 2001 and draws on the recent extensive review by the Agence Franaise de ScuriSanitaire des Aliments (AFSSA, 2002), which covered mutagenic, carcinogenic and neurological effects."

    Source & : EC-SCF Update on the Safety of Aspartame

    Back to Details Level 3 Questions Level 1 Conclusions

    Level 1 Questions Next Question

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    Aspartame : 2. How much aspartame do people consume ?

    ome > Studies > Aspartame > Level 3 > Question 2

    Scientific Facts on Aspartame

    Source & : EC-SCF Update on the Safety of Aspartame

    Previous Question Level 1 Questions Next Question

    2. How much aspartame do people consume ?

    "Exposure assessment

    European Commission report on Food Additive Intake

    In the European Commission report on Dietary Food Additive Intake in the European Union (EC, 2001), estimates ofintake were calculated using a tiered approach. Tier 1 is based on theoretical food consumption data and maximumusage levels for additives as permitted by relevant Community legislation. The second and third tiers refer toassessment at the level of individual Member States, combining national data on food consumption with themaximum permitted usage levels for the additive (Tier 2) and with its actual usage patterns (Tier 3). Aspartame habeen examined at Tier 1 for adults and at Tier 2 for children.

    Aspartame intakes for adults were estimated at Tier 1 to be 21.3 mg/kg bw/day in the European Union. The Tier 1approach is likely to be an overestimate of actual intake even by high level consumers of aspartame-sweetened

    foods. More refined intake estimates (Tier 2) were performed for children. Information from individual member statshowed that the refined estimated intake for children was 1-40% of the ADI. Therefore aspartame was excluded frofurther consideration as both adults and children were shown to be unlikely to exceed the ADI of 40 mg/kg bw.

    Other published intake estimates for European countries

    In addition to the Commission report, a number of reports have been published from1990 onwards with estimates of aspartame intake in European countries (Br and Biermann, 1992; Butchko andStargel, 2001; Garnier-Sagne et al., 2001; Hinson and Nicol, 1992; Leclercq et al., 1999; MAFF, 1990 and 1995;Renwick, 1990; Salminen and Penttil, 1999). The table below shows the highest reported intake estimates fordifferent age groups of the general population and people with diabetes. The data are based on actual foodconsumption combined with the actual sweetener levels present in the foods (equivalent to Tier 3 in the Commissioreport) or the maximum permitted aspartame levels (Tier 2). The estimates of intake by mean and high level

    consumers are fairly consistent between European countries even though slightly different approaches were used.High level consumers, both adults and children, are unlikely to exceed the ADI of 40 mg/kg bw for aspartame.Special groups such as diabetics that are likely to be high consumers of foods containing aspartame are also wellbelow the ADI. Therefore, from the available data it appears that no group is likely to exceed the ADI for aspartameon a regular basis.

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    Aspartame : 2. How much aspartame do people consume ?

    * using maximum permitted level of sweeteners in different food categories (Tier 2 approach). All the other figuresare derived using actual sweetener levels present in foods."

    Source & : EC-SCF Update on the Safety of Aspartame

    Back to Details Level 3 Questions Level 1 Conclusions

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    Aspartame : 3. What happens to aspartame once it is ingested ?

    ome > Studies > Aspartame > Level 3 > Question 3

    Scientific Facts on Aspartame

    Source & : EC-SCF Update on the Safety of Aspartame

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    3. What happens to aspartame once it is ingested ?

    "Abso rption, distribution, metabolism and excretion

    The metabolism of aspartame and its metabolic breakdown products in animals, healthy individuals and in PKU

    subjects has been comprehensively reviewed by Lajtha et al. (1994). Aspartame is metabolised by gut esterases anpeptidases to three common dietary components - two amino acids (aspartic acid and Phe) and methanol.

    Animal studies have demonstrated that the metabolic breakdown products of aspartame are absorbed andmetabolised similarly whether they are given alone or derived from aspartame. The extensive presystemicmetabolism of aspartame results in little or no parent compound reaching the general circulation.

    Initial studies focused on the effects of ingesting single bolus doses of aspartame on plasma aspartate and Phe leveand blood methanol concentrations in normal adults. These studies were done with doses of aspartame

    approximating current levels of dietary exposure (4 and 10 mg/kg bw), doses representative of premarketing

    projections of the high level intake and the ADI (34 and 40 mg/kg bw respectively), and abuse doses of 100, 150and 200 mg/kg bw (Stegink and Filer 1996).

    The plasma Phe concentrations in healthy adults administered various doses of aspartame have been compared tovalues obtained: (1) in the fasting and postprandial state; (2) in individuals who are heterozygous for PKU; and (3)

    subjects with various forms of hyperphenylalaninaemia other than PKU (Stegink et al 1990; Stegink and Filer, 1996

    The data indicated that the plasma Phe concentrations after single bolus doses (ranging between 4 and 50 mg/kgbw) and repeated doses (30 and 69 mg/kg bw given as 3 and 8 divided doses respectively) of aspartame weregenerally within the normal postprandial range for this amino acid and well below those measured in subjectshomozygous for PKU after ingestion of aspartame.

    The aspartate component is rapidly metabolised and thus the plasma aspartate concentrations are not significantly

    elevated following aspartame doses of 34 to 50 mg/kg bw, whereas plasma Phe concentrations may increasedepending on dose (Stegink, 1984). Methanol is also rapidly metabolised and blood levels are usually not detectableunless large bolus doses of aspartame (>50 mg/kg bw) are administered."

    Source & : EC-SCF Update on the Safety of Aspartame

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    Aspartame : 4. Can aspartame affect human health ?

    ome > Studies > Aspartame > Level 3 > Question 4

    Scientific Facts on Aspartame

    Source & : EC-SCF Update on the Safety of Aspartame

    AFSSA Aspartame Assessment Report

    1985 Reports of the Scientific Committee for Food, 16th Series

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    4.1 Can aspartame cause cancer or induce genetic damage ?

    4.1.1 Laboratory studies

    4.1.2 Epidemiological data

    4.1.1 Laboratory studies

    "Genotoxicity and carcinogenicity

    The available mutagenicity and long-term carcinogenicity studies on aspartame were recently reviewed by AFSSA(2002). AFSSA noted that:

    "Aspartame is not genotoxic in a reverse mutation test on S. typhimurium, in two chromosome aberration tests in

    vivo on somatic cells and in Rodent dominant lethal test on germ cells (JECFA, 1980). Recently, two studies haveconfirmed the absence of clastogenic potential (Durnev et al., 1995; Mukhopadhyay et al., 2000) of the compound.

    The AFSSA report also noted:

    "Trocho et al., (1998) demonstrated that aspartame, radio-labelled on the methanol, induced in the liver stable DNA

    and protein adducts. According to these authors, the accumulation of these adducts after repeated administration oaspartame could pose problems oftoxicity and car