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Q&A about aspartame

Available for almost 25 years, aspartame is approved for use by the general population in 130 countries around the world. Aspartame is one of the most thoroughly tested food additives in history with a comprehensive battery of studies done in humans and animals, including toxicity and carcinogenicity studies. All demonstrated that aspartame was safe for human consumption. Safety authorities have regularly reviewed new studies and they have always reconfirmed aspartame's safety. Recently, aspartame has been again the subject of a public controversy after a new study was published linking the sweetener with a raised incidence of some tumours in rats. The European Food Safety Authority (EFSA) acknowledged to consider the new findings and ordered a review of aspartame's safety, which confirmed the safety of the product.

What is aspartame and why is it used?
Aspartame is a low-calorie, intense sweetener. Aspartame provides 4 calories per gram but because, weight for weight, it is approximately 200 times sweeter than sugar, very little aspartame is needed to adequately sweeten foods, and hence adds practically no calories to foods. Aspartame mimics well the taste of sugar, enhances citrus and other fruit flavours, and does not contribute to tooth decay.

In which products is it used?
Aspartame is a food additive and is authorized for use as a sweetener in a particular number of foods.

Aspartame is used to sweeten around 6,000 foods and beverages such as drinks, desserts, sweets, chewing gum, yogurt, energy-reduced and weight control products and as a tabletop sweetener.

What happens to aspartame in the body once it is ingested?
Following ingestion, aspartame breaks down in the gut into its three constituent parts: two amino acids - aspartic acid and phenylalanine-, and methanol, which are then absorbed into the blood.

The two amino acids (aspartic acid and phenylalanine) are building blocks of protein and are found naturally in all protein-containing foods, including meats, grains and dairy products. Methanol is also found naturally in many foods such as fruits and vegetables, and their juices and is part of the normal diet.

These components are used in the body in exactly the same ways as when they are also derived, in much greater amounts, from common foods and beverages (e.g. eggs, milk, cheese, meat, fish, fruits and vegetables). For example, a serving of non-fat milk provides about 6 times more phenylalanine and 13 times more aspartic acid than the same amount of beverage sweetened with aspartame; a serving of tomato juice provides about 6 times more methanol than the same amount of aspartame-sweetened beverage. Neither aspartame nor its components accumulates in the body over time.

How can I tell if a product contains aspartame?
Consumers can identify those foodstuffs containing aspartame by looking at the ingredients lists on product labelling. Like all food additives approved for use in the European Union (EU), aspartame has been assigned an "E-number". Its presence in foods can be indicated either by its name (ie "aspartame") or by its number E-951.

Foodstuffs containing aspartame should also state that it is a source of phenylalanine, because people suffering from phenylketonuria cannot metabolise this amino acid.

How has aspartame's safety been tested?
Prior to its approval, aspartame and its breakdown products have been a matter of thorough investigation for more than 20 years including experimental animal studies, clinical research, intake and epidemiological studies and post-marketing surveillance.

Aspartame has undergone extensive testing in animals (in several animal species) and studies in humans, including four animal carcinogenicity (ability to cause cancer) studies conducted during the 1970s and early 1980s. These studies, together with studies on genotoxicity (ability to damage the genetic material, but not necessarily causing cancer), were evaluated by regulatory bodies worldwide and it was concluded that they did not show evidence of genotoxic or carcinogenic potential for aspartame.

All those studies have been reviewed by regulatory scientists around the world, including the US Food and Drug Administration (FDA) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). In each case, aspartame was determined to be safe for human consumption.

Scientific issues regarding the safety of aspartame have been raised since its approval, with discussions focusing not only on the safety of aspartame itself, but also on the safety of its breakdown products (aspartic acid, phenylalanine and methanol). In response, post-marketing surveillance and numerous additional animal and human studies were conducted and regular reviews of aspartame safety were undertaken, and to date all have confirmed the conclusions of earlier studies, that aspartame is safe and has no adverse health effects.

How was aspartame approved in the European Union?
In the EU, aspartame was first authorised for use by several Member States in the 1980s and European legislation harmonising its use in foodstuffs was introduced in 1994, following thorough safety evaluations (in 1984, 1987, 1988) by the European Commission Scientific Committee for Food (SCF), who set a European ADI (see below)

A further review of all the original and more recent data on aspartame was carried out in 2002 by the SCF. Both published and unpublished data, including all the information on genotoxicity and carcinogenicity in animals and humans, were considered at that time. The SCF reconfirmed the safety of aspartame and its previously established ADI. At present, it is the European Food Safety Authority (EFSA) Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC Panel), who has taken the relay from the SCF and is in charge of this task.

How much aspartame can be safely consumed? What is the Acceptable Daily Intake?
The Acceptable Daily Intake (ADI) of aspartame in the European Union is 40 milligrams per kilogram of body weight. The ADI refers to the amount of aspartame that can be taken daily in the diet, over a lifetime, without any health problem. This is equivalent to 2,800 milligrams for an average adult. An adult would have to drink about 14 cans of a sugar-free drink every day of his/her life before reaching the ADI. So if you exceed the ADI for aspartame, you will not suffer any negative effects because this possibility has already been taken into account in the calculation, as it has been set on an average daily consumption over a lifetime.

Additionally, an ADI provides a large margin of safety. Authorities set a maximum level of an additive that has no demonstrable toxic effect, scale this level by a safety factor of around 100 (to account for the difference between animals and humans and the different sensitivities between humans), and then calculate the 'Acceptable Daily Intake'.

Real aspartame consumption was evaluated all around the world and found to be remarkably consistent and by far lower than the ADI, even in people on weight-reduction diets, diabetics or children. Monitoring of aspartame intake in the general population is still done regularly to ensure that levels of intake are below the ADI. In the recent EFSA evaluation, dietary exposure to intense sweeteners in the population was assessed in a number of European countries. Dietary exposure to aspartame was well below the ADI of 40 mg/kg bw (up to 10 mg /kg bw), even in high consumers.

Why did the European Food Safety Authority (EFSA) carry out a recent review on aspartame's safety?
In 2005, the European Ramazzini Foundation of Oncology and Environmental Sciences (ERF) published a new study on the carcinogenicity of aspartame carried out in rats. As is customary in such cases, EFSA took to review this new study. It asked its Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food to review the study and ordered an immediate review of the sweetener's safety. The panel experts took into account also other recent studies and data available to date in the scientific literature on the sweetener aspartame.

What were EFSA's conclusions?
The EFSA Panel found that the Ramazzini study has several flaws (amongst which an unusual design; using a single generation, closed colony comprising healthy and unhealthy animals until natural death)which bring into question the validity of the study results and conclusions.

EFSA concluded, on the basis of all the evidence currently available from recent studies and previous evaluations, that aspartame remains safe for human consumption and there is no reason to revise the previously established ADI for aspartame of 40 mg/kg body weight or to advise consumers to modify their dietary habits.

For more information

Please refer to the following credible bodies from around the world below

Brazilian Health Ministry

This press release and clarification report regarding a scientific forum about aspartame held by the Health Surveillance Agency, an organization of the Brazilian Health Ministry, confirms that aspartame is not harmful and can be an excellent tool in managing diabetes and weight-loss programs.

http://www.anvisa.gov.br/divulga/cursos/al_aspartame.htm

Centers for Disease Control & Prevention(CDC)

After investigating consumer inquiries, the CDC concludes that, although certain individuals may be unusually sensitive to aspartame, there is no evidence of any serious, widespread, adverse health consequences attendant upon its use. An agency of the Department of Health and Human Services, CDC's mission is to promote health and quality of life by preventing and controlling disease, injury, and disability.

http://www.cdc.gov/mmwr/preview/mmwrhtml/00000426.htm

Health Canada

Health Canada states, "...Before consideration was given to permitting aspartame for use in foods in Canada, officials of Health Canada evaluated an extensive array of toxicological tests in laboratory animals and, since its listing for use, they have examined the results of a number of clinical studies in humans. There is no evidence to suggest that the consumption of foods containing this sweetener, according to the provisions of the Food and Drug Regulations and as part of a well-balanced diet, would pose a health hazard to consumers."

http://www.hc-sc.gc.ca/food-aliment/cs-ipc/chha-edpcs/e_aspartame01.html

French Food Safety Agency (AFSSA)

The French Food Safety Agency (AFSSA) recently completed a two year study by the French Expert Committee on Flavourings, Food Additives and Processing Aids and has confirmed the safety of aspartame once again. The English translation on its report and opinion on the safety of aspartame is now available.

http://www.aspartame.org/pdf/AFSSA-Eng.pdf

Scientific Committee on Food of the European Commission

The food safety advisory body in Europe, the Scientific Committee on Food (SCF) of the European Commission, has reconfirmed aspartame's clean bill of health following a comprehensive review of the sweetener's safety. The SCF is a body of independent scientific experts which advises the European Commission on matters of food safety; its aspartame report was issued on December 10, 2002.

http://europa.eu.int/comm/food/fs/sc/scf/out155_en.pdf

Alzheimer's Association

The Alzheimer's Association is the largest national voluntary health organization supporting Alzheimer's research and care. The site specifically states, "Several studies have been conducted on aspartame's effect on cognitive function in both animals and humans. These studies found no scientific evidence of a link between aspartame and memory loss."

http://www.alz.org/AboutAD/Myths.asp

American Academy of Family Physicians

The American Academy of Family Physicians is one of the largest national medical organizations, representing more than 94,300 family physicians, family practice residents and medical students nationwide. The site states that aspartame is not related to ADHD in children or brain tumours in the general population. The site also notes that the claims made against aspartame are false.

http://www.aafp.org/afp/20001101/diary.html http://www.aafp.org/afp/980600ap/quantum.html

American Cancer Society

The American Cancer Society (ACS) is committed to fighting cancer through balanced programs of research, education, patient service, advocacy, and rehabilitation. The ACS's Web site clearly states that aspartame does not cause cancer. In fact, aspartame (due to the nature in which it is metabolized) never reaches the organs of the body.

http://www.cancer.org/docroot/ped/content/ped_1_3x_aspartame.asp http://www.cancer.org/docroot/PED/content/PED_3_2X_Common_Questions_About_Diet_and_Cancer.asp http://www.cancer.org/docroot/CRI/content/CRI_2_4_2X_What_are_the_risk_factors_for_brain_and_spinal_cord_tumors_4.asp?sitearea=

American Council on Science and Health

After receiving many emails regarding allegations about aspartame that were circulating on the Internet, ACSH reminds consumers that aspartame is safe and offers further general information on artificial sweeteners. ACSH is a consumer education consortium concerned with helping consumers distinguish between real and hypothetical health risks.

http://www.acsh.org/healthissues/newsID.265/healthissue_detail.asp
http://www.acsh.org/factsfears/newsID.641/news_detail.asp

American Diabetes Association

American Diabetes Association, the nation's leading non-profit health organization providing diabetes research, information and advocacy, states that there is no credible scientific evidence linking aspartame to any health-related problems for people with diabetes.

http://www.diabetes.org/nutrition-and-recipes/nutrition/sweeteners.jsp
http://www.diabetes.org/nutrition-and-recipes/nutrition/faqs.jsp#Sweetener

American Dietetic Association

ADA concludes aspartame is safe and has issued a position statement approving non-nutritive sweeteners including aspartame. ADA is the professional organization that establishes standards of quality for practice for nearly 70,000 dietetic professionals, most of whom are registered dieticians.

http://www.eatright.org/cps/rde/xchg/SID-5303FFEA-92F276FF/ada/hs.xsl/home_3794_ENU_HTML.htm http://www.eatright.org/cps/rde/xchg/SID-5303FFEA-1D8EEF93/ada/hs.xsl/advocacy_3311_ENU_HTML.htm http://www.eatright.org/cps/rde/xchg/SID-5303FFEA-F176CC3D/ada/hs.xsl/home_adar1002b_ENU_HTML.htm

American Heart Association

The American Heart Association is dedicated to providing education and information on fighting heart disease and stroke. At this link discussing artificial sweeteners such as aspartame, the organization has found, through extensive investigation, that aspartame has not caused any serious side effects.

http://www.americanheart.org/presenter.jhtml?identifier=4447

Asthma and Allergy Foundation of America

The Asthma and Allergy Foundation of America is dedicated to helping those with asthma and allergies improve their quality of life through education, advocacy and research. This site notes that alleged reactions to aspartame have not been verified and claims that products containing aspartame cause hyperactivity in children are not supported by studies.

http://www.aafa.org/display.cfm?id=9&sub=20&cont=285

British Medical Journal Editorial Concludes Aspartame Criticisms Are Unfounded

The October 2, 2004 issue of the British Medical Journal carries an editorial concluding that aspartame has been "demonised unfairly" in sections of the press and on the Internet.

http://www.aspartame.org/pdf/bmj.pdf

Canadian Diabetes Association

The Canadian Diabetes Association recently confirmed the safety of aspartame as part if its "Canadian Diabetes Association National Nutrition Committee Technical Review: Non-nutritive Intense Sweeteners in Diabetes Management," which was published in the Canadian Journal of Diabetes. The review specifically notes, "At this time, there is no scientific evidence to support the negative health effects that have been ascribed to aspartame."

http://www.diabetes.ca/Section_Professionals/pub_cjd_dec2004.asp#5

Diabetes U.K.

Diabetes U.K. is the largest advocacy organization for people living with diabetes in the United Kingdom. They fund research, act as a lobbying group and campaign for the improvement of those living with diabetes. Diabetes U.K. provides position statements on the safety and helpfulness of aspartame and other low-calorie sweeteners, stating there is no evidence to support any of the questions being raised in relation to the safety of aspartame.

http://www.diabetes.org.uk/infocentre/state/aspart.htm
http://www.diabetes.org.uk/infocentre/state/intense.htm

Lupus Foundation of America

The Lupus Foundation of America is a nationwide volunteer organization serving the lupus community, including patients, their families, physicians, researchers, and the general public. The site notes in this question asking whether there was "any truth to the claims being circulated on the Internet that lupus is caused by the artificial sweetener, aspartame?" that there is no credible scientific evidence to support a link between aspartame and lupus.

http://www.lupus.org/education/faq.html#22

Massachusetts Institute of Technology

Scientists at the Massachusetts Institute of Technology's Clinical Research Center conducted a study which concluded that aspartame is safe for the general population. Findings are noted here in this section entitled "Study reaffirms safety of aspartame." MIT is known for its Nobel prize-winning staff and excellence in science and math.

http://web.mit.edu/newsoffice/tt/1998/sep16/aspartame.html

Mayo Clinic

The Mayo Clinic asserts that aspartame is not to blame for brain tumours and notes that The Multiple Sclerosis Foundation, the Arthritis Foundation and the American Cancer Society, among other reputable sources, have all rebutted this widely circulated myth that Aspartame causes multiple sclerosis, lupus and tumours. This multi-campus health system is a leader in clinical practice, research and education and is a trusted name in health care.

http://www.mayoclinic.com/invoke.cfm?objectid=C367D268-8929-4BA8-8DBACAD0320E8099

Multiple Sclerosis Society of Canada

The Multiple Sclerosis Society of Canada refutes the claims made against aspartame and notes that there has been no published peer-reviewed research on aspartame and multiple sclerosis which support such claims.

http://www.mssociety.ca/en/research/PC990122.htm

Multiple Sclerosis Foundation

The Multiple Sclerosis Foundation's site is a comprehensive on-line MS information centre. The article notes, "The CDC also noted that there was no evidence supporting the claim that aspartame could cause certain diseases (i.e. multiple sclerosis, lupus, etc.)."

http://www.msfocus.org/publications/pub_articles_aspart.html

National Cancer Institute

The National Cancer Institute is a valuable resource for both scientists and the general public. Information is provided on types of cancer, the latest treatments and statistics as well as funding opportunities, training programs and up-to-date news and information. A recent analysis of NCI statistics on cancer incidence in the United States does not support an association between the use of aspartame and an increased incidence of brain tumours. National Multiple Sclerosis Society

The National Multiple Sclerosis Society states that "stories linking aspartame and MS are unfounded" and that "several websites and documents circulating on the Internet are making unsubstantiated claims about aspartame. NMSS Web site offers access to the latest information about MS, diagnosis and treatments, resources for living with MS and Society-funded research efforts.

http://www.cancer.gov/cancertopics/factsheet/Risk/artificial-sweeteners

National Parkinson Foundation

The National Parkinson Foundation states that there is no evidence indicating that aspartame is linked to Parkinson's disease and that "Aspartame has been approved as safe for human consumption by the United States Food and Drug Administration, by regulatory authorities in over 90 countries." The National Parkinson Foundation is an organization dedicated to finding the cause and cure for Parkinson's disease and related neurodegenerative disorders through research.

http://www.parkinson.org/site/apps/s/content.asp?c=9dJFJLPwB&b=108269&ct=89681

The Nemours Foundation

The Nemours Foundation is dedicated to improving the health and spirit of children and supports the operation of a number of renowned children's health facilities throughout the nation, including the Alfred I. duPont Hospital for Children in Wilmington, Delaware, and the Nemours Children's Clinics throughout Florida. The Foundation states that aspartame is safe for the general population, including children.

http://www.kidshealth.org/parent/growth/feeding/aspartame.html

U.K. Ministry of Agriculture, Fisheries and Food (MAFF)

Aspartame was first approved for use in the UK in 1982 following a review by the Committee on Toxicity (COT), a group of independent experts who advise the Government on the safety of food ingredients. The COT has fully reviewed aspartame after studying all the available scientific information and found it to be safe for consumption. Up-to-date bulletins regarding this information can be found here.

http://www.foodstandards.gov.uk/safereating/additivesbranch/sweeteners/55174 http://www.foodstandards.gov.uk/news/newsarchive/2002/dec/aspartamereview

U.S. Consumer Information Center

Established in 1966, the U.S. Consumer Information Center is a point of contact for people who have questions about Federal agencies, programs, and services. The FDA stands behind its original approval of aspartame, and subsequent evaluations have shown that the product is safe.

http://www.pueblo.gsa.gov/cic_text/food/sugar-sub/sub.html

U.S. FDA Consumer Magazine

This article address both natural and artificial sweeteners. The FDA stands behind its original approval of aspartame, and subsequent evaluations have shown that the product is safe.

http://www.fda.gov/fdac/features/1999/699_sugar.html

WebMD

WebMD is an online community that provides valuable health information, tools for managing your health, and support to those who seek information. The site describes aspartame as "thoroughly tested by the FDA and deemed safe for the general population."

http://my.webmd.com/content/Article/54/65230.htm?pagenumber=1

Fuente: El Consejo Europeo de Información sobre la Alimentación

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