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EUROPEAN RAMAZZINI FOUNDATION STANDS BEHIND ASPARTAME STUDY RESULTS, ANNOUNCES ONGOING RESEARCH ON ARTIFICIAL SWEETENERS

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05 May 2006
EUROPEAN RAMAZZINI FOUNDATION STANDS BEHIND ASPARTAME STUDY RESULTS, ANNOUNCES ONGOING RESEARCH ON ARTIFICIAL SWEETENERS
Response to EFSA’s AFC panel decision

The European Foundation of Oncology and Environmental Sciences “B. Ramazzini”, the sole sponsor of a long-term carcinogenesis study demonstrating that aspartame is a multipotential carcinogenic agent in rodents, responded today to the opinion announced by the European Food Safety Authority’s Panel on Food Additives, Flavorings, Processing Aids and Materials (AFC).

Scientific Director of the European Ramazzini Foundation and primary author of the aspartame study, Dr. Morando Soffritti, M.D., underlined the importance of EFSA’s interest in the European Ramazzini Foundation’s aspartame study saying, “as the Director of an independent, non-profit institution, I consider it an important recognition to have our data carefully considered by EFSA.” Prior long-term carcinogenesis studies on aspartame (4 total) were conducted over 20 years ago by the producers of the artificial sweetener using a small number of animals per sex per group. The results of these studies provided the basis for the current opinion regarding the non-carcinogenicity of aspartame.

In responding to the AFC panel comments, Soffritti noted that “what the panel considers shortcomings of the study are instead distinctive and positive characteristics of our research protocol, research which has provided the scientific basis for changes in international regulations numerous times over the last 30 years.” For instance, the European Ramazzini Foundation conducts what are known as lifespan mega-experiments, meaning that large groups of rodents are allowed to live out their natural lifespan and are examined for histopathological changes upon spontaneous death. This model is in contrast with most laboratories where rodents are sacrificed at 110 weeks of age (representing about 2/3 of the lifespan). The Ramazzini study design closely mirrors the human condition in which persons may be exposed to agents in the industrial and general environments from embryonic life until natural death.Since 80% of cancer is diagnosed in humans over the age of 55, it is of paramount importance to observe how an agent affects laboratory animals in the last third of their lives”, notes Soffritti. He added that “occurrence of chronic pulmonary inflammation is common in the natural dying process. Moreover, inflammation was observed in both animals who were treated with aspartame as well as in the control group.”

With regard to a pathology review, it was not deemed appropriate or necessary to subject a small subset of the 34,000 slides to external review, especially given the statistical power of an experiment of this size. Slides of previous carcinogenesis studies on aspartame were not reviewed by the AFC panel, an action that Dr. Soffritti believes should have been obligatory in light of the European Ramazzini Foundation’s results, at the very least those involving haemopoietic and lymphoid organs and tissues. At the highest dose level tested in the Ramazzini study, 25% of female rats bore lymphomas-leukemias compared with 8.7% in the controls.

Because of the globalization of the industrialized diet and the ever-increasing use of artificial sweeteners among billions of people in both industrialized and developing countries, the European Ramazzini Foundation considers its work on sweeteners to be of the highest priority for the protection of public health, in particular the health of children and pregnant women who are among the most vulnerable populations. In light of this goal, and given the inadequacy of most of the previous carcinogenicity studies on artificial sweeteners, Soffritti announced today that “we have planned and are conducting additional research, not only on aspartame, but also on other widely diffused artificial sweeteners and blends used in thousands of foods, beverages and pharmaceutical products. International agencies like EFSA will continue to be our first point of reference and we will continue to keep them informed of our results in a timely manner as always.”

Press Contact:
Kathryn Knowles
Director of Resource Development
European Foundation of Oncology and Environmental Sciences “B. Ramazzini”
+39 0516640460 (ext.3 )
development@ramazzini.it

Information on the European Ramazzini Foundation’s study on aspartame:
The long term bioassay on aspartame conducted in the laboratories of the Cesare Maltoni Cancer Research Center of European Foundation of Oncology and Environmental Sciences “B. Ramazzini”, represents the largest, most comprehensive carcinogenicity study ever performed on aspartame, both in terms of number of rodents and dose levels tested. The study used 1,800 Sprague-Dawley rats (900 males, 900 females) of the colony used in the same laboratory for over 30 years. In order to simulate daily human intake, aspartame was added to the standard rat diet in quantities of 5000, 2500, 100, 500, 20, 4, and 0 mg/Kg of body weight. Treatment of the animals began at 8 weeks of age and continued until spontaneous death. A complete necropsy and histopathological evaluation of tissues and organs was then performed on each deceased animal, for a total of over 34,000 slides examined by microscope.

Results of the study demonstrate that aspartame, administered at varying levels in feed, causes a statistically significant, dose-related increase of lymphomas-leukemias and malignant tumors of the renal pelvis in female rats and malignant tumors of peripheral nerves in male rats. These results demonstrate for the first time that aspartame is a carcinogenic agent, capable of inducing malignancies at dose levels lower than the current acceptable daily intake for humans (40 mg/kg of body weight in the EU, 50 mg/kg of body weight in the US).

The first results of the European Ramazzini Foundation’s long term study on aspartame were reported to the Ministry of Health and to the Superior Institute of Health of the Italian government in April 2005. In mid-June, these findings were then communicated to the European Food Safety Authority (EFSA), the Herbert Irving Comprehensive Cancer Center of Columbia University, the National Cancer Institute of the US government, and the National Toxicology Program of the US National Institutes of Health. First results, "Aspartame induces lymphomas and leukemias in rats" were published in the peer-reviewed European Journal of Oncology June 2005, Vol.10, n.2, pp.107-116. Final results of the study, "First Demonstration of the Multipotential Carcinogenic Effects of Aspartame Administered in the Feed to Sprague-Dawley Rats" were published in Environmental Health Perspectives March 2006, Vol.114, n.3, pp. 379-386. Environmental Heath Perspectives is published by the National Institute of Environmental Health Sciences, part of the US Department of Health and Human Services. Internationally, it ranks in the top two environmental sciences journals and top five public health journals.

A 2400+ page report, containing individual rodent data on survival and all pathological results (both benign and malignant) as well a complete statistical evaluation was delivered upon request to the Council of the Superior Institute of Health of the Italian Ministry of Health, EFSA’s Department of Food Additives, Flavorings, Processing Aids and Materials in Contact with Food, the Center for Food Safety and Applied Nutrition of the United States Food and Drug Administration and the Bureau of Chemical Safety of Health Canada.

About the European Ramazzini Foundation:
The European Foundation of Oncology and Environmental Sciences "B. Ramazzini" is a non-profit, private institution with official governmental recognition located in Bologna, Italy. Its facilities include an Epidemiological Research Center and the Cesare Maltoni Cancer Research Center (CMCRC) of Bentivoglio, where one of world’s largest and longest existing programs of carcinogenicity bioassays is conducted. In the 10,000 m2 CMCRC laboratories, experiments on up to 15,000 rodents may be conducted simultaneously and carcinogenicity studies on more than 200 compounds present in the work and the general environments have been performed. Compounds demonstrated to be carcinogenic by the CMCRC include vinyl chloride, benzene, formaldehyde, gasolines and their components, some pesticides and aspartame. Current research includes mega-experiments on electromagnetic fields originating from 50 Hz electric current and electromagnetic fields generated from radio base stations used in mobile telephone technologies. www.ramazzini.it



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3 Comments

Since my wife died of Lymphoma of the brain in 2005 I have been concerned, as has my family, about the safety of the use of aspartame in our diets. I have coffee each morning with a couple of packets in each of 2 drinks. My wife did also. Her mother died of cancer, by the way. My children drink a lot of diet sodas with aspartame. Are we at risk or am I just worried about nothing?

This is very interesting site

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http://groups.yahoo.com/group/aspartameNM/message/1334
European Food Safety Authority discounts Ramazzini study re many
cancers in 1800 rats fed lifetime doses of aspartame:
Calorie Control Council press release: Murray 2006.05.05


"Concerning the malignant tumors of the peripheral nerves,
the numbers of tumours were low with no clear dose-response
relationship over a wide dose range.

There is also uncertainty about the diagnosis of these tumours.

The Panel indicated that this finding can only be fully evaluated
by an independent peer-review of the relevant tissues."

http://www.efsa.eu.int/press_room/press_release/1472_en.html

EFSA assesses new aspartame study and reconfirms its safety
Last updated: 05 May 2006

The AFC Panel of the European Food Safety Authority (EFSA)
has evaluated the new long-term study on the carcinogenicity
of aspartame conducted by the European Ramazzini Foundation
in Bologna, Italy.

Press release

EFSA assesses new aspartame study and reconfirms its safety

The AFC Panel[1] of the European Food Safety Authority (EFSA)
has evaluated the new long-term study on the carcinogenicity
of aspartame conducted by the European Ramazzini Foundation [2]
in Bologna, Italy. In its opinion published today, the Panel concluded,
on the basis of all the evidence currently available,
that there is no need to further review the safety of aspartame
nor to revise the previously established Acceptable Daily Intake (ADI)
for aspartame (40 mg/kg body weight).
The Panel also noted that intakes of aspartame in Europe,
with levels up to 10 mg/kg body weight per day, are well below the ADI.

Aspartame, an intense sweetener, has been authorized for use in foods
and as a table-top sweetener for more than 20 years in many countries
throughout the world.
Extensive investigations have been carried out on aspartame and its
breakdown products through experimental animal and human studies,
intake studies and post-marketing surveillance.
In addition to a number of safety evaluations conducted in the past,
the Scientific Committee on Food (SCF) carried out a review of all
original and more recent studies on aspartame in 2002[3]
and reconfirmed that aspartame is safe for human consumption.

However, since it was introduced onto the market,
the safety of aspartame has been a controversial issue.
In 2005, the European Ramazzini Foundation published new findings
of a long-term study on aspartame conducted in rats. The scientists
from the European Ramazzini Foundation concluded that the results
of their study indicate that aspartame can cause cancer and that the
current guidelines on the use and consumption of the sweetener
should be re-evaluated.
EFSA immediately undertook the evaluation of the new findings
and requested that the European Ramazzini Foundation provide all study
details necessary for the assessment.
The European Commission confirmed the need to assess the study
and supported the high priority given to this work.

The Panel has evaluated extensive data from the new study on
aspartame provided to EFSA by the European Ramazzini Foundation.
The Panel noted that this lifetime study used more animals
per dose group and a larger number of doses
than conventional carcinogenicity studies.
It therefore represented a substantial effort and had the potential
to be more sensitive to low incidence effects.
However, a number of major issues with the study were identified
by the Panel which made interpretation of the findings difficult.
Notably, a high background incidence of chronic inflammatory disease
in the lung and other organs was observed in all the animal groups
including controls which did not receive aspartame,
as reported by the European Ramazzini Foundation.
This was considered to be a major confounding factor.

In detail the Panel concluded the following:
The slight increase in incidence of cancers known as lymphomas
and leukemias in treated rats was considered to be unrelated
to aspartame treatment and most likely attributed
to the high background incidence of inflammatory changes in the lung.
In addition, there was no dose-response relationship
with respect to increasing doses of aspartame.

The findings in the kidney, ureter and bladder,
observed mainly in female rats, are not specific to aspartame
and have been observed with a number of chemicals
administered to rats at high dose levels.

Such changes are normally the result of irritation or imbalances in
calcium metabolism specific to rats and are of no relevance for humans.

Concerning the malignant tumors of the peripheral nerves,
the numbers of tumours were low with no clear dose- response
relationship over a wide dose range.

There is also uncertainty about the diagnosis of these tumours.

The Panel indicated that this finding can only be fully evaluated
by an independent peer-review of the relevant tissues.

Finally the Panel concluded that based on all the available data to date
there is no reason to further review the previous scientific opinion
on the safety of aspartame nor to revise the Acceptable Daily Intake
(ADI) for aspartame of 40 mg/kg body weight.
Commenting on the AFC Panel's risk assessment,

Dr. Herman Ko�ter, EFSA Acting Executive Director, said:
"EFSA considers that the results of this new study on aspartame
do not provide a scientific basis for reconsidering its use in foods.
If any new information would become available in the future,
EFSA will review these as a matter of priority."

The full text of the opinion is available at:
http://www.efsa.eu.int/science/afc/afc_opinions/1471_en.html

For additional information, please see the related background
documents (Frequently Asked Questions on aspartame)
and links to previous press releases and risk assessments
related to aspartame which are provided on the EFSA website at:
http://www.efsa.eu.int/press_room/focus_on_the_issues/aspartame/catindex_en.html

Note to editors

The data from the new study on aspartame presented in the
European Ramazzini Foundation's publications[4] were insufficient
for the AFC Panel to evaluate the study and its findings.

Following discussions with the Foundation in June 2005,
EFSA requested access to further scientific information required
for the evaluation.
In December 2005, EFSA received an extended dossier of the findings.

An EFSA Working Group on aspartame consisting of independent
scientific experts in the area was set up immediately after the receipt
of the data at the end of 2005.

However, some crucial information and data were still lacking.
On request, the European Ramazzini Foundation provided EFSA
on 19th April 2006 with further data.
However on review, they did not contribute significantly
to the evaluation of the findings.

For media enquiries, please contact:
E-mail: Press@efsa.eu.int
Carola Sondermann, Senior Press Officer
carola.sondermann@efsa.eu.int

Tel: + 39 0521 036 294 - Mobile: +39 340 49 24 207
or
Anne-Laure Gassin, EFSA Communications Director
Mobile: + 39 348 640 34 34 Anne-Laure.Gassin@efsa.eu.int

[1] Panel on food additives, flavourings, processing aids and materials
in contact with food (AFC)

[2] European Foundation of Oncology and Environmental Sciences
"B. Ramazzini"

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

[4] http://www.ramazzini.it/fondazione/docs/AspartameGEO2005.pdf
http://www.ehponline.org/members/2005/8711/8711.html

Publication date: 04 May 2006 Europeak

Dr. Herman Ko�ter -- EFSA Acting Executive Director
+390521036205 Herman.Koeter@efsa.eu.int
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http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/05-05-2006/0004355402&EDATE=

Comprehensive Review of Ramazzini Study Demonstrates
No Scientific Evidence of Aspartame and Cancer Link

ATLANTA, May 5 /PRNewswire/ --
The European Food Safety Authority (EFSA) announced today
there is no reason to recommend any dietary change
in regard to the low-calorie sweetener, aspartame.

The report from EFSA's
Scientific Panel on Food Additives, Flavourings, Processing Aids and
Materials in Contact with Food (AFC) specifically states,
"In its opinion published today, the Panel concluded,
on the basis of all the evidence currently available,
that there is no need to further review the safety of aspartame
nor to revise the previously established Acceptable Daily Intake
(ADI) for aspartame (40 mg/kg body weight)."

EFSA's statement is the result of its review of a recent study by the
Ramazzini Institute, which alleged an increased risk of leukemia and
lymphoma with aspartame use.

According to Dr. Herman Koeter, EFSA Acting Executive Director,
"EFSA considers that the results of this new study on aspartame
[by Ramazzini researchers] do not provide scientific basis
for reconsidering its [aspartame's] use in foods."

The design and execution of the Ramazzini study did not follow
guidelines set up by the National Toxicology Program (NTP), the U.S.
government toxicology initiative. Ramazzini researchers did not follow
internationally established protocols for evaluation of animal
carcinogenicity study findings. The NTP and other organizations have
established guidelines for pathology peer review in order to provide
scientific consensus that study conclusions are valid. Such an independent
review of the pathology slides from this study has not been conducted.

The findings by EFSA further support a recent epidemiology study
from the National Cancer Institute which found no link between
aspartame consumption and leukemias, lymphomas and brain tumors.
The study, presented at the American Association of Cancer Research
meeting in Washington, DC, on April 4, 2006, evaluated over 500,000
men and women between the ages of 50 and 69 over a five-year period.
The researchers found (compared with those who did not consume
aspartame) that there was no evidence of an increased risk of leukemias,
lymphomas and brain tumors among those who use aspartame.
The researchers report, "Our findings from this epidemiologic
study suggest that consumption of aspartame-containing beverages does
not raise the risk of hematopoietic or brain malignancies."

Additionally, three recent animal studies conducted by the National
Toxicology Program (NTP) designed to evaluate whether aspartame
is capable of causing cancer were published in October of 2005.
These U.S. government-funded and managed studies were conducted
using Good Laboratory Practices (GLP).
The results of these cancer studies, in which aspartame was fed to
mice bred to be especially sensitive to cancer-causing agents,
unequivocally indicated that "there was no evidence of carcinogenic
activity [cancer] of aspartame."

The U.S. Food & Drug Administration (FDA) also supports the fact
that aspartame is a safe low-calorie sweetener. According to the FDA,
"Based on the large body of evidence we have reviewed, including
several studies on carcinogenicity which showed no adverse effects
and data on how aspartame is metabolized by humans, we have no
reason to believe that aspartame would cause cancer. Thus, it remains
FDA's position that use [of aspartame] is safe."

Aspartame is one of the most thoroughly studied food ingredients
with more than 200 studies supporting its safety. In addition to the FDA,
the Joint Expert Committee on Food Additives (JECFA) of the World
Health Organization and Food and Agriculture Organization,
the Scientific Committee on Food of the European Union and regulatory
agencies in more than 100 countries have reviewed aspartame and found
it to be safe for use.

"We are pleased with EFSA's findings as we have had major concerns
about the Ramazzini study including a lack of Good Laboratory Practices,
the methodology, the fact that it has not undergone the NTP peer review
process, etc.," noted Lyn Nabors, President of the Calorie Control
Council. "The findings from EFSA, the NTP, and other leading
regulatory and health agencies should provide consumers with confidence
in the safety of aspartame," she added.

To read the EFSA press release visit:
http://www.efsa.eu.int/press_room/press_release/1472_en.html

For more information about aspartame please visit:

http://www.aspartame.org

The Calorie Control Council, established in 1966, is an international
non-profit association representing the low-calorie and reduced-fat
food and beverage industry.
SOURCE Calorie Control Council http://www.aspartame.org
http://www.efsa.eu.int/press_room/press_release/1472_en.html

Issuers of news releases and not PR Newswire are solely responsible
for the accuracy of the content.
Terms and conditions, including restrictions on redistribution, apply.
Copyright � 1996-2006 PR Newswire Association LLC.
All Rights Reserved. A United Business Media company.
*******************************************************

http://groups.yahoo.com/group/aspartameNM/message/957
safety of aspartame Part 1/2 12.4.2: EC HCPD-G SCF:
Murray 2003.01.12 rmforall EU Scientific Committee on Food,
a whitewash

http://groups.yahoo.com/group/aspartameNM/message/1045
http://www.holisticmed.com/aspartame/scf2002-response.htm
Mark Gold exhaustively critiques European Commission Scientific
Committee on Food re aspartame ( 2002.12.04 ):
59 pages, 230 references

http://groups.yahoo.com/group/aspartameNM/message/1327
rebuttals of CCC aspartame PR spin re NCI 15 min talk: Mark Gold:
Betty Martini and independent experts: Murray 2006.04.11

http://groups.yahoo.com/group/aspartameNM/message/1189
Michael F. Jacobson of CSPI now and in 1985 re aspartame toxicity,
letter to FDA Commissioner Lester Crawford;
California OEHHA aspartame critique 2004.03.12;
Center for Consumer Freedom denounces CSPI: Murray 2004.07.27
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http://groups.yahoo.com/group/aspartameNM/message/1328
migraine from sucralose, Bigal ME & Krymchantowski AV,
Headache 2006 March; formaldehyde from 11% methanol part of
aspartame or from red wine causes same toxicity (hangover) harm:
Murray 2006.05.04

http://groups.yahoo.com/group/aspartameNM/message/1329
aspartame or MSG affects circadian rhythms in rats, two studies,
P. Subramanian, T. Manivasagam et al 2004:
Murray 2006.04.27


"Of course, everyone chooses, as a natural priority,
to actively find, quickly share, and positively act upon the facts
about healthy and safe food, drink, and environment."

Rich Murray, MA Room For All rmforall@comcast.net
505-501-2298 1943 Otowi Road Santa Fe, New Mexico 87505

http://groups.yahoo.com/group/aspartameNM/messages
group with 152 members, 1,334 posts in a public, searchable archive
http://RMForAll.blogspot.com http://AspartameNM.blogspot.com

Dark wines and liquors, as well as aspartame, provide
similar levels of methanol, above 120 mg daily, for
long-term heavy users, 2 L daily, about 6 cans.

Within hours, methanol is inevitably largely turned into formaldehyde,
and thence largely into formic acid -- the major causes of the dreaded
symptoms of "next morning" hangover.

Fully 11% of aspartame is methanol -- 1,120 mg aspartame
in 2 L diet soda, almost six 12-oz cans, gives 123 mg
methanol (wood alcohol). If 30% of the methanol is turned
into formaldehyde, the amount of formaldehyde, 37 mg,
is 18.5 times the USA EPA limit for daily formaldehyde in
drinking water, 2.0 mg in 2 L average daily drinking water.

http://groups.yahoo.com/group/aspartameNM/message/1143
methanol (formaldehyde, formic acid) disposition: Bouchard M
et al, full plain text, 2001: substantial sources are
degradation of fruit pectins, liquors, aspartame, smoke:
Murray 2005.04.02

Any unsuspected source of methanol, which the body always quickly
and largely turns into formaldehyde and then formic acid, must be
monitored, especially for high responsibility occupations, often with
night shifts, such as pilots and nuclear reactor operators.

http://groups.yahoo.com/group/aspartameNM/message/1291
European Food Safety Authority to decide aspartame safety by May:
caffeine diet drinks cause female hypertension, WC Winkelmayer et al,
JAMA 2005.11.09: PubMed lists 50 items for "diet soft drinks" since
2004 Oct.: Murray 2006.01.24

http://groups.yahoo.com/group/aspartameNM/message/1279
all three aspartame metabolites harm human erythrocyte [red blood cell]
membrane enzyme activity, KH Schulpis et al, two studies in 2005,
Athens, Greece, 2005.12.14: 2004 research review, RL Blaylock:
Murray 2006.01.14

http://groups.yahoo.com/group/aspartameNM/message/939
aspartame (aspartic acid, phenylalanine) binding to DNA:
Karikas July 1998: Murray 2003.01.05 rmforall
Karikas GA, Schulpis KH, Reclos GJ, Kokotos G
Measurement of molecular interaction of aspartame and
its metabolites with DNA. Clin Biochem 1998 Jul; 31(5): 405-7.
Dept. of Chemistry, University of Athens, Greece
http://www.chem.uoa.gr gkokotos@atlas.uoa.gr;
K.H. Schulpis inchildh@otenet.gr; G.J. Reclos reklos@otenet.gr;

http://groups.yahoo.com/group/aspartameNM/message/1271
combining aspartame and quinoline yellow, or MSG and brilliant blue,
harms nerve cells, eminent C. Vyvyan Howard et al, 2005
education.guardian.co.uk, Felicity Lawrence: Murray 2005.12.21

http://groups.yahoo.com/group/aspartameNM/message/925
aspartame puts formaldehyde adducts into tissues, Part 1/2
full text Trocho & Alemany 1998.06.26
Universitat Aut�noma de Barcelona : Murray 2002.12.22

http://groups.yahoo.com/group/aspartameNM/message/1250
aspartame causes cancer in rats at levels approved for humans,
Morando Soffritti et al, Ramazzini Foundation, Italy &
National Toxicology Program
of National Institute of Environmental Health Sciences
2005.11.17 Env. Health Pers. 35 pages: Murray

http://groups.yahoo.com/group/aspartameNM/message/1106
hangover research relevant to toxicity of 11% methanol in aspartame
(formaldehyde, formic acid): Calder I (full text): Jones AW:
Murray 2004.08.05 rmforall

Since no adaquate data has ever been published on the exact disposition
of toxic metabolites in specific tissues in humans of the 11% methanol
component of aspartame, the many studies on morning-after hangover
from the methanol impurity in alcohol drinks are the main available
resource to date.

Jones AW (1987) found next-morning hangover from red wine with
100 to 150 mg methanol
(9.5% w/v ethanol, 100 mg/l methanol, 0.01%,
one part in ten thousand).

http://groups.yahoo.com/group/aspartameNM/message/1100
research on aspartame (methanol, formaldehyde, formic acid) toxicity:
Murray 2004.07.19 rmforall
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