Review Postscript of the Analysis of the EC/SCF Aspartame Document
Analysis of the EC/SCF Aspartame Document
Independent Analysis of the "Opinion of the European Commission, Scientific
Committee on Food: Update on the Safety of Aspartame / E951"
was written in 2002, several key pieces of information have come to light:
- A 2004 assessment by the European Anti-Fraud Agency (OLAF) revealed that
the original "Opinion of the European Commission, Scientific
Committee on Food: Update on the Safety of Aspartame / E951" was
written by a single individual who works at the UK Food Safety Agency
and not by the entire Scientific Committee on Food (SCF). OLAF did not
reveal the name of this individual or what, if any, scientific expertise
or conflict of interest this person had. The Opinion was then reviewed by
the members of the SCF before approval, but according the OLAF, there
were no significant changes that affected the conclusion.
What is particularly interesting is that each Opinion of these Committees is
prepared by one unnamed individual. Then the draft is reviewed by persons
who are often industry consultants. It is clear that neither the original
author nor the Committe (including industry consultants) had any familiarity
with research related to aspartame (as detailed in the
- The European Commission, Scientific Committee on Food is no longer active.
All of the European Commission reviews are now being conducted by the
European Food Safety Agency (EFSA). Some of the same scientists with
conflicts of interest on the Scientific Committee on Food and other
European Commission scientific committess are now at
the EFSA. At the end of this postscript, there is an article about another
product originally put out by Monsanto (the original manufacturer of
aspartame), a study demonstrating harmful effects and how EFSA avoided
telling the public about this study and gave rubber-stamp approval.
- Three key studies that relate to aspartame have recently been completed:
- A long-term study linking aspartame ingestion to lymphomas and leukemias in animals.
The full study can be read at:
Russell Blaylock M.D. commented: "The new study released in the European Journal of Oncology by
Morando Soffritti and co-workers should terrify mothers and all those consuming aspartame
sweetened products. This was a carefully done study which clearly demonstrated a statistically
significant increase in several types of lymphomas and leukemias in rats. Both of these
malignancies have increased significantly in this country since the widespread use of aspartame.
"This study confirmed the previous study by Dr. Trocho and co-workers, which also found the
formaldehyde breakdown product of aspartame to be damaging to cellular DNA and that this
damage was accumulative. The type of damage was a duplicate of that associated with cancers.
Along with this most recent study, this means that drinking a single diet cola sweetened with
aspartame every day could increase one's risk of developing a lymphoma or leukemia.
"They also found an increased incidence of malignant brain tumors, even though it was not
statistically significant. This does not mean there is no association to brain tumors,
since only the animals exposed to aspartame developed the tumors. With children and pregnant
women drinking the largest amount of diet colas, this puts their children at the greatest
risk of developing one of these horrible diseases. Their study found that even low doses
of aspartame could cause these malignancies; yet, the higher the dose, the more cancers
that were seen."
- A study conducted at the University of Texas Health Sciences Center reported a
"41% increase in risk of being overweight for every can or bottle of diet soft drink
a person consumes each day." The findings come from eight years of collecting data by
Sharon P. Fowler, MPH and colleagues. The results of the study was reported at the
65th Annual Scientific Sessions of the American Diabetes Association in San Diet on
June 10-14, 2005 (Abstract 1058-P). While this study, by itself, does not prove that
aspartame causes weight gain, it adds to the evidence seen in independent research.
For example, a study conducted by Dr. H.J. Roberts found that 5% of subjects reporting
symptoms from aspartame also reported a "paridoxic weight gain."
(Reactions Attributed to Aspartame-Containing Products: 551 Cases," Journal of Applied
Nutrition, Volume 40, page 85-94). Lavin found that females with eating restraint
had a higher Calorie intake subsequent to aspartame intake as opposed to sugar or water
intake. (Lavin, J.H., S.J. French, N.W. Read, 1997. "The Effect of Sucrose- and
Aspartame-Sweetened Drinks on Energy Intake, Hunger and Food Choice of Female,
Moderately Restrained Eaters," International Journal of Obesity, Volume 21,
pages 37-42, 1997.)
- A study published in Toxicology (2005 Jun 1; 210(2-3): 235-45.
"Cytotoxic effect of formaldehyde with free radicals via increment of
cellular reactive oxygen species.") by Saito and colleagues demonstrates
that formaldehyde is much more toxic to cells when free radical levels
are increased. As has been demonstrated by Trocho, et al. in 1998,
aspartame ingestion leads to the significant exposure to and accumulation
of formaldehyde adducts in the organs and tissues. In addition, 40% of
aspartame breaks down into an excitotoxic amino acid. As Neuroscientist
Russell Blaylock points out, "Excitotoxins destroy neurons partly by
stimulating the generation of large numbers of free radicals."
- The European Food Safety Agency (EFSA) has stated that it will
review the study linking aspartame ingestion to lymphomas and leukemias
"...as a matter of high priority, in the context of the previous extensive
safety data available on aspartame." If that quote doesn't give
one a clue as to what the results of their review will be, I will
be more clear: The review by EFSA (industry consultants) will find no
problem with aspartame. That is a guarantee. You read it here first.
The following article describes a study revealing health problems associated
with a genetically modified corn and the attempts by Monsanto and European
regulators to distort the findings. As this longer-than-normal column provides
in-depth analysis of a current newsworthy controversy, please pass this article
on to reporters who can freely reprint in whole or in part, or use it as
Genetically Modified Corn Study Reveals Health Damage and Cover-up
By Jeffrey M. Smith, author of Seeds of Deception
When a German court ordered Monsanto to make public a controversial 90-day rat
study on June 20, 2005, the data upheld claims by prominent scientists who said
that animals fed the genetically modified (GM) corn developed extensive health
effects in the blood, kidneys and liver and that humans eating the corn might
be at risk. The 1,139 page research paper on Monsanto's "Mon 863" variety also
revealed that European regulators accepted the company's assurances that their
corn is safe, in spite of the unscientific and contradictory rationale that was
used to dismiss significant problems. In addition, the study is so full of flaws
and omissions, critics say it wouldn't qualify for publication in most journals
and yet it is the primary document used to evaluate the health impacts.
Mon 863 is genetically engineered to produce a form of a pesticide called
bacillus thuringiensis or Bt, designed to attack a corn pest called the root worm.
Rats fed Mon 863 developed several reactions, including those typically found with
allergies (increased basophils), in response to infections, toxins and various
diseases including cancer (increased lymphocytes and white blood cells), and in
the presence of anemia (decreased reticulocyte count) and blood pressure problems
(decreased kidney weights). There were also increased blood sugar levels, kidney
inflammation, liver and kidney lesions, and other changes. According to top
research biologist Arpad Pusztai, who was commissioned by the German government
to evaluate the study in 2004, based on the evidence no one can say that Mon 863
will cause cancer or allergies or anything specific. The results are preliminary
and must be followed-up to rule these out. He warns, however, "It is almost
impossible to imagine that major lesions in important organs. . . . or changes
in blood parameters. . . . that occurred in GM maize-fed rats, is incidental and
due to simple biological variability."
French Professor Gilles-Eric Seralini, a molecular endocrinologist at the
University of Caen, agrees that the results indicate a toxic reaction. Seralini
is a member of two French government commissions that evaluate GM food, one of
which originally rejected a request for approval of the corn variety in October, 2003
due to the adverse findings of the study. Seralini won a French lawsuit allowing him
to express his concerns in public, and now Greenpeace has won a German court battle
that makes public the data that is the source of his concerns.
Pusztai and Seralini spoke about the Mon 863 study at a June 22 press conference
in Berlin organized by Greenpeace. Both scientists are uniquely qualified to
evaluate the study. Seralini studies endocrine disruptors and the impact of
pesticides on health. He was one of four experts appointed to respond to the
WTO challenge filed by the US against the European Union's policy on GM food and
crops. He has read all of the industry's GM-food submissions to Europe as well as
all the commentaries on the submissions. Pusztai is the leading authority in his
field of protein science (lectins) and had been commissioned by the UK government
in the 1990s to develop the ideal testing protocol for all GM foods. Although his
protocol was supposed to be adopted by the UK government and eventually in Europe,
Pusztai's controversial finding that GM potatoes damaged the health of rats
ultimately stopped the work. Pusztai has also been commissioned to evaluate all
published studies on GM foods, and has analyzed most of the confidential submissions
made by industry.
Both scientists have expressed alarm about the unsupported arguments that Monsanto
and some European regulators use to force product approvals. Now that the Mon 863
study is available, other scientists and the public can evaluate the industry's
defense, which Pusztai and Seralini say contradict well established scientific
principles. Chief among their concerns are the ways Monsanto explains away statistically
Faulty Comparisons Hide Problems
In animal feeding studies, researchers attempt to minimize differences between the
test animals and the control groups, so that only the impact of the item being analyzed
will stand out. In this study therefore, the test rats ate Mon 863 and the control group
ate non-GM corn from the same parent line, i.e., corn whose genetics are the same except
for the insertion of the genetic material and its impact. When comparing the results of
these two appropriate groups, the health impacts were unambiguous and occurred at a rate
that the scientific community accepts as not due to chance. But Monsanto and their
supporters in the European Food Safety Authority (EFSA) appear to throw away the
accepted methods of science that have been used for decades in order to rationalize
- Researchers used six additional control groups, which were fed commercial corn
varieties with entirely different genetics. While such comparisons are appropriate
for commercial studies, it is entirely inappropriate for a safety assessment,
according to Pusztai. Monsanto claimed that when the changes in the test rats were
compared to this much larger, irrelevant control group, many changes were no longer
- In spite of the strained logic, many results were still statistically significant
when compared to these six other controls and were reported as such by the laboratory
that Monsanto used to conduct the study. Monsanto therefore ignored the study's figures
and claimed that since the changes in the rats were still within a wide range of
reactions that are normal for the animals, they should be considered biologically
irrelevant. Using this argument, for example, they declared that a 52% decrease in
reticulocytes (immature blood cells) was "attributable to normal biological
variability." According to Pusztai, an allowance of 5% variability is the norm in
food experiments. Similarly, he says that the increase in blood sugar levels by 10%
"cannot be written off as biologically insignificant, given the epidemic of diabetes."
To put Monsanto's claims into perspective, suppose that a large number of women who
were fed a carefully controlled diet had a 25% increase in breast cancer compared to
matched controls on another diet. Using Monsanto's logic, the findings can be
dismissed because the increase was still within the normal variability of breast
cancer for the whole population.
- In spite of the statistical slight-of-hand, several results could still not be
dismissed since they were well beyond the range Monsanto had defined as normal.
So the company claimed that the potentially dangerous health effects were not
considered significant because the reaction among the rats was not consistent
between males and females. "This is really ridiculous," says Seralini, because
everyone studying cancer and endocrinology, for example, knows that there are differences
- When even the gender defense could not be applied to a particular finding,
Monsanto dismissed it since the reactions were not always dose specific. Specifically,
the results observed in rats fed a diet that was 11% Mon 863 were sometimes more
pronounced than results found in rats fed a 33% diet. Seralini notes that in
endocrinology and toxicology research, differences are not always proportional
to effects noted. A small dose of a hormone, for example, can cause a woman to
ovulate, while a larger dose can make her infertile.
- When all other excuses failed, Monsanto claimed that with such a large study,
one would expect lots of results to fall in the statistically significant category
purely by chance. Thus, no follow-up is required.
Seralini says, "It is dishonest not to do the tests again if you have statistical
significance." Pusztai similarly asks, "What is the point of doing a study if you
dismiss the results you find?" He insists that you design a study specifically so
that statistical significance indicates biological significance.
In spite of the fact that Monsanto's explanations were at odds with time-honored
principles of science, the European Food Standards Agency (EFSA) recommended that
Mon 863 be approved. In fact, the agency's justification mimics that of Monsanto,
point for point. In spite of EFSA's recommendation to approve Mon 863, the majority
of the countries in the EU Council of Ministers voted not to approve the corn on
July 24, 2005. But EU law requires a "qualified majority" on such a vote, and so
the pro-GM European Commission is now authorized to make the decision and is
expected to approve Mon 863 within a few months.
Mon 863 will not be the first approved GM food in Europe to have shown significant
health effects in rats. According to Seralini, an oilseed rape (GT 73),
Roundup Ready corn (NK 603), and two Bt corn varieties (Bt11 and Mon 810) all
showed statistically significant problems that regulators did not pursue with
follow-up research. Seralini said that the effects of the GM crops were similar
to that of pesticides. Some included inflammation disorders and problems in the
livers and kidneys, the two major organs involved with detoxification. Seralini
is part of a research group raising money to do independent research on a GM variety
he says showed more than 50 significant rat anomalies.
GM Food is Prone to Unpredicted Effects
How can a GM crop create so many significant unpredicted side effects? There are
several ways. The process of gene insertion, for example, typically results in
hundreds or thousands of mutations throughout the genome. Insertion also changes
the amount of protein that natural genes produce (5% of the genes in one study)
and can destroy natural genes altogether. The protein created by the inserted gene
may also create allergies or toxins. Several studies indicate, for example, that
the Bt pesticide may cause allergic or immune system effects. Furthermore, according
to Monsanto's submission on Mon 863 to Australia and New Zealand, some of the
foreign genetic material that was added into the corn was mutated during the
insertion process. This means that the composition of the Bt protein that the corn
creates is actually different than the one scientists intended.
With so many ways to create side effects, many scientists and consumer groups are
demanding extensive evaluations and insist that a simple 90-day rat experiment is
not competent to protect the public. In the EU, pesticide approvals require research
on three types of mammals, with feeding studies ranging from 90 days to two years.
Seralini points out that Bt crops create new pesticides. Mon 863, for example, is
unique; it differs from the natural version of Bt pesticide in seven ways and should,
according to Seralini, require at least the same level of evaluation as chemical
pesticides. The same holds true for herbicide tolerant crops, which are engineered
to survive large applications of weed killers such as Monsanto's Roundup. Seralini
points out that these GM plants have far more herbicide residues in the edible
portions and extensive toxicity tests must be performed. But the biotech industry
claims that they could not afford to introduce GM crops if they had to pay for the
tests normally required for pesticides in Europe. For GM crop approvals in the US,
they spend even less. US authorities require only 30-day studies for the Bt plants
and no safety tests whatsoever are required for herbicide tolerant varieties.
Flaws in the Mon 863 Study Should Have Caused It to be Rejected
According to Pusztai, the quality of Monsanto's study was well below that normally
required for a peer reviewed publication. He says, "It is odd, therefore, that it
remains the central document considered by government regulatory authorities upon
which to make a decision to protect the health of European citizens."
Several features of the study appear to have been rigged to avoid finding problems.
Nutritional studies, for example, typically use young, fast-growing animals, which
are sensitive to toxic and nutritional effects. By using a mix of young and old
animals, Monsanto's research design may have hidden serious problems. Similarly,
they used rats with a huge range of starting weights. According to Pusztai, the
starting weights in a rat feeding study should not vary more than 2% from the average.
By contrast, the male starting weights in Monsanto's study ranged from 198.4 to
259.8 grams (or 143 to 186 grams according to the conflicting data in the study's
appendix). In either case, says Pusztai, the wide range "can make it impossible
to find significant differences in animal weights at the end of the experiment."
Monsanto tested the effects of two diets: in one Mon 863 constituted 33% of the
rats' diet, and in the other, it was 11%. Even in the 33% group, GM corn protein
comprised only about 15% of the rats' total protein. According to Pusztai, researchers
should have started with the maximum amount of corn possible (while maintaining a
balanced diet), and then used lower concentrations to evaluate any dose effect.
(Since rats are stand-ins for humans, it is interesting to note that African aid
recipients typically rely on corn for 90% of their total caloric intake.) Researchers
also supplemented the corn with a commercial animal feed. Although its composition
wasn't reported, it may have contained GM soy, which could have skewed the results.
The study relied on analytical methods that are half a century old and ignored
powerful new methods, such as profiling techniques, DNA chips, proteomics, and
others. They relied on just two observation times (week 5 and week 14), which will
not give data about the intervening periods. And the short 90-day time period will
miss chronic and reproductive problems, as well as problems in the next generation.
The analysis of the findings was obscured by using six irrelevant control groups
fed commercial diets, as well as data from historical databases. Such comparisons
are totally unacceptable in the field of nutrition. According to Pusztai, "The study
should have included a control group fed the non-GM parent line, spiked with the
Bt obtained from the Mon 863. If rats reacted badly to this diet, it would show that
the genetic engineering process and its unpredicted side effects, and not the
Bt toxin, were responsible. Pusztai says, "A second parental line spiked with a
known toxin would also be useful as a positive control," to make sure the measurements
are sensitive enough to detect the expected impact of the toxin. Without this,
it is difficult to know if the methods were working properly.
Monsanto also defended changes in kidney weights by comparing the values with a
separate study, which used different corn genetics and a different lab. According
to Pusztai, this absurd inter-experimental comparison is never done and should be
Some of the reported weight measurements were also bizarre, suggesting possible
problems with animal management or faulty data. One rat dropped 53 grams in one week
and gained 102 grams in the next. Some that were heaviest at the beginning of the
experiment were the lightest at the end. And the rats hardly grew at all during the
last four weeks.
Overall, the research paper was confusing, conflicting, and poorly reported. It failed
to disclose, for example, the nutritional composition of the feed - backed up by
chemical analysis - and the methods used to measure changes in the animals. Since
these most basic requirements for a nutritional study were not provided, the research
cannot be repeated and the results remain suspect.
Referring to the study as a whole, Pusztai says, "Nutritional scientists and leading
journals would not accept these blatant inadequacies and misinterpretations."
The Politics of Science Fails to Protect the Public
When Seralini wanted to voice his concerns about the industry's safety studies, he
was told by French authorities that he was legally bound to keep even his opinions
confidential. A lawsuit eventually granted him the right to speak, but until
June 20, 2005, biotech companies were able to keep their feeding studies hidden
by claiming that they contained confidential business information. Seralini says
that "No one can understand, even among EU regulators, why the composition of the
blood of rats that have eaten the GM is secret." The precedent established by the
German court may open the door for more biotech studies to be made public. Without
disclosure, says Seralini, just a few toxicologists can make the decision without
public evaluation. And too often, the decision-making body is heavily influenced by
the applying company.
In his French Commission for Biomolecular Genetics (CBG), for example, the government
nominates three candidates for the position of the very important "external referee."
That referee studies the application and presents the relevant facts to the
18-member committee. For about ten years, the applicant companies such as Monsanto
were able to choose which candidate of the three was to be the referee overseeing their
products' approval process. Seralini says, "I had a big fight with the commission"
over the conflict of interest. As a result, the government changed the rules, and for
the Mon 863 application they allowed the president of the commission the right to
choose the referee. The president, however, is a geneticist who works very closely
with industry. He appointed the same person that the biotech industry had chosen in
After the CBG failed to approve Monsanto's corn in 2003, the president asked for an
outside scientist to re-evaluate just one of the significant differences - kidney
weight. According to Seralini, the consultant ignored the blood and liver disorders
entirely. And no additional research was actually conducted; the consultant simply
re-examined the same data and declared the results insignificant. The commission
scheduled another vote, but failed to achieve a quorum. The president ruled that a
quorum would not be needed in the next meeting, and only five members showed up. The
president cast the deciding vote that approved Mon 863, 3 votes to 2. The other votes
in favor came from the commission's vice-president, who works at an organization that
conducts agricultural research, and a scientist. According to Seralini, the scientist
is a toxicologist who, oddly enough, is "always against long animal toxicity tests."
In fact, he had been part of the French committee that approved Novartis (now Syngenta)
E 176 corn after it had been tested for only two weeks with three cows. Actually, there
were four cows at the start of the study, but one died and was removed.
The toxicologist is also on the European Food Standards Agency that endorsed Mon 863.
EFSA has come under attack for including primarily pro-GM scientists. According to a
November 2004 report by Friends of the Earth, "One member has direct financial links
with the biotech industry and others have indirect links. . . . Two members have even
appeared in promotional videos produced by the biotech industry." And several members,
including the chairman, have been part of an EU-funded project with the stated goal to
"facilitate market introduction of GMO's in Europe."
US Pushes its Agenda, and its Pests, on Europe
The United States government's support for biotech is no secret. In fact, it is the
official policy in several US agencies to promote the industry, and some of them have
attempted to push acceptance of GM crops in Europe. In the case of Mon 863, it seems
that the corn is designed to solve a European problem that the US introduced. The corn
is engineered with a pesticide to attack insects such as Diabrotica. According to
Seralini, "Diabrotica is from a very dangerous family of insects for a wide range of
crops and was absent from the European countries until the late 1990s, forbidden even
in laboratories because it is very difficult to eliminate it with known chemical
insecticides." He says it appears to have entered Europe from the US in large numbers
during the Balkan war. Specifically, it was widespread around US military airports,
whose planes were likely to have carried the pest. It has since spread primarily in
Italy, France, and Germany.
According to Seralini, "Monsanto seems to have anticipated this problem." Before any
infestation had been discovered, they were already field testing their corn in France
in the late 1990s. Since it takes about five years of local field trials for a
GM variety to be accepted in an EU nation, such early testing was necessary.
In addition to the crop pests, Europe may have also imported the US tradition of
approving GM products based on faulty studies. Documents stolen from the US FDA reveal
that when Monsanto's researchers intended to illustrate that their GM bovine growth
hormone did not interfere with cows'; fertility, they allegedly added cows to the study
that were pregnant prior to injection. An FDA whistle-blower also charged that sick cows
were removed from industry studies altogether (see Seeds of Deception, chapter 3).
Critics demand that regulators use independent studies, not industry studies, to prevent
manipulation of data. But there are only a few independently funded researchers. Biology
professor Bela Darvas of Hungary's Debrecen University is one of them. After discovering
that one of Monsanto's Bt corn varieties, Mon 810, is lethal to two Hungarian protected
species and one insect classified as a rare, he ran into an unexpected obstacle. Now
Monsanto refuses to give him any more Mon 810 corn to use in his tests. They also
refused his request for Mon 863.
Perhaps with the court's release of Monsanto's rat study, the public will demand a
more thorough investigation into GM foods and a change in the review and approval
process. Until then, Europeans are relatively safe from the unintended effects, since
most manufacturers refuse to use even approved GM ingredients there (with the
exception of animal feed). Meanwhile, consumers in the US will unwittingly serve as
the guinea pigs.
This is the June 2005 issue of Spilling the Beans, published by the Institute for
Responsible Technology (
http://www.responsibletechnology.org/ ). Permission is granted to reproduce
this in whole or in part.
C 2005 Jeffrey M. Smith
For Dr. Arpad Pusztai's review comments commissioned by the German
authorities on both the full 90-day study and a Monsanto summary,
For Dr. Pusztai's review, in easy-to-read table form, of some of the
significant differences found in the rat-feeding study, go to
For Dr. Pusztai's list of reasons why the Mon 863 study should have
been rejected, go to
See detailed information on the study provided by Professor
Seralini to the Greenpeace press conference at:
For the full 1139 page study, go to:
For Monsanto's 11 page summary of safety information, go to:
For the Friends of the Earth report on conflicts of interest in the European
Food Standards Agency, go to: