- CRC/ERF
- Results of study on the carcinogenicity of the artificial
sweetener aspartame
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- Summary
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- A long-term study to evaluate the potential carcinogenic
effects of aspartame, an artificial sweetener used in more than 6,000 food
and pharmaceutical products has recently been completed in the experimental
laboratories of its Cancer Research Center of the European Foundation of
Oncology and Environmental Sciences "B. Ramazzini" in Bologna,
Italy.
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- The first results of the experiment 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, 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.
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- First results demonstrate that aspartame, when administered
to rats for the entire life span, induces an increase of lymphomas and
leukemias in female rats. The study is currently being published in the
European Journal of Oncology
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- ( http://www.ramazzini.it/fondazione/docs/AspartameGEO2005.pdf
)
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- and final results will be presented at the 3rd international
scientific conference of the Collegium Ramazzini, "Framing the Future
in Light of the Past: Living in a Chemical World", to be held in Bologna,
Italy from September 18-21, 2005, the proceedings of which will be published
in the Annals of the New York Academy of Sciences.
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- Communication
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- Aspartame is an artificial sweetener consumed by hundreds
of millions of people worldwide. It is used in over 6,000 diet products
including soft drinks, chewing gum, candy, desserts, yogurt as well as
in pharmaceuticals, in particular, syrups and antibiotics for children.
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- The average daily intake of aspartame is calculated to
be about 2-3 mg/Kg of body weight, a figure which increases for children
and women of childbearing age. Current daily intake allowed by regulatory
bodies is 50 mg/Kg of body weight in the US and 40 mg/Kg of body weight
the European Union.
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- Prior to the commercialization of aspartame in the 1970s,
the manufacturers of the compound conducted various experimental studies
on rats and mice to test its carcinogenicity. When taken together, the
results of these studies were considered negative with regard to the carcinogenicity
of aspartame. Doubts were however raised by some in the scientific community
about the conduct of the experiments and the fact that some cases of malignant
brain tumors were found among animals treated with aspartame while none
were found among the control group.
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- Given the limitations of these studies and the ever-growing
use of aspartame throughout the years, the European Ramazzini Foundation
decided in the late 1990s to plan and perform an experiment that would,
based on the total number of animals used, the number of dose levels studied,
and the conduct of the experiment according to Good Laboratory Practices,
provide an adequate evaluation of the potential carcinogenic effects of
aspartame.
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- The CRC/ERF study was conducted on 1800 rats (900 males,
900 females) of the colony used for over 30 years by the Foundation. 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 30,000 slides examined by microscope.
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- The first results of the experiment show:
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- 1) a dose-related statistically significant increase
of lymphomas and leukemias in female rats. This statistically significant
increase was also observed at a dose level of 20 mg/Kg of body weight,
a dose inferior to the accepted daily intake permitted by current regulations
(50-40 mg/Kg of body weight);
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- 2) that the addition of aspartame to the diet induces
a dose-related reduction in food consumption, without however causing a
difference in body weight between treated and untreated animals.
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- The above results demonstrate for the first time that
aspartame is a carcinogenic agent, capable of inducing lymphomas and leukemias
in female rats, including when administered at dose levels very close to
the acceptable daily intake for humans. In addition, the data demonstrate
that the integration of aspartame into the diet did not affect the body
weight of treated animals compared with untreated animals.
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- As recognized by the International Agency for Research
on Cancer (IARC) of the World Health Organization, results of long-term
bioassays conducted on rodents (rats and mice) are highly predictive of
carcinogenic risk for humans. In light of this fact, the results of the
CRC/ERF study on aspartame call for urgent reconsideration of regulations
governing its use as an artificial sweetener in order to better protect
public health, in particular that of children.
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- Websites
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- European Foundation for Oncology and Environmental Sciences
"B. Ramazzini" www.ramazzini.it/fondazione/eng
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- 3rd international scientific conference of the Collegium
Ramazzini
- www.ramazzini.it/living2005
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- Contact
- Kathryn Knowles
- Director of Resource Development
- European Foundation of Oncology and Environmental Sciences
"B. Ramazzini"
- development@ramazzini.it
- +39 0516640460
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- Movie/Video Clips
- http://www.soundandfury.tv/pages/rumsfeld.html
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- http://www.soundandfury.tv/media/Blaylock512.wmv
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