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.”
Director of Resource Development
European Foundation of Oncology and Environmental Sciences “B. Ramazzini”
+39 0516640460 (ext.3 ) email@example.com
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