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 KnowlesDirector of Resource DevelopmentEuropean Ramazini Foundation<a href=”mailto:development@ramazzini.it”>development@ramazzini.it</a>+39 051.6640460
ERF stands behind aspartame study results, announces ongoing research on artificial sweeteners: Response to EFSA’s AFC panel decision
Leggi lo Statuto | Credits
