Artificial sweeteners, aspartame and cancer or pregnancy risks: the opinion of the European Food Safety Agency EFSA unchanged

The Scientific Committee on food additives and food supplements (ANS) of the European Food Safety Authority (EFSA) is comprised of experts in risk assessment of various European nationalities highly skilled and with expertise in all relevant areas. On Februry 28, EFSA gave its opinion on two recent studies related to aspartame.

The first study is a recent carcinogenicity study on aspartame conducted in the mouse by Soffritti et al. (2010). The EFSA Committee concluded that the results presented in Soffritti et al. (2010) do not provide a sufficient basis to reconsider the previous evaluations by EFSA on aspartame

The Scientific Committee of EFSA also considered a Danish epidemiological study on the relationship between consumption of sweetened soft drinks and the risk of premature delivery (Halldorson et al, 2010). EFSA assessed this study and concluded that there is no evidence available to support a causal relationship between the consumption of artificially sweetened soft drinks and preterm delivery and that additional studies are required to reject or confirm an association.The ANS Committee had previously informed EFSA to the need for specific expertise in epidemiology to evaluate the methodology and statistical considerations and take into account confounding factors, as suggested by the authors of the study.

In 2009, following a request from the European Commission, the ANS Committee of  EFSA was already asked to give an opinion on the potential carcinogenicity of aspartame in the light of new information . The Committee then confirmed the acceptable daily intake (ADI) of 40 mg / kg body weight/ day recommended in 2006. This was after the publication of a long-term carcinogenicity study in rats published in June 2007, on prenatal exposure to the artificial sweetener aspartame. The evaluation took into consideration both the published data and additional data provided by the authors to facilitate the interpretation of the results.   Overall, the ANS Committee estimated on the basis of all evidence available, including the 2007 study, that no new data demonstrating a genotoxic or carcinogenic potential of aspartame would justify a review of the previously established ADI for aspartame and already reconfirmed in 2006.
The summary of the opinion and the full report of the Scientific Committee of the EFSA published in 2009 are available at:

Regarding the lymphomas and leukemias observed in some treated animals in the 2007 study, in line with its previous opinion, these changes were not considered by the ANS Committee as related to the aspartame treatment. Similarly, given the available data, the increased incidence of breast carcinomas had also not been considered to indicate a carcinogenic potential of aspartame.

Earlier evaluations of aspartame by European and US health authorities

In 2006, based on all available evidence, studies and previous evaluations, the ANS Committee had already considered there was no reason to revise the previously established ADI for aspartame (EFSA, 2006).  During the 1980s, the use of aspartame was allowed for use in foods and as a tabletop sweetener by several member states and through the European legislation introduced in 1994 to harmonize its use in foods, this after thorough evaluations made by the Scientific Committee for Food (SCF) in 1984 and 1988. Further reviews of data on aspartame were also conducted by the SCF in 1997 and 2002.

Similarly,  the US Food and Drug Administration (FDA)  reviewed the data of the same study of 2007 made available to them by the authors and identified significant shortcomings in the design, conduct, reporting, and interpretation of this study. The FDA finds that the reliability and interpretation of the study outcome is compromised by these shortcomings and uncontrolled variables, such as the presence of infection in the test animals. On this basis, the FDA found  that it did not support ERF’s conclusion that aspartame is a carcinogen. Additionally, these data did not provide evidence to alter FDA’s previous conclusion that the use of aspartame is safe.
Aspartame: L-aspartyl-L-phenylalanine methyl ester, CAS No. 22839-47-0; E 951

see also:  GreenFacts’ Digest “Scientific consensus on aspartame” which is a faithful summary of the full report of the Scientific Committee for Food (SCF) produced in 2002 :

Note : the shorts excerpts of summaries or conclusions of scientific reports prepared for the blog of GreenFacts are not reviewed by its Scientific Board

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