Two studies published last year have attracted specific EFSA interest: a study from the Ramazzini Institute reporting carcinogenicity in mice exposed to aspartame prenatally and for their lifetime (Soffritti et al., American Journal of Industrial Medicine 2010, 53, 1197), and a prospective cohort study involving nearly 60,000 pregnant women that reported an association between the consumption of diet soft drinks and increased risk of preterm delivery (Halldorsson et al., American Journal of Clinical Nutrition 2010, 92, 626). In its assessment of the carcinogenicity study, EFSA noted that the “validity of the study and its statistical approach cannot be assessed” on the basis of the information presented in the publication, and that therefore the study’s results could not be interpreted. EFSA also had reservations about whether all the tumours observed in the mice were relevant to the human risk assessment process. In its consideration of the study on pregnancy duration and artificially sweetened soft drinks, EFSA noted that this was the first investigation of its kind and that further studies (taking into account potentially important confounding factors) would be necessary to establish a causal relationship between consumption of these beverages and preterm delivery. Overall, EFSA concluded that the information available from the publications “do not give reason to reconsider the previous evaluations of aspartame or of other food additive sweeteners authorised in the European Union.”

[European Food Safety Authority. Statement on the scientific evaluation of two studies related to the safety of artificial sweeteners. Published on 28 February 2011. EFSA Journal 2011, 9(2): 2089 (accessible at] {187181}

The above item was taken from the April 2011 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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