EFSA Reaffirms Safety of Aspartame For Consumers

PARMA, ItalyThe European Food Safety Authority (EFSA) has concluded its first full risk assessment of the artificial sweetener aspartame and determined aspartame and its breakdown products are safe for human consumption at current levels of exposure.

EFSAs Panel on Food Additives and Nutrient Sources Added to Foods (ANS Panel) considered all available information and, following a detailed analysis, and concluded that the current Acceptable Daily Intake (ADI) of 40mg/kg of body weight a day is protective for the general population.

Following a thorough review of evidence provided both by animal and human studies, the Panel ruled out a potential risk of aspartame causing damage to genes and inducing cancer. The Panel also concluded that aspartame does not harm the brain, the nervous system or affect behavior or cognitive function in children or adults. With respect to pregnancy, the Panel noted that there was no risk to the developing fetus from exposure to phenylalanine derived from aspartame at the current ADI (with the exception of women suffering from PKU).

This opinion represents one of the most comprehensive risk assessments of aspartame ever undertaken. Its a step forward in strengthening consumer confidence in the scientific underpinning of the EU food-safety system and the regulation of food additives", said the Chair of EFSAs Panel on Food Additives and Nutrient Sources Added to Foods (ANS Panel), Dr. Alicja Mortensen.

The review was made possible following two public calls for data that made available a large body of scientific information, comprising both published and previously unpublished data and studies. EFSA considered the more than 200 comments during the public consultation on the draft opinion from Jan. 9 to Feb. 15, 2013. During the consultative phase EFSA also held a hearing with interested parties to discuss its draft opinion and the feedback received from the online public consultation. EFSAs dialogue with stakeholders revealed that there were important aspects of the draft opinion that needed to be clarified in the final output.

The opinion makes clear that the breakdown products of aspartame (phenylalanine, methanol and aspartic acid) are also naturally present in other foods like fruit and vegetables. The contribution of breakdown products of aspartame to the overall dietary exposure to these substances is low.

In 2011, the European Commission asked EFSA to reaffirm its position on aspartame. EFSA was asked to review two studies published last yeara carcinogenicity study in mice from the Ramazzini Institute (Soffritti et al., 2010) linking aspartame to lung and liver cancer, and a prospective cohort study linking artificially-sweetened soft drinks to premature birth (Halldorsson et al., 2010).

EFSA 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. For the Halldorsson et al. (2010) study, EFSA concluded there is no evidence available to support a causal relationship between the consumption of artificially sweetened soft drinks and preterm delivery and additional studies are required to reject or confirm an association.

EFSA concluded that the information available from the two studies was insufficient to reconsider the previous evaluations of aspartame or of other food additive sweeteners authorized in the European Union.