The European Food Safety Authority’s (EFSA’s) Panel on Food Additives and Nutrient Sources Added to Food (ANS) has published its full risk assessment on aspartame, concluding that the food additive is safe at current levels of exposure. In addition to noting that aspartame’s breakdown products— phenylalanine, methanol and aspartic acid—occur naturally in other foods, EFSA’s experts found that aspartame’s acceptable daily intake (ADI) of 40 mg/kg bw/day “is protective for the general population,” with the exception of those individuals with phenylketonuria, a medical condition that necessitates a diet low in phenylalanine.
 
At the request of the European Commission, the ANS Panel analyzed “all available information” in an effort to resolve uncertainties related to the re-evaluation of aspartame as a food additive. In particular, the panel’s final scientific opinion assessed both human and animal studies submitted in response to public calls for data; previous evaluations; and additional literature that became available during and after the initial public consultation and release of a draft scientific opinion in February 2013.
 
“The Panel noted that although many of the studies were old and were not performed according to current standards (e.g. Good Laboratory Practice (GLP) and Organization for Economic Co-operation and Development (OECD) guidelines), they should be considered in the re-evaluation of the sweetener as long as the design of such studies and the reporting of the data were considered appropriate,” explains the scientific opinion. “In its re-evaluation of aspartame, the Panel also considered the safety of its gut hydrolysis metabolites methanol, phenylalanine and aspartic acid and of its degradation products 5-benzyl-3,6-dioxo-2-piperazine acetic acid (DKP) and β-aspartame, which may be present in the sweetener as impurities.”
 
After reviewing these data as well as 200 comments replying to its draft opinion, the ANS Panel ruled out “a potential risk of aspartame causing damage to genes and inducing cancer,” and concluded that the food additive “does not harm the brain, the nervous system or affect behavior or cognitive function in children or adults.” It also reported “no risk to the developing fetus from exposure to phenylalanine derived from aspartame at the current ADI.”
 
“This opinion represents one of the most comprehensive risk assessments of aspartame ever undertaken,” said ANS Panel Chair Alicja Mortensen. “It’s a step forward in strengthening consumer confidence in the scientific underpinning
of the EU food safety system and the regulation of food additives.” See EFSA Press Release, December 10, 2013.
 
Meanwhile, the Center for Science in the Public Interest (CSPI) has already criticized the risk assessment as flawed, claiming that the scientific opinion failed to properly consider animal studies conducted by the Ramazzini Institute that purportedly linked aspartame to rare kidney tumors in rats.Although EFSA panels ultimately identified methodological problems with these reports, CSPI faulted the agency for disputing the laboratory’s diagnosis of lymphoma or leukemia in two animal studies.
 
“Three large, independent studies that found a link between aspartame and cancer are far more reliable than inferior industry-funded studies that do not even meet current standards and did not find a link,” opined CSPI Senior Scientist Lisa Lefferts. “Yet the EFSA dismissed the independent studies, effectively whitewashing valid safety concerns. Aspartame just isn’t worth the risk it poses to consumers.” See CSPI News Release, December 10, 2013.