European Food Safety Authority Releases Draft Scientific Opinion on Aspartame and Requests Public Comment

  • The European Food Safety Authority (EFSA) launched a public consultation on its draft scientific opinion on the safety of the low-calorie sweetener aspartame.      
  • EFSA's scientific experts have drawn upon all available information on aspartame and its breakdown products and, following a detailed and methodical analysis, concluded in this draft opinion that aspartame poses no toxicity concern for consumers at current levels of exposure.                
  • The current Acceptable Daily Intake (ADI) is considered to be safe for the general population and consumer exposure to aspartame is below this ADI.  
  • The draft Opinion abstract is copied below, and the full 245-page draft scientific opinion is located here.
  • EFSA also prepared a set of Frequently Asked Questions to help explain some of the key scientific concepts and initial conclusions of the draft opinion.           
  • The deadline for public comments on the draft Opinion is February 15, 2013.  See the EFSA Press Release for more details.  
  • Feedback from the consultation will be compiled in a report and, where appropriate, incorporated into the final scientific opinion, which the ANS Panel aims to adopt by May 2013.  


The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of aspartame (E951). Aspartame (E 951) is an artificial sweetener authorized as a food additive in the EU that was previously evaluated by JECFA, SCF and EFSA. JECFA and SCF established an ADI of 40 mg/kg bw/day. The Panel based its evaluation on original reports, previous evaluations, additional literature available since these evaluations and the data available following a public call for data. Aspartame is rapidly and completely hydrolysed in the gastrointestinal tract to methanol and the amino acids phenylalanine and aspartic acid. DKP is a degradation product of aspartame. The Panel concluded that chronic toxicity and reproductive and developmental toxicity were the critical endpoints in the animal database.
The Panel considered that the evaluation of long-term effects of aspartame should continue to be based upon the animal data. Based on a MoA analysis and the weight-of-evidence, the Panel considered that the reproductive and developmental toxicity in animals was due to phenylalanine released from aspartame and concluded that the basis for evaluation of the reproductive and developmental endpoint should be the available data in humans. From the aspartame dose-plasma phenylalanine concentration response modelling, the Panel considered that aspartame intakes up to the ADI of 40 mg/kg bw/day in addition to phenylalanine from a meal would not lead to peak plasma phenylalanine concentrations above the current clinical guideline for prevention of adverse effects in the fetuses of PKU mothers. The Panel concluded that there were no safety concerns at the current ADI of 40 mg/kg bw/day. Therefore, there was no reason to revise the ADI for aspartame. Conservative estimates of exposure to aspartame and its degradation product DKP made by the Panel for the general population were below their respective ADIs.