Statement on two reports published after the closing date of the public consultation of the draft Scientific Opinion on the re-evaluation of aspartame (E 951) as a food additive

aspartame, E 951, methanol, carcinogenicity, lymphoma, EPA, exposure
First published in the EFSA Journal
10 décembre 2013
5 décembre 2013


Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) of the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the re-evaluation of aspartame (E 951) as a food additive. After the end of the public consultation on the draft opinion on the re-evaluation of aspartame (E951) (15th February 2013, the cut-off date for the inclusion of new literature in the assessment), two papers were brought to the attention of EFSA as relevant for the evaluation of aspartame. One was the evaluation by Gift et al. (2013) of several studies carried out by the European Ramazzini Foundation (ERF) and the second was the Toxicological Review of Methanol (Noncancer) by the US-EPA. The Panel noted that the Gift et al. (2013) review of the ERF studies is consistent with EFSA’s conclusions on the lack of carcinogenic activity of aspartame. The Panel also analysed US-EPA’s Toxicological Review of Methanol (Noncancer) in the context of the safety assessment of aspartame. The Panel noted that the combination of the endpoint used, a benchmark dose response (BMR) of 5% and the uncertainty factors applied, resulted in a Reference Dose (RfD) for exogenous methanol of 2 mg/kg bw/day that was overly conservative. This RfD was by definition in addition to dietary intakes of methanol which were included in the background exposure estimates used by the US EPA. Taking all these factors into consideration, the Panel concluded that the toxicological review of methanol by US-EPA and the review by Gift et al. (2013) do not alter the conclusions on the risk assessment of aspartame performed by EFSA. EFSA confirmed the Acceptable Daily Intake (ADI) for aspartame of 40 mg/kg bw/day.

Panel members at the time of adoption

Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Alicja Mortensen, Pasquale Mosesso, Agneta Oskarsson, Dominique Parent-Massin, Martin Rose, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen and Matthew Wright.
Panel on Food Additives and Nutrient Sources Added to Food
ans [at]
EFSA Journal 2013;11(12):3504
Question Number
On request from
European Commission