Scientific Opinion on the re-evaluation of aspartame (E 951) as a food additive

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Article
Panel on Food Additives and Nutrient Sources Added to Food
Acknowledgements

The Panel wishes to thank the members of the ANS Working Group on Aspartame: Fernando Aguilar, Wilfried Bursch (resigned in July 2013), David Coggon, David Gott, John Duffus (until October 2012), Edeltraut Garbe (until October 2012), Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Alicja Mortensen, David Harrison (until October 2012), Pasquale Mosesso, Ivonne M.C.M. Rietjens (resigned in February 2012), Andy Smith, Beate Ulbrich, Ine Waalkens-Berendsen and Matthew Wright for the preparatory work on this scientific opinion and, the hearing experts: Pierre Galtier, Rudolf Antonius Woutersen, and EFSA staff: Davide Arcella, Maria Carfi, José Cortinas Abrahantes, Jean-Lou Dorne, Maria Luisa Escudero Hernandez, Georges Kass, Hugues Kenigswald, Federica Lodi, Ana Rincon, Salomon Sand, Alexandra Tard and Natalie Thatcher for the support provided to this scientific opinion.

EFSA Journal
EFSA Journal 2013;11(12):3496 [263 pp.].
doi
10.2903/j.efsa.2013.3496
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.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2011-00406
Adopted
28 novembre 2013
Published
10 dicembre 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

The EFSA ANS Panel provides a scientific opinion on the safety of aspartame (E 951). Aspartame is a sweetener authorised as a food additive in the EU. In previous evaluations by JECFA and the SCF, an ADI of 40 mg/kg bw/day was established based on chronic toxicity in animals. Original reports, previous evaluations, additional literature and data made available following a public call were evaluated. Aspartame is rapidly and completely hydrolysed in the gastrointestinal tract to phenylalanine, aspartic acid and methanol. Chronic and developmental toxicities were relevant endpoints in the animal database. From chronic toxicity studies in animals, a NOAEL of 4000 mg/kg bw/day was identified. The possibility of developmental toxicity occurring at lower doses than 4000 mg/kg in animals could not be excluded. Based on MoA and weight-of-evidence analysis, the Panel concluded that developmental toxicity in animals was attributable to phenylalanine. Phenylalanine at high plasma levels is known to cause developmental toxicity in humans. The Panel concluded that human data on developmental toxicity were more appropriate for the risk assessment. Concentration-response modelling was used to determine the effects of aspartame administration on plasma phenylalanine using human data after phenylalanine administration to normal, PKU heterozygote or PKU homozygote individuals. In normal and PKU heterozygotes, aspartame intakes up to the ADI of 40 mg/kg bw/day, in addition to dietary phenylalanine, would not lead to peak plasma phenylalanine concentrations above the current clinical guideline for the prevention of adverse effects in fetuses. The Panel concluded that aspartame was not of safety concern at the current aspartame exposure estimates or at the ADI of 40 mg/kg bw/day. Therefore, there was no reason to revise the ADI of aspartame. Current exposures to aspartame - and its degradation product DKP - were below their respective ADIs. The ADI is not applicable to PKU patients.

Keywords
aspartame, E 951, methanol, sweetener, EINECS number 245-261-3
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Number of Pages
263