Title: Scientific Opinion on the re‐evaluation of aspartame (E 951) as a food additive
Abstract: EFSA JournalVolume 11, Issue 12 3496 OpinionOpen Access Scientific Opinion on the re-evaluation of aspartame (E 951) as a food additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)Search for more papers by this author EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)Search for more papers by this author First published: 10 December 2013 https://doi.org/10.2903/j.efsa.2013.3496Citations: 39 Panel members: 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. Correspondence: [email protected] Acknowledgement: 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. Adoption date: 28 November 2013 Published date: 10 December 2013 Question number: EFSA-Q-2011-00406 On request from: European Commission AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat 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. References Hastie TJ and Tibshirani RJ, 1986. Generalized additive models. Statistical Science, 1, 297– 318. Hastie TJ and Tibshirani RJ, 1990. 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