• Open Access

Scientific Opinion on the safety of advantame for the proposed uses as a food additive

Authors

  • EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)


  • Panel members: Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Pasquale Mosesso, Alicja Mortensen, Agneta Oskarsson, Dominique Parent-Massin, Martin Rose, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Ruud Woutersen and Matthew Wright
  • Correspondence: ans@efsa.europa.eu
  • Acknowledgement: The Panel wishes to thank the members of the Working Group “A” Food Additives and Nutrient Sources (2008–2011): Fernando Aguilar, Nawel Bemrah, Pierre Galtier, John Gilbert, Sandro Grilli, Rainer Gürtler, Claude Lambré, John Christian Larsen, Jean-Charles Leblanc, Alicja Mortensen, Iona Pratt, Ivan Stankovic and Christina Tlustos and the members of the ANS Panel (2008–2011): Fernando Aguilar, Birgit Dusemund, Pierre Galtier, John Gilbert, David Gott, Sandro Grilli, Rainer Gürtler, Jürgen König, Claude Lambré, John Christian Larsen, Jean-Charles Leblanc, Alicja Mortensen, Dominique Parent-Massin, Iona Pratt, Ivonne Rietjens, Ivan Stankovic, Paul Tobback, Tatjana Verguieva and Ruud Woutersen for the preparatory work on this scientific opinion and the hearing expert: Henk van Loveren and EFSA staff: Federica Lodi, Ana Rincon and Alexandra Tard for the support provided to this scientific opinion.
  • Adoption date: 3 July 2013
  • Published date: 31 July 2013
  • Question number: EFSA-Q-2010-00943
  • On request from: European Commission

Abstract

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the safety of advantame as a sweetener for use in the food categories specified in the dossier. Advantame is stable under normal storage conditions. The Panel noted that there is an indication of advantame instability in acidic beverages and thermally treated foods. Metabolism and toxicokinetics of advantame and its main metabolite, ANS9801-acid, have been studied in mice, rats, rabbits, dogs and humans. Advantame is rapidly but poorly absorbed and the main excretion route is via faeces. The Panel concluded that advantame does not raised concern with regards to genotoxicity and carcinogenicity. The critical effect observed in animal studies was maternal toxicity (gastrointestinal disturbances) in the prenatal developmental toxicity study in rabbits. The NOAEL for this effect was 500 mg advantame/kg bw/day. Advantame was well tolerated in single or repeated doses up to 0.5 mg/kg bw/day by normo-glycemic or diabetic subjects. The Panel established an ADI of 5 mg/kg bw/day based on the application of a 100-fold uncertainty factor to the NOAEL of 500 mg/kg bw/day for maternal toxicity from the prenatal developmental toxicity study in the rabbit. Conservative estimates of advantame exposure for high level adults and children consumers were below the ADI for the proposed use levels.

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