• Open Access

Scientific Opinion on the evaluation of the safety in use of Yohimbe (Pausinystalia yohimbe (K. Schum.) Pierre ex Beille)

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 on Botanicals in Food: Ulla Beckman-Sund, Leon Brimer, Birgit Dusemund, Pierre Galtier, Ursula Gundert-Remy, Ivan Stankovic, Jaroslav Toth, Jacqueline Wiesner and Ruud Woutersen for the preparatory work on this scientific opinion and EFSA staff: Davide Arcella and Camilla Smeraldi for the support provided to this scientific opinion.
  • Adoption date: 3 July 2013
  • Published date: 24 July 2013
  • Question number: EFSA-Q-2012-00228
  • On request from: European Commission

Abstract

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion evaluating the safety in use of yohimbe bark and its preparations originating from Yohimbe (Pausinystalia yohimbe (K. Schum.) Pierre ex Beille when used in food, e.g. in food supplements. The bark of the plant contains a number of indole alkaloids of biological relevance and preparations of yohimbe bark have been traditionally used as general tonic, performance enhancer and as an aphrodisiac. Food supplements containing yohimbe bark preparations are available nowadays, especially via internet retail. Yohimbine, the major alkaloid of yohimbe bark and raubasine, another alkaloid occurring in lower concentrations in the bark, are used as active ingredients in a number of medicinal products for which adverse effects are described. The Panel reviewed the available scientific data on a possible association between the intake of yohimbe bark and its preparations and potential harmful effects on health. When those data were not available, priority was given to yohimbine, as the only alkaloid for which occurrence had been shown and quantified in food supplements containing yohimbe bark. The Panel concluded that the chemical and toxicological characterisation of yohimbe bark and its preparations for use in food are not adequate to conclude on their safety as ingredients of food, e.g. in food supplements. Thus the Panel could not provide advice on a daily intake of yohimbe bark and its preparations that do not give rise to concerns about harmful effects to health. An estimation of exposure to yohimbine from food supplements was performed showing that theoretical maximum daily intake may exceed the maximum approved daily dose of yohimbine from use as a medicinal product.

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