• Open Access

Scientific Opinion on Tropane alkaloids in food and feed


  • EFSA Panel on Contaminants in the Food Chain (CONTAM)

  • Panel members: Diane Benford, Sandra Ceccatelli, Bruce Cottrill, Michael DiNovi, Eugenia Dogliotti, Lutz Edler, Peter Farmer, Peter Fürst, Anne Katrine Lundebye, Laurentius (Ron) Hoogenboom, Helle Katrine Knutsen, Manfred Metzler, Carlo Stefano Nebbia, Michael O‘Keeffe, Ivonne Rietjens, Dieter Schrenk, Vittorio Silano, Hendrik Van Loveren, Christiane Vleminckx and Pieter Wester.
  • Correspondence: contam@efsa.europa.eu
  • Acknowledgement: The Panel wishes to thank the members of the Working Group on alkaloids: Diane Benford, Till Beuerle, Leon Brimer, Bruce Cottrill, Daniel Doerge, Birgit Dusemund, Peter Farmer, Peter Fürst, Hans-Ulrich Humpf and Patrick Mulder for the preparatory work on this scientific opinion and the hearing expert Lutz Edler, and EFSA staff Davide Arcella, Katleen Baert, Bistra Benkova, Marco Binaglia, Gina Cioacata, José Angel Gomez Ruiz and Enikö Varga for the support provided to this scientific opinion. The CONTAM Panel acknowledges all European competent authorities and other stakeholders that provided tropane alkaloids occurrence data for food and feed, and supported the consumption data collection for the Comprehensive European Food Consumption Database. The Panel wishes to thank Lucija Perharic for providing the heart rate data of all subjects as reported by Perharic et al. (2013a) and further information on the study design.
  • Adoption date: 27 September 2013
  • Published date: 15 October 2013
  • Question number: EFSA-Q-2010-01038
  • On request from: European Commission


The European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the risks to human and animal health related to the presence of tropane alkaloids (TAs) in food and feed. TAs are secondary metabolites which occur in several plant families. Although more than 200 different TAs have been identified in various plants, respective data on toxicity and occurrence in food and feed are limited. Therefore, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) could only perform a risk assessment on (-)-hyoscyamine and (-)-scopolamine, the two TAs for which occurrence and toxicity data were available. Since the pharmacological effects of (-)-hyoscyamine and (-)-scopolamine occur within a short time after administration, the CONTAM Panel concluded that it was appropriate to establish an Acute Reference Dose (ARfD) for these substances. Based on the results for decreased heart rate in a human volunteer study, the CONTAM Panel established a group ARfD of 0.016 μg/kg body weight (b.w.) expressed as the sum of (-)-hyoscyamine and (-)-scopolamine, assuming equivalent potency. Results on TAs in 124 food and 611 feed samples were collected in two Member States. Most of the food and feed samples were left-censored (below limit of detection/limit of quantification). A reliable exposure estimate was only possible for one food and one age class (toddlers). Based on the limited information, the CONTAM Panel concluded that the dietary exposure of toddlers could be up to seven times the group ARfD and could exceed the group ARfD on approximately 11 to 18 % of consumption days. TA toxicosis in livestock and companion animals is relatively rare.