Scientific Opinion on Tropane alkaloids in food and feed

tropane alkaloids (TAs), origin, chemistry, analysis, dietary exposure, risk assessment, health based guidance value
First published in the EFSA Journal
15 October 2013
27 September 2013
Scientific Opinion


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.

Panel members at the time of adoption

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.
Panel on Contaminants in the Food Chain
contam [at]
EFSA Journal 2013;11(10):3386
Question Number
On request from
European Commission