Category Research project
  • Analytik

EU-FORA 2021/22: Risk Assessment of Botanical Preparations used in Food Supplements and Fortified Foods

Project status
Completed
Project start
Jan 2021
Project end
Dec 2021
Acronym
EU-FORA 2021/22-3
Department
Lebensmittelsicherheit

Description and Objective

The present project involves the hosting and supervision of a fellow at the BfRshort forGerman Federal Institute for Risk Assessment Unit of Nutritional Risks, Allergies and Novel Foods at the Department of Food Safety, in the context of the EFSAshort forEuropean Food Safety Authority European Food Safety Risk Assessment Fellowship Programme. Preparations of Mitragyna speciosa (Kratom) have been selected as first candidates for the safety assessment of botanicals. Risk assessments will be performed in accordance with EFSAshort forEuropean Food Safety Authority`s risk assessment methodologies, e. g. in accordance with the EFSAshort forEuropean Food Safety Authority Guidance on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements (EFSAshort forEuropean Food Safety Authority J. 2009, Volume 7, Issue 9, Pp 1249).

Result

The Project was successfully completed in 2021 and the technical report published in EFSAshort forEuropean Food Safety Authority Journal in 2022 as "Assessment of the possible health risks associated with the consumption of botanical preparations of Mitragyna speciosa (kratom)" (EFSAshort forEuropean Food Safety Authority Journal 2022;20(S1):e200415); cf. https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2022.e200415.The corresponding results of the project are summarised in the abstract of the technical report:The current report summarises the work performed in the context of the European Food Risk Assessment Fellowship Programme (EU-FORA), which included the evaluation of health risks associated with the consumption of botanical preparations of Mitragyna speciosa (kratom). Mitragyna speciosa is a tree native to Southeast Asia, where its leaves and preparations of the leaves have been used for centuries, among others, as a stimulant or as a traditional herbal medicine. Preparations of the plant have recently gained increasing popularity in other parts of the world, and are presently also accessible via online platforms, e.g. as food supplements. Kratom has been considered a botanical of possible health concern by the FDA and EFSA, which together with its increasing popularity, makes kratom a subject of international concern. Major alkaloids of the plant, mitragynine and 7-hydroxymitragynine, are agonists of the μ-opioid human receptor and are assumed to be mainly responsible for its psychoactive effects. The aim of the present project was to conduct an assessment of potential health risks associated with oral use of kratom-based preparations. The animal and human data that were evaluated in the course of the current assessment indicate that kratom consumption has the potential to not only lead to adverse neurological effects, including addiction and withdrawal syndrome, but also to elicit distinct organ toxicity with respect to e. g. liver and kidney as target organs. Nevertheless, actual risk characterisation is impeded by considerable uncertainties. Such uncertainties, based on the variability in composition of kratom preparations, insufficient information on dose–response relationships and  limited data on long-term use effects, currently do not allow the derivation of distinct health-based guidance values for kratom/kratom preparations. Further information from well-designed studies, conducted with kratom preparations that have been clearly defined with respect to their composition, would be required to enable a more refined risk assessment of this botanical.
Type of project

Third-party funded project

Research focus

Internationale Zusammenarbeit / Gesundheit von Mensch, Tier und Umwelt (One Health)

Organisational units and partners

Lead specialist group: Neuartige Lebensmittel, GMO, Lebensmittelzusatz-, Aroma- und Futtermittelzusatzstoffe (83)
Contact persons: PDshort foroutside lecturer Dr. Karen Ildico Hirsch-Ernst
Involved BfR partners: Lebensmittelsicherheit

Funding body and grant number

Europäische Behörde für Lebensmittelsicherheit
GP/EFSAshort forEuropean Food Safety Authority/ENCO/2018/05-GA20

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