Editorial: The European Food Risk Assessment Fellowship Programme (EU-FORA)
Bronzwaer, S., Le Gourierec, N., & Koulouris, S. (2016). Editorial: The European Food Risk Assessment Fellowship Programme (EU-FORA). EFSA Journal, 14(11).
Scientific reports of the Fellows
Published in special issues of the EFSA Journal
2022
Papadi G; Bakhiya N; Hirsch-Ernst K I
Assessment of the possible health risks associated with the consumption of botanical preparations of Mitragyna speciosa (kratom) Journal Article
In: EFSA Journal, vol. 20, no. S1, pp. e200415, 2022.
Abstract | Links | Tags: addiction, food supplement, herb-induced liver toxicity, kratom, Mitragyna speciosa, withdrawal, μ-opioid agonist
@article{https://doi.org/10.2903/j.efsa.2022.e200415,
title = {Assessment of the possible health risks associated with the consumption of botanical preparations of Mitragyna speciosa (kratom)},
author = {Georgia Papadi and Nadiya Bakhiya and Karen Ildico Hirsch-Ernst},
url = {https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2022.e200415},
doi = {https://doi.org/10.2903/j.efsa.2022.e200415},
year = {2022},
date = {2022-01-01},
journal = {EFSA Journal},
volume = {20},
number = {S1},
pages = {e200415},
abstract = {Abstract 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 on 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.},
keywords = {addiction, food supplement, herb-induced liver toxicity, kratom, Mitragyna speciosa, withdrawal, μ-opioid agonist},
pubstate = {published},
tppubtype = {article}
}
Abstract 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 on 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.
2020
Raclariu-Manolica A C; Bakhiya N; Hirsch-Ernst K I
Risk assessment regarding the use of Annona muricata in food supplements Journal Article
In: EFSA Journal, vol. 18, no. S1, pp. e181112, 2020.
Abstract | Links | Tags: Annona muricata L., annonacin, botanical preparation, food, food supplement, neurotoxicity, risk assessment
@article{https://doi.org/10.2903/j.efsa.2020.e181112,
title = {Risk assessment regarding the use of Annona muricata in food supplements},
author = {Ancuta Cristina Raclariu-Manolica and Nadiya Bakhiya and Karen Ildico Hirsch-Ernst},
url = {https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2020.e181112},
doi = {https://doi.org/10.2903/j.efsa.2020.e181112},
year = {2020},
date = {2020-01-01},
journal = {EFSA Journal},
volume = {18},
number = {S1},
pages = {e181112},
abstract = {Abstract The current risk assessment was performed in the context of the European Food Risk Assessment Fellowship Programme (EU-FORA) supported by EFSA and was intended to evaluate possible health risks associated with the consumption of Annona muricata L. (Annonaceae) and derived food supplements. A. muricata grows as a tree and is native to the Caribbean and Central America. Preparations made from different plant parts of A. muricata (i.e. fruit, leaves, bark, roots) have been used as herbal medicine and are also marketed worldwide as over-the-counter food supplements that have been purported to support general health or to treat a wide range of health conditions, particularly cancer and parasitic infections. However, open questions remain regarding the safety of A. muricata-based food supplements, since Annonaceae have been reported to contain potentially neurotoxic compounds, i.e. acetogenins. The assessment conducted within the present fellowship programme shows that substantial uncertainties exist regarding the safe use of A. muricata-based supplements. The available data provide indications of neurotoxic potential of certain A. muricata preparations. The paucity of adequate studies, particularly related to long-term use of A. muricata supplements, currently does not allow the establishment of a safe intake level. Within this technical report a workflow of the project is presented.},
keywords = {Annona muricata L., annonacin, botanical preparation, food, food supplement, neurotoxicity, risk assessment},
pubstate = {published},
tppubtype = {article}
}
Abstract The current risk assessment was performed in the context of the European Food Risk Assessment Fellowship Programme (EU-FORA) supported by EFSA and was intended to evaluate possible health risks associated with the consumption of Annona muricata L. (Annonaceae) and derived food supplements. A. muricata grows as a tree and is native to the Caribbean and Central America. Preparations made from different plant parts of A. muricata (i.e. fruit, leaves, bark, roots) have been used as herbal medicine and are also marketed worldwide as over-the-counter food supplements that have been purported to support general health or to treat a wide range of health conditions, particularly cancer and parasitic infections. However, open questions remain regarding the safety of A. muricata-based food supplements, since Annonaceae have been reported to contain potentially neurotoxic compounds, i.e. acetogenins. The assessment conducted within the present fellowship programme shows that substantial uncertainties exist regarding the safe use of A. muricata-based supplements. The available data provide indications of neurotoxic potential of certain A. muricata preparations. The paucity of adequate studies, particularly related to long-term use of A. muricata supplements, currently does not allow the establishment of a safe intake level. Within this technical report a workflow of the project is presented.
2018
Marakis G; Ziegenhagen R; Lampen A; Hirsch-Ernst K
Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre Journal Article
In: EFSA Journal, vol. 16, no. S1, pp. e16083, 2018.
Abstract | Links | Tags: botanical, food supplement, Gymnema sylvestre, risk assessment
@article{https://doi.org/10.2903/j.efsa.2018.e16083,
title = {Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre},
author = {G Marakis and R Ziegenhagen and A Lampen and KI Hirsch-Ernst},
url = {https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2018.e16083},
doi = {https://doi.org/10.2903/j.efsa.2018.e16083},
year = {2018},
date = {2018-01-01},
journal = {EFSA Journal},
volume = {16},
number = {S1},
pages = {e16083},
abstract = {Abstract Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU-FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as food supplements, they may appeal to people who are suffering from metabolic syndrome and/or diabetes mellitus. A scientific literature search was carried out using PubMed/MEDLINE and EMBASE electronic databases. Experience was gained by the fellow in systematic data extraction from scientific publications, structuring of the data and evaluating toxicological key parameters, outcomes of clinical significance, pharmacokinetic and pharmacodynamic interactions, uncertainties and methodological shortcomings of studies. Limited evidence from toxicological in vivo studies and human clinical studies suggested lack of relevant adverse effects of this botanical. However, human studies provided some indications that certain Gymnema extracts may enhance the glucose-lowering effects of certain antidiabetic drugs. Considering the uncertainties for the composition of different Gymnema preparations, potential herb–drug interactions and the indications of glucose lowering or hypoglycaemic effects, the use of Gymnema-based food supplements in combination with authorised antidiabetic drugs may be associated with risks. The procedures learned for the safety evaluation of Gymnema may be similarly applied by the fellow for the risk assessment of other substances with nutritional or physiological effect added to foods and food supplements. Furthermore, apart from learning by conducting exercises in risk assessment, the fellow was able to develop other skills (e.g. communication skills), diversify his competencies and expand his network of scientific connections for future collaborations in the field of nutritional risk assessment.},
keywords = {botanical, food supplement, Gymnema sylvestre, risk assessment},
pubstate = {published},
tppubtype = {article}
}
Abstract Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU-FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA’s guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as food supplements, they may appeal to people who are suffering from metabolic syndrome and/or diabetes mellitus. A scientific literature search was carried out using PubMed/MEDLINE and EMBASE electronic databases. Experience was gained by the fellow in systematic data extraction from scientific publications, structuring of the data and evaluating toxicological key parameters, outcomes of clinical significance, pharmacokinetic and pharmacodynamic interactions, uncertainties and methodological shortcomings of studies. Limited evidence from toxicological in vivo studies and human clinical studies suggested lack of relevant adverse effects of this botanical. However, human studies provided some indications that certain Gymnema extracts may enhance the glucose-lowering effects of certain antidiabetic drugs. Considering the uncertainties for the composition of different Gymnema preparations, potential herb–drug interactions and the indications of glucose lowering or hypoglycaemic effects, the use of Gymnema-based food supplements in combination with authorised antidiabetic drugs may be associated with risks. The procedures learned for the safety evaluation of Gymnema may be similarly applied by the fellow for the risk assessment of other substances with nutritional or physiological effect added to foods and food supplements. Furthermore, apart from learning by conducting exercises in risk assessment, the fellow was able to develop other skills (e.g. communication skills), diversify his competencies and expand his network of scientific connections for future collaborations in the field of nutritional risk assessment.