Safety of Eurycoma longifolia (Tongkat Ali) root extract as a novel food pursuant to Regulation (EU) 2015/2283
[EN]Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on Eurycoma longifolia (Tongkat Ali) root extract as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is standardised water extract p...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Formato: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2021 |
| País: | España |
| Recursos: | Ajuntament de Barcelona |
| Repositorio: | BULERIA. Repositorio Institucional de la Universidad de León |
| OAI Identifier: | oai:buleria.unileon.es:10612/21362 |
| Acesso em linha: | https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2021.6937 https://hdl.handle.net/10612/21362 |
| Access Level: | acceso abierto |
| Palavra-chave: | Tecnología de los alimentos Novel food Eurycoma longifolia Water extrac Food supplement Genotoxicity 3309 Tecnología de Los Alimentos |
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Safety of Eurycoma longifolia (Tongkat Ali) root extract as a novel food pursuant to Regulation (EU) 2015/2283Turck, DominiqueBohn, TorstenCastenmiller, JacquelineDe Henauw, StefaanHirsch‐Ernst, Karen IldicoMaciuk, AlexandreMangelsdorf, IngeMcArdle, Harry JNaska, AndronikiPeláez, CarmenPentieva, KristinaSiani, AlfonsoThies, FrankTsabouri, SophiaVinceti, MarcoCubadda, FrancescoFrenzel, ThomasHeinonen, MarinaPrieto Maradona, MiguelMarchelli, RosangelaNeuhäeuser-Berthold, MonikaPoulsen, MortenSchlatter, Josef Rudolfvan Loveren, HenkMatijević, LeonardKnutsen, Helle KatrineTecnología de los alimentosNovel foodEurycoma longifoliaWater extracFood supplementGenotoxicity3309 Tecnología de Los Alimentos[EN]Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on Eurycoma longifolia (Tongkat Ali) root extract as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is standardised water extract prepared from the dried ground root chips of Tongkat Ali (Eurycoma longifolia Jack) and proposed by the applicant to be used as food supplement in amounts up to 200 mg/day. The target population is the adult population, except pregnant and lactating women. The characteristic components of the NF are glycosaponins (40–65%) and eurycomanone (0.8–1.5%). It can also contain canthin-6-one alkaloids and isoscopoletin (coumarin). The NF has been present in various international markets since 2009. The Panel notes positive results from the submitted in vitro chromosome aberration test, which indicates clastogenic properties of the NF. In the requested follow-up in vivo mammalian alkaline comet assay, the NF induced positive results at the highest dose tested (2,000 mg/kg body weight (bw)) at the tissues of the first site of contact (stomach and duodenum). Histopathological evaluation of the tested tissues indicated that the positive results of the comet assay were rather due to genotoxicity than cytotoxicity. Taken together, the Panel concludes that the NF has the potential to induce DNA damage, which is of concern, particularly locally for tissues that represent first sites of contact. The Panel concludes that the safety of NF has not been established under any condition of use.SIWiley Open AccessNutricion y BromatologiaFacultad de Veterinaria2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2021.6937https://hdl.handle.net/10612/21362reponame:BULERIA. Repositorio Institucional de la Universidad de Leóninstname:Ajuntament de BarcelonaIngléshttp://creativecommons.org/licenses/by-nd/4.0/info:eu-repo/semantics/openAccessoai:buleria.unileon.es:10612/213622026-06-24T12:43:27Z |
| dc.title.none.fl_str_mv |
Safety of Eurycoma longifolia (Tongkat Ali) root extract as a novel food pursuant to Regulation (EU) 2015/2283 |
| title |
Safety of Eurycoma longifolia (Tongkat Ali) root extract as a novel food pursuant to Regulation (EU) 2015/2283 |
| spellingShingle |
Safety of Eurycoma longifolia (Tongkat Ali) root extract as a novel food pursuant to Regulation (EU) 2015/2283 Turck, Dominique Tecnología de los alimentos Novel food Eurycoma longifolia Water extrac Food supplement Genotoxicity 3309 Tecnología de Los Alimentos |
| title_short |
Safety of Eurycoma longifolia (Tongkat Ali) root extract as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_full |
Safety of Eurycoma longifolia (Tongkat Ali) root extract as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_fullStr |
Safety of Eurycoma longifolia (Tongkat Ali) root extract as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_full_unstemmed |
Safety of Eurycoma longifolia (Tongkat Ali) root extract as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_sort |
Safety of Eurycoma longifolia (Tongkat Ali) root extract as a novel food pursuant to Regulation (EU) 2015/2283 |
| dc.creator.none.fl_str_mv |
Turck, Dominique Bohn, Torsten Castenmiller, Jacqueline De Henauw, Stefaan Hirsch‐Ernst, Karen Ildico Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Peláez, Carmen Pentieva, Kristina Siani, Alfonso Thies, Frank Tsabouri, Sophia Vinceti, Marco Cubadda, Francesco Frenzel, Thomas Heinonen, Marina Prieto Maradona, Miguel Marchelli, Rosangela Neuhäeuser-Berthold, Monika Poulsen, Morten Schlatter, Josef Rudolf van Loveren, Henk Matijević, Leonard Knutsen, Helle Katrine |
| author |
Turck, Dominique |
| author_facet |
Turck, Dominique Bohn, Torsten Castenmiller, Jacqueline De Henauw, Stefaan Hirsch‐Ernst, Karen Ildico Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Peláez, Carmen Pentieva, Kristina Siani, Alfonso Thies, Frank Tsabouri, Sophia Vinceti, Marco Cubadda, Francesco Frenzel, Thomas Heinonen, Marina Prieto Maradona, Miguel Marchelli, Rosangela Neuhäeuser-Berthold, Monika Poulsen, Morten Schlatter, Josef Rudolf van Loveren, Henk Matijević, Leonard Knutsen, Helle Katrine |
| author_role |
author |
| author2 |
Bohn, Torsten Castenmiller, Jacqueline De Henauw, Stefaan Hirsch‐Ernst, Karen Ildico Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Peláez, Carmen Pentieva, Kristina Siani, Alfonso Thies, Frank Tsabouri, Sophia Vinceti, Marco Cubadda, Francesco Frenzel, Thomas Heinonen, Marina Prieto Maradona, Miguel Marchelli, Rosangela Neuhäeuser-Berthold, Monika Poulsen, Morten Schlatter, Josef Rudolf van Loveren, Henk Matijević, Leonard Knutsen, Helle Katrine |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Nutricion y Bromatologia Facultad de Veterinaria |
| dc.subject.none.fl_str_mv |
Tecnología de los alimentos Novel food Eurycoma longifolia Water extrac Food supplement Genotoxicity 3309 Tecnología de Los Alimentos |
| topic |
Tecnología de los alimentos Novel food Eurycoma longifolia Water extrac Food supplement Genotoxicity 3309 Tecnología de Los Alimentos |
| description |
[EN]Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on Eurycoma longifolia (Tongkat Ali) root extract as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is standardised water extract prepared from the dried ground root chips of Tongkat Ali (Eurycoma longifolia Jack) and proposed by the applicant to be used as food supplement in amounts up to 200 mg/day. The target population is the adult population, except pregnant and lactating women. The characteristic components of the NF are glycosaponins (40–65%) and eurycomanone (0.8–1.5%). It can also contain canthin-6-one alkaloids and isoscopoletin (coumarin). The NF has been present in various international markets since 2009. The Panel notes positive results from the submitted in vitro chromosome aberration test, which indicates clastogenic properties of the NF. In the requested follow-up in vivo mammalian alkaline comet assay, the NF induced positive results at the highest dose tested (2,000 mg/kg body weight (bw)) at the tissues of the first site of contact (stomach and duodenum). Histopathological evaluation of the tested tissues indicated that the positive results of the comet assay were rather due to genotoxicity than cytotoxicity. Taken together, the Panel concludes that the NF has the potential to induce DNA damage, which is of concern, particularly locally for tissues that represent first sites of contact. The Panel concludes that the safety of NF has not been established under any condition of use. |
| publishDate |
2021 |
| dc.date.none.fl_str_mv |
2021 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
| format |
article |
| status_str |
publishedVersion |
| dc.identifier.none.fl_str_mv |
https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2021.6937 https://hdl.handle.net/10612/21362 |
| url |
https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2021.6937 https://hdl.handle.net/10612/21362 |
| dc.language.none.fl_str_mv |
Inglés |
| language_invalid_str_mv |
Inglés |
| dc.rights.none.fl_str_mv |
http://creativecommons.org/licenses/by-nd/4.0/ info:eu-repo/semantics/openAccess |
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http://creativecommons.org/licenses/by-nd/4.0/ |
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openAccess |
| dc.publisher.none.fl_str_mv |
Wiley Open Access |
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Wiley Open Access |
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reponame:BULERIA. Repositorio Institucional de la Universidad de León instname:Ajuntament de Barcelona |
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Ajuntament de Barcelona |
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BULERIA. Repositorio Institucional de la Universidad de León |
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BULERIA. Repositorio Institucional de la Universidad de León |
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15,81155 |