Safety of an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum 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 an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food (NF) pursuant to Regulation (EU) 2015/2283....
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2023 |
| País: | España |
| Institución: | Universidad de León |
| Repositorio: | BULERIA. Repositorio Institucional de la Universidad de León |
| OAI Identifier: | oai:buleria.unileon.es:10612/20054 |
| Acceso en línea: | https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.8072 https://hdl.handle.net/10612/20054 |
| Access Level: | acceso abierto |
| Palabra clave: | Tecnología de los alimentos Novel foods Food safety Food supplement Phaeodactylum tricornutum Microalgae Lipids Fucoxanthin 3309 Tecnología de Los Alimentos |
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Safety of an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum 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, MarcoAguilera Gómez, MargaritaCubadda, FrancescoFrenzel, ThomasHeinonen, MarinaMarchelli, RosangelaNeuhäuser‐Berthold, MonikaPoulsen, MortenPrieto Maradona, MiguelSiskos, AlexandrosSchlatter, Josef Rudolfvan Loveren, HenkMuñoz González, AlejandraRossi, AnnamariaVerveris, ErmolaosKnutsen, Helle KatrineTecnología de los alimentosNovel foodsFood safetyFood supplementPhaeodactylum tricornutumMicroalgaeLipidsFucoxanthin3309 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 an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is an ethanolic extract of the dried biomass of the microalga P. tricornutum diluted in a medium-chain triglyceride oil carrier, with standardised fucoxanthin and tocopherol content. The main component of the NF is fat (78% on average), followed by crude protein (10% on average). The Panel is of the view that a consistent and safe production process has not been demonstrated. Additionally, the Panel considers that the information provided on the composition of the NF is not complete and may raise safety concerns. The applicant proposed to use the NF as a food supplement at the use level of 437 mg/day, with the target population being adults, excluding pregnant and breastfeeding women. There is no history of use of the NF or of its source, i.e. P. tricornutum. The Panel notes that the source of the NF, P. tricornutum, was not granted the qualified presumption of safety (QPS) status by the EFSA Panel on Biological Hazards (BIOHAZ), due to the lack of a safe history of use in the food chain and on its potential for production of bioactive compounds with toxic effects. There were no concerns regarding genotoxicity of the NF. In the 90-day study provided, a number of adverse effects were observed, some of them seen already at the lowest dose tested (750 mg/kg body weight (bw) day), which was identified by the Panel as the lowest-observed-adverse-effect-level (LOAEL). The potential phototoxicity of pheophorbide A and pyropheophorbide A in the NF was not addressed in this study. Although noting the uncertainties identified by the Panel regarding the analytical determination of these substances in the NF and the limitations in the publicly available toxicity data, a low margin of exposure (MoE) was calculated for these substances at the proposed use levels. The Panel concludes that the safety of the NF under the proposed uses and use levels has not been established.SIWiley Open AccessTecnologia de los AlimentosFacultad de Veterinaria2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.8072https://hdl.handle.net/10612/20054reponame:BULERIA. Repositorio Institucional de la Universidad de Leóninstname:Universidad de LeónIngléshttp://creativecommons.org/licenses/by-nd/4.0/info:eu-repo/semantics/openAccessoai:buleria.unileon.es:10612/200542026-06-24T12:43:27Z |
| dc.title.none.fl_str_mv |
Safety of an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food pursuant to Regulation (EU) 2015/2283 |
| title |
Safety of an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food pursuant to Regulation (EU) 2015/2283 |
| spellingShingle |
Safety of an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food pursuant to Regulation (EU) 2015/2283 Turck, Dominique Tecnología de los alimentos Novel foods Food safety Food supplement Phaeodactylum tricornutum Microalgae Lipids Fucoxanthin 3309 Tecnología de Los Alimentos |
| title_short |
Safety of an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_full |
Safety of an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_fullStr |
Safety of an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_full_unstemmed |
Safety of an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_sort |
Safety of an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum 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 Aguilera Gómez, Margarita Cubadda, Francesco Frenzel, Thomas Heinonen, Marina Marchelli, Rosangela Neuhäuser‐Berthold, Monika Poulsen, Morten Prieto Maradona, Miguel Siskos, Alexandros Schlatter, Josef Rudolf van Loveren, Henk Muñoz González, Alejandra Rossi, Annamaria Ververis, Ermolaos 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 Aguilera Gómez, Margarita Cubadda, Francesco Frenzel, Thomas Heinonen, Marina Marchelli, Rosangela Neuhäuser‐Berthold, Monika Poulsen, Morten Prieto Maradona, Miguel Siskos, Alexandros Schlatter, Josef Rudolf van Loveren, Henk Muñoz González, Alejandra Rossi, Annamaria Ververis, Ermolaos 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 Aguilera Gómez, Margarita Cubadda, Francesco Frenzel, Thomas Heinonen, Marina Marchelli, Rosangela Neuhäuser‐Berthold, Monika Poulsen, Morten Prieto Maradona, Miguel Siskos, Alexandros Schlatter, Josef Rudolf van Loveren, Henk Muñoz González, Alejandra Rossi, Annamaria Ververis, Ermolaos 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 author author author author |
| dc.contributor.none.fl_str_mv |
Tecnologia de los Alimentos Facultad de Veterinaria |
| dc.subject.none.fl_str_mv |
Tecnología de los alimentos Novel foods Food safety Food supplement Phaeodactylum tricornutum Microalgae Lipids Fucoxanthin 3309 Tecnología de Los Alimentos |
| topic |
Tecnología de los alimentos Novel foods Food safety Food supplement Phaeodactylum tricornutum Microalgae Lipids Fucoxanthin 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 an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is an ethanolic extract of the dried biomass of the microalga P. tricornutum diluted in a medium-chain triglyceride oil carrier, with standardised fucoxanthin and tocopherol content. The main component of the NF is fat (78% on average), followed by crude protein (10% on average). The Panel is of the view that a consistent and safe production process has not been demonstrated. Additionally, the Panel considers that the information provided on the composition of the NF is not complete and may raise safety concerns. The applicant proposed to use the NF as a food supplement at the use level of 437 mg/day, with the target population being adults, excluding pregnant and breastfeeding women. There is no history of use of the NF or of its source, i.e. P. tricornutum. The Panel notes that the source of the NF, P. tricornutum, was not granted the qualified presumption of safety (QPS) status by the EFSA Panel on Biological Hazards (BIOHAZ), due to the lack of a safe history of use in the food chain and on its potential for production of bioactive compounds with toxic effects. There were no concerns regarding genotoxicity of the NF. In the 90-day study provided, a number of adverse effects were observed, some of them seen already at the lowest dose tested (750 mg/kg body weight (bw) day), which was identified by the Panel as the lowest-observed-adverse-effect-level (LOAEL). The potential phototoxicity of pheophorbide A and pyropheophorbide A in the NF was not addressed in this study. Although noting the uncertainties identified by the Panel regarding the analytical determination of these substances in the NF and the limitations in the publicly available toxicity data, a low margin of exposure (MoE) was calculated for these substances at the proposed use levels. The Panel concludes that the safety of the NF under the proposed uses and use levels has not been established. |
| publishDate |
2023 |
| dc.date.none.fl_str_mv |
2023 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
| status_str |
publishedVersion |
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https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.8072 https://hdl.handle.net/10612/20054 |
| url |
https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.8072 https://hdl.handle.net/10612/20054 |
| dc.language.none.fl_str_mv |
Inglés |
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Inglés |
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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 |
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Wiley Open Access |
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Wiley Open Access |
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reponame:BULERIA. Repositorio Institucional de la Universidad de León instname:Universidad de León |
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Universidad de León |
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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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1869405083029995520 |
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15,228081 |