Safety of calcidiol monohydrate produced by chemical synthesis 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 the safety of calcidiol monohydrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including its bioavailability as a metabolite of...

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Autores: Turck, Dominique, Castenmiller, Jacqueline, Henauw, Stefaan de, Hirsch‐Ernst, Karen Ildico, Kearney, John, 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, Marchelli, Rosangela, Neuhauser‐Berthold, Monika, Poulsen, Morten, Prieto Maradona, Miguel, Schlatter, Josef Rudolf, van Loveren, Henk, Dumas, Céline, Roldán Torres, Ruth, Steinkellner, Hans, Knutsen, Helle Katrine
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:Ajuntament de Barcelona
Repositorio:BULERIA. Repositorio Institucional de la Universidad de León
OAI Identifier:oai:buleria.unileon.es:10612/24174
Acceso en línea:https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2021.6660
https://hdl.handle.net/10612/24174
Access Level:acceso abierto
Palabra clave:Tecnología de los alimentos
Novel Foods
Calcidiol monohydrate
Food supplement
Safety
Bioavailability
Vitamin D
3309 Tecnología de Los Alimentos
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spelling Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283Turck, DominiqueCastenmiller, JacquelineHenauw, Stefaan deHirsch‐Ernst, Karen IldicoKearney, JohnMaciuk, AlexandreMangelsdorf, IngeMcArdle, Harry JNaska, AndronikiPeláez, CarmenPentieva, KristinaSiani, AlfonsoThies, FrankTsabouri, SophiaVinceti, MarcoCubadda, FrancescoFrenzel, ThomasHeinonen, MarinaMarchelli, RosangelaNeuhauser‐Berthold, MonikaPoulsen, MortenPrieto Maradona, MiguelSchlatter, Josef Rudolfvan Loveren, HenkDumas, CélineRoldán Torres, RuthSteinkellner, HansKnutsen, Helle KatrineTecnología de los alimentosNovel FoodsCalcidiol monohydrateFood supplementSafetyBioavailabilityVitamin D3309 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 the safety of calcidiol monohydrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including its bioavailability as a metabolite of vitamin D3 when added for nutritional purposes to food supplements. The NF is produced chemically. It is proposed in food supplements up to 10 μg/day for individuals ≥ 11 years of age, including pregnant and lactating women and up to 5 μg/day in 3- to 10-year-old children. The production process, composition, specifications and stability of the NF do not raise safety concerns. Animal and human data indicate efficient absorption. The NF contains a fraction of nanoparticles, which are fat soluble and unlikely to reach systemic distribution. There are no concerns regarding genotoxicity. Human adult studies do not raise safety concerns. Combined intake estimates of calcidiol from the NF and calcidiol and vitamin D from the diet were below the tolerable upper intake level (UL) for vitamin D for subjects above 11 years of age. The achieved mean serum 25(OH)D concentration in adults supplemented with 10 μg NF per day remained below 200 nmol/L. The Panel concludes that the NF is safe under the proposed conditions of use and use levels for individuals ≥ 11 years old, including pregnant and lactating women. The applicant did not provide data on the bioavailability and safety of the NF in children. The combined intake estimation in children (3–10 years) is close to the UL for vitamin D. Therefore, the Panel could not conclude on the safety of consumption of the NF in children (3–10 years) at the proposed daily intake. The NF is a bioavailable source of the biologically active metabolite of vitamin D, i.e. 1,25-dihydroxyvitamin D.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.2021.6660https://hdl.handle.net/10612/24174reponame: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:10612/241742026-06-24T12:43:27Z
dc.title.none.fl_str_mv Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283
title Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283
spellingShingle Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283
Turck, Dominique
Tecnología de los alimentos
Novel Foods
Calcidiol monohydrate
Food supplement
Safety
Bioavailability
Vitamin D
3309 Tecnología de Los Alimentos
title_short Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283
title_full Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283
title_fullStr Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283
title_full_unstemmed Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283
title_sort Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283
dc.creator.none.fl_str_mv Turck, Dominique
Castenmiller, Jacqueline
Henauw, Stefaan de
Hirsch‐Ernst, Karen Ildico
Kearney, John
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
Marchelli, Rosangela
Neuhauser‐Berthold, Monika
Poulsen, Morten
Prieto Maradona, Miguel
Schlatter, Josef Rudolf
van Loveren, Henk
Dumas, Céline
Roldán Torres, Ruth
Steinkellner, Hans
Knutsen, Helle Katrine
author Turck, Dominique
author_facet Turck, Dominique
Castenmiller, Jacqueline
Henauw, Stefaan de
Hirsch‐Ernst, Karen Ildico
Kearney, John
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
Marchelli, Rosangela
Neuhauser‐Berthold, Monika
Poulsen, Morten
Prieto Maradona, Miguel
Schlatter, Josef Rudolf
van Loveren, Henk
Dumas, Céline
Roldán Torres, Ruth
Steinkellner, Hans
Knutsen, Helle Katrine
author_role author
author2 Castenmiller, Jacqueline
Henauw, Stefaan de
Hirsch‐Ernst, Karen Ildico
Kearney, John
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
Marchelli, Rosangela
Neuhauser‐Berthold, Monika
Poulsen, Morten
Prieto Maradona, Miguel
Schlatter, Josef Rudolf
van Loveren, Henk
Dumas, Céline
Roldán Torres, Ruth
Steinkellner, Hans
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
dc.contributor.none.fl_str_mv Nutricion y Bromatologia
Facultad de Veterinaria
dc.subject.none.fl_str_mv Tecnología de los alimentos
Novel Foods
Calcidiol monohydrate
Food supplement
Safety
Bioavailability
Vitamin D
3309 Tecnología de Los Alimentos
topic Tecnología de los alimentos
Novel Foods
Calcidiol monohydrate
Food supplement
Safety
Bioavailability
Vitamin D
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 the safety of calcidiol monohydrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including its bioavailability as a metabolite of vitamin D3 when added for nutritional purposes to food supplements. The NF is produced chemically. It is proposed in food supplements up to 10 μg/day for individuals ≥ 11 years of age, including pregnant and lactating women and up to 5 μg/day in 3- to 10-year-old children. The production process, composition, specifications and stability of the NF do not raise safety concerns. Animal and human data indicate efficient absorption. The NF contains a fraction of nanoparticles, which are fat soluble and unlikely to reach systemic distribution. There are no concerns regarding genotoxicity. Human adult studies do not raise safety concerns. Combined intake estimates of calcidiol from the NF and calcidiol and vitamin D from the diet were below the tolerable upper intake level (UL) for vitamin D for subjects above 11 years of age. The achieved mean serum 25(OH)D concentration in adults supplemented with 10 μg NF per day remained below 200 nmol/L. The Panel concludes that the NF is safe under the proposed conditions of use and use levels for individuals ≥ 11 years old, including pregnant and lactating women. The applicant did not provide data on the bioavailability and safety of the NF in children. The combined intake estimation in children (3–10 years) is close to the UL for vitamin D. Therefore, the Panel could not conclude on the safety of consumption of the NF in children (3–10 years) at the proposed daily intake. The NF is a bioavailable source of the biologically active metabolite of vitamin D, i.e. 1,25-dihydroxyvitamin D.
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.2021.6660
https://hdl.handle.net/10612/24174
url https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2021.6660
https://hdl.handle.net/10612/24174
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
rights_invalid_str_mv http://creativecommons.org/licenses/by-nd/4.0/
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Wiley Open Access
publisher.none.fl_str_mv Wiley Open Access
dc.source.none.fl_str_mv reponame:BULERIA. Repositorio Institucional de la Universidad de León
instname:Ajuntament de Barcelona
instname_str Ajuntament de Barcelona
reponame_str BULERIA. Repositorio Institucional de la Universidad de León
collection BULERIA. Repositorio Institucional de la Universidad de León
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.811543

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