Safety of magnesium orotate dihydrate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC

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 magnesium orotate dihydrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of magnesium...

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Autores: EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), Turck, Dominique, Bohn, Torsten, Cámara Hurtado, María de la Montaña, Castenmille, Jacqueline, Henauw, Stefaan de, Jos Gallego, Ángeles Mencía, McArdle, Harry J.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/179044
Acceso en línea:https://hdl.handle.net/11441/179044
https://doi.org/10.2903/j.efsa.2025.9528
Access Level:acceso abierto
Palabra clave:Food supplement
Magnesium
Magnesium orotate dihydrate
Novel foods
Nutrient source
Orotic acid
Safety
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spelling Safety of magnesium orotate dihydrate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/ECEFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens)Turck, DominiqueBohn, TorstenCámara Hurtado, María de la MontañaCastenmille, JacquelineHenauw, Stefaan deJos Gallego, Ángeles MencíaMcArdle, Harry J.Food supplementMagnesiumMagnesium orotate dihydrateNovel foodsNutrient sourceOrotic acidSafetyFollowing 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 magnesium orotate dihydrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of magnesium from this source in the context of Directive 2002/46/EC. The NF is produced by chemical synthesis and is proposed to be used in food supplements at a maximum intake level of 6100 mg per day by adults. This intake level corresponds to around 5000 mg/day orotic acid and 400 mg/day magnesium. The Panel notes that this would exceed the established UL for supplemental magnesium of 250 mg/day, therefore the use of the NF could be nutritionally disadvantageous. The Panel also notes the previous safety assessment of magnesium orotate dihydrate, where concerns were raised regarding the exposure to orotic acid, based on several animal studies demonstrating tumour-promoting effects. The ANS Panel derived a no observed adverse effect level (NOAEL) for orotic acid of 50 mg/kg bw per day. The margin between the derived NOAEL for orotic acid and the exposure resulting from the proposed maximum use level of the NF is 0.7 (based on the average bw of an adult person of 70 kg) which is even lower than the margin considered by the ANS Panel of being inadequate. The applicant has not provided any toxicological data on the NF or on orotic acid that could address or mitigate these safety concerns. The Panel concludes that the safety of the NF, magnesium orotate dihydrate, cannot be established under the proposed conditions of use. The assessment of bioavailability of magnesium from the NF in comparison to natural sources was not conducted.WileyNutrición y Bromatología, Toxicología y Medicina Legal2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/179044https://doi.org/10.2903/j.efsa.2025.9528reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésEFSA Journal, 23 (7), e9528.https://doi.org/10.2903/j.efsa.2025.9528info:eu-repo/semantics/openAccessoai:idus.us.es:11441/1790442026-06-17T12:51:07Z
dc.title.none.fl_str_mv Safety of magnesium orotate dihydrate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC
title Safety of magnesium orotate dihydrate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC
spellingShingle Safety of magnesium orotate dihydrate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC
EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens)
Food supplement
Magnesium
Magnesium orotate dihydrate
Novel foods
Nutrient source
Orotic acid
Safety
title_short Safety of magnesium orotate dihydrate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC
title_full Safety of magnesium orotate dihydrate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC
title_fullStr Safety of magnesium orotate dihydrate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC
title_full_unstemmed Safety of magnesium orotate dihydrate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC
title_sort Safety of magnesium orotate dihydrate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC
dc.creator.none.fl_str_mv EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens)
Turck, Dominique
Bohn, Torsten
Cámara Hurtado, María de la Montaña
Castenmille, Jacqueline
Henauw, Stefaan de
Jos Gallego, Ángeles Mencía
McArdle, Harry J.
author EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens)
author_facet EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens)
Turck, Dominique
Bohn, Torsten
Cámara Hurtado, María de la Montaña
Castenmille, Jacqueline
Henauw, Stefaan de
Jos Gallego, Ángeles Mencía
McArdle, Harry J.
author_role author
author2 Turck, Dominique
Bohn, Torsten
Cámara Hurtado, María de la Montaña
Castenmille, Jacqueline
Henauw, Stefaan de
Jos Gallego, Ángeles Mencía
McArdle, Harry J.
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Nutrición y Bromatología, Toxicología y Medicina Legal
dc.subject.none.fl_str_mv Food supplement
Magnesium
Magnesium orotate dihydrate
Novel foods
Nutrient source
Orotic acid
Safety
topic Food supplement
Magnesium
Magnesium orotate dihydrate
Novel foods
Nutrient source
Orotic acid
Safety
description 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 magnesium orotate dihydrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of magnesium from this source in the context of Directive 2002/46/EC. The NF is produced by chemical synthesis and is proposed to be used in food supplements at a maximum intake level of 6100 mg per day by adults. This intake level corresponds to around 5000 mg/day orotic acid and 400 mg/day magnesium. The Panel notes that this would exceed the established UL for supplemental magnesium of 250 mg/day, therefore the use of the NF could be nutritionally disadvantageous. The Panel also notes the previous safety assessment of magnesium orotate dihydrate, where concerns were raised regarding the exposure to orotic acid, based on several animal studies demonstrating tumour-promoting effects. The ANS Panel derived a no observed adverse effect level (NOAEL) for orotic acid of 50 mg/kg bw per day. The margin between the derived NOAEL for orotic acid and the exposure resulting from the proposed maximum use level of the NF is 0.7 (based on the average bw of an adult person of 70 kg) which is even lower than the margin considered by the ANS Panel of being inadequate. The applicant has not provided any toxicological data on the NF or on orotic acid that could address or mitigate these safety concerns. The Panel concludes that the safety of the NF, magnesium orotate dihydrate, cannot be established under the proposed conditions of use. The assessment of bioavailability of magnesium from the NF in comparison to natural sources was not conducted.
publishDate 2025
dc.date.none.fl_str_mv 2025
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://hdl.handle.net/11441/179044
https://doi.org/10.2903/j.efsa.2025.9528
url https://hdl.handle.net/11441/179044
https://doi.org/10.2903/j.efsa.2025.9528
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv EFSA Journal, 23 (7), e9528.
https://doi.org/10.2903/j.efsa.2025.9528
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Wiley
publisher.none.fl_str_mv Wiley
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
reponame_str idUS. Depósito de Investigación de la Universidad de Sevilla
collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
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