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Safety of magnesium l-threonate 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 Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, Margarita Aguilera-Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Rosangela Marchelli, Monika Neuhäuser-Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Wolfgang Gelbmann, Helle Katrine Knutsen
EFSA journal. European Food Safety Authority 2024 22(3):e8656

Bibliography

PubMed
PMID 38481468
PubMed Central
PMC10934248
DOI
10.2903/j.efsa.2024.8656
Funding
Funding attribution is not supplied in the indexed abstract; consult the linked original publication.
Competing interests
If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu.

Study snapshot

DesignRegulatory scientific safety and bioavailability assessment
ModelAssessment of laboratory, animal and human evidence
SampleEFSA assessment of an applicant dossier; not a new participant-enrollment study
InterventionSpecified magnesium L-threonate novel food proposed at up to 3,000 mg/day, supplying approximately 250 mg/day magnesium
DurationEvidence assessment; duration varied across the underlying studies
EndpointsSafety under proposed conditions of use; Magnesium bioavailability; Genotoxicity and constituent exposure

What the study showed, in plain terms

The EFSA panel judged the specified magnesium L-threonate novel food safe under its proposed adult conditions of use and regarded it as a bioavailable magnesium source. The assessed population excluded pregnant and lactating women.

Key findings

The EFSA panel judged the specified magnesium L-threonate novel food safe under its proposed adult conditions of use and regarded it as a bioavailable magnesium source. The assessed population excluded pregnant and lactating women.

What this study can and cannot tell us

This is a specification- and use-specific safety opinion, not proof of cognitive or sleep efficacy. It does not establish safety for children, pregnancy, breastfeeding, kidney disease or all other formulations at the same compound weight.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology