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Safety of beta-nicotinamide mononucleotide (β-NMN) pursuant the regulation (EU) 2015/2283 and the bioavailability of nicotinamide 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, Montaña Cámara, Jacqueline Castenmiller, Stefaan De Henauw, Ángeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Margarita Aguilera-Gómez, Francesco Cubadda, Thomas Frenzel, Ursula Gundert-Remy, Francesca Marcon, Harry J McArdle, Monika Neuhäuser-Berthold, Miguel Prieto Maradona, Alexandros Siskos, Matthew Wright, Elisa Beneventi, Annamaria Rossi, Maura Magani, Karen Ildico Hirsch-Ernst
EFSA Journal 2026 24(5):e10007

Bibliography

PubMed
PMID 42125559
PubMed Central
PMC13158811
DOI
10.2903/j.efsa.2026.10007
Funding
Scientific opinion prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens following a request from the European Commission.
Competing interests
EFSA publishes declarations of interest for scientific experts through its transparency system; this opinion directs readers to those declarations.

Study snapshot

DesignRegulatory scientific safety and bioavailability assessment under EU novel-food legislation; integrates chemistry/manufacturing data, genotoxicity, repeated-dose toxicology and human evidence.
ModelA specified chemically synthesized β-NMN novel food intended for adult food supplements; pregnant and lactating women excluded from the proposed target population.
SampleEvidence dossier rather than a single trial; included a human intervention study plus toxicological and compositional evidence.
InterventionProposed use up to 300 mg/day β-NMN in adult food supplements; human bioavailability comparison included equimolar β-NMN and nicotinamide.
DurationMultiple evidence sources; not a single intervention duration.
EndpointsIdentity and specifications; Manufacturing and composition; Nicotinamide bioavailability; Genotoxicity; 90-day repeated-dose toxicity; Human safety; Margin of exposure

What the study showed, in plain terms

In this 2026 scientific opinion, EFSA evaluated a specific chemically synthesized β-NMN novel food proposed for use in adult supplements at up to 300 mg/day.

The panel concluded that the evaluated product is safe under the proposed conditions of use for adults excluding pregnant and lactating women, and that it is a bioavailable source of nicotinamide.

This is strong regulatory safety evidence for the specific novel-food dossier and use conditions. It does not establish that every commercial NMN product is equivalent, prove anti-aging efficacy, or establish safety at higher doses or in excluded populations.

Key findings

  • The evaluated β-NMN was proposed for adult food supplements at up to 300 mg/day, excluding pregnant and lactating women.
  • EFSA accepted a conversion factor of 1 for nicotinamide bioavailability; 300 mg/day β-NMN corresponds to about 109.7 mg/day nicotinamide.
  • The corresponding nicotinamide exposure remained below the 900 mg/day tolerable upper intake level cited by the panel.
  • No genotoxicity concern was identified.
  • A 90-day rat study identified a NOAEL of 400 mg/kg body weight/day, giving a margin of exposure of 93 under the proposed use.
  • The available human study did not raise safety concerns, and the panel concluded the novel food was safe under the specified conditions.

What this study can and cannot tell us

The conclusion applies to the specific β-NMN material, specifications, manufacturing process, target population and maximum proposed use evaluated in the dossier; it should not be generalized automatically to every NMN product or dose.

The opinion is a safety and nutrient-source assessment, not evidence that NMN prevents aging or treats disease. Pregnant and lactating women were excluded from the proposed target population.

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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