Tier 2 — strong

Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), Dominique Turck, Jean-Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Marco Vinceti, Peter Willatts, Karl-Heinz Engel, Rosangela Marchelli, Annette Pöting, Morten Poulsen, Josef Rudolf Schlatter, Emanuela Turla, Henk van Loveren
EFSA journal. European Food Safety Authority 2017 15(11):e05057

Bibliography

PubMed
PMID 32625349
PubMed Central
PMC7009864
DOI
10.2903/j.efsa.2017.5057
Funding
Funding was not specified in the indexed record or accessible funding metadata.
Competing interests
A competing-interest declaration was not available in the indexed record or accessible disclosure metadata.

Study snapshot

DesignRegulatory safety assessment
ModelEvidence synthesis; mixed research models
SampleHuman, animal and exposure evidence evaluated by an EFSA panel
InterventionSpecified novel-food uses; supplementary exposure assessed separately from normal diet
Duration2017 opinion with later editorial amendment
EndpointsExposure assessment; Lipids; Safety margin

What the study showed, in plain terms

Published in 2017, this source examined safety assessments and evidence synthesis. Its evidence base was Human, animal and exposure evidence evaluated by an EFSA panel. It evaluated Specified novel-food uses; supplementary exposure assessed separately from normal diet across 2017 opinion with later editorial amendment.

The panel did not accept the proposed 2.5 g/day use as adequately supported and derived a conservative additional-intake level of 6 mg/kg/day for the assessed population.

A regulatory assessment for defined food uses, not a universal toxic dose or therapeutic limit. The amended version should be used. The original 2017 EFSA opinion was later amended. The additional-intake assessment is expressed by body weight (6 mg/kg/day) and applies to the evaluated novel-food use, rather than being a universal therapeutic limit. Publication update

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Key findings

  • The panel did not accept the proposed 2.5 g/day use as adequately supported and derived a conservative additional-intake level of 6 mg/kg/day for the assessed population.
  • The recorded outcome domains were Exposure assessment; Lipids; Safety margin.

What this study can and cannot tell us

  • A regulatory assessment for defined food uses, not a universal toxic dose or therapeutic limit. The amended version should be used. The original 2017 EFSA opinion was later amended. The additional-intake assessment is expressed by body weight (6 mg/kg/day) and applies to the evaluated novel-food use, rather than being a universal therapeutic limit. Publication update
  • The conclusions inherit the limitations of the underlying studies. A narrative interpretation or guideline recommendation is not a new randomized treatment comparison.
  • Source basis: Accessible full-text extract plus indexed bibliographic data. Missing method details, funding information or participant denominators are not inferred.

Related papers in the corpus

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Effects of betaine supplementation on cardiovascular markers: A systematic review and Meta-analysis
Damoon Ashtary-Larky et al. · Critical reviews in food science and nutrition · 2022
Tier 1
Betaine Supplementation Moderately Increases Total Cholesterol Levels: A Systematic Review and Meta-Analysis
Emilia E Zawieja et al. · Journal of dietary supplements · 2021
Tier 2
Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283
EFSA Panel on Nutrition, Novel Foods and Food Allergens (EFSA NDA Panel) et al. · EFSA journal. European Food Safety Authority · 2019
Tier 4
Postauthorization safety study of betaine anhydrous
Ulrike Mütze et al. · Journal of inherited metabolic disease · 2022

Editorial review

Reviewed by the Biohack Blueprint research team

Last verified

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