Tier 2 — strong

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), Dominique Turck, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, John Kearney, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, Francesco Cubadda, Karl Heinz Engel, Thomas Frenzel, Marina Heinonen, Rosangela Marchelli, Monika Neuhäuser-Berthold, Annette Pöting, Morten Poulsen, Yolanda Sanz, Josef Rudolf Schlatter, Henk van Loveren, Emanuela Turla, Helle Katrine Knutsen
EFSA journal. European Food Safety Authority 2019 17(4):e05658

Bibliography

PubMed
PMID 32626284
PubMed Central
PMC7009179
DOI
10.2903/j.efsa.2019.5658
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
SampleEFSA evaluation of revised population food-exposure estimates
InterventionRevised uses and levels of betaine as a novel food
Duration2019 assessment
EndpointsNovel-food exposure; Conditions of safe use

What the study showed, in plain terms

Published in 2019, this source examined safety assessments and evidence synthesis. Its evidence base was EFSA evaluation of revised population food-exposure estimates. It evaluated Revised uses and levels of betaine as a novel food across 2019 assessment.

Estimated intake under the revised uses remained below the previously established additional-intake level; the panel considered those specified uses safe.

The conclusion applies to the proposed food-use conditions and does not endorse every high-dose supplement regimen.

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Key findings

  • Estimated intake under the revised uses remained below the previously established additional-intake level; the panel considered those specified uses safe.
  • The recorded outcome domains were Novel-food exposure; Conditions of safe use.

What this study can and cannot tell us

  • The conclusion applies to the proposed food-use conditions and does not endorse every high-dose supplement regimen.
  • 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.

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Betaine Supplementation Moderately Increases Total Cholesterol Levels: A Systematic Review and Meta-Analysis
Emilia E Zawieja et al. · Journal of dietary supplements · 2021
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Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) et al. · EFSA journal. European Food Safety Authority · 2017
Tier 4
Postauthorization safety study of betaine anhydrous
Ulrike Mütze et al. · Journal of inherited metabolic disease · 2022

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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