Betaine Anhydrous | whatsinit

About

What it is and where it shows up.

Betaine anhydrous (trimethylglycine) is a naturally occurring zwitterionic compound found in beets, spinach, cereals, and seafood; it is a metabolite of choline that functions as a methyl group donor in transmethylation reactions and as an osmolyte. It is added to functional foods, sports performance supplements, and animal feeds to support homocysteine metabolism, osmoprotection, and liver function.

Safety summary

The regulatory and scientific consensus.

EFSA concluded that betaine as a novel food is safe at a maximum intake of 6 mg/kg body weight per day (approximately 400 mg/day) in addition to background dietary intake from conventional foods. At high therapeutic doses used for homocystinuria, cerebral edema has been reported in patients with hypermethioninemia, particularly those with cystathionine beta-synthase (CBS) deficiency, due to further elevation of plasma methionine. No IARC carcinogenicity classification exists; the compound is considered broadly safe for the general adult population at supplemental and novel food intake levels.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Approved as a novel food under Regulation (EU) 2015/2283; maximum safe intake established at 6 mg/kg bw/day (equivalent to ~400 mg/day for a 70 kg adult) in addition to background dietary intake. Target population includes sportspeople above 10 years of age. Betaine anhydrous is also separately authorised as a nutritional feed additive (code 3a920) for all animal species under Commission Regulation (EU) 2015/1060, with a maximum supplementation rate of 2000 mg/kg complete feed. As a novel food ingredient for human consumption, it does not carry an E number.source
FDA (Food and Drug Administration) (United States)	Approved	Betaine is listed in the FDA Substances Added to Food (formerly EAFUS) database. Betaine anhydrous is also FDA-approved as a prescription drug (Cystadane, NDA/ANDA) for treatment of homocystinuria. No formal GRAS notification ceiling for food use was confirmed; no population-level maximum intake established for dietary supplement or food ingredient use.source

Who should approach with care

Whose guidance would steer them away.

Infants — The EFSA novel food approval specifically targets sportspeople above 10 years of age, and no safety data support supplemental betaine use in infants; it is excluded from infant food applications.

Pregnancy — Betaine supplementation at higher doses alters homocysteine and methionine metabolism, and safety data in pregnant women are insufficient to confirm the same intake thresholds apply.

Kidney Disease — Betaine metabolism intersects with renal handling of methylated compounds; while low betaine is associated with kidney damage, high supplemental doses and altered methionine levels may require monitoring in chronic kidney disease patients.

Liver Disease — High-dose betaine therapy for homocystinuria can further elevate plasma methionine, which has been linked to cerebral edema and metabolic stress, making physician oversight necessary in individuals with pre-existing liver dysfunction.

Research citations

The sources behind this verdict.

1FDA. Cystadane (betaine anhydrous for oral solution) — DailyMed Prescribing Information. dailymed.nlm.nih.gov
2EFSA. Assessment of the feed additives betaine anhydrous (3a920) and betaine hydrochloride (3a925) for all animal species for the renewal of their authorisations (Orffa Additives B.V.), 2025. efsa.europa.eu
3PubMed. Betaine as a Functional Ingredient: Metabolism, Health-Promoting Attributes, Food Sources, Applications and Analysis Methods, 2023. pmc.ncbi.nlm.nih.gov
4EFSA. Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283, 2019. efsa.europa.eu
5EFSA. Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97, 2017. efsa.europa.eu

Independently researched5 citations