Flavor ingredient regulatory record
Choline chloride
Choline chloride is a quaternary ammonium compound in the savory family, FEMA GRAS under FEMA number 4500 (CAS 67-48-1). Its odor is slightly fishy, salty, earthy, umami.
- FEMA
- 4500
- CAS
- 67-48-1
- JECFA
- 2003
- Formula
- C5H14ClNO
- EC
- 200-655-4
GRAS status: FEMA GRAS, publication 24. Recorded by FDA in the Substances Added to Food inventory under CAS 977188-01-4.
Structure
Identity
Also known as: Ethanaminium, 2-hydroxy-N,N,N-trimethyl-, chloride (1:1), Choline, chloride, Ethanaminium, 2-hydroxy-N,N,N-trimethyl-, chloride, Biocolina, Hepacholine, (2-Hydroxyethyl)trimethylammonium chloride, Lipotril, Cholinium chloride, (β-Hydroxyethyl)trimethylammonium chloride, Bilineurin chloride, Luridin chloride, Biocoline.
Can Choline chloride be labeled natural?
Choline chloride occurs in nature, so the label depends on the route: choline chloride won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized choline chloride is artificial. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material identical-to-natural.
- United States
- Natural or artificial, by process
- European Union and UK
- Natural only from natural material
- Mercosur and Mexico
- Natural or identical-to-natural
How each market defines the classes: natural vs artificial flavor under 21 CFR 101.22.
Regulatory status, with citations
United States
Choline chloride is FEMA GRAS under FEMA number 4500. It is cited in the Code of Federal Regulations at 21 CFR 172.515.
European Union and United Kingdom
No EU FL number is on file for Choline chloride. That is not a finding either way. The Union List covers defined flavouring substances, so natural complex materials are handled as flavouring preparations under Parts B to F and never receive a number, and substances used as additives sit under Regulation 1333/2008 instead. Confirm the position before EU or UK use.
JECFA (WHO / FAO)
JECFA number 2003, evaluated at the 73rd meeting in 2010. No safety concern at current levels of intake when used as a flavouring agent.
Other US flags
Not on the California Proposition 65 list.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. Choline chloride appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 67-48-1, where EPA names it Ethanaminium, 2-hydroxy-N,N,N-trimethyl-, chloride (1:1).
Active in US commerce
EPA designates this substance active, so no Notice of Activity Form B is required before manufacturing. What active and inactive mean.
EPA publishes no regulatory flags on this listing. What the flags mean.
From the EPA non-confidential TSCA Inventory, July 2026 release. EPA also maintains a confidential portion it does not publish. Search the Inventory by CAS number.
Odor and taste
Odor: Slightly fishy, salty, earthy, umami.
Taste: Salty, savory, mild.
Where it is used
Choline chloride is used in nutritional supplements, animal feed, flavor enhancer and functional foods, typically as a savory note.
More quaternary ammonium compounds in this index
DL-(3-Amino-3-carboxypropyl)dimethylsufonium chloride · Trimethylamine oxide · Betaine
Choline chloride FAQ
Is choline chloride FEMA GRAS?
Yes. The FEMA Expert Panel lists choline chloride as GRAS under FEMA number 4500. It is also codified at 21 CFR 172.515.
What are the FEMA and CAS numbers for choline chloride?
Choline chloride is FEMA 4500, CAS 67-48-1. FEMA files it in the savory flavor category.
Does choline chloride count as natural in the US and the EU?
Since choline chloride is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when choline chloride is synthesized. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material identical-to-natural.
Is choline chloride approved in the EU?
No EU FL number is on file for choline chloride. It has a JECFA evaluation (JECFA 2003), which the EU list draws on, but the Union List entry itself should be confirmed before EU use.
Has JECFA evaluated choline chloride?
Yes. JECFA number 2003, evaluated at the 73rd meeting in 2010. Conclusion: No safety concern at current levels of intake when used as a flavouring agent.
How is choline chloride described, and where does it show up?
Flavorists describe choline chloride as slightly fishy, salty, earthy, umami. On the palate it is salty, savory, mild. It is used in nutritional supplements, animal feed, flavor enhancer and functional foods.
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Sources and attribution. The identity and regulatory facts on this page are taken from the FDA Substances Added to Food inventory, a US government record, which lists this substance as CHOLINE CHLORIDE(ALSO INCLUDES CHOLINE) under CAS 977188-01-4 and carries its FEMA number, its JECFA flavor number. The inventory is searchable at FDA. FDA records its technical effect as flavoring agent or adjuvant.
A FEMA GRAS conclusion is reached by the Expert Panel of the Flavor and Extract Manufacturers Association of the United States, and the FEMA number names that conclusion. FEMA publishes its own entry for this substance in the FEMA Flavor Library, which is the authoritative record of what the Panel decided and is worth reading alongside this page.
Ambrose Compliance is not affiliated with, endorsed by, or sponsored by FEMA. FEMA and FEMA GRAS are used here as identifiers for a published regulatory determination, not as marks of any relationship between FEMA and Ambrose.
About this page. Facts come from the FDA Substances Added to Food inventory, the Code of Federal Regulations, the EPA TSCA Inventory, the EU Union List, JECFA and the Ambrose database, with FEMA's published determination cited where it applies; parts of the text are written by Ambrose AI, which can make mistakes. Check the cited source before relying on anything here. This is not regulatory or legal advice.