Flavor ingredient regulatory record
N-Lactoyl ethanolamine
N-Lactoyl ethanolamine is a lactone in the dairy family, FEMA GRAS under FEMA number 4256 (CAS 5422-34-4). Its odor is creamy, milky, sweet, buttery.
- FEMA
- 4256
- CAS
- 5422-34-4
- JECFA
- 1774
- EU FL
- 16.103
- Formula
- C5H11NO3
- EC
- 226-546-1
GRAS status: FEMA GRAS, publication 23. Recorded by FDA in the Substances Added to Food inventory under CAS 5422-34-4.
Structure
Identity
Also known as: Propanamide, 2-hydroxy-N-(2-hydroxyethyl)-, Lactamide, N-(2-hydroxyethyl)-, 2-Hydroxy-N-(2-hydroxyethyl)propanamide, N-(β-Hydroxyethyl)-2-hydroxypropionamide, N-(β-Hydroxyethyl)lactamide, N-(2-Hydroxyethyl)lactamide, Propanamide, 2-hydroxy-N-(2-hydroxyethyl)-, (±)-, Incromectant LMEA, Lactamide MEA, NSC 11062, Lactic acid monoethanolamide, Lipamide LMEA.
Can N-Lactoyl ethanolamine be labeled natural?
Nature occurrence: Not yet found in nature (provisional).
Nature occurrence has not been settled for this substance, so the natural or artificial class is not stated here. The FEMA GRAS status does not depend on it.
Regulatory status, with citations
United States
N-Lactoyl ethanolamine is FEMA GRAS under FEMA number 4256. It is cited in the Code of Federal Regulations at 21 CFR 172.515.
European Union and United Kingdom
Listed on the Union List of flavouring substances as FL 16.103, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (EFSA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 1774, evaluated at the 68th meeting in 2007. 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. N-Lactoyl ethanolamine appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 5422-34-4, where EPA names it Propanamide, 2-hydroxy-N-(2-hydroxyethyl)-.
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: Creamy, milky, sweet, buttery.
Where it is used
N-Lactoyl ethanolamine is used in dairy, confection, bakery and ice cream, typically as a dairy note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to N-Lactoyl ethanolamine by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| l-Glutamic acid | 3285 | 69% | In nature |
| D-Xylose | 3606 | 68% | In nature |
| 2-Oxopentanedioic acid | 3891 | 67% | In nature |
| Ascorbic Acid | 2109 | 65% | In nature |
| L-Methionylglycine | 4692 | 64% | Not determined |
More lactones in this index
gamma-Dodecalactone · gamma-Valerolactone · 3,9-Dimethyl-6-(1-methylethyl)-1,4-dioxaspiro[4.5]decan-2-one · Octahydrocoumarin · 4-Hydroxybutyric acid lactone · 4-Acetoxy-2,5-dimethyl-3(2H)furanone
N-Lactoyl ethanolamine FAQ
Is N-Lactoyl ethanolamine on the FEMA GRAS list?
It is. FEMA number 4256 covers N-Lactoyl ethanolamine. It is also codified at 21 CFR 172.515.
What is the FEMA number for N-Lactoyl ethanolamine?
The FEMA number for N-Lactoyl ethanolamine is 4256 and its CAS registry number is 5422-34-4. FEMA files it in the dairy flavor category.
Is N-Lactoyl ethanolamine approved in the EU?
N-Lactoyl ethanolamine is on the EU Union List of flavouring substances as FL 16.103 (Annex I Part A) under Regulation 1334/2008.
Has JECFA evaluated N-Lactoyl ethanolamine?
Yes. JECFA number 1774, evaluated at the 68th meeting in 2007. Conclusion: No safety concern at current levels of intake when used as a flavouring agent.
What is N-Lactoyl ethanolamine used for?
N-Lactoyl ethanolamine is described as creamy, milky, sweet, buttery. It shows up in dairy, confection, bakery and ice cream.
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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 N-LACTOYL ETHANOLAMINE under CAS 5422-34-4 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.