Flavor ingredient regulatory record
Lactylated fatty acid esters of glycerol and propylene glycol
Lactylated fatty acid esters of glycerol and propylene glycol is a natural complex flavoring material in the fruity family, FEMA GRAS under FEMA number 4153 (CAS 444004-59-5).
- FEMA
- 4153
- CAS
- 444004-59-5
GRAS status: FEMA GRAS, publication 22. Recorded by FDA in the Substances Added to Food inventory under CAS 977050-66-0.
Structure
Material
Lactylated fatty acid esters of glycerol and propylene glycol is a natural complex material rather than a single molecule, so it has no one structure. FEMA lists it as Lactylated fatty acid esters of glycerol and propylene glycol.
Identity
Also known as: Soybean oil, hydrogenated, mixed esters with lactic acid and propylene glycol.
Can Lactylated fatty acid esters of glycerol and propylene glycol be labeled natural?
Nature makes lactylated fatty acid esters of glycerol and propylene glycol, which is why the US label turns on process. A natural route gives natural flavor; synthesis gives artificial lactylated fatty acid esters of glycerol and propylene glycol, same molecule. 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
Lactylated fatty acid esters of glycerol and propylene glycol is FEMA GRAS under FEMA number 4153. It is cited in the Code of Federal Regulations at 21 CFR 172.850.
European Union and United Kingdom
No EU FL number is on file for Lactylated fatty acid esters of glycerol and propylene glycol. 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)
Lactylated fatty acid esters of glycerol and propylene glycol has not been evaluated by JECFA as a flavouring agent, or no evaluation is on file.
Other US flags
Not on the California Proposition 65 list. Listed on the EPA TSCA inventory.
Odor and taste
Taste: Sweet, mild, creamy.
Where it is used
Lactylated fatty acid esters of glycerol and propylene glycol is used in beverage, dairy, confection, bakery and snack foods, typically as a fruity note.
More esters in this index
Ethyl 2-(methylthio)acetate · Isoamyl octanoate · Bornyl butyrate · (E,Z)-Phytyl acetate · Dodecyl lactate · 1-Isobutoxy-1-ethoxyethane
Lactylated fatty acid esters of glycerol and propylene glycol FAQ
Does lactylated fatty acid esters of glycerol and propylene glycol have FEMA GRAS status?
Lactylated fatty acid esters of glycerol and propylene glycol holds FEMA GRAS status under FEMA number 4153. The Code of Federal Regulations lists it at 21 CFR 172.850.
How do I cite lactylated fatty acid esters of glycerol and propylene glycol by FEMA or CAS number?
Cite lactylated fatty acid esters of glycerol and propylene glycol as FEMA 4153 or CAS 444004-59-5; both point to the same entry. Its flavor category is fruity.
Can lactylated fatty acid esters of glycerol and propylene glycol be labeled a natural flavor?
The process decides for lactylated fatty acid esters of glycerol and propylene glycol. It occurs in nature, so a natural-source, natural-process material is natural flavor in the US and synthetic lactylated fatty acid esters of glycerol and propylene glycol is artificial. The EU and UK grant the natural claim only to that natural route; Mercosur and Mexico call synthetic material identical-to-natural.
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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 LACTYLATED FATTY ACID ESTERS OF GLYCEROL AND PROPYLENE GLYCOL under CAS 977050-66-0 and carries its FEMA number and its 21 CFR citations. The inventory is searchable at FDA. FDA records its technical effect as emulsifier or emulsifier salt, formulation aid, surface-active agent.
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.