Flavor ingredient regulatory record
Paraldehyde
Paraldehyde is an aldehyde in the fruity family, FEMA GRAS under FEMA number 4010 (CAS 123-63-7). Its odor is sweet, fruity, citrus, green, pungent.
- FEMA
- 4010
- CAS
- 123-63-7
- EU FL
- 05.053
- Formula
- C6H12O3
- EC
- 204-639-8
GRAS status: FEMA GRAS, publication 20. Recorded by FDA in the Substances Added to Food inventory under CAS 123-63-7.
Structure
Identity
Also known as: 1,3,5-Trioxane, 2,4,6-trimethyl-, s-Trioxane, 2,4,6-trimethyl-, 2,4,6-Trimethyl-1,3,5-trioxane, Paraacetaldehyde, Paracetaldehyde, PCHO, s-Trimethyltrioxymethylene, 2,4,6-Trimethyl-s-trioxane, 1,3,5-Trimethyl-2,4,6-trioxane, Elaldehyde, Paral, 2,4,6-Trimethyl-1,3,5-trioxacyclohexane.
Can Paraldehyde 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
Paraldehyde is FEMA GRAS under FEMA number 4010. 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 05.053, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (SCF/CoE). The UK retains the same list.
JECFA (WHO / FAO)
Paraldehyde 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.
TSCA Inventory status
A flavor ingredient is also an industrial chemical. Paraldehyde appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 123-63-7, where EPA names it 1,3,5-Trioxane, 2,4,6-trimethyl-.
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 regulatory flags
| Flag | EPA definition | What it obliges |
|---|---|---|
| SP | Indicates a substance that is identified in a proposed Significant New Use Rule. | No significant new use notice yet. Export notification under TSCA section 12(b) already applies, because 40 CFR 721.20 reaches substances named in a proposed rule as well as a final one. Read more |
SP does not establish: A proposed rule may change or may never be finalized. Read the proposal.
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: Sweet, fruity, citrus, green, pungent.
Taste: Sweet, slightly bitter, tangy.
Where it is used
Paraldehyde is used in beverage, flavoring agent, confection and baked goods, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to Paraldehyde by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| Trimethyloxazole | 4394 | 82% | In nature |
| 2,4-Dimethyl-1,3-dioxolane | 4099 | 81% | Not determined |
| Ethyl Acetate | 2414 | 80% | In nature |
| 2,4,5-Trimethyl-delta-3-oxazoline | 3525 | 68% | In nature |
More aldehydes in this index
Nona-2,4,6-trienal · p-Menth-1-en-9-al · trans-2-Hexenal glyceryl acetal · Decanal dimethyl acetal · 2,8-Dithianon-4-ene-4-carboxaldehyde · 4,5-Epoxy-(E)-2-decenal
Paraldehyde FAQ
Is paraldehyde on the FEMA GRAS list?
It is. FEMA number 4010 covers paraldehyde. It is also codified at 21 CFR 172.515.
What is the FEMA number for paraldehyde?
The FEMA number for paraldehyde is 4010 and its CAS registry number is 123-63-7. FEMA files it in the fruity flavor category.
Is paraldehyde approved in the EU?
Paraldehyde is on the EU Union List of flavouring substances as FL 05.053 (Annex I Part A) under Regulation 1334/2008.
What is paraldehyde used for?
Paraldehyde is described as sweet, fruity, citrus, green, pungent. On the palate it is sweet, slightly bitter, tangy. It shows up in beverage, flavoring agent, confection and baked goods.
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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 PARALDEHYDE under CAS 123-63-7 and carries its FEMA number and its 21 CFR citations. 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.