Flavor ingredient regulatory record
5-Hydroxy-8-undecenoic acid delta-lactone
5-Hydroxy-8-undecenoic acid delta-lactone is a lactone in the fruity family, FEMA GRAS under FEMA number 3758 (CAS 68959-28-4). Its odor is sweet, fruity, creamy, floral.
- FEMA
- 3758
- CAS
- 68959-28-4
- JECFA
- 248
- EU FL
- 10.035
- Formula
- C11H18O2
- EC
- 273-411-8
GRAS status: FEMA GRAS, publication 15. Recorded by FDA in the Substances Added to Food inventory under CAS 68959-28-4.
Structure
Identity
Also known as: 2H-Pyran-2-one, 6-(3Z)-3-hexen-1-yltetrahydro-, 2H-Pyran-2-one, 6-(3-hexenyl)tetrahydro-, (Z)-, 2H-Pyran-2-one, 6-(3Z)-3-hexenyltetrahydro-, 6-(3Z)-3-Hexen-1-yltetrahydro-2H-pyran-2-one, (z)-6-(3-hexenyl)tetrahydro-2h-pyran-2-one, 5-hydroxy-cis-8-undecenoic acid lactone, 2h-pyran-2-one, 6-(3z)-3-hexenyltetrahydro-, 6-(3-hexenyl)tetrahydro-2h-pyran-2-one, (z)-, 2h-pyran-2-one, 6-(3-hexenyl)tetrahydro-, (z)-, 2h-pyran-2-one, 6-(3z)-3-hexen-1-yltetrahydro-, 5-hydroxy-8-undecenoic acid delta-lactone, (8z)-, (z)-6-(hex-3-en-1-yl)tetrahydro-2h-pyran-2-one.
Can 5-Hydroxy-8-undecenoic acid delta-lactone be labeled natural?
Since 5-Hydroxy-8-undecenoic acid delta-lactone is found in nature, US labeling follows how it was obtained: natural flavor from a natural source and a natural process, artificial when 5-Hydroxy-8-undecenoic acid delta-lactone is synthesized. 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
5-Hydroxy-8-undecenoic acid delta-lactone is FEMA GRAS under FEMA number 3758. 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 10.035, Annex I Part A under Regulation (EC) 1334/2008, evaluation status approved (JECFA). The UK retains the same list.
JECFA (WHO / FAO)
JECFA number 248, evaluated at the 49th meeting in 1997. 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. 5-Hydroxy-8-undecenoic acid delta-lactone appears on the EPA Toxic Substances Control Act Chemical Substance Inventory under CAS 68959-28-4, where EPA names it 2H-Pyran-2-one, 6-(3Z)-3-hexen-1-yltetrahydro-.
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: Sweet, fruity, creamy, floral.
Where it is used
5-Hydroxy-8-undecenoic acid delta-lactone is used in beverage, confection, fruit flavors, dairy and bakery, typically as a fruity note.
Structurally similar flavor ingredients
Flavor ingredients with a GRAS determination closest to 5-Hydroxy-8-undecenoic acid delta-lactone by structure. Whether one can replace it is a sensory and regulatory call; the reformulation tool works that through.
| Material | FEMA | Similarity | Occurrence |
|---|---|---|---|
| 5&6-Decenoic acid | 3742 | 85% | In nature |
| gamma-Decalactone | 2360 | 84% | In nature |
| 2,4-Hexadienyl propionate | 4131 | 83% | Not determined |
| 5-Hydroxyundecanoic acid lactone | 3294 | 81% | In nature |
| delta-Decalactone | 2361 | 78% | In nature |
More lactones in this index
4-Hydroxy-3-methyloctanoic acid gamma-lactone · 4-Hydroxybutyric acid lactone · epsilon-Decalactone · Phthalide · Dihydrocoumarin · Hydroxynonanoic acid delta-lactone
5-Hydroxy-8-undecenoic acid delta-lactone FAQ
Is 5-Hydroxy-8-undecenoic acid delta-lactone on the FEMA GRAS list?
It is. FEMA number 3758 covers 5-Hydroxy-8-undecenoic acid delta-lactone. It is also codified at 21 CFR 172.515.
What is the FEMA number for 5-Hydroxy-8-undecenoic acid delta-lactone?
The FEMA number for 5-Hydroxy-8-undecenoic acid delta-lactone is 3758 and its CAS registry number is 68959-28-4. FEMA files it in the fruity flavor category.
Is 5-Hydroxy-8-undecenoic acid delta-lactone natural or artificial?
5-Hydroxy-8-undecenoic acid delta-lactone occurs in nature, so the label depends on the route: 5-Hydroxy-8-undecenoic acid delta-lactone won from a natural source by a physical, enzymatic or microbiological process is natural flavor in the United States, and synthesized 5-Hydroxy-8-undecenoic acid delta-lactone is artificial. In the EU and UK the natural claim likewise needs the natural route, while Mercosur and Mexico keep a third class, identical-to-natural, for the synthetic material.
Is 5-Hydroxy-8-undecenoic acid delta-lactone approved in the EU?
5-Hydroxy-8-undecenoic acid delta-lactone is on the EU Union List of flavouring substances as FL 10.035 (Annex I Part A) under Regulation 1334/2008.
Has JECFA evaluated 5-Hydroxy-8-undecenoic acid delta-lactone?
Yes. JECFA number 248, evaluated at the 49th meeting in 1997. Conclusion: No safety concern at current levels of intake when used as a flavouring agent.
What is 5-Hydroxy-8-undecenoic acid delta-lactone used for?
5-Hydroxy-8-undecenoic acid delta-lactone is described as sweet, fruity, creamy, floral. It shows up in beverage, confection, fruit flavors, dairy and bakery.
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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 5-HYDROXY-8-UNDECENOIC ACID DELTA-LACTONE under CAS 68959-28-4 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.