# Hydroxynonanoic Acid, Delta-lactone

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**Safety rating:** UNKNOWN
**CAS number:** 3301-94-8
**Category:** flavoring
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

Hydroxynonanoic acid, delta-lactone (CAS 3301-94-8) is a synthetic flavoring compound used to impart fruity and coconut-like notes in food products. It functions as a flavoring agent or adjuvant in the food industry.

## Regulatory status

| Country | Status |
| --- | --- |
| United States | approved |
| European Union | not_evaluated |
| United Kingdom | not_evaluated |
| Canada | not_evaluated |
| Australia | not_evaluated |
| Japan | not_evaluated |
| South Korea | not_evaluated |
| Brazil | not_evaluated |
| China | not_evaluated |
| India | not_evaluated |

## Detailed analysis

## What is Hydroxynonanoic Acid, Delta-lactone?

Hydroxynonanoic acid, delta-lactone is a synthetic organic compound classified as a lactone—a cyclic ester formed from hydroxy acids. This particular compound is derived from a nine-carbon chain with hydroxyl and carboxylic acid functional groups that cyclize to form the lactone ring structure. The chemical structure gives it characteristic fruity and coconut-like aromatic properties, making it valuable in flavor chemistry. CAS Number 3301-94-8 serves as its unique chemical identifier in regulatory and scientific databases.

## Common Uses

This flavoring agent is used primarily in processed foods and beverages where fruity or coconut flavor profiles are desired. Applications include:

- Flavored beverages and soft drinks
- Dairy products such as yogurts and flavored milk
- Confectionery and candy formulations
- Baked goods and snack foods
- Ice cream and frozen desserts
- Flavorings used in food manufacturing

Typically used in very small quantities, hydroxynonanoic acid, delta-lactone concentrates the flavor impact while minimizing ingredient lists in finished products. The exact usage levels vary by food category and desired flavor intensity.

## Safety Assessment

Hydroxynonanoic acid, delta-lactone currently does not hold FDA GRAS (Generally Recognized As Safe) status, meaning it has not undergone the standard GRAS notification process or formal FDA approval. However, this does not indicate the substance is unsafe—rather, it reflects that formal safety documentation and approval through FDA channels has not been completed or submitted.

Key safety indicators include:

- **Adverse Events**: Zero reported adverse events associated with this additive in FDA databases
- **Recalls**: No food recalls involving this ingredient have been documented by the FDA
- **Toxicology**: Limited but available safety data suggests low systemic toxicity at exposure levels relevant to food flavoring use

As a lactone compound, hydroxynonanoic acid, delta-lactone shares structural similarities with naturally occurring lactones found in foods such as fruits, dairy products, and fermented foods. This structural relationship provides some basis for safety assessment, though each compound must be evaluated individually.

## Regulatory Status

In the United States, this compound is not approved as a direct food additive under FDA regulations and does not hold GRAS status. This means it cannot be legally added to food products marketed in the U.S. without prior FDA approval or a successful GRAS petition.

Regulatory status varies internationally:
- **European Union**: The compound is not listed in the EU's approved flavoring substances database
- **Other Countries**: Approval status varies by jurisdiction and should be verified with local regulatory authorities

Manufacturers interested in using this flavoring would need to submit appropriate safety documentation to the FDA or relevant regulatory bodies in their target markets before commercialization.

## Key Studies

Limited published scientific literature is available specifically for hydroxynonanoic acid, delta-lactone. Existing safety information relies on:

- General toxicology data for similar lactone compounds
- In vitro and animal model studies examining metabolic fate and toxicity profiles
- Structural similarity assessments with established safe flavoring compounds
- Absence of epidemiological evidence of harm

The lack of reported adverse events and recalls suggests no widespread safety concerns have emerged from any use or exposure to this compound. However, the limited GRAS status indicates that comprehensive safety dossiers required for formal FDA approval have not been submitted or completed.

Researchers and manufacturers with safety data on this compound are encouraged to engage with FDA's flavor petition process if they wish to establish its safety profile for food use in the United States.

## Sources

- FDA Substances Added to Food (CFSAN)
- OpenFDA Adverse Event Reporting System (AERS)
- OpenFDA Food Recalls
- EFSA OpenFoodTox
- EU Food Additive Portal

## Citation

Additive Facts. "Hydroxynonanoic Acid, Delta-lactone — Safety, regulation, and evidence." https://additivefacts.com/additives/hydroxynonanoic-acid-delta-lactone. Accessed 2026-05-12.