# Levulinic Acid

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**Safety rating:** UNKNOWN
**CAS number:** 123-76-2
**Category:** flavoring
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

Levulinic acid is an organic compound classified as a flavor enhancer and flavoring agent. It is not currently approved as a food additive by the FDA and remains largely experimental in food applications, with potential use in developing novel flavoring systems.

## 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 Levulinic Acid?

Levulinic acid (also known as 4-oxopentanoic acid) is an organic compound with the chemical formula C₅H₈O₃ and CAS number 123-76-2. It is a naturally occurring keto acid that can be found in small quantities in certain foods and beverages, particularly those that have undergone heat treatment or fermentation. The compound exists as a colorless to pale yellow liquid with a characteristic acidic profile.

Levulinic acid has generated scientific interest in recent years as a platform chemical with potential applications in food flavoring, largely due to its ability to be derived from cellulose and other biomass sources through biochemical conversion processes.

## Common Uses

Levulinic acid is not currently approved for use as a food additive in the United States, European Union, or most other major regulatory jurisdictions. Its applications remain primarily in research and development contexts. When studied, potential uses have focused on:

- Flavor enhancement and development in processed foods
- Component in experimental flavoring formulations
- Research applications in food chemistry and flavor science
- Potential precursor in the synthesis of other flavoring compounds

Because it is not approved for food use in major markets, levulinic acid is not present in commercially available consumer food products in the United States or EU.

## Safety Assessment

The safety profile of levulinic acid for food use remains underdeveloped relative to approved food additives. The FDA has received zero adverse event reports and zero recall reports associated with this substance, though this likely reflects minimal food exposure rather than comprehensive safety data.

Levulinic acid has not undergone the formal safety evaluation processes required for GRAS (Generally Recognized As Safe) status with the FDA. This means either that a formal petition has not been submitted, or that submitted petitions have not been granted GRAS determination.

Limited toxicological data exists in the scientific literature. Some research has examined levulinic acid in non-food contexts, including its potential industrial and pharmaceutical applications, but comprehensive food safety studies specifically evaluating acceptable daily intake levels, genotoxicity, and long-term effects in humans have not been published in mainstream peer-reviewed literature.

The European Food Safety Authority (EFSA) has not established a safety evaluation for levulinic acid as a food additive, and it does not appear on the EU's list of approved flavoring agents.

## Regulatory Status

Levulinic acid is not approved for food use in the United States under FDA regulations. It does not have GRAS status, meaning it cannot be legally added to foods marketed in the U.S. without prior FDA approval through the food additive petition process.

Within the European Union, levulinic acid is not listed among the approved flavoring substances in Regulation (EC) No 1334/2008, making it unavailable for legal use in food products marketed in EU member states.

No other major food regulatory jurisdictions, including Health Canada, Food Standards Australia New Zealand (FSANZ), or Japan's Ministry of Health, Labour and Welfare, have approved this substance for food applications.

The compound is commercially available for industrial, research, and non-food applications.

## Key Studies

Peer-reviewed research specifically addressing levulinic acid's safety for food use is limited. Published studies have primarily focused on:

- Levulinic acid as a platform chemical derived from biomass conversion
- Synthetic and chemical properties of the compound
- Non-food industrial applications and potential pharmaceutical uses
- Detection of levulinic acid as a naturally occurring compound in foods subjected to heating

The absence of published toxicological studies specifically evaluating this substance for food safety purposes contributes to the lack of regulatory approval in major markets. Interested parties seeking to bring levulinic acid to market as a food additive would need to commission comprehensive safety studies meeting FDA or EFSA requirements.

## 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. "Levulinic Acid — Safety, regulation, and evidence." https://additivefacts.com/additives/levulinic-acid. Accessed 2026-05-19.