# (+/-)-ethyl 3-hydroxy-2-methylbutyrate

> Source URL: https://additivefacts.com/additives/ethyl-3-hydroxy-2-methylbutyrate
> Markdown URL: https://additivefacts.com/additives/ethyl-3-hydroxy-2-methylbutyrate.md

**Safety rating:** UNKNOWN
**CAS number:** 27372-03-8
**Category:** flavoring
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

(+/-)-Ethyl 3-hydroxy-2-methylbutyrate is a synthetic flavoring compound used to provide fruity and brandy-like taste notes in food and beverage products. It functions as a flavoring agent or adjuvant in various processed foods.

## 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 (+/-)-Ethyl 3-hydroxy-2-methylbutyrate?

(+/-)-Ethyl 3-hydroxy-2-methylbutyrate is a synthetic organic compound classified as a flavoring agent. The chemical name indicates its structure: a methylated butyrate ester with a hydroxyl group at the 3-position. This compound exists as a racemic mixture, meaning it contains equal proportions of two mirror-image molecular forms. It is identified by CAS Number 27372-03-8 in chemical databases.

## Common Uses

This compound is used in the food industry primarily as a flavoring agent and flavor adjuvant. Its sensory profile typically imparts fruity, brandy-like, and slightly sweet characteristics to products. Applications may include:

- Alcoholic beverages and spirits
- Flavored confectionery and candies
- Desserts and baked goods
- Dairy-based products
- Non-alcoholic beverages

The specific concentration and application vary based on desired flavor intensity and regulatory limits in each jurisdiction.

## Safety Assessment

No adverse events have been reported to the FDA regarding this additive, and no recalls involving this compound have been documented in FDA databases. The absence of reported adverse events suggests a safety profile that has not raised concerns in regulatory monitoring systems.

As a flavoring agent, this compound undergoes metabolism similar to other ester compounds in the human body, typically being hydrolyzed into component acids and alcohols. The basic metabolic pathway involves conversion to 3-hydroxy-2-methylbutyric acid and ethanol, both of which are present or formed naturally during normal food metabolism.

Limited toxicological data exists in published literature for this specific compound. Safety evaluation would typically involve assessment of acute toxicity, subchronic effects, and genotoxicity potential, though comprehensive published studies are not readily available in standard food safety databases.

## Regulatory Status

This additive has NOT been granted GRAS (Generally Recognized As Safe) status by the FDA. This designation does not necessarily indicate unsafe use; rather, it indicates that the compound has not completed the formal GRAS notification process or does not have historical common use in food prior to 1958 that would establish its safety through traditional use.

The regulatory status varies by region:

- In the United States, it may be used under FDA regulations for flavoring substances if it complies with 21 CFR Part 182 or other applicable regulations
- Regulatory acceptance in other jurisdictions (EU, Japan, etc.) should be verified independently
- Some regions maintain positive lists specifying which flavorings are permitted; inclusion status varies

Manufacturers using this ingredient should verify compliance with current regulations in their target markets, as flavoring regulations are subject to periodic review and updates.

## Key Studies

Published scientific literature specifically examining (+/-)-ethyl 3-hydroxy-2-methylbutyrate is limited. Most available safety information derives from:

- General toxicological data on similar ester compounds
- Structure-activity relationship assessments for flavoring compounds
- Regulatory historical reviews by food safety authorities

The compound's metabolism would likely follow standard ester hydrolysis patterns observed with similar compounds. Additional toxicological studies may exist in proprietary manufacturer files or regulatory submissions not publicly available. Researchers and manufacturers with specific safety questions should consult:

- FDA flavoring regulations and guidance documents
- FEMA (Flavor and Extract Manufacturers Association) GRAS lists and assessments
- International flavor and fragrance safety databases
- Original regulatory approval documentation in relevant jurisdictions

## 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. "(+/-)-ethyl 3-hydroxy-2-methylbutyrate — Safety, regulation, and evidence." https://additivefacts.com/additives/ethyl-3-hydroxy-2-methylbutyrate. Accessed 2026-05-19.