# 3,4-xylenol

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> Markdown URL: https://additivefacts.com/additives/3-4-xylenol.md

**Safety rating:** UNKNOWN
**CAS number:** 95-65-8
**Category:** flavoring
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-04

## Summary

3,4-xylenol (CAS 95-65-8) is an organic compound used as a flavoring agent in food products. It is not affirmed as Generally Recognized As Safe (GRAS) by the FDA, though it has no reported adverse events or recalls associated with its use.

## Regulatory status

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

## Detailed analysis

## What is 3,4-xylenol?

3,4-xylenol is an organic chemical compound with the CAS number 95-65-8. It is a methylated phenol (a dimethyl-substituted phenol) belonging to the xylenol family of compounds. In its pure form, 3,4-xylenol exists as a white to pale crystalline solid. The compound has the molecular formula C8H10O and contains two methyl groups attached to a benzene ring with a hydroxyl group.

## Common Uses

3,4-xylenol is used in the food industry as a flavoring agent or flavoring adjuvant. Flavoring agents are substances added to foods and beverages to impart or enhance taste and aroma characteristics. As a xylenol derivative, it may contribute specific aromatic or phenolic notes to food products, though specific applications remain limited in commercial food manufacturing.

Like other flavoring compounds, 3,4-xylenol would typically be used in very small quantities, as flavoring agents are potency compounds requiring only trace amounts to achieve desired sensory effects.

## Safety Assessment

The available safety data for 3,4-xylenol in food use is limited. The FDA has not affirmed this compound as Generally Recognized As Safe (GRAS), meaning it has not undergone the formal GRAS notification process or been included in the GRAS list for food use. This status does not inherently indicate safety concerns but rather reflects the absence of formal FDA approval through either GRAS notification or Food Additive Petition procedures.

No adverse events have been reported to the FDA related to 3,4-xylenol, and there have been no product recalls associated with this additive. These facts suggest no documented safety incidents in the United States food supply.

Toxicological data on 3,4-xylenol is relatively sparse compared to widely used food additives. Xylenols in general have been studied to varying degrees, but comprehensive safety assessments specific to 3,4-xylenol's food use are not readily available in published literature. The compound's status outside the GRAS framework means it would require specific authorization or petition for use in food products in the United States.

## Regulatory Status

In the United States, 3,4-xylenol is not on the FDA's GRAS list for food use. This means that any manufacturer wishing to use it as a food additive would need to submit a Food Additive Petition to the FDA or provide a GRAS notification letter demonstrating that the substance is generally recognized as safe by qualified experts.

The regulatory status varies internationally. Some other countries may permit this compound under different regulatory frameworks, though comprehensive global regulatory information would require consultation of individual country food additive databases.

The lack of GRAS status, combined with limited documented use in food manufacturing, suggests that 3,4-xylenol remains an uncommon food additive in commercial applications.

## Key Studies

Limited peer-reviewed studies specifically examining 3,4-xylenol's safety in food applications are readily available. Broader research on xylenol compounds exists in toxicology and chemical literature, but comprehensive safety dossiers for food use approval of this specific isomer do not appear to be published in mainstream databases.

Any manufacturer considering use of this additive would need to generate or compile safety data demonstrating its safety at intended use levels, including absorption, distribution, metabolism, and excretion data, as well as potential toxicity studies.

## 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. "3,4-xylenol — Safety, regulation, and evidence." https://additivefacts.com/additives/3-4-xylenol. Accessed 2026-05-20.