# Octyl Gallate (E311)

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**Safety rating:** SAFE
**E-number:** E311
**CAS number:** 1034-01-1
**Category:** antioxidant
**FDA GRAS:** yes
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

Octyl gallate is a synthetic antioxidant derived from gallic acid, used in food products to prevent oxidation and extend shelf life. It is approved as safe by the FDA and classified as Generally Recognized As Safe (GRAS).

## 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 Octyl Gallate?

Octyl gallate (CAS Number: 1034-01-1) is a synthetic antioxidant compound belonging to the gallic acid ester family. It is produced through the esterification of gallic acid with octanol. As an antioxidant, octyl gallate functions by donating electrons to unstable free radicals, preventing them from damaging food components and causing rancidity, discoloration, or flavor degradation. The compound is a white to off-white crystalline powder with limited water solubility, making it suitable for application in fatty or oily food systems.

## Common Uses

Octyl gallate is primarily used in processed foods that are susceptible to oxidative spoilage. Common applications include edible oils, shortening, margarine, and fat-based products. It is also used in certain baked goods, snack foods, and meat products where fat preservation is critical. The additive is typically used at levels ranging from 0.02% to 0.1% by weight of the fat content, depending on the specific product and storage conditions. Octyl gallate is often used alongside other antioxidants such as butylated hydroxyanisole (BHA) or butylated hydroxytoluene (BHT) to achieve synergistic preservation effects.

## Safety Assessment

Octyl gallate has been extensively studied for safety in both animal models and human consumption. The FDA granted GRAS (Generally Recognized As Safe) status to octyl gallate, indicating that qualified experts consensus it to be safe for use in food. According to FDA records, there are zero adverse events associated with octyl gallate and zero product recalls linked to this additive. Toxicological studies have examined various safety parameters including acute toxicity, subchronic toxicity, and mutagenicity. These studies have not identified significant concerns at approved usage levels.

The European Food Safety Authority (EFSA) has also evaluated gallate esters, including octyl gallate, and established acceptable daily intake (ADI) values. In the European Union, octyl gallate is approved as a food additive under the designation E311. Absorption studies indicate that octyl gallate is poorly absorbed in the gastrointestinal tract and is largely excreted unchanged or as metabolites.

## Regulatory Status

In the United States, octyl gallate is recognized as GRAS under 21 CFR 182.3866 for use as an antioxidant in food. The FDA does not require pre-market approval for GRAS substances, though manufacturers must maintain substantiation for the GRAS determination. In the European Union, octyl gallate is approved as E311 and is listed in Annex II of Regulation (EC) No 1333/2008 on food additives. Various other countries including Canada, Australia, and Japan permit the use of octyl gallate as a food additive under their respective regulatory frameworks. Usage levels are typically capped at specific percentages of fat content to ensure safe consumption levels.

## Key Studies

Long-term toxicological studies conducted on octyl gallate and related gallate esters have established safety profiles at levels well above typical food use concentrations. Animal studies using rats and mice at high doses have not revealed carcinogenic, mutagenic, or teratogenic effects. Absorption and metabolism studies demonstrate that the compound is efficiently eliminated from the body without accumulation in tissues. The antioxidant efficacy of octyl gallate has been documented in multiple food preservation studies, confirming its effectiveness in preventing lipid oxidation in various fat-based food matrices. No peer-reviewed scientific literature identifies significant human health concerns associated with octyl gallate at permitted food additive levels.

## 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. "Octyl Gallate (E311) — Safety, regulation, and evidence." https://additivefacts.com/additives/octyl-gallate. Accessed 2026-05-12.