# Dodecyl Gallate (E312)

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**Safety rating:** SAFE
**E-number:** E312
**CAS number:** 1166-52-5
**Category:** antioxidant
**FDA GRAS:** yes
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

Dodecyl gallate is a synthetic antioxidant compound derived from gallic acid that prevents oxidation and spoilage in processed foods. It is approved as a food additive by the FDA and used to extend shelf life in various food products containing oils and fats.

## 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 Dodecyl Gallate?

Dodecyl gallate (CAS Number: 1166-52-5) is a synthetic antioxidant belonging to the gallate family of compounds. It consists of gallic acid esterified with a twelve-carbon (dodecyl) alkyl chain. This chemical structure allows dodecyl gallate to be lipophilic, meaning it dissolves readily in fats and oils, making it particularly effective at preventing oxidative degradation in fatty food systems.

## Common Uses

Dodecyl gallate is primarily used in foods containing fats and oils where oxidation can lead to rancidity and quality deterioration. Common applications include:

- Edible oils and shortenings
- Processed meat products
- Snack foods and chips
- Baked goods and mixes
- Nuts and nut butters
- Dried fruits
- Candy and confectionery products

The additive works by donating hydrogen atoms to free radicals formed during oxidation, thereby interrupting the chain reaction that leads to fat degradation. This extends product shelf life and maintains sensory quality without refrigeration.

## Safety Assessment

Dodecyl gallate has an established safety record in food applications. According to FDA records, there have been zero adverse events reported in connection with this additive, and zero product recalls have been attributed to dodecyl gallate exposure. The FDA classifies dodecyl gallate as Generally Recognized As Safe (GRAS), indicating that the additive meets established safety standards for food use.

Toxicological studies on gallate esters, including dodecyl gallate, have not identified significant safety concerns at levels used in food. The compound is metabolized relatively quickly in the body and does not bioaccumulate. Like other food additives in the gallate family, dodecyl gallate undergoes esterase-mediated hydrolysis in the gastrointestinal tract, breaking down into gallic acid and the dodecyl alcohol component.

Some regulatory jurisdictions, including the European Union, permit gallate antioxidants with specific usage restrictions and maximum residue levels. The acceptable daily intake (ADI) for gallate antioxidants collectively has been established by food safety authorities based on animal studies and epidemiological data.

## Regulatory Status

In the United States, dodecyl gallate is approved as a food additive under 21 CFR 182.3555 for use in foods containing fat or oil. The FDA permits its use at levels not to exceed 0.02 percent (200 ppm) in the finished food product. This regulation ensures that additive levels remain below amounts shown to cause any adverse effects in safety studies.

The European Union permits gallate antioxidants (E310-E312) under Regulation (EC) No 1333/2008, though with specific restrictions on food categories and maximum levels. Other countries including Canada, Japan, and Australia similarly recognize the safety of gallate antioxidants when used in accordance with prescribed limits.

## Key Studies

Toxicological evaluations of gallate antioxidants have included acute toxicity studies, subchronic feeding studies in rats and dogs, and genetic toxicity assessments. These studies, conducted over several decades, have consistently demonstrated that dodecyl gallate and related compounds do not present significant health risks at food-use levels.

Research on antioxidant efficacy demonstrates that dodecyl gallate effectively prevents lipid oxidation in various food matrices, with particular effectiveness in oily systems due to its lipophilic nature. Comparative studies show it performs similarly to other permitted gallate antioxidants while offering advantages in certain applications due to its chemical properties.

## 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. "Dodecyl Gallate (E312) — Safety, regulation, and evidence." https://additivefacts.com/additives/dodecyl-gallate. Accessed 2026-05-11.