Our Verdict: SAFE

Ascorbyl Palmitate

E-numberE304CAS137-66-6FDA GRAS

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Ascorbyl Palmitate — food additive

Ascorbyl palmitate is a fat-soluble derivative of vitamin C used as an antioxidant in food products. It prevents oxidation and rancidity in oils, fats, and fatty foods by neutralizing free radicals.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is Ascorbyl Palmitate?

Ascorbyl palmitate (CAS Number 137-66-6) is a synthetic compound created by combining ascorbic acid (vitamin C) with palmitic acid, a saturated fatty acid. This modification makes vitamin C soluble in fats and oils, allowing it to function as an antioxidant in lipid-rich food environments where water-soluble vitamin C would be ineffective. The compound appears as a white to off-white powder with a slightly fatty appearance.

Common Uses

Ascorbyl palmitate is primarily used in processed foods containing fats and oils. Common applications include:

- Vegetable oils and margarine

- Meat and poultry products

- Baked goods and cereals

- Snack foods and nuts

- Dairy products

- Supplements and fortified foods

The additive extends shelf life by preventing lipid oxidation, which causes rancidity, off-flavors, and nutritional degradation. It works synergistically with other antioxidants like vitamin E and BHA/BHT to protect food quality during storage and distribution.

Safety Assessment

Ascorbyl palmitate has an established safety profile supported by regulatory approval and scientific evidence. The FDA recognizes it as Generally Recognized As Safe (GRAS), indicating it is safe for its intended use in food. The FDA database contains zero reported adverse events associated with ascorbyl palmitate and zero product recalls linked to this ingredient.

The European Food Safety Authority (EFSA) evaluated ascorbyl palmitate and established an Acceptable Daily Intake (ADI) of 5 mg/kg body weight per day. Toxicological studies in laboratory animals showed no concerning effects at high doses. The compound is metabolized similarly to vitamin C and palmitic acid when ingested, breaking down into recognized nutritional components.

Since ascorbyl palmitate is derived from vitamin C, consumers may wonder about excessive intake. However, the levels used in food preservation are minimal—typically 0.02% or less of product weight—and pose no risk of hypervitaminosis from food sources alone.

Regulatory Status

Ascorbyl palmitate is approved for use in numerous countries:

- **United States**: FDA GRAS status; approved for use in various food categories

- **European Union**: Authorized as food additive E304 with specific usage limits

- **Australia/New Zealand**: Listed as approved food additive

- **Canada**: Permitted food additive with specified maximum levels

- **Japan**: Approved for use in food preservation

Regulatory agencies specify maximum usage levels to ensure it is used only where functionally necessary. These limits vary by food category but are consistently set well below levels that would pose safety concerns.

Key Studies

Scientific research supports the safety of ascorbyl palmitate:

- **Toxicology Studies**: Animal feeding studies demonstrated no adverse effects at doses substantially higher than potential dietary exposure.

- **Stability Data**: Research confirms ascorbyl palmitate effectively prevents oxidation in various food matrices over extended shelf life.

- **Metabolic Studies**: Upon ingestion, the compound hydrolyzes into ascorbic acid and palmitic acid, both normal dietary components with established metabolic pathways.

- **Long-term Use**: Decades of safe use in the global food supply provide additional evidence of safety.

The scientific consensus supports ascorbyl palmitate as a safe and effective food preservation tool when used according to regulatory specifications.

Frequently Asked Questions

What is Ascorbyl Palmitate?

Ascorbyl palmitate is a fat-soluble derivative of vitamin C used as an antioxidant in food products. It prevents oxidation and rancidity in oils, fats, and fatty foods by neutralizing free radicals.

Is Ascorbyl Palmitate safe?

Ascorbyl Palmitate is currently rated "safe" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Ascorbyl Palmitate banned in any country?

Ascorbyl Palmitate is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.