Our Verdict: USE WITH CAUTION

Ethoxyquin

CAS91-53-2

Some regulatory concerns have been raised

This additive has been flagged by at least one major regulatory agency or peer-reviewed study. Review the evidence below before forming conclusions.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Ethoxyquin — food additive

Ethoxyquin is a synthetic antioxidant used primarily in animal feed and some food applications to prevent fat oxidation and maintain nutritional quality. It is not approved as a food additive in the European Union and has limited approval in the United States.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

Banned in 2 jurisdictionsRestricted in 1 jurisdiction
United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
BannedUK FSA
Canada
RestrictedHealth Canada
Australia
BannedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
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 Ethoxyquin?

Ethoxyquin (6-ethoxy-1,2-dihydro-2,2,4-trimethylquinoline) is a synthetic antioxidant compound identified by CAS number 91-53-2. It functions by inhibiting lipid peroxidation and preventing the degradation of fats and fat-soluble vitamins. The compound was first synthesized in the 1950s and has been used in various industrial and agricultural applications for over 60 years.

Common Uses

Ethoxyquin is primarily used as a preservative in animal feed, particularly in pet food formulations and aquaculture feed, where it protects fish meals and other fat-containing ingredients from rancidity. Its application in direct human food consumption is limited in most regulatory jurisdictions. The additive is valued in animal feed because it effectively prevents oxidative degradation during storage, which can extend shelf life and maintain nutritional integrity of feed products. It has also historically been used in spice preservation and certain cosmetic applications.

Safety Assessment

Ethoxyquin has generated scientific discussion regarding its safety profile. The FDA has not designated ethoxyquin as GRAS (Generally Recognized as Safe) for use in human food, though it permits its use in animal feed at specified levels. The compound has not been associated with reported adverse events in the FDA adverse event database, nor has it been subject to FDA recalls.

Toxicological studies on ethoxyquin have examined potential effects on liver function, reproductive health, and long-term consumption patterns. Some studies in animal models have suggested potential concerns at high doses, though the relevance of these findings to human exposure at typical dietary levels remains debated within the scientific community. The European Food Safety Authority (EFSA) has not approved ethoxyquin for use in the European Union, reflecting a more restrictive regulatory approach in that jurisdiction.

Research on ethoxyquin metabolism indicates the compound is absorbed and metabolized relatively quickly, with limited accumulation in tissues under normal exposure conditions. However, the EFSA's decision to restrict its use reflects concerns about adequately characterizing its long-term safety profile.

Regulatory Status

Regulatory approval for ethoxyquin varies significantly by region. In the United States, the FDA permits ethoxyquin in animal feed at maximum levels of 150 mg/kg. In the European Union, ethoxyquin is not approved for use as a food additive for human consumption, and its use in animal feed has also been restricted or prohibited. Canada permits use in animal feeds within defined limits. This divergence in regulatory approaches reflects different risk assessment philosophies and data interpretation standards among regulatory bodies.

The lack of GRAS status in the United States for human food applications indicates the FDA requires more comprehensive safety data or has identified insufficient evidence to classify it as recognized as safe by qualified experts.

Key Studies

Scientific literature on ethoxyquin includes studies examining its antioxidant efficacy, toxicological profiles, and metabolic fate. Research has demonstrated its effectiveness in preventing lipid oxidation in feed applications. Toxicological investigations have evaluated potential hepatic effects, reproductive endpoints, and genotoxicity. The variation in regulatory decisions suggests ongoing scientific discussion about data interpretation and acceptable safety margins for this compound.

Frequently Asked Questions

What is Ethoxyquin?

Ethoxyquin is a synthetic antioxidant used primarily in animal feed and some food applications to prevent fat oxidation and maintain nutritional quality. It is not approved as a food additive in the European Union and has limited approval in the United States.

Is Ethoxyquin safe?

Ethoxyquin is currently rated "caution" 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 Ethoxyquin banned in any country?

Ethoxyquin 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.