Our Verdict: USE WITH CAUTION

Canthaxanthin

E-numberE161gCAS514-78-3

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

Canthaxanthin — food additive

Canthaxanthin is a carotenoid pigment used as a food colorant to impart red-orange hues to various food products. It is not approved by the FDA as a food additive but is permitted in certain applications in other regulatory jurisdictions.

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
Not EvaluatedUK FSA
Canada
Not EvaluatedHealth Canada
Australia
Not EvaluatedFSANZ
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 Canthaxanthin?

Canthaxanthin (CAS Number 514-78-3) is a naturally occurring carotenoid pigment belonging to the xanthophyll family of compounds. It is characterized by a red-orange color and is found in some algae, crustaceans, and other organisms in nature. Chemically, canthaxanthin is a keto-carotenoid with the molecular formula C40H52O2. The compound can be synthesized chemically or derived from natural sources for use as a food colorant.

Common Uses

Canthaxanthin is primarily used as a coloring agent in food products where a red to orange hue is desired. Its applications have historically included coloring in aquaculture feeds (particularly for farmed salmon and trout) to enhance the flesh color of the fish. In some jurisdictions, it has been used in food products such as certain beverages, dairy products, and processed foods to achieve desired color characteristics. The pigment's stability and intensity make it valuable in food manufacturing, though its approved uses vary significantly by region and regulatory authority.

Safety Assessment

The safety profile of canthaxanthin as a food additive has been evaluated by multiple regulatory bodies with varying conclusions. In the United States, the FDA has not approved canthaxanthin as a direct food additive, meaning it cannot be intentionally added to human food. However, the FDA has recorded zero adverse events and zero recalls associated with canthaxanthin, indicating no documented safety incidents in the U.S. market.

The European Food Safety Authority (EFSA) has assessed canthaxanthin and established conditions for its use, including specified maximum levels in certain feed applications and food products. The EFSA's evaluations have examined absorption, metabolism, and potential systemic effects, with particular attention given to studies on ocular and dermatological effects from high-level exposure.

Toxicological studies have been conducted to evaluate canthaxanthin's safety profile. Most research has focused on oral administration in animal models and has not identified significant acute toxicity at typical exposure levels. However, some studies examining very high doses or specific exposure scenarios have noted potential concerns that warrant consideration, particularly regarding long-term high-level consumption.

Regulatory Status

Canthaxanthin's regulatory status is complex and varies by country and application. In the United States, it is not approved as a food additive for human consumption. The FDA maintains this restriction despite canthaxanthin being used in other countries and in animal feed applications in some jurisdictions.

In the European Union, canthaxanthin is authorized as a food colorant (E161g) but with specific limitations on use and maximum levels depending on the food category. It is permitted in certain cheeses, margarines, and other products under defined conditions.

Canada, Australia, and other countries have their own approval determinations for canthaxanthin use in foods. Internationally, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) has evaluated canthaxanthin, though it has not been assigned an Acceptable Daily Intake (ADI) in some cases due to insufficient data or specific concerns raised in evaluations.

Key Studies

Research on canthaxanthin has examined its bioavailability, metabolism, and potential health effects. Studies have investigated how canthaxanthin is absorbed and processed in the human body, with findings indicating it accumulates in certain tissues including the skin and eyes. Some research has examined potential effects on vision and skin health following high-level exposure, though results vary and the relevance to typical food consumption levels remains under discussion among experts. The lack of approval in major markets like the United States reflects regulatory caution regarding long-term safety data at food-relevant exposure levels.

Frequently Asked Questions

What is Canthaxanthin?

Canthaxanthin is a carotenoid pigment used as a food colorant to impart red-orange hues to various food products. It is not approved by the FDA as a food additive but is permitted in certain applications in other regulatory jurisdictions.

Is Canthaxanthin safe?

Canthaxanthin 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 Canthaxanthin banned in any country?

Canthaxanthin 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.