Our Verdict: RATING UNKNOWN

Trans-anethole

CAS4180-23-8

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Trans-anethole — food additive

Trans-anethole is a naturally occurring organic compound that provides a distinctive licorice or anise-like flavor to foods and beverages. It is commonly used as a flavoring agent in confectionery, beverages, and other food products where an anise taste is desired.

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 Trans-anethole?

Trans-anethole (CAS Number: 4180-23-8) is an organic compound belonging to the class of phenylpropenes. It is the primary active compound responsible for the characteristic licorice or anise flavor found in anise seeds, fennel, and star anise. Trans-anethole exists naturally in these plant sources and can also be synthesized chemically for use as a food flavoring agent. The compound is a colorless to pale yellow liquid with a strong aromatic profile.

Common Uses

Trans-anethole is utilized as a flavoring agent in various food and beverage applications. Common uses include:

- Confectionery products such as candies and licorice

- Alcoholic beverages, particularly anise-flavored spirits like ouzo, pastis, and sambuca

- Non-alcoholic beverages and syrups

- Baked goods and desserts

- Chewing gum and other flavored products

The compound is valued by food manufacturers for delivering authentic anise and licorice flavors without relying solely on whole plant materials. Typical usage levels are relatively low, as trans-anethole is highly potent and provides significant flavor impact at small concentrations.

Safety Assessment

Trans-anethole has been studied for potential health effects, though comprehensive toxicological data remains limited. The FDA has not designated this additive as Generally Recognized As Safe (GRAS) for all food applications, indicating that formal safety approval through the standard GRAS process has not been completed in the United States.

However, the absence of FDA GRAS status should be distinguished from a safety determination. The European Food Safety Authority (EFSA) has evaluated trans-anethole and similar compounds from anise and fennel sources. In natural sources, trans-anethole is consumed at levels considered safe by regulatory agencies.

Available toxicological studies on trans-anethole in laboratory animals have not identified significant acute toxicity concerns at dietary exposure levels. The compound has been evaluated for potential estrogenic activity based on its chemical structure, though results from available studies suggest it does not pose significant endocrine disruption concerns at typical food flavoring use levels.

The FDA Adverse Events Reporting System (FAERS) contains zero reported adverse events associated with trans-anethole, and there have been no FDA-initiated recalls involving this compound. This record indicates that at current usage levels in food products, no widespread safety concerns have been documented.

Regulatory Status

Trans-anethole's regulatory status varies internationally:

**United States:** Not GRAS-designated by the FDA, meaning it may be used only in products where pre-market approval was obtained or in specific limited applications. Manufacturers should verify specific allowances for their intended use.

**European Union:** Evaluated under the EU's flavoring regulations. The EFSA has assessed anethole-containing ingredients and natural extracts containing anethole as acceptable for food use at established levels.

**Other jurisdictions:** Permitted in various countries as a food flavoring ingredient, often under specific concentration limits.

Food manufacturers using trans-anethole should verify current regulatory requirements for their target markets and ensure compliance with local food additive regulations.

Key Studies

Scientific literature on trans-anethole remains relatively limited compared to more extensively studied food additives. Key research areas include:

- Toxicological evaluations from the EFSA on anise and fennel extracts containing anethole

- Studies examining the chemical stability and flavor profile characteristics of trans-anethole in various food matrices

- Investigation into potential metabolic pathways of anethole in human consumers

- Research on the sensory perception and threshold levels for trans-anethole detection

Additional comprehensive safety studies, particularly dose-response data and long-term consumption studies in humans, would provide further certainty regarding the safety profile of this flavoring compound. The scientific community continues to evaluate essential oils and their components, including trans-anethole, to establish evidence-based safety benchmarks.

Frequently Asked Questions

What is Trans-anethole?

Trans-anethole is a naturally occurring organic compound that provides a distinctive licorice or anise-like flavor to foods and beverages. It is commonly used as a flavoring agent in confectionery, beverages, and other food products where an anise taste is desired.

Is Trans-anethole safe?

Trans-anethole is currently rated "unknown" 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 Trans-anethole banned in any country?

Trans-anethole 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.