Our Verdict: SAFE

Anise, Star, Oil (illicium Verum Hook, F.)

CAS68952-43-2

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

Anise, Star, Oil (illicium Verum Hook, F.) — food additive

Star anise oil is a flavoring agent extracted from the star-shaped fruit of Illicium verum, a tree native to Southeast Asia. It is used in food products to impart a characteristic licorice-like flavor and aroma, commonly appearing in beverages, confections, baked goods, and spice blends.

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
ApprovedUK FSA
Canada
ApprovedHealth Canada
Australia
ApprovedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
ApprovedANVISA
China
Not EvaluatedNHC / GB 2760
India
ApprovedFSSAI
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 Star Anise Oil?

Star anise oil (CAS Number 68952-43-2) is an essential oil derived from the dried fruit of Illicium verum Hook, F., commonly known as star anise. The oil is typically obtained through steam distillation or solvent extraction of the star-shaped pods. The primary active compound responsible for its characteristic flavor is anethole, which comprises approximately 80-90% of the oil's composition. Star anise oil is distinct from aniseed oil, though both share similar sensory properties and chemical constituents.

The oil appears as a colorless to pale yellow liquid with a warm, sweet, licorice-like odor. It has been used in culinary applications for centuries, particularly in Asian, Mediterranean, and Middle Eastern cuisines.

Common Uses

Star anise oil functions as a flavoring agent and flavor adjuvant in various food and beverage applications. Common uses include:

- Alcoholic beverages (anisette, ouzo, pastis)

- Non-alcoholic beverages (teas, soft drinks)

- Confectionery and candy

- Baked goods and bread products

- Savory dishes and spice blends

- Dental products and oral care items

The oil is used in very small quantities, typically in the range of parts per million, to achieve the desired flavor profile. Regulatory frameworks generally recognize specific usage levels as safe for its intended purpose.

Safety Assessment

Star anise oil has a long history of use in food and traditional medicine applications. According to available safety data, there have been zero adverse events reported to the FDA associated with this additive, and no FDA recalls are documented. The oil's safety profile appears consistent with its long-standing culinary use.

The primary compound, anethole, has been studied for potential health properties. While some traditional uses suggest medicinal applications, food safety assessments focus on its use as a flavoring agent at typical dietary exposure levels. The European Food Safety Authority (EFSA) has evaluated anethole and related compounds in flavoring applications.

Toxicological studies on anethole and star anise oil suggest low toxicity when used at food-grade concentrations. LD50 values (lethal dose in 50% of test animals) in animal studies indicate relatively low acute toxicity. However, concentrated essential oils differ significantly from diluted food flavoring applications.

Potential concerns primarily relate to estragole, a minor component in some star anise oils that has shown carcinogenic potential in animal studies at high doses. Quality control and sourcing of star anise oil can affect the presence of this compound. Products derived from Illicium verum typically contain lower estragole levels compared to some botanical alternatives.

Regulatory Status

Star anise oil is not listed as GRAS (Generally Recognized As Safe) by the FDA, meaning it does not have specific GRAS affirmation. However, this does not indicate it is unsafe; rather, it reflects that it was not subjected to the formal GRAS petition process. Many traditional flavoring agents lack GRAS status despite safe historical use.

The additive is permitted for use in food in various countries, including the United States, under food additive regulations when used in accordance with good manufacturing practices and at appropriate levels. The FDA's Color Additives Status List does not restrict star anise oil, and it appears in the List of Substances Used as Flavoring Agents and Related Substances.

The EFSA has evaluated natural flavor complexes containing star anise constituents and established acceptable intake levels for anethole.

Key Studies

Safety evaluations of star anise oil and its primary constituents have included:

- Acute and chronic toxicity studies on anethole in laboratory animals

- Genotoxicity and mutagenicity assessments

- Flavor safety evaluations by the Flavor and Extract Manufacturers Association (FEMA)

- Historical use documentation and traditional safety data

These studies collectively support the safety of star anise oil when used as a food flavoring at typical dietary exposure levels. The lack of reported adverse events and FDA recalls further supports its safety record in commercial food applications.

Frequently Asked Questions

What is Anise, Star, Oil (illicium Verum Hook, F.)?

Star anise oil is a flavoring agent extracted from the star-shaped fruit of Illicium verum, a tree native to Southeast Asia. It is used in food products to impart a characteristic licorice-like flavor and aroma, commonly appearing in beverages, confections, baked goods, and spice blends.

Is Anise, Star, Oil (illicium Verum Hook, F.) safe?

Anise, Star, Oil (illicium Verum Hook, F.) 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 Anise, Star, Oil (illicium Verum Hook, F.) banned in any country?

Anise, Star, Oil (illicium Verum Hook, F.) 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.