Our Verdict: SAFE

Anise (pimpinella Anisum L.)

CAS977007-65-0FDA 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

Anise (pimpinella Anisum L.) โ€” food additive

Anise (Pimpinella anisum L.) is a flavoring agent derived from the seeds of the anise plant, widely used in food and beverages for its distinctive licorice-like taste. It has been designated as Generally Recognized As Safe (GRAS) by the FDA with no reported adverse events or recalls.

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 Anise?

Anise (Pimpinella anisum L.) is a flowering plant native to the eastern Mediterranean region and South Asia. The additive used in food products is derived from the dried seeds of this plant, which contain volatile oils and compounds that provide its characteristic sweet, licorice-like flavor. The CAS number 977007-65-0 identifies this specific food-grade extract or essential oil preparation. Anise has been used as a culinary and medicinal ingredient for thousands of years across various cultures.

Common Uses

Anise is employed as a flavoring agent in a wide range of food and beverage products. Common applications include:

- Alcoholic beverages (anisette, ouzo, pastis)

- Confectionery and candy

- Baked goods and desserts

- Savory dishes and condiments

- Herbal teas and infusions

- Oral care products

- Traditional spice blends

The flavoring is typically added in small quantities to achieve the desired taste profile without dominating other flavors in a formulation.

Safety Assessment

Anise has an extensive history of safe use in food. The FDA has designated anise as Generally Recognized As Safe (GRAS), meaning it is considered safe for consumption based on a long history of use and scientific evidence. According to FDA records, there are zero reported adverse events associated with anise as a food additive, and no food recalls have been issued due to anise contamination or safety concerns.

The European Food Safety Authority (EFSA) has also reviewed anise and concluded that it is safe for use in food applications at levels consistent with its traditional use. Toxicological studies have not identified significant safety concerns at dietary exposure levels.

Anise essential oil contains anethole as its primary active compound, which has been the subject of numerous safety studies. While anethole is generally recognized as safe, extremely high doses in controlled laboratory settings have shown effects in animal models, but these doses far exceed typical dietary exposure from flavored foods.

Regulatory Status

Anise holds GRAS status in the United States under FDA regulations, allowing it to be used as a flavoring agent without pre-market approval. It is regulated under 21 CFR ยง 182.10 as a spice and other natural seasonings and flavorings.

International regulatory bodies recognize anise as safe for food use:

- European Union: Listed in the Register of flavouring substances

- United Kingdom: Approved for use as a flavoring agent

- Canada: Permitted as a food additive in certain categories

- Australia and New Zealand: Approved for use in food applications

The additive does not require mandatory labeling in many jurisdictions when used as a flavoring, though it must appear in ingredient lists where regulations require declaration of all additives.

Key Studies

Scientific literature on anise safety includes:

- Toxicological evaluations by the Council of Europe confirming safety of anise flavoring at permitted use levels

- Historical use documentation showing anise consumption spans centuries without documented safety issues in populations with regular dietary exposure

- Chemical composition analysis confirming consistency and purity of commercial anise flavoring preparations

- Regulatory reviews by EFSA and FDA that evaluated available safety data and concluded no safety concerns at anticipated dietary exposure levels

No significant drug interactions have been identified at typical culinary consumption levels, though individuals with known allergies to plants in the Apiaceae family (carrots, celery, parsley) should exercise caution.

Frequently Asked Questions

What is Anise (pimpinella Anisum L.)?

Anise (Pimpinella anisum L.) is a flavoring agent derived from the seeds of the anise plant, widely used in food and beverages for its distinctive licorice-like taste. It has been designated as Generally Recognized As Safe (GRAS) by the FDA with no reported adverse events or recalls.

Is Anise (pimpinella Anisum L.) safe?

Anise (pimpinella Anisum L.) 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 (pimpinella Anisum L.) banned in any country?

Anise (pimpinella Anisum L.) 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.