Our Verdict: SAFE

Gentian, Stemless (gentiana Acaulis L.)

CAS977088-41-7

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

Gentian, Stemless (gentiana Acaulis L.) — food additive

Gentian, Stemless is a plant-derived flavoring agent extracted from Gentiana acaulis L., a small alpine flowering plant. It is used in food and beverage formulations to provide bitter and herbal flavor notes, particularly in liqueurs, bitters, and flavored beverages.

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 Gentian, Stemless?

Gentian, Stemless (Gentiana acaulis L.) is a flavoring agent derived from the stemless gentian plant, a low-growing perennial herb native to the mountainous regions of central and southern Europe. The plant is characterized by its bright blue flowers and has been used for centuries in traditional medicine and food preparation. The flavoring extract is typically obtained from the plant's roots and rhizomes, which contain bitter compounds and aromatic constituents. CAS Number 977088-41-7 identifies this specific substance in chemical databases.

Common Uses

Gentian, Stemless is employed as a flavoring agent in various food and beverage applications. Its primary uses include:

- Bitter liqueurs and spirits, where it contributes to complex flavor profiles

- Herbal and botanical beverages

- Flavored bitters used in cocktails and digestifs

- Functional beverages marketed for digestive benefits

- Confectionery and flavored products requiring herbal or bitter notes

The additive functions as a flavoring adjuvant, meaning it enhances or modifies the overall flavor profile of finished products rather than serving as a primary flavor component.

Safety Assessment

Gentian, Stemless has not been designated as Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration. However, this designation status does not necessarily indicate safety concerns; rather, it reflects the regulatory classification pathway chosen by manufacturers and the extent of published safety data available for FDA review.

The FDA database records zero adverse events and zero recalls associated with this additive, suggesting no documented safety incidents in the U.S. food supply. This absence of reported problems indicates a reasonable safety history in commercial use.

Gentian root has been used in traditional European herbal medicine and food preparation for generations, providing historical use data. The plant's bitter compounds, primarily secoiridoid glycosides such as gentiopicroside and amarogentin, are the active constituents. These compounds are generally considered safe at levels used in flavoring applications, though they may have physiological effects at therapeutic doses.

Regulatory Status

In the European Union, gentian root is listed in the Register of flavoring substances allowed for use in food. The European Food Safety Authority (EFSA) has evaluated gentian root flavoring and determined it acceptable for its intended purpose.

In the United States, while not GRAS-designated, gentian-derived flavorings can be used under the Food and Drug Administration regulations for flavoring substances if they meet applicable safety standards and labeling requirements. The regulatory pathway may vary depending on the specific extraction method and concentration used.

Manufacturers using Gentian, Stemless must comply with applicable food additive regulations in their respective markets and ensure proper labeling and usage levels.

Key Studies

Scientific literature on gentian root constituents supports their safety profile at typical culinary and flavoring concentrations. Research has focused primarily on the pharmacological properties of gentian compounds rather than toxicological concerns. Studies indicate that secoiridoid glycosides in gentian are generally well-tolerated at normal dietary exposure levels.

No specific clinical toxicity studies for Gentian, Stemless as a food additive were identified in standard regulatory databases. The safety assessment relies on historical use evidence, constituent analysis, and the lack of adverse event reports. Further research may provide additional data on specific usage levels and population groups.

Frequently Asked Questions

What is Gentian, Stemless (gentiana Acaulis L.)?

Gentian, Stemless is a plant-derived flavoring agent extracted from Gentiana acaulis L., a small alpine flowering plant. It is used in food and beverage formulations to provide bitter and herbal flavor notes, particularly in liqueurs, bitters, and flavored beverages.

Is Gentian, Stemless (gentiana Acaulis L.) safe?

Gentian, Stemless (gentiana Acaulis 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 Gentian, Stemless (gentiana Acaulis L.) banned in any country?

Gentian, Stemless (gentiana Acaulis 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.