Our Verdict: RATING UNKNOWN

Elecampane Root, Extract (inula Helenium L.)

CAS84012-20-4

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

Elecampane Root, Extract (inula Helenium L.) — food additive

Elecampane root extract is derived from Inula helenium L., a plant traditionally used in herbal preparations. Its function in food products remains unclear, and it is not approved as a food additive by the FDA.

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 Elecampane Root, Extract?

Elecampane root extract (CAS Number: 84012-20-4) is derived from Inula helenium L., commonly known as elecampane, a perennial plant in the Asteraceae family native to Asia and Europe. The extract is obtained from the dried rhizomes and roots of the plant. Elecampane has a long history in traditional medicine systems, particularly in European herbal traditions, where it has been used in teas, tinctures, and other preparations for centuries.

Common Uses

Historically, elecampane root has been incorporated into herbal beverages, dietary supplements, and traditional medicine formulations rather than conventional food products. The plant contains several bioactive compounds including inulin, alantolactone, and isoalantolactone. While these compounds have been studied for various properties in research settings, the specific function of elecampane root extract in modern food applications remains undefined in regulatory documentation. If present in foods in the United States, it would typically appear in herbal teas, botanical beverages, or specialized dietary products rather than mainstream processed foods.

Safety Assessment

The FDA has not classified elecampane root extract as Generally Recognized as Safe (GRAS) for use as a food additive. This designation does not necessarily indicate a safety concern but rather reflects the absence of formal FDA recognition or substantial market history as a food ingredient in the United States. No adverse events related to elecampane root extract have been reported to the FDA, and no product recalls involving this ingredient have been issued. However, the lack of adverse event reports may reflect limited use in FDA-regulated food products rather than comprehensive safety evidence.

Traditional use does not establish modern food safety standards. Individual sensitivity or allergic reactions are theoretically possible, as elecampane belongs to the Asteraceae family, which includes ragweed and other plants known to trigger allergic responses in sensitive individuals. The European Food Safety Authority (EFSA) has not established a comprehensive food additive safety assessment for this ingredient.

Regulatory Status

In the United States, elecampane root extract is not approved as a food additive under FDA regulations. It may be marketed as a dietary supplement ingredient under the Dietary Supplement Health and Education Act (DSHEA), which has different approval requirements than food additives. Some European countries permit limited use of elecampane in traditional herbal preparations, though regulations vary by jurisdiction. Any food product in the U.S. containing this ingredient would need to comply with applicable labeling regulations and ingredient disclosure requirements.

Key Studies

Scientific research on elecampane has focused primarily on its chemical composition and traditional uses rather than its safety as a food additive. Studies have identified and characterized the plant's constituents, particularly sesquiterpene lactones, which are believed to contribute to its traditional applications. However, comprehensive toxicological studies specifically designed to evaluate safety as a food ingredient are limited. Any manufacturer considering use of this ingredient in food products would need to conduct or obtain appropriate safety data to support such use and comply with FDA regulations regarding food additive petitions or GRAS status determinations.

Frequently Asked Questions

What is Elecampane Root, Extract (inula Helenium L.)?

Elecampane root extract is derived from Inula helenium L., a plant traditionally used in herbal preparations. Its function in food products remains unclear, and it is not approved as a food additive by the FDA.

Is Elecampane Root, Extract (inula Helenium L.) safe?

Elecampane Root, Extract (inula Helenium L.) 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 Elecampane Root, Extract (inula Helenium L.) banned in any country?

Elecampane Root, Extract (inula Helenium 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.