Our Verdict: SAFE

Horehound Extract (marrubium Vulgare L.)

CAS84696-20-8

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

Horehound Extract (marrubium Vulgare L.) — food additive

Horehound extract is a flavoring agent derived from the horehound plant (Marrubium vulgare L.), used to impart a distinctive bitter, herbal taste to food and beverage products. It functions as a flavoring adjuvant in confectionery, beverages, and other food applications.

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 Horehound Extract?

Horehound extract (CAS Number 84696-20-8) is derived from Marrubium vulgare L., commonly known as white horehound, a plant in the mint family native to Europe and western Asia. The extract is obtained through processing of the plant material and is used as a natural flavoring agent in the food industry. Horehound has a long history of use in traditional beverages, particularly in confectionery products like lozenges and hard candies, where its characteristic bitter, slightly sweet, and herbal flavor profile is valued.

Common Uses

Horehound extract is primarily used as a flavoring agent in:

- Candy and confectionery products

- Herbal and botanical beverages

- Non-alcoholic drinks

- Flavored syrups and concentrates

- Throat lozenges and cough drops

- Liqueurs and alcoholic beverages in some regions

The extract typically appears in formulations at relatively low concentrations, as its intense bitter flavor requires minimal amounts to achieve the desired taste profile. Its use is particularly prevalent in traditional and nostalgic candy formulations.

Safety Assessment

Horehound extract has no reported adverse events in the FDA database and has not been associated with any food recalls. The plant itself has been used in traditional medicine and food applications for centuries, particularly in European countries, which supports a long history of use.

The compound contains naturally occurring constituents including marrubin, which gives horehound its characteristic bitter taste. While the plant has traditional use in herbal remedies, the flavoring application involves minimal dietary exposure through food products.

Toxicological data on horehound extract is limited in published scientific literature. The extract is generally recognized as safe for culinary flavoring purposes in most food applications where it has been traditionally used. Individuals with allergies to plants in the mint family (Lamiaceae) should be aware of potential cross-reactivity, though such reactions are rare.

Regulatory Status

Horehound extract does not have FDA GRAS (Generally Recognized as Safe) status, meaning it has not undergone the formal GRAS notification process with the FDA. However, the absence of GRAS status does not indicate the ingredient is unsafe; rather, it reflects that manufacturers may not have pursued formal GRAS determination or FDA approval through pre-market notification.

The ingredient is permitted in food use in various countries, including European Union member states where it appears on flavoring substance lists. In the EU, horehound extract is recognized as a traditional flavoring ingredient with a long history of safe use in food.

Regulatory frameworks vary by jurisdiction, and food manufacturers using horehound extract should verify compliance with local food safety regulations and labeling requirements in their target markets.

Key Studies

Published scientific literature on horehound extract is limited compared to other common food additives. Most safety information derives from:

- Historical use data spanning centuries in European food and traditional medicine

- General phytochemical analysis of Marrubium vulgare constituents

- Traditional use patterns in confectionery and beverage applications

No significant adverse effects have been documented in available scientific or regulatory databases. The lack of FDA adverse event reports and recalls suggests no significant safety concerns have emerged from its use in food products. Additional toxicological studies would further characterize the safety profile, though existing evidence supports safe use at typical food flavoring concentrations.

Frequently Asked Questions

What is Horehound Extract (marrubium Vulgare L.)?

Horehound extract is a flavoring agent derived from the horehound plant (Marrubium vulgare L.), used to impart a distinctive bitter, herbal taste to food and beverage products. It functions as a flavoring adjuvant in confectionery, beverages, and other food applications.

Is Horehound Extract (marrubium Vulgare L.) safe?

Horehound Extract (marrubium Vulgare 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 Horehound Extract (marrubium Vulgare L.) banned in any country?

Horehound Extract (marrubium Vulgare 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.