Our Verdict: SAFE

Eugenol

CAS97-53-0

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

Eugenol — food additive

Eugenol is a naturally occurring organic compound derived primarily from clove oil and other plant sources. It functions as a flavoring agent in food products, providing characteristic spice and clove-like taste notes.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

Restricted in 2 jurisdictions
United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
ApprovedUK FSA
Canada
ApprovedHealth Canada
Australia
ApprovedFSANZ
Japan
RestrictedMHLW
South Korea
ApprovedMFDS
Brazil
ApprovedANVISA
China
RestrictedNHC / 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 Eugenol?

Eugenol (4-allyl-2-methoxyphenol) is an aromatic organic compound with the chemical formula C10H10O2 and CAS number 97-53-0. It is a naturally occurring phenylpropanoid found abundantly in clove buds, clove leaf oil, cinnamon, nutmeg, and other spice plants. The compound appears as a colorless to pale yellow oily liquid with a characteristic spicy, clove-like aroma. Eugenol can be extracted from natural sources or synthesized chemically for use in various applications.

Common Uses

In the food industry, eugenol serves as a flavoring agent and flavor adjuvant, contributing spice and aromatic notes to food and beverage products. It is commonly used in small quantities in products such as baked goods, beverages, confectionery, meat products, and seasonings. Due to its potent flavor profile, only minute amounts are typically required to achieve the desired taste effect. Beyond food applications, eugenol has historical use in dental products, pharmaceuticals, and personal care items.

Safety Assessment

Eugenol has been extensively studied for safety in various contexts. The FDA has recorded zero adverse events and zero recalls associated with eugenol as a food additive. When used at typical flavoring levels in food products, eugenol is generally recognized as safe by the scientific and regulatory communities. The compound has low acute toxicity when ingested in food-relevant quantities.

Toxicological studies indicate that eugenol demonstrates low systemic toxicity at food-use levels. The LD50 (lethal dose) in animals is relatively high, indicating low acute toxicity. Chronic safety studies support the use of eugenol as a food flavoring at concentrations present in food applications. The European Food Safety Authority (EFSA) and other international regulatory bodies have assessed eugenol and determined acceptable levels for food use.

It should be noted that eugenol is not currently on the FDA's Generally Recognized As Safe (GRAS) list, though this designation does not indicate safety concerns. Rather, GRAS status represents a specific regulatory pathway for substances with a long history of safe use. Many natural flavoring compounds maintain safe usage without formal GRAS designation.

Regulatory Status

Eugenol is regulated as a food additive in multiple jurisdictions. In the European Union, eugenol is permitted as a flavoring substance with established usage levels. The FDA permits eugenol as a food additive for flavoring purposes, though it operates under standard food additive regulations rather than the GRAS pathway. Other countries including Canada, Australia, and Japan permit eugenol use in foods at specified concentrations.

Regulatory agencies establish maximum use levels based on safety assessments to ensure consumer protection. These permitted levels reflect safe exposure through normal dietary consumption patterns.

Key Studies

Numerous safety studies have evaluated eugenol's toxicological profile. Research indicates eugenol does not cause genotoxicity or mutagenicity at relevant exposure levels. Reproductive and developmental toxicity studies in animals have not identified significant concerns at food-use concentrations. Metabolic studies demonstrate that eugenol is efficiently metabolized and cleared from the body.

Laboratory research has explored eugenol's antioxidant and antimicrobial properties, which contribute to its traditional use in preserved foods. These properties, combined with its flavoring function, explain its long historical use in food preparation across various cultures.

Frequently Asked Questions

What is Eugenol?

Eugenol is a naturally occurring organic compound derived primarily from clove oil and other plant sources. It functions as a flavoring agent in food products, providing characteristic spice and clove-like taste notes.

Is Eugenol safe?

Eugenol 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 Eugenol banned in any country?

Eugenol 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.