Our Verdict: SAFE

Isoeugenol

CAS97-54-1

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

Isoeugenol — food additive

Isoeugenol is a naturally occurring aromatic compound derived from eugenol, used as a flavoring agent in food products. It imparts a spicy, clove-like taste and aroma, and is commonly found in beverages, baked goods, and confectionery items.

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
ApprovedHealth 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 Isoeugenol?

Isoeugenol (CAS Number 97-54-1) is an organic compound belonging to the class of phenylpropanoids. It is the isomer of eugenol, sharing the same molecular formula (C10H10O2) but with a different structural arrangement. Isoeugenol occurs naturally in various essential oils, including clove oil, ylang-ylang oil, and nutmeg oil. The compound is colorless to pale yellow and has a characteristic spicy, warm, clove-like odor with subtle floral notes.

Common Uses

Isoeugenol is primarily used in the food industry as a flavoring agent and flavoring adjuvant. It appears in a variety of food products including:

- Alcoholic and non-alcoholic beverages

- Baked goods and bread products

- Confectionery and candy

- Dairy products

- Processed meats and savory foods

- Condiments and sauces

The compound is valued for its ability to provide spice notes without the heat of actual peppers, making it useful in formulations where a subtle warming flavor is desired. It is often used in very small quantities, typically measured in parts per million (ppm).

Safety Assessment

Isoeugenol has been studied for safety in food applications. According to FDA records, there have been zero adverse events reported and zero recalls associated with isoeugenol use in food products. The compound has been used in food flavoring for many decades without documented safety incidents in the United States.

The European Food Safety Authority (EFSA) has also evaluated isoeugenol as part of the flavoring compounds review process. In animal studies, isoeugenol has demonstrated low toxicity when administered orally. The compound is metabolized relatively quickly in the body and does not bioaccumulate.

Some toxicological studies have examined potential sensitization or allergenic properties, particularly given that eugenol (a related compound) is known to cause contact sensitization in some individuals. However, isoeugenol at the concentrations used in food products is not considered a significant sensitization concern for the general population when consumed orally, though individuals with specific sensitivities should exercise caution.

Regulatory Status

Isoeugenol does not have FDA GRAS (Generally Recognized as Safe) status in the United States. However, the absence of GRAS status does not indicate a safety concern; rather, it reflects regulatory classification decisions. The compound may be used in food products under FDA regulations governing flavoring substances, where permitted use levels are established based on safety data and historical use patterns.

In the European Union, isoeugenol is listed in the Community list of flavoring substances and may be used in food in accordance with Regulation (EC) No 1334/2008 and subsequent amendments. It has been assigned a Flavoring Evaluation Procedure (FEMA GRAS) number (2611) by the Flavor and Extract Manufacturers' Association, indicating professional assessment of safety when used at appropriate levels.

Key Studies

The safety profile of isoeugenol has been assessed through:

1. Acute and subchronic oral toxicity studies in laboratory animals, which established relatively high LD50 values indicating low acute toxicity

2. Metabolic pathway studies demonstrating rapid hepatic metabolism and elimination

3. Genotoxicity assessments showing negative results in standard screening tests

4. Historical use data spanning decades of food industry application

The safety assessment of isoeugenol is strengthened by its natural occurrence in foods at low levels and its chemical similarity to eugenol, which has an extensive safety history. Current evidence supports the safety of isoeugenol when used as a flavoring agent at typical food use levels.

Frequently Asked Questions

What is Isoeugenol?

Isoeugenol is a naturally occurring aromatic compound derived from eugenol, used as a flavoring agent in food products. It imparts a spicy, clove-like taste and aroma, and is commonly found in beverages, baked goods, and confectionery items.

Is Isoeugenol safe?

Isoeugenol 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 Isoeugenol banned in any country?

Isoeugenol 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.