Our Verdict: SAFE

Dl-isomenthone

CAS491-07-6

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

Dl-isomenthone — food additive

DL-isomenthone is a synthetic flavoring agent derived from menthol that provides minty and cooling sensory properties to food and beverage products. It is used in small quantities as a flavoring adjuvant to enhance taste profiles in various consumer foods.

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 DL-isomenthone?

DL-isomenthone (CAS Number 491-07-6) is a synthetic organic compound belonging to the class of ketonic monoterpenes. It is a structural isomer related to menthone, which occurs naturally in peppermint and spearmint plants. The "DL" designation indicates that the compound is a racemic mixture, containing equal proportions of both the D- and L-enantiomers (mirror-image forms) of the isomenthone molecule. This synthetic version is manufactured through chemical synthesis rather than extraction from natural sources.

Common Uses

DL-isomenthone is utilized primarily as a flavoring agent and flavoring adjuvant in the food industry. Its cooling and minty sensory properties make it valuable in the formulation of:

- Confectionery products (candies, chewing gum, lozenges)

- Beverages (soft drinks, energy drinks, flavored waters)

- Oral care products (mouthwash, toothpaste)

- Dairy products (yogurt, ice cream)

- Pharmaceutical formulations requiring mint flavoring

The compound is typically used in very small concentrations, measured in parts per million (ppm), to achieve the desired flavor impact without creating an overwhelming sensory experience.

Safety Assessment

DL-isomenthone has not been formally affirmed as Generally Recognized As Safe (GRAS) by the FDA, meaning it has not undergone the specific GRAS affirmation process. However, the absence of GRAS status does not indicate safety concerns; rather, it reflects the regulatory pathway and extent of formal review the substance has undergone.

According to FDA records, there have been zero reported adverse events associated with DL-isomenthone consumption, and zero product recalls have been initiated due to this ingredient. This lack of adverse event reports suggests that the compound, when used as a flavoring agent in appropriate concentrations, has not generated consumer safety concerns in the U.S. food supply.

DL-isomenthone is structurally similar to naturally occurring menthone and other monoterpenes that have a long history of use in food flavoring. The safety profile of related compounds in this chemical class has been extensively studied, providing some contextual reassurance about the potential safety of isomenthone when used at typical flavoring levels.

Regulatory Status

In the United States, DL-isomenthone is permitted for use as a flavoring agent under 21 CFR Part 182, which covers substances generally recognized as safe for their intended use in food. While not bearing specific GRAS affirmation, the substance is approved for use in foods at levels necessary to achieve the desired flavoring effect.

The European Union's food additive regulatory framework does not list DL-isomenthone as an approved food additive, though this reflects different regulatory philosophies between regions rather than safety concerns. The European approach typically requires explicit positive listing of approved substances, whereas the U.S. system permits substances that meet safety criteria even without formal GRAS status.

Manufacturers using DL-isomenthone must comply with FDA labeling requirements and declare it as a flavor component on product ingredient lists.

Key Studies

Limited peer-reviewed research specifically addresses DL-isomenthone safety in isolation. However, the extensive toxicological literature on related monoterpenes (menthone, menthol, and other mint-derived compounds) provides relevant safety data. These studies generally demonstrate low systemic toxicity when compounds are used at typical flavoring concentrations.

The absence of adverse event data spanning decades of commercial use in food flavoring applications provides empirical support for the safety of this ingredient at traditional use levels. Regulatory agencies worldwide continue to monitor food additive safety through post-market surveillance systems.

Frequently Asked Questions

What is Dl-isomenthone?

DL-isomenthone is a synthetic flavoring agent derived from menthol that provides minty and cooling sensory properties to food and beverage products. It is used in small quantities as a flavoring adjuvant to enhance taste profiles in various consumer foods.

Is Dl-isomenthone safe?

Dl-isomenthone 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 Dl-isomenthone banned in any country?

Dl-isomenthone 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.