Our Verdict: SAFE

D-neomenthol

CAS2216-52-6

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

D-neomenthol — food additive

D-neomenthol is a naturally occurring monoterpene alcohol used as a flavoring agent in food and beverages. It provides a cooling, minty taste profile and is derived from or chemically similar to compounds found in peppermint and spearmint plants.

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 D-neomenthol?

D-neomenthol (CAS Number 2216-52-6) is a colorless to pale yellow liquid belonging to the monoterpene alcohol family. It is the dextrorotatory enantiomer of neomenthol, a naturally occurring compound found in essential oils of mint species, particularly peppermint (Mentha piperita) and spearmint (Mentha spicata). The compound has a characteristic cool, refreshing minty flavor and aroma, making it valuable in the flavor industry.

Common Uses

D-neomenthol is primarily used as a flavoring agent and flavor adjuvant in food and beverage products. Its applications include:

- Confectionery products such as candies, mints, and chewing gums

- Beverages including non-alcoholic drinks, energy drinks, and flavored waters

- Oral care products including toothpaste and mouthwash

- Pharmaceutical formulations where flavor masking is desired

- Baked goods and desserts requiring minty flavoring

The cooling sensation associated with D-neomenthol is achieved through its interaction with cold-sensitive receptors on taste buds, similar to other menthol compounds.

Safety Assessment

D-neomenthol has been used in food applications without reported adverse events documented in FDA records. The FDA has received zero adverse event reports associated with this additive and no product recalls have been initiated due to D-neomenthol contamination or safety concerns.

The toxicological profile of neomenthol compounds is generally considered favorable. Studies on structurally similar menthol compounds have demonstrated low acute toxicity with high LD50 values in animal models. The compound does not exhibit mutagenic or carcinogenic properties based on available scientific literature.

As with all flavor compounds, D-neomenthol is used at very low concentrations in final food products—typically measured in parts per million (ppm)—which further reduces any potential risk. The flavoring industry maintains strict purity and manufacturing standards for such compounds.

Regulatory Status

D-neomenthol has not been granted FDA GRAS (Generally Recognized As Safe) status, meaning it does not appear on the FDA's GRAS list. However, this designation does not indicate the substance is unsafe; rather, it reflects that formal GRAS petitions have not been submitted to or approved by the FDA.

The compound may be used in flavoring formulations under the FDA's indirect food additive regulations for flavor compounds (21 CFR Part 182), provided manufacturers follow established safety guidelines and use levels. In the European Union, neomenthol-type compounds may be permitted under flavor regulations depending on specific national provisions.

Manufacturers using D-neomenthol must ensure it meets food-grade purity specifications and is produced under appropriate quality control measures.

Key Studies

While D-neomenthol specifically has limited dedicated research, the safety of structurally related menthol and neomenthol compounds has been evaluated through:

- Acute and subacute toxicity studies demonstrating minimal hazard potential

- Metabolism studies showing rapid absorption and excretion in animal models

- Organoleptic assessments confirming efficacy at typical use levels (0.1-10 ppm)

- Historical use data spanning decades in mint-flavored products

The scientific consensus supports the use of D-neomenthol as a flavoring agent when applied according to established food additive manufacturing practices. Additional safety data would further establish formal regulatory acceptance, but current evidence does not suggest concerns at authorized use levels.

Frequently Asked Questions

What is D-neomenthol?

D-neomenthol is a naturally occurring monoterpene alcohol used as a flavoring agent in food and beverages. It provides a cooling, minty taste profile and is derived from or chemically similar to compounds found in peppermint and spearmint plants.

Is D-neomenthol safe?

D-neomenthol 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 D-neomenthol banned in any country?

D-neomenthol 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.