Our Verdict: RATING UNKNOWN

P-menthane-3,8-diol

CAS42822-86-6

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

P-menthane-3,8-diol — food additive

P-menthane-3,8-diol is a naturally-derived flavoring compound used to impart minty and cooling sensations in food and beverage products. It functions as a flavoring agent and sensory adjuvant in various consumer products.

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
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
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 P-menthane-3,8-diol?

P-menthane-3,8-diol (PMD) is an organic compound with the CAS number 42822-86-6. It is a cyclic monoterpene diol derived from or chemically similar to compounds found in mint plants, particularly Eucalyptus and Mentha species. The compound has a characteristic cooling and minty flavor profile, making it valuable in food flavoring applications. PMD is structurally related to naturally occurring compounds but is typically produced through chemical synthesis for commercial use.

Common Uses

P-menthane-3,8-diol is primarily used as a flavoring agent and sensory adjuvant in the food and beverage industry. Its applications include:

- Confectionery and candy products

- Chewing gums and breath fresheners

- Beverage flavoring formulations

- Oral care products

- Savory food applications requiring cooling or mint notes

The compound's function extends beyond simple flavor contribution; it acts as a sensory modifier that can enhance perceived cooling sensations without lowering temperature, making it valuable for product innovation in both food and personal care categories.

Safety Assessment

P-menthane-3,8-diol has not been formally evaluated or granted GRAS (Generally Recognized as Safe) status by the FDA. However, the safety profile appears favorable based on available data. As of the latest FDA records, there are zero reported adverse events associated with this additive and zero product recalls linked to its use. This absence of safety incidents in the market suggests acceptable tolerability at typical use levels.

The compound's safety profile is further supported by its structural similarity to naturally occurring compounds in mint plants, though similarity to natural substances does not automatically confer safety approval. The lack of reported adverse events and recalls indicates no acute toxicity concerns have emerged from consumer exposure.

Typical safety considerations for flavoring compounds include assessment of acute toxicity, potential for allergenicity, and metabolism in the human body. The minuscule quantities typically used in flavoring applications—often measured in parts per million—further reduce potential exposure risk.

Regulatory Status

P-menthane-3,8-diol currently does not hold FDA GRAS status in the United States. This means it has not undergone the formal FDA GRAS notification process or received formal approval as a food additive. However, its use may be permitted in certain jurisdictions or under specific regulatory frameworks.

Manufacturers seeking to use this compound in food products should verify regulatory status in their target markets, as regulations vary internationally. Some regions may permit its use under existing flavor regulations or as part of essential oil preparations, while others may require specific authorization.

The absence of FDA GRAS status does not indicate a safety concern; rather, it reflects that the formal approval process has not been completed. Many food flavoring compounds operate in this regulatory space, with use determined by individual country regulations and industry standards.

Key Studies

Scientific literature on P-menthane-3,8-diol remains limited compared to more extensively studied additives. However, the compound has been evaluated in the context of natural mint-derived products and their sensory properties. Research on structurally similar monoterpene compounds provides supportive safety data.

The absence of reported adverse events in the FDA database, combined with zero recalls, suggests either minimal market exposure, good safety profile, or both. Further formal toxicological evaluation would be necessary to support GRAS petition submission, should manufacturers pursue FDA approval.

When evaluating this additive, consumers and manufacturers should consider current regulatory guidance in their specific jurisdictions and consult product labeling for ingredient disclosures.

Frequently Asked Questions

What is P-menthane-3,8-diol?

P-menthane-3,8-diol is a naturally-derived flavoring compound used to impart minty and cooling sensations in food and beverage products. It functions as a flavoring agent and sensory adjuvant in various consumer products.

Is P-menthane-3,8-diol safe?

P-menthane-3,8-diol is currently rated "unknown" 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 P-menthane-3,8-diol banned in any country?

P-menthane-3,8-diol 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.