Our Verdict: RATING UNKNOWN

Menthyl Isovalerate

CAS16409-46-4

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

Menthyl Isovalerate โ€” food additive

Menthyl isovalerate is a synthetic flavoring compound that imparts minty and cooling sensations to food and beverages. It is commonly used in confectionery, chewing gum, and mint-flavored products to enhance flavor profile and create a refreshing taste experience.

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 Menthyl Isovalerate?

Menthyl isovalerate (CAS Number: 16409-46-4) is a synthetic organic compound classified as a flavoring agent. It is the ester formed from the combination of menthol and isovaleric acid. This compound belongs to the broader category of menthol derivatives, which are widely used in the food industry for their characteristic cooling and minty sensory properties. The compound exists as a clear to pale yellow liquid with a strong minty aroma.

Common Uses

Menthyl isovalerate is primarily used as a flavoring agent in food and beverage applications. Its main uses include:

- Chewing gums and mints

- Hard candies and lozenges

- Confectionery products

- Breath fresheners

- Flavored beverages

- Oral hygiene products

The compound is valued for its ability to provide a cooling sensation combined with mint flavor, enhancing the sensory experience of products designed to refresh the palate. Due to its potency, it is typically used at very low concentrations in finished products.

Safety Assessment

Menthyl isovalerate has not been evaluated and approved for food use under the FDA's Generally Recognized as Safe (GRAS) classification. However, this designation does not indicate unsafe useโ€”rather, it reflects the regulatory pathway and evaluation status. The compound has generated zero adverse event reports and zero product recalls in FDA databases, suggesting no documented safety incidents associated with its use in food products.

The safety profile of menthyl isovalerate is informed by knowledge of its parent compounds: menthol, which has extensive use history and GRAS status, and isovaleric acid, a naturally occurring compound. Menthol has been safely used in food products for decades. The esterification of these components creates a stable compound with a well-defined chemical structure.

As a flavoring agent used at minimal concentrations in food products, systemic exposure to menthyl isovalerate through dietary consumption is expected to be very low. Flavoring compounds in this category are typically used at parts-per-million levels, minimizing potential exposure.

Regulatory Status

Menthyl isovalerate is not listed on the FDA's GRAS list for food use. This means it has not undergone the formal GRAS notification process that some flavoring compounds have completed. However, it may be used in food products under the FDA's Flavor and Extract Manufacturers Association (FEMA) system or other regulatory pathways in jurisdictions where it is permitted.

The European Commission's Scientific Committee on Food and successor bodies have evaluated various menthol derivatives, though specific comprehensive assessments for menthyl isovalerate may be limited. International regulatory frameworks vary; approval status differs by country and region.

Manufacturers using this ingredient in food products are responsible for ensuring compliance with applicable regulations in their target markets and maintaining documentation supporting safe use.

Key Studies

Limited published scientific literature specifically addresses menthyl isovalerate in isolation. Most relevant data comes from broader research on menthol derivatives and menthol itself. Studies on menthol demonstrate its safety in food applications and traditional use history spanning centuries in oral care and flavoring. The esterification process used to create menthyl isovalerate is a standard chemical technique that yields stable, well-characterized compounds.

Additional information would benefit from targeted safety studies, though the absence of adverse events and recalls provides some indirect evidence of safe use in existing applications. Any new or expanded uses would ideally be supported by appropriate safety data and regulatory documentation.

Frequently Asked Questions

What is Menthyl Isovalerate?

Menthyl isovalerate is a synthetic flavoring compound that imparts minty and cooling sensations to food and beverages. It is commonly used in confectionery, chewing gum, and mint-flavored products to enhance flavor profile and create a refreshing taste experience.

Is Menthyl Isovalerate safe?

Menthyl Isovalerate 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 Menthyl Isovalerate banned in any country?

Menthyl Isovalerate 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.