Our Verdict: RATING UNKNOWN

Hexyl Isovalerate

CAS10032-13-0

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

Hexyl Isovalerate — food additive

Hexyl isovalerate is a synthetic flavoring compound used to impart fruity, apple-like notes in food and beverage products. It is not currently approved as Generally Recognized as Safe (GRAS) by the FDA but has no reported adverse events or recalls associated with its use.

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 Hexyl Isovalerate?

Hexyl isovalerate (CAS Number: 10032-13-0) is a synthetic ester compound belonging to the class of organic flavor compounds. It is chemically formed from the combination of hexyl alcohol and isovaleric acid. This colorless to pale yellow liquid is characterized by a fruity, apple-like aroma with subtle floral undertones, making it a valuable ingredient in the flavor industry.

Common Uses

Hexyl isovalerate is used primarily as a flavoring agent in food and beverage applications. It appears in formulations for:

- Fruit-flavored beverages and juices

- Confectionery and candy products

- Baked goods and desserts

- Dairy products such as yogurts and ice creams

- Non-alcoholic beverages

The compound is typically used in very small concentrations, measured in parts per million (ppm), to achieve the desired sensory profile without overwhelming other flavor components.

Safety Assessment

Hexyl isovalerate has generated zero adverse event reports in FDA databases and zero product recalls. This absence of reported safety issues suggests that the compound, when used at typical flavor levels, has not caused identifiable harm to consumers.

The safety profile of hexyl isovalerate is supported by its structural similarity to naturally occurring esters and its low use levels in food products. Esters of this type are commonly found in nature—for example, in apple peels and various fruits—though hexyl isovalerate itself is produced synthetically.

As with most flavor compounds, toxicological considerations focus on acute and chronic exposure at consumption-relevant doses. The compound's low volatility and use concentrations suggest minimal systemic exposure from dietary intake.

Regulatory Status

Hexyl isovalerate is not currently listed on the FDA's GRAS (Generally Recognized as Safe) list. This designation does not indicate the substance is unsafe; rather, it means the FDA has not made a formal determination of its GRAS status through either a regulatory petition process or through the consensus of qualified experts based on published scientific data.

Companies wishing to use hexyl isovalerate in food products intended for the United States market may pursue GRAS self-affirmation procedures or submit a petition to the FDA for approval as a food additive. In the European Union, flavoring substances are regulated under Regulation (EC) No. 1334/2008, though regulatory status varies by member state.

The compound may be approved for use in other countries and regions with established flavor regulations.

Key Studies

Scientific literature on hexyl isovalerate is limited compared to more widely used flavor compounds. Most available information derives from:

- General toxicological data on ester compounds and their metabolic pathways

- Flavor industry databases and specifications

- Organoleptic (taste and smell) characterization studies

The metabolism of hexyl isovalerate, like other esters, would involve hydrolysis to hexyl alcohol and isovaleric acid, both of which undergo further metabolic processing in the body. Hexyl alcohol itself has been studied in toxicological contexts, with generally favorable safety profiles at typical exposure levels.

Research gaps remain regarding specific pharmacokinetic and pharmacodynamic studies of hexyl isovalerate at food-relevant doses. However, the absence of reported adverse events and recalls, combined with decades of use in flavor applications globally, provides empirical evidence supporting its safety at current use levels.

Future safety assessments may benefit from standardized toxicological testing should regulatory approval be pursued in jurisdictions requiring such data.

Frequently Asked Questions

What is Hexyl Isovalerate?

Hexyl isovalerate is a synthetic flavoring compound used to impart fruity, apple-like notes in food and beverage products. It is not currently approved as Generally Recognized as Safe (GRAS) by the FDA but has no reported adverse events or recalls associated with its use.

Is Hexyl Isovalerate safe?

Hexyl 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 Hexyl Isovalerate banned in any country?

Hexyl 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.