Our Verdict: RATING UNKNOWN

Isoamyl Hexanoate

CAS2198-61-0

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

Isoamyl Hexanoate — food additive

Isoamyl hexanoate is a synthetic flavoring compound used to impart fruity, banana-like notes to food and beverage products. It is not currently approved as a food additive by the FDA under the Generally Recognized as Safe (GRAS) classification.

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 Isoamyl Hexanoate?

Isoamyl hexanoate (CAS Number: 2198-61-0) is a synthetic ester compound belonging to the family of organic esters commonly used in the flavor industry. It is also known as isoamyl caproate and consists of isoamyl alcohol esterified with hexanoic acid. The compound is a clear, colorless to pale yellow liquid with a characteristic fruity aroma, particularly reminiscent of banana and pineapple notes. As a synthetic flavoring agent, it is manufactured through chemical synthesis rather than derived from natural sources.

Common Uses

Isoamyl hexanoate functions as a flavoring agent or flavor adjuvant in the food and beverage industry. Its primary application is in the formulation of fruit-flavored products, where it contributes to the overall sensory profile. Common applications include:

- Confectionery and candy formulations

- Beverage flavorings (soft drinks, juices)

- Dairy products (yogurts, flavored milk)

- Baked goods and desserts

- Flavoring compounds for processed foods

The compound is typically used in very small quantities, measured in parts per million, to achieve the desired flavor intensity without overwhelming other flavor components.

Safety Assessment

Isoamyl hexanoate has not been submitted to or approved by the FDA as a GRAS (Generally Recognized as Safe) substance. This designation does not necessarily indicate a safety concern but rather reflects that the compound has not undergone the formal FDA review process for this classification. The absence of reported adverse events in the FDA database and zero associated recalls indicate that documented safety incidents in the U.S. food supply are absent.

The compound belongs to a chemical class of esters that are generally considered low-toxicity substances. Similar ester compounds have been evaluated for safety by regulatory bodies including the European Food Safety Authority (EFSA) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Toxicological data on structurally similar esters suggest low acute toxicity profiles when used in typical food applications at low concentrations.

As with all synthetic flavoring agents, isoamyl hexanoate should only be used in compliance with applicable food regulations and at levels that ensure flavor efficacy without exceeding safe consumption thresholds.

Regulatory Status

In the United States, isoamyl hexanoate does not have FDA GRAS approval. This means it cannot be marketed as a food additive under the standard U.S. regulatory framework without specific FDA authorization or approval through the Food Additive Petition process. However, the absence of GRAS status does not prohibit its use in all jurisdictions or applications—regulatory frameworks vary significantly by country and region.

In the European Union and other regions, certain ester-based flavorings including similar compounds may be evaluated under Regulation (EC) No 1334/2008 on flavorings. Individual member states and regulatory bodies maintain their own approved flavoring substances lists.

Manufacturers and food companies seeking to use isoamyl hexanoate must verify compliance with their specific national or regional food regulations before incorporation into food products intended for sale.

Key Studies

While specific published safety studies on isoamyl hexanoate as an isolated compound are limited in public literature, the broader chemical class of short-chain aliphatic esters has been evaluated for safety. Toxicological assessments of structurally related compounds (such as other hexanoate esters) have been conducted by international food safety authorities, generally demonstrating low toxicity at food-use concentrations. The ester functional group itself is considered metabolically stable and readily hydrolyzable to component alcohols and acids, which the body can further metabolize through normal pathways.

Frequently Asked Questions

What is Isoamyl Hexanoate?

Isoamyl hexanoate is a synthetic flavoring compound used to impart fruity, banana-like notes to food and beverage products. It is not currently approved as a food additive by the FDA under the Generally Recognized as Safe (GRAS) classification.

Is Isoamyl Hexanoate safe?

Isoamyl Hexanoate 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 Isoamyl Hexanoate banned in any country?

Isoamyl Hexanoate 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.