Our Verdict: RATING UNKNOWN

Gamma-octalactone

CAS104-50-7

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

Gamma-octalactone — food additive

Gamma-octalactone is a naturally occurring organic compound used as a flavoring agent in food products. It provides a creamy, buttery, and slightly fruity taste characteristic and is commonly employed in dairy, baked goods, and beverage formulations.

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
ApprovedHealth 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 Gamma-Octalactone?

Gamma-octalactone (CAS Number 104-50-7) is an eight-membered lactone—a cyclic ester compound—found naturally in various foods including fruits, dairy products, and fermented beverages. The compound is characterized by a molecular formula of C₈H₁₄O₂ and exists as a colorless to pale yellow liquid. Its chemical structure contains a lactone ring, which contributes to its distinctive sensory properties.

As a naturally occurring substance, gamma-octalactone is identified in food sources such as coconut, peach, strawberry, and dairy products. The compound has been isolated from fermented foods and is produced through microbial fermentation in some manufacturing processes, as well as through chemical synthesis.

Common Uses

Gamma-octalactone functions as a flavoring agent and flavoring adjuvant in the food industry. Its primary applications include:

- **Dairy Products**: Used in yogurt, cheese flavors, and dairy-based beverages to enhance creamy and buttery notes

- **Baked Goods**: Incorporated into bread, pastries, and cake formulations for enhanced flavor complexity

- **Beverages**: Added to fruit juices, soft drinks, and flavored water products

- **Confectionery**: Used in chocolate products, candies, and dessert formulations

- **Dairy Alternatives**: Employed in plant-based milk and yogurt products to replicate dairy sensory profiles

The compound typically appears in food formulations at very low concentrations, measured in parts per million (ppm), which aligns with standard flavoring agent usage levels.

Safety Assessment

Gamma-octalactone has not generated adverse event reports in the FDA database, with zero recorded incidents. Additionally, no FDA recalls have been associated with this ingredient, indicating no documented safety concerns related to its use in commercial food products.

The compound's safety profile reflects its natural occurrence in foods and its use at minimal concentrations typical of flavoring agents. As with most flavoring substances used in food, the safety assessment is based on the principle of GRAS (Generally Recognized As Safe) assessment and consumption pattern analysis.

The absence of adverse events and recalls suggests that current food industry usage practices have not identified safety concerns. However, as with all food additives, consumption exposure remains minimal due to the low concentrations required for flavor impact.

Regulatory Status

Gamma-octalactone does not currently hold FDA GRAS (Generally Recognized As Safe) status. However, this designation absence does not indicate a safety concern; rather, it reflects that a formal GRAS petition or notification has not been submitted and approved through the FDA's established procedures.

The ingredient may be used in food products under various regulatory pathways, depending on the jurisdiction and specific product category. In the European Union, flavoring substances are evaluated under Regulation (EC) No 1334/2008, though specific EFSA documentation on gamma-octalactone's assessment status may vary.

Manufacturers utilizing gamma-octalactone in food products are responsible for ensuring compliance with all applicable food safety regulations in their target markets. The lack of GRAS status does not prohibit use but may require alternative regulatory justification depending on the application.

Key Studies

Literature on gamma-octalactone remains limited in peer-reviewed food safety databases. The compound's safety record relies heavily on:

- Its natural occurrence in foods and long history of consumption

- Low usage concentrations required for flavoring efficacy

- The absence of documented adverse effects in regulatory databases

- General knowledge of lactone compound metabolism and safety profiles

The lack of specific published safety studies reflects both the minor status of this ingredient in the food supply and the minimal exposure levels at which it is used. Further safety data would require formal toxicological studies or GRAS petition submissions to regulatory agencies.

As with many flavor compounds, the safety assessment framework relies on structural class analysis, natural occurrence data, and absence of reported adverse events rather than extensive clinical study databases.

Frequently Asked Questions

What is Gamma-octalactone?

Gamma-octalactone is a naturally occurring organic compound used as a flavoring agent in food products. It provides a creamy, buttery, and slightly fruity taste characteristic and is commonly employed in dairy, baked goods, and beverage formulations.

Is Gamma-octalactone safe?

Gamma-octalactone 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 Gamma-octalactone banned in any country?

Gamma-octalactone 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.