Our Verdict: SAFE

6-hydroxy-3,7-dimethyloctanoic Acid Lactone

CAS499-54-7

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

6-hydroxy-3,7-dimethyloctanoic Acid Lactone — food additive

6-hydroxy-3,7-dimethyloctanoic acid lactone, commonly known as massoia lactone, is a naturally occurring organic compound used as a flavoring agent in food products. It imparts a creamy, coconut-like flavor profile and is derived from or chemically synthesized to replicate compounds found in natural sources.

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 6-hydroxy-3,7-dimethyloctanoic Acid Lactone?

6-hydroxy-3,7-dimethyloctanoic acid lactone (CAS Number: 499-54-7) is an organic lactone compound belonging to the class of flavor compounds. It is structurally similar to naturally occurring flavor compounds found in certain plant sources, particularly in massoia bark. The compound exists as a white to off-white crystalline solid and is lipophilic, making it suitable for incorporation into fatty food systems.

The lactone ring structure is characteristic of many natural flavor compounds and contributes to its sensory properties. This compound can be synthesized through chemical processes designed to replicate its natural occurrence, making it available for use in food applications without relying exclusively on natural extraction.

Common Uses

Massoia lactone is utilized primarily in flavoring applications for processed foods and beverages. Its creamy, coconut-like, and buttery flavor notes make it valuable in:

- Dairy products including yogurts, ice creams, and flavored milk beverages

- Bakery products and baked goods

- Confectionery items such as candies and chocolate products

- Beverage formulations seeking tropical or creamy flavor profiles

- Savory applications in seasonings and flavor blends

The compound is typically used in very small quantities—measured in parts per million—due to its potent flavor impact. This characteristic makes it economically efficient for manufacturers while keeping overall additive exposure minimal in finished products.

Safety Assessment

The safety profile of 6-hydroxy-3,7-dimethyloctanoic acid lactone reflects several key factors:

**FDA Data**: The compound has generated zero adverse event reports in FDA databases and has not been associated with any product recalls. This absence of reported safety incidents represents a substantial safety track record in commercial use.

**GRAS Status**: This additive does not hold GRAS (Generally Recognized as Safe) designation from the FDA. GRAS status represents formal FDA acknowledgment of safety for a specific use; its absence does not indicate the substance is unsafe, but rather that formal GRAS notification procedures were not pursued or completed. Many flavoring compounds operate safely in commerce without GRAS designation.

**Chemical Properties**: As a lactone compound, it shares structural similarities with many naturally occurring flavor compounds that have long histories of safe use. The compound's lipophilic nature means it distributes into fatty components of food rather than remaining in aqueous solutions, potentially limiting systemic absorption.

**Exposure Considerations**: Because massoia lactone is used at very low concentrations (typically less than 10 ppm in finished products), actual dietary exposure remains minimal. Flavor compounds are generally evaluated based on intended use levels and resulting human exposure.

Regulatory Status

Regulatory approaches to massoia lactone vary by jurisdiction:

- **United States**: The compound may be used in flavoring formulations under FDA regulations for food additives, though without GRAS designation it requires documentation of safe use or petition submission for certain applications.

- **European Union**: Similar lactone flavoring compounds have been evaluated by EFSA (European Food Safety Authority), though specific authorizations vary by intended use.

- **International**: The compound appears in various national food additive registries and flavor databases, indicating acceptance in multiple regulatory jurisdictions.

Manufacturers utilizing this compound typically maintain documentation supporting its safe use at intended levels, including data on chemical identity, purity specifications, and intended use concentrations.

Key Studies

Scientific literature on massoia lactone and structurally similar lactone compounds indicates:

- Lactone flavor compounds are generally recognized for low systemic toxicity due to rapid metabolism and excretion

- Sensory evaluation studies confirm the compound's flavor potency, supporting its use at minimal concentrations

- No published research has identified specific safety concerns at levels used in food flavoring applications

- The compound's chemical stability and behavior in food matrices have been characterized in flavor chemistry literature

The absence of published adverse findings, combined with the minimal exposure levels in food applications, supports the practical safety of this ingredient when used according to established flavor industry practices and regulatory guidelines.

Frequently Asked Questions

What is 6-hydroxy-3,7-dimethyloctanoic Acid Lactone?

6-hydroxy-3,7-dimethyloctanoic acid lactone, commonly known as massoia lactone, is a naturally occurring organic compound used as a flavoring agent in food products. It imparts a creamy, coconut-like flavor profile and is derived from or chemically synthesized to replicate compounds found in natural sources.

Is 6-hydroxy-3,7-dimethyloctanoic Acid Lactone safe?

6-hydroxy-3,7-dimethyloctanoic Acid Lactone is currently rated "safe" 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 6-hydroxy-3,7-dimethyloctanoic Acid Lactone banned in any country?

6-hydroxy-3,7-dimethyloctanoic Acid Lactone 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.