Our Verdict: RATING UNKNOWN

3-methyl-gamma-decalactone

CAS67663-01-8

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

3-methyl-gamma-decalactone — food additive

3-methyl-gamma-decalactone is a synthetic flavoring compound used to create fruity, coconut, and creamy notes in food products. It is not currently approved as Generally Recognized as Safe (GRAS) by the FDA, though it has not been associated with adverse events or recalls.

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 3-methyl-gamma-decalactone?

3-methyl-gamma-decalactone (CAS Number: 67663-01-8) is a synthetic organic compound belonging to the lactone family of flavoring agents. Lactones are naturally occurring compounds found in various foods, particularly fruits and dairy products, but this particular compound is chemically synthesized for use as a food flavoring. It is a colorless to pale yellow liquid with characteristic fruity and creamy organoleptic properties.

Common Uses

This flavoring agent is primarily used in the food and beverage industry to create or enhance fruity flavors, particularly coconut and peach notes. It may be incorporated into products such as flavored dairy products, beverages, baked goods, confectionery, and other processed foods where fruity or creamy flavor profiles are desired. As a flavoring agent, it would typically be used in very small concentrations, measured in parts per million (ppm).

Safety Assessment

According to FDA records, 3-methyl-gamma-decalactone has not been associated with any reported adverse events or consumer complaints. Additionally, there are no FDA-documented recalls linked to this additive. The compound has not generated safety concerns significant enough to warrant restrictions in major regulatory jurisdictions.

The absence of adverse event reports and recalls suggests a favorable safety profile in practical use. However, the lack of GRAS status indicates that the FDA has not formally evaluated this compound through the standard GRAS notification process, or that such evaluation has not been completed or accepted.

Regulatory Status

3-methyl-gamma-decalactone does not currently hold GRAS (Generally Recognized as Safe) status with the FDA. This means it cannot be used as a flavoring in foods without prior FDA approval through the food additive petition process, or it may only be permitted under specific regulatory frameworks in certain jurisdictions.

Regulatory approaches to synthetic flavoring agents vary internationally. The European Food Safety Authority (EFSA) and other regulatory bodies maintain separate evaluation processes for flavoring compounds. The regulatory status of this additive should be verified for specific jurisdictions and applications, as approval determinations are product-specific and region-specific.

Key Studies

Published scientific literature on 3-methyl-gamma-decalactone is limited in the public domain. Like many synthetic flavoring compounds, detailed toxicological data may exist in proprietary industry databases or regulatory dossiers not publicly available. The lack of documented adverse events suggests that any safety studies conducted have not identified significant hazards at exposure levels resulting from food use.

For flavoring agents generally, regulatory agencies typically evaluate acute toxicity, chronic toxicity, genotoxicity, and reproductive/developmental toxicity. The specific toxicological profile of 3-methyl-gamma-decalactone would have been or would need to be assessed according to these standard safety parameters if regulatory approval were sought.

Consumers seeking information about products containing this additive should consult product labels and contact manufacturers directly for more detailed information about the specific safety testing and approval status for their intended use.

Frequently Asked Questions

What is 3-methyl-gamma-decalactone?

3-methyl-gamma-decalactone is a synthetic flavoring compound used to create fruity, coconut, and creamy notes in food products. It is not currently approved as Generally Recognized as Safe (GRAS) by the FDA, though it has not been associated with adverse events or recalls.

Is 3-methyl-gamma-decalactone safe?

3-methyl-gamma-decalactone 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 3-methyl-gamma-decalactone banned in any country?

3-methyl-gamma-decalactone 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.