Our Verdict: RATING UNKNOWN

Gamma-valerolactone

CAS108-29-2

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-valerolactone — food additive

Gamma-valerolactone (CAS 108-29-2) is a cyclic ester compound used as a flavoring agent and flavor adjuvant in food products. It contributes fruity and creamy taste notes to beverages, dairy products, and confectionery items.

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
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
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-valerolactone?

Gamma-valerolactone, also known as 5-methyl-2(3H)-furanone or γ-valerolactone, is a naturally occurring organic compound belonging to the lactone family of chemicals. With the CAS number 108-29-2, it is a cyclic ester that exists as a colorless to pale yellow liquid. The compound has a distinctive fruity aroma reminiscent of apples, strawberries, and other berries, making it valuable in the flavor industry.

Common Uses

Gamma-valerolactone is primarily employed as a flavoring agent and flavor adjuvant in the food and beverage industry. It appears in formulations for:

- Fruit-flavored beverages and soft drinks

- Dairy products including yogurts and flavored milk

- Confectionery and candy products

- Baked goods and desserts

- Ice cream and frozen desserts

Typical usage levels are minimal, measured in parts per million (ppm), as the compound is highly potent and only small quantities are needed to achieve desired flavor profiles. It is often used in combination with other flavoring agents to create complex taste experiences.

Safety Assessment

Gamma-valerolactone has not received GRAS (Generally Recognized as Safe) status from the FDA, meaning it has not undergone the formal GRAS determination process. However, this absence of formal GRAS status does not inherently indicate safety concerns. The compound may be used under FDA authorization through Food Additive Petitions or under other regulatory frameworks, or it may be employed in jurisdictions with different regulatory approval pathways.

According to available FDA records, there are zero documented adverse events associated with gamma-valerolactone and zero product recalls linked to this substance. This absence of reported safety incidents suggests the additive has not generated consumer health concerns in reported use.

The compound's flavor potency and intended use at very low concentrations mean that human dietary exposure is minimal. The small quantities employed in food products, combined with the absence of adverse event reports, indicate a favorable safety profile in practical food applications.

Regulatory Status

Gamma-valerolactone's regulatory status varies by jurisdiction. In the United States, while it lacks GRAS status, it may be used as a food additive under FDA regulations if it meets applicable requirements or has been approved through appropriate regulatory channels. In the European Union, lactone-based flavoring compounds are evaluated by the European Food Safety Authority (EFSA) and may appear on approved flavor lists depending on their specific approval status.

The lack of GRAS status should not be interpreted as prohibition; rather, it indicates the compound has not undergone or completed the GRAS determination process with the FDA. Food manufacturers using this ingredient should ensure compliance with all applicable regulations in their specific markets.

Key Studies

Scientific literature on gamma-valerolactone is limited compared to more widely-used additives, reflecting its specialized role in flavor chemistry. Available research has focused on:

- Chemical characterization and flavor properties

- Sensory evaluation and threshold detection levels

- Stability under various processing conditions

- Interaction with other flavor compounds

The absence of published toxicology studies in mainstream databases, combined with zero FDA adverse events and recalls, suggests this compound has not raised sufficient safety concerns to warrant intensive regulatory scrutiny or independent research initiatives. For substances used at extremely low concentrations with no history of problems, comprehensive toxicological data may not be prioritized.

Frequently Asked Questions

What is Gamma-valerolactone?

Gamma-valerolactone (CAS 108-29-2) is a cyclic ester compound used as a flavoring agent and flavor adjuvant in food products. It contributes fruity and creamy taste notes to beverages, dairy products, and confectionery items.

Is Gamma-valerolactone safe?

Gamma-valerolactone 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-valerolactone banned in any country?

Gamma-valerolactone 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.