Our Verdict: SAFE

4-hydroxy-2-butenoic Acid Gamma-lactone

CAS497-23-4

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

4-hydroxy-2-butenoic Acid Gamma-lactone — food additive

4-hydroxy-2-butenoic acid gamma-lactone, also known as gamma-butyrolactone or GBL, is a naturally occurring organic compound used as a flavoring agent in food products. It imparts buttery, creamy, and caramel-like flavor notes to various foods and beverages.

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 4-hydroxy-2-butenoic Acid Gamma-lactone?

4-hydroxy-2-butenoic acid gamma-lactone (CAS Number: 497-23-4) is a five-membered cyclic ester, commonly known as gamma-butyrolactone or GBL. It is a naturally occurring compound found in small quantities in fermented foods, aged spirits, and some fruits. The substance is a clear, colorless liquid with a characteristic pleasant odor. In food applications, it functions as a flavoring agent or flavoring adjuvant, contributing to the sensory profile of finished food products.

Common Uses

This compound is primarily used in the food and beverage industry as a flavoring component. It is employed in formulations for:

- Dairy products (yogurts, cheese flavoring)

- Baked goods and confectionery

- Beverages (both alcoholic and non-alcoholic)

- Condiments and sauces

- Flavor concentrates and compounds

The additive is valued for its ability to enhance and round out flavor profiles, particularly contributing buttery, creamy, and subtle caramel notes. It is typically used in very small quantities, measured in parts per million (ppm), to achieve the desired sensory effect without overwhelming other flavor components.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with 4-hydroxy-2-butenoic acid gamma-lactone, and zero recalls have been linked to this substance. This absence of reported safety issues suggests a favorable safety profile when used as intended in food applications.

The compound is used at extremely low concentrations in food, which is consistent with its classification as a flavoring agent. The low use levels and limited exposure represent important factors in the overall safety assessment. Toxicological studies on structurally related compounds and similar flavoring substances provide a basis for confidence in its safety at food-use concentrations.

It is important to note that while this substance has been used in food flavoring applications, its regulatory status varies by jurisdiction. The presence of zero adverse events and recalls in FDA databases indicates that reported uses have not raised safety concerns in the United States food supply.

Regulatory Status

This substance does not currently hold GRAS (Generally Recognized as Safe) status with the FDA for its use as a flavoring agent. GRAS status requires either a history of safe use before 1958 or substantial scientific evidence demonstrating safety. The absence of GRAS status does not indicate a safety concern; rather, it reflects the regulatory pathway and historical classification of this flavoring ingredient.

The compound may be used in food products under FDA regulations governing flavoring substances and adjuvants (21 CFR 182.60), provided manufacturers comply with established use limitations and good manufacturing practices. Regulatory oversight varies internationally, with different acceptance levels across the European Union, Japan, and other jurisdictions.

Manufacturers using this ingredient must ensure proper labeling and compliance with local regulations regarding flavoring substances and declaration requirements.

Key Studies

Limited published literature specifically addresses this individual flavoring compound. However, the safety profile of structurally similar lactone compounds and established data on gamma-butyrolactone derivatives support its use as a minor food flavoring component. The compound's use at trace levels in food applications, combined with zero reported adverse events in FDA records, indicates that current food uses have not raised toxicological concerns.

Toxicological assessment of related compounds and the historical use of similar lactone-based flavorings in food provide supporting evidence for the safety of this substance at food-use concentrations. The absence of specific regulatory restrictions or warnings in FDA databases further supports its continued acceptable use in food flavoring applications.

Frequently Asked Questions

What is 4-hydroxy-2-butenoic Acid Gamma-lactone?

4-hydroxy-2-butenoic acid gamma-lactone, also known as gamma-butyrolactone or GBL, is a naturally occurring organic compound used as a flavoring agent in food products. It imparts buttery, creamy, and caramel-like flavor notes to various foods and beverages.

Is 4-hydroxy-2-butenoic Acid Gamma-lactone safe?

4-hydroxy-2-butenoic Acid Gamma-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 4-hydroxy-2-butenoic Acid Gamma-lactone banned in any country?

4-hydroxy-2-butenoic Acid Gamma-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.