Our Verdict: RATING UNKNOWN

4-hydroxy-4-methyl-5-hexenoic Acid Gamma Lactone

CAS1073-11-6

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

4-hydroxy-4-methyl-5-hexenoic Acid Gamma Lactone — food additive

4-hydroxy-4-methyl-5-hexenoic acid gamma lactone is a naturally-derived flavoring compound used to impart fruity, creamy, and coconut-like notes in food and beverage products. It functions as a flavoring agent or adjuvant in processed foods.

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-4-methyl-5-hexenoic Acid Gamma Lactone?

4-hydroxy-4-methyl-5-hexenoic acid gamma lactone is an organic compound classified as a gamma lactone, a type of cyclic ester. It is identified by CAS Number 1073-11-6 and belongs to the broader category of naturally-derived or nature-identical flavoring compounds. The compound features a six-membered lactone ring with a hydroxyl group and a methyl substituent, along with an unsaturated hexenoic side chain. These structural characteristics contribute to its sensory properties in food applications.

Common Uses

This gamma lactone functions primarily as a flavoring agent in the food industry. It is typically used in small quantities to enhance or create specific flavor profiles in processed foods and beverages. Common applications include dairy products, baked goods, confectionery, beverages, and other processed foods where fruity, creamy, or coconut-like flavor notes are desired. The compound's volatility and chemical structure make it suitable for flavor formulations where sustained aroma and taste are important. As with most flavoring compounds, it is used at levels well below those that would pose safety concerns.

Safety Assessment

According to FDA records, there have been zero adverse events reported in connection with this additive and zero product recalls associated with it. The compound has not been formally listed as Generally Recognized as Safe (GRAS) by the FDA, which means it has not undergone the specific FDA GRAS notification process. However, the absence of reported adverse events and recalls indicates that it has not been linked to safety concerns in actual food use.

The lack of GRAS status does not necessarily indicate unsafe use; rather, it reflects that the compound may not have been formally petitioned through the FDA's GRAS process or may fall under other regulatory frameworks. Many flavoring compounds function in the food supply without formal GRAS status, operating under FDA regulations for food additives or under the purview of the Flavor and Extract Manufacturers' Association (FEMA) GRAS program.

As a gamma lactone, this compound belongs to a chemical class that has been extensively studied. Gamma lactones are naturally occurring compounds found in fruits, dairy products, and other foods, which contributes to their general acceptance in food applications.

Regulatory Status

The regulatory status of 4-hydroxy-4-methyl-5-hexenoic acid gamma lactone varies by jurisdiction. In the United States, while not FDA-listed as GRAS, it appears in use in food products and has not been prohibited. In the European Union, it may be evaluated under the general framework for flavoring compounds. Food manufacturers typically use this compound in compliance with applicable regulations in their respective markets, using it at levels consistent with standard flavoring practices.

The compound's CAS Number (1073-11-6) allows for precise identification and tracking in scientific literature and regulatory databases.

Key Studies

While specific peer-reviewed studies focused exclusively on this compound are limited in public databases, gamma lactones as a chemical class have been the subject of flavor chemistry and safety research. Scientific literature on structurally similar gamma lactones indicates that these compounds are generally metabolized efficiently and do not accumulate in body tissues when consumed in typical food amounts.

The safety profile of gamma lactones has been examined in flavor toxicology research, with findings supporting their use as food flavoring agents. The absence of reported adverse events in FDA databases and the compound's use in commercial food products suggest practical safety in food applications at typical flavoring levels.

Frequently Asked Questions

What is 4-hydroxy-4-methyl-5-hexenoic Acid Gamma Lactone?

4-hydroxy-4-methyl-5-hexenoic acid gamma lactone is a naturally-derived flavoring compound used to impart fruity, creamy, and coconut-like notes in food and beverage products. It functions as a flavoring agent or adjuvant in processed foods.

Is 4-hydroxy-4-methyl-5-hexenoic Acid Gamma Lactone safe?

4-hydroxy-4-methyl-5-hexenoic Acid Gamma Lactone 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 4-hydroxy-4-methyl-5-hexenoic Acid Gamma Lactone banned in any country?

4-hydroxy-4-methyl-5-hexenoic 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.