Our Verdict: RATING UNKNOWN

2-(2-hydroxy-4-methyl-3-cyclohexenyl)propionic Acid Gamma-lactone

CAS57743-63-2

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

2-(2-hydroxy-4-methyl-3-cyclohexenyl)propionic Acid Gamma-lactone — food additive

2-(2-hydroxy-4-methyl-3-cyclohexenyl)propionic Acid Gamma-lactone is a synthetic flavoring compound used to impart fruity and woody notes to food products. It functions as a flavoring agent or adjuvant in various food applications.

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 2-(2-hydroxy-4-methyl-3-cyclohexenyl)propionic Acid Gamma-lactone?

2-(2-hydroxy-4-methyl-3-cyclohexenyl)propionic Acid Gamma-lactone, identified by CAS Number 57743-63-2, is a synthetic organic compound belonging to the lactone family of flavor compounds. Lactones are naturally occurring and synthetically produced chemicals that contribute fruity, woody, and creamy flavor notes to foods and beverages. This particular compound is characterized by a cyclohexenyl ring structure with hydroxyl and methyl substituents, which contribute to its distinctive sensory properties.

Common Uses

This flavoring agent is utilized in the food and beverage industry to enhance flavor profiles in various products. It is typically employed in small concentrations to impart subtle fruity and woody undertones. Common applications may include beverages, confectionery, baked goods, and other processed foods where complex flavor development is desired. As with most synthetic flavoring agents, the actual usage is determined by achieving the desired sensory outcome while maintaining regulatory compliance.

Safety Assessment

The safety profile of this additive is characterized by limited but available data. According to FDA records, there have been zero reported adverse events associated with this compound, and no food recalls have been initiated due to safety concerns related to its use. This suggests that at current usage levels in food applications, the compound has not demonstrated acute or chronic safety issues in the consumer population.

However, it is important to note that this compound is not listed on the FDA's Generally Recognized as Safe (GRAS) list. This designation does not indicate that the substance is unsafe; rather, it reflects that the additive has not undergone the GRAS notification process or that sufficient consensus among qualified experts has not been formally established through this particular regulatory pathway. The absence of GRAS status may indicate limited submission of safety data to the FDA through formal channels, or that the compound may be used under FDA regulations as a permitted food additive through other approval mechanisms.

Regulatory Status

The regulatory status of this flavoring agent varies by jurisdiction. In the United States, flavoring agents are regulated under 21 CFR Part 182 and other applicable sections. The compound's regulatory pathway suggests it may be permitted for use as a flavoring agent, though the specific allowable uses and concentration limits would be defined by applicable regulations and any relevant FDA guidance.

In the European Union, flavoring substances are regulated under Regulation (EC) No 1334/2008, which maintains a positive list of approved flavorings. The presence or absence of this compound on such lists would determine its legality in EU food products. Manufacturers using this flavoring agent must ensure compliance with regulations in all markets where their products are distributed.

Key Studies

Scientific literature on this specific compound is limited in the public domain. Most data regarding lactone-type flavoring compounds derives from broader studies on synthetic flavor safety and metabolism. General toxicological studies on structurally similar lactone compounds have not identified significant safety concerns at typical usage levels in food applications.

The lack of reported adverse events and recalls provides practical evidence of safety under current usage conditions. Manufacturers and regulatory bodies typically rely on both historical use data and any proprietary safety assessments submitted during product registration or approval processes.

As with all food additives, responsible use at levels necessary to achieve intended flavor effects remains the standard practice in food manufacturing.

Frequently Asked Questions

What is 2-(2-hydroxy-4-methyl-3-cyclohexenyl)propionic Acid Gamma-lactone?

2-(2-hydroxy-4-methyl-3-cyclohexenyl)propionic Acid Gamma-lactone is a synthetic flavoring compound used to impart fruity and woody notes to food products. It functions as a flavoring agent or adjuvant in various food applications.

Is 2-(2-hydroxy-4-methyl-3-cyclohexenyl)propionic Acid Gamma-lactone safe?

2-(2-hydroxy-4-methyl-3-cyclohexenyl)propionic 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 2-(2-hydroxy-4-methyl-3-cyclohexenyl)propionic Acid Gamma-lactone banned in any country?

2-(2-hydroxy-4-methyl-3-cyclohexenyl)propionic 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.