Our Verdict: RATING UNKNOWN

4-hydroxy-3-pentenoic Acid Lactone

CAS591-12-8

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

4-hydroxy-3-pentenoic Acid Lactone โ€” food additive

4-hydroxy-3-pentenoic acid lactone (also known as mevalonolactone) is a naturally occurring organic compound used as a flavoring agent in food products. It is not currently approved as a GRAS substance by the FDA, though it has not been associated with adverse events or recalls in the United States.

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-3-pentenoic Acid Lactone?

4-hydroxy-3-pentenoic acid lactone, identified by CAS number 591-12-8, is a lactoneโ€”a cyclic ester formed from a hydroxyl acid. This compound occurs naturally in small quantities in various foods and is structurally related to mevalonic acid, an intermediate in cholesterol biosynthesis. The chemical is a colorless to pale yellow liquid with a characteristic fruity odor, making it useful in flavor applications.

Common Uses

This additive functions as a flavoring agent or flavoring adjuvant in food products. It is primarily used in the fragrance and flavoring industries to impart fruity, buttery, or creamy notes to foods and beverages. Due to its aromatic properties, it may appear in products such as dairy foods, baked goods, candies, and flavored beverages. The compound is sometimes used in combination with other flavoring agents to create complex flavor profiles.

Safety Assessment

As of current records, the FDA has not received any adverse event reports associated with 4-hydroxy-3-pentenoic acid lactone, and no recalls involving this substance have been documented. This absence of reported safety incidents suggests the compound has not raised acute safety concerns in the U.S. food supply. However, the lack of adverse reports does not constitute a formal safety approval or comprehensive safety assessment.

The compound's safety profile would be informed by its chemical structure and metabolism. As a lactone related to naturally occurring metabolites, it may undergo hydrolysis in the digestive system. Limited published toxicological data is available specifically for this substance, which is not uncommon for minor flavoring agents used in small quantities.

Regulatory Status

4-hydroxy-3-pentenoic acid lactone has not been approved as a GRAS (Generally Recognized As Safe) substance by the FDA. This classification does not indicate the substance is unsafe; rather, it has not undergone or completed the FDA's GRAS determination process. GRAS status requires either prior sanctioning, extensive use history demonstrating safety, or submission of a GRAS notice supported by scientific evidence.

The compound may be used in the United States under FDA regulations for flavoring substances that are used in accordance with good manufacturing practices, but the lack of GRAS designation means it operates under different regulatory oversight than GRAS-approved flavorings. Some regulatory databases and international food authorities may list this substance differently based on regional approval status.

Key Studies

Published scientific literature specifically on 4-hydroxy-3-pentenoic acid lactone toxicity or metabolism is limited in the public domain. Most safety information for minor flavoring agents of this type comes from structure-activity relationship assessments rather than dedicated human studies. The broader lactone class of compounds has been studied for safety in food applications, and many lactones are recognized as safe flavoring ingredients.

The absence of adverse event reports and recalls in the FDA database over decades of potential use suggests that if this substance is employed in food products, it has not generated consumer safety concerns requiring regulatory action. Flavor manufacturers typically conduct safety assessments based on intended use levels, which for flavoring agents are generally very low (parts per million).

For additional information about this or other food additives, consult the FDA's Code of Federal Regulations (CFR), specifically Title 21 sections covering food additives and flavoring regulations.

Frequently Asked Questions

What is 4-hydroxy-3-pentenoic Acid Lactone?

4-hydroxy-3-pentenoic acid lactone (also known as mevalonolactone) is a naturally occurring organic compound used as a flavoring agent in food products. It is not currently approved as a GRAS substance by the FDA, though it has not been associated with adverse events or recalls in the United States.

Is 4-hydroxy-3-pentenoic Acid Lactone safe?

4-hydroxy-3-pentenoic Acid 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-3-pentenoic Acid Lactone banned in any country?

4-hydroxy-3-pentenoic Acid 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.