Our Verdict: RATING UNKNOWN

4-hydroxy-5-methyl-3(2h)-furanone

CAS19322-27-1

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-5-methyl-3(2h)-furanone — food additive

4-hydroxy-5-methyl-3(2h)-furanone is a naturally-derived organic compound used as a flavoring agent to provide fruity, strawberry-like notes in food and beverages. It enhances taste profiles in various processed foods and is structurally similar to compounds found in fruits.

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
ApprovedHealth 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-5-methyl-3(2h)-furanone?

4-hydroxy-5-methyl-3(2h)-furanone, also known as EHMF or strawberry furanone, is an organic heterocyclic compound classified as a flavoring agent. With CAS number 19322-27-1, this compound features a furanone ring structure with hydroxyl and methyl functional groups. It is structurally related to natural flavor compounds found in fruits, particularly strawberries, though it is typically synthesized for commercial use rather than extracted directly from fruit sources.

Common Uses

This flavoring agent is utilized primarily in the food and beverage industry to impart fruity, sweet, and strawberry-like flavor characteristics. Common applications include:

- Fruit-flavored beverages and soft drinks

- Yogurt and dairy products

- Confectionery and candy

- Baked goods and desserts

- Nutritional supplements and functional foods

- Ice cream and frozen desserts

The compound is valued for its ability to enhance fruity flavor profiles at low concentration levels, requiring only small amounts to achieve the desired sensory effect in finished products.

Safety Assessment

According to FDA records, there have been zero adverse events reported associated with 4-hydroxy-5-methyl-3(2h)-furanone and zero product recalls linked to this additive. The compound has not generated significant safety concerns in regulatory databases.

Toxicological data on this compound is limited in publicly available literature. Like many synthetic flavoring agents, safety assessments typically evaluate acute toxicity, chronic toxicity, genotoxicity, and potential reproductive effects. The limited adverse event history suggests that at levels used in food applications, this compound has not demonstrated notable toxicological effects in consumer populations.

The absence of FDA GRAS (Generally Recognized as Safe) status indicates that this additive has not undergone the formal GRAS notification process or received an affirmative GRAS determination. This does not necessarily indicate safety concerns; rather, it reflects the regulatory pathway chosen by manufacturers and the extent of safety documentation submitted to FDA.

Regulatory Status

4-hydroxy-5-methyl-3(2h)-furanone is not listed on the FDA's GRAS list, meaning it does not have the formal determination that experts generally recognize it as safe for its intended use. However, it may be used in foods under the Food Additive Amendment if it has been approved through the food additive petition process or under relevant regulations for flavoring substances.

In the European Union, this compound may be listed among approved flavoring substances under Regulation (EC) No 1334/2008, which establishes rules for flavoring agents in foods. Regulatory status can vary by country and region, and manufacturers must ensure compliance with local food additive regulations in markets where they distribute products containing this ingredient.

The compound's regulatory history shows no bans or restrictions in major regulatory jurisdictions, and it continues to be available for use in flavoring applications where regulations permit.

Key Studies

Published scientific literature on 4-hydroxy-5-methyl-3(2h)-furanone is relatively limited compared to more extensively studied food additives. Available research has focused on:

- Flavor chemistry and sensory characteristics of the compound

- Synthesis methods and industrial production

- Stability of the compound in various food matrices

- Comparative flavor profiles with natural fruit compounds

The lack of extensive toxicological literature may reflect both the limited use history and the general safety profile of synthetic flavoring agents in this chemical class. Additional safety data may exist in manufacturer submissions to regulatory agencies that are not publicly available.

Frequently Asked Questions

What is 4-hydroxy-5-methyl-3(2h)-furanone?

4-hydroxy-5-methyl-3(2h)-furanone is a naturally-derived organic compound used as a flavoring agent to provide fruity, strawberry-like notes in food and beverages. It enhances taste profiles in various processed foods and is structurally similar to compounds found in fruits.

Is 4-hydroxy-5-methyl-3(2h)-furanone safe?

4-hydroxy-5-methyl-3(2h)-furanone 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-5-methyl-3(2h)-furanone banned in any country?

4-hydroxy-5-methyl-3(2h)-furanone 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.