Our Verdict: SAFE

4-hydroxy-2,5-dimethyl-3(2h)-furanone

CAS3658-77-3

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-2,5-dimethyl-3(2h)-furanone — food additive

4-hydroxy-2,5-dimethyl-3(2h)-furanone is a synthetic flavoring compound that mimics strawberry and other fruity notes. It is used in very small quantities in food and beverage products to enhance or create fruit flavors.

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-2,5-dimethyl-3(2h)-furanone?

4-hydroxy-2,5-dimethyl-3(2h)-furanone, also known as HDMF or strawberry furanone, is a synthetic organic compound with the CAS number 3658-77-3. This furanone derivative is a colorless to pale yellow liquid or solid that naturally occurs in strawberries and other fruits in trace amounts. The compound has become commercially valuable in the flavor industry due to its potent fruity aroma profile, particularly its strawberry-like character.

The chemical structure of this furanone consists of a five-membered ring containing oxygen, with hydroxyl and dimethyl substituents. This specific molecular configuration is responsible for its distinctive sensory properties and flavor impact.

Common Uses

4-hydroxy-2,5-dimethyl-3(2h)-furanone is primarily used as a flavoring agent in the food and beverage industry. Its applications include:

- Strawberry-flavored beverages and soft drinks

- Dairy products, including yogurts and flavored milks

- Confectionery and candy products

- Baked goods and desserts

- Flavored dessert sauces and toppings

- Nutritional and dietary supplement beverages

The compound is used in extremely small concentrations—typically measured in parts per million (ppm)—to achieve desired flavor profiles. This high potency means that only trace amounts are necessary to impart significant fruity notes to food products.

Safety Assessment

This flavoring compound has not received FDA GRAS (Generally Recognized as Safe) designation. However, this designation status does not necessarily indicate safety concerns; rather, it reflects the submission history and regulatory pathway chosen by manufacturers.

Available safety data for 4-hydroxy-2,5-dimethyl-3(2h)-furanone indicates no reported adverse events associated with its use as a food additive according to FDA records. Additionally, there have been no FDA recalls specifically involving this compound as the causative agent.

The compound has undergone safety evaluations by regulatory agencies in various countries. Some regional regulatory bodies have permitted its use as a flavoring agent based on available toxicological data, though the extent of safety testing varies by jurisdiction. The substance appears in the flavor industry's databases as a recognized flavoring with a long history of use.

As with all synthetic food additives, exposure occurs at extremely low levels through normal food consumption. The concentration and frequency of use are carefully controlled by manufacturers and regulated by food safety authorities.

Regulatory Status

4-hydroxy-2,5-dimethyl-3(2h)-furanone's regulatory status varies globally:

- **United States**: Not on the FDA's GRAS list, but permitted in foods under 21 CFR Part 182 for certain applications as a flavoring agent

- **European Union**: Permitted as a flavoring substance in certain food categories under EU Regulation 1334/2008

- **Other jurisdictions**: Approved in various countries including Canada, Japan, and Australia with specific use limitations

Manufacturers using this ingredient must comply with regional restrictions, maximum use levels, and labeling requirements. Food products containing this flavoring must declare it appropriately in ingredient lists, typically labeled as "natural and artificial flavoring" or "strawberry flavor."

Key Studies

Limited published peer-reviewed research specifically addresses 4-hydroxy-2,5-dimethyl-3(2h)-furanone in isolation, largely because it occurs naturally in foods and is used in trace amounts. Most safety assessments rely on industry-conducted toxicological studies and structural similarity to known safe compounds.

Flavor industry databases document the compound's sensory properties, volatility, and chemical stability. The naturally occurring presence of this compound in strawberries and other fruits has been documented in food chemistry literature, supporting its characterization as a naturally-derived flavoring substance.

Regulatory agency approvals have been based on unpublished safety studies conducted according to standard toxicological protocols.

Frequently Asked Questions

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

4-hydroxy-2,5-dimethyl-3(2h)-furanone is a synthetic flavoring compound that mimics strawberry and other fruity notes. It is used in very small quantities in food and beverage products to enhance or create fruit flavors.

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

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

4-hydroxy-2,5-dimethyl-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.