Our Verdict: RATING UNKNOWN

4,5-dimethyl-3-hydroxy-2,5-dihydrofuran-2-one

CAS28664-35-9

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

4,5-dimethyl-3-hydroxy-2,5-dihydrofuran-2-one — food additive

4,5-dimethyl-3-hydroxy-2,5-dihydrofuran-2-one is a synthetic organic compound used as a flavoring agent in food products. This furan derivative contributes fruity and caramel-like flavor notes to beverages, baked goods, and other 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 4,5-dimethyl-3-hydroxy-2,5-dihydrofuran-2-one?

4,5-dimethyl-3-hydroxy-2,5-dihydrofuran-2-one (CAS 28664-35-9) is a synthetic flavoring compound belonging to the furan family of organic molecules. It features a five-membered ring structure containing oxygen, with specific methyl and hydroxyl substituents that contribute to its sensory properties. This compound is manufactured through chemical synthesis for use as a food flavoring agent.

Common Uses

This flavoring agent is primarily used in the food industry to enhance or impart fruity, caramel, and toasted flavor notes. It may be found in a variety of food applications including:

- Beverages (soft drinks, juices, flavored waters)

- Baked goods and bakery products

- Dairy products (yogurts, flavored milks)

- Confectionery and candy

- Processed snack foods

- Condiments and sauces

The compound is typically used in very small quantities—measured in parts per million—because of its intense flavor profile. Manufacturers use this additive as part of complex flavor formulations to achieve desired taste characteristics.

Safety Assessment

The FDA has received zero adverse event reports associated with this additive, and there have been no product recalls attributed to 4,5-dimethyl-3-hydroxy-2,5-dihydrofuran-2-one. This absence of reported incidents suggests a benign safety profile in actual food use.

As a synthetic flavoring compound, this additive undergoes evaluation based on its chemical structure, intended use level, and toxicological data. The furan family of compounds has varying safety profiles; while some furan derivatives have raised concerns, this particular compound has not been identified as a safety concern by regulatory agencies. The low concentrations used in food—typically 1-10 ppm or less—further reduces potential exposure.

Like other synthetic flavorings, this compound is metabolized and eliminated by the body relatively quickly. No studies have indicated bioaccumulation or chronic toxicity concerns at food use levels.

Regulatory Status

This additive does not have FDA GRAS (Generally Recognized As Safe) status, which means it has not undergone the standard GRAS notification process or received formal FDA approval through a food additive petition. However, the absence of GRAS status does not indicate that a substance is unsafe—rather, it reflects whether formal regulatory pathways have been completed.

In the United States, this flavoring may be used under FDA's flavor regulations if it complies with established guidelines for synthetic flavoring substances. The European Union's food additive regulations and EFSA (European Food Safety Authority) assessments may classify this compound differently based on their evaluation protocols.

The lack of FDA action (no adverse events or recalls) suggests that current use levels have not triggered safety concerns from regulatory monitoring. Food manufacturers using this additive are responsible for ensuring it meets regulatory requirements in their respective markets.

Key Studies

Published scientific literature specifically examining 4,5-dimethyl-3-hydroxy-2,5-dihydrofuran-2-one is limited. Most available data comes from manufacturer technical documents and standard toxicological assessments conducted for regulatory compliance.

Research on structurally similar furan-based flavorings has generally shown low toxicity at food use levels. The compound's chemical stability and rapid metabolism suggest minimal accumulation in body tissues.

As with many synthetic flavoring agents used at very low concentrations, the absence of dedicated safety studies does not necessarily indicate risk—rather, it reflects the historical practice of assuming safety for substances used in minimal amounts without observed adverse effects.

Frequently Asked Questions

What is 4,5-dimethyl-3-hydroxy-2,5-dihydrofuran-2-one?

4,5-dimethyl-3-hydroxy-2,5-dihydrofuran-2-one is a synthetic organic compound used as a flavoring agent in food products. This furan derivative contributes fruity and caramel-like flavor notes to beverages, baked goods, and other processed foods.

Is 4,5-dimethyl-3-hydroxy-2,5-dihydrofuran-2-one safe?

4,5-dimethyl-3-hydroxy-2,5-dihydrofuran-2-one 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 4,5-dimethyl-3-hydroxy-2,5-dihydrofuran-2-one banned in any country?

4,5-dimethyl-3-hydroxy-2,5-dihydrofuran-2-one 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.