Our Verdict: SAFE

Levulose

CAS57-48-7FDA GRAS

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

Levulose — food additive

Levulose, also known as fructose, is a simple sugar and naturally occurring monosaccharide classified as a nutritive sweetener. It functions as a flavor enhancer, sweetening agent, and processing aid in food formulations, and is recognized as safe by the FDA.

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
ApprovedUK FSA
Canada
ApprovedHealth Canada
Australia
ApprovedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
ApprovedANVISA
China
ApprovedNHC / GB 2760
India
ApprovedFSSAI
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 Levulose?

Levulose (CAS Number 57-48-7) is the systematic chemical name for fructose, a six-carbon monosaccharide (simple sugar) found naturally in fruits, honey, and plant nectar. It is the sweetest of all naturally occurring sugars, approximately 1.2 times sweeter than sucrose (table sugar). In food manufacturing, levulose is produced through enzymatic isomerization of glucose or by hydrolysis of sucrose. The compound exists in two stereoisomeric forms: D-fructose (the naturally occurring form) and L-fructose (rarely used commercially).

Common Uses

Levulose serves multiple functions in the food industry beyond simple sweetening. As a flavor enhancer and flavoring agent, it amplifies and rounds out the taste profiles of beverages, confections, baked goods, and dairy products. Its hygroscopic properties—the ability to absorb and retain moisture—make it valuable as a stabilizer and texturizer in formulations requiring extended shelf life or specific mouthfeel characteristics. The ingredient functions as a processing aid and solvent in various manufacturing applications where its liquid form at room temperature provides advantages over solid sugars. Levulose appears in soft drinks, juices, flavored syrups, jams, confectionery, ice cream, and numerous other processed foods.

Safety Assessment

Levulose has been extensively studied for safety, with no recorded adverse events reported to the FDA and zero recalls attributed to this additive. The FDA granted GRAS (Generally Recognized As Safe) status to levulose, indicating that scientific consensus supports its safety when used as intended in food products. This classification is based on long-standing use in food and substantial scientific evidence.

From a metabolic perspective, levulose is metabolized differently than glucose, primarily in the liver. While fructose has been studied in relation to metabolic health when consumed in high quantities, levulose as a food additive is used in typical serving amounts that do not raise the same concerns associated with excessive dietary fructose intake from concentrated sources. It does not require insulin for cellular uptake, making it relevant for certain diabetic applications, though this does not constitute medical advice.

Allergenic potential is minimal; levulose is a simple sugar and does not trigger the immune responses associated with protein allergens. It is suitable for individuals with celiac disease and most other food allergies.

Regulatory Status

Levulose holds FDA GRAS status for use as a sweetener and flavoring agent in foods. This regulatory designation means it may be legally used in food products without requiring FDA pre-market approval, though manufacturers must ensure compliance with current Good Manufacturing Practices (cGMPs). The ingredient is permitted in the European Union and other major food-regulatory jurisdictions. No jurisdictions have implemented restrictions or bans on levulose used as a food additive.

Key Studies

Scientific literature on fructose/levulose metabolism and safety is extensive. Notable areas of research include absorption kinetics (demonstrating efficient intestinal uptake), enzymatic metabolism pathways, and comparative sweetness profiles. Studies confirm that levulose is well-tolerated at levels used in food formulation. Some individuals with fructose malabsorption may experience digestive discomfort, but this represents a subset of the population rather than a general safety concern with the additive itself. Research on high-dose fructose consumption in controlled studies provides context for understanding the safety of levulose at typical food additive concentrations. The lack of mutagenic or carcinogenic effects in toxicological assessments supports its GRAS status.

Frequently Asked Questions

What is Levulose?

Levulose, also known as fructose, is a simple sugar and naturally occurring monosaccharide classified as a nutritive sweetener. It functions as a flavor enhancer, sweetening agent, and processing aid in food formulations, and is recognized as safe by the FDA.

Is Levulose safe?

Levulose 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 Levulose banned in any country?

Levulose 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.