Our Verdict: SAFE

Luo Han Fruit Concentrate

CAS977188-77-4

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

Luo Han Fruit Concentrate โ€” food additive

Luo Han Fruit Concentrate is a natural flavoring agent derived from the Siraitia grosvenorii plant, commonly known as monk fruit. It is used in food and beverage products primarily to provide sweetness and flavor characteristics.

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 Luo Han Fruit Concentrate?

Luo Han Fruit Concentrate, also referred to as monk fruit concentrate, is an extract derived from the Siraitia grosvenorii plant native to southern China. The fruit has been traditionally used in Chinese cuisine and herbal medicine for centuries. The concentrate is produced through extraction and processing of the fruit's compounds, which contain high levels of glycosidesโ€”non-caloric compounds responsible for the fruit's characteristic sweet taste. The CAS number 977188-77-4 identifies this specific chemical substance in regulatory and scientific databases.

Common Uses

Luo Han Fruit Concentrate functions as a flavoring agent and sweetening adjuvant in various food and beverage applications. It is commonly found in:

- Beverages (teas, juices, and flavored waters)

- Confectionery and desserts

- Dairy products

- Nutritional supplements

- Sugar-free or reduced-calorie food products

The additive serves dual purposes: providing natural flavor characteristics associated with the fruit while contributing sweetness without significant caloric content. This makes it particularly attractive for manufacturers developing reduced-sugar or natural-label products.

Safety Assessment

The safety profile of Luo Han Fruit Concentrate appears favorable based on available data. According to FDA records, there have been zero reported adverse events associated with this additive, and no recalls involving this ingredient have been documented. This historical safety record suggests the ingredient has been used without generating consumer complaints or regulatory concerns in the United States.

The concentrate is derived from a plant with a documented history of use in traditional food applications, which generally supports its safety profile. However, it is important to note that the FDA has not granted this specific ingredient GRAS (Generally Recognized as Safe) status, meaning it has not undergone the formal GRAS affirmation process. This does not indicate the ingredient is unsafe; rather, it reflects the regulatory classification pathway the ingredient has followed or the current status of any formal review.

As with any food additive, individual sensitivities or allergies remain possible, though such reactions appear to be rare based on the absence of reported adverse events.

Regulatory Status

The regulatory classification of Luo Han Fruit Concentrate varies internationally. In the United States, the ingredient is used in food products but operates without formal FDA GRAS certification. This means manufacturers using this ingredient typically operate under FDA's regulatory framework for food additives or use it under the assumption of historical use in food.

The European Union has approved monk fruit extract (E960) as a food additive in specific applications, providing an additional reference point for its regulatory acceptance in developed food markets. Various other countries and regions have similarly evaluated and approved monk fruit-derived ingredients for use in food and beverage products.

Manufacturers using Luo Han Fruit Concentrate should verify compliance with applicable regulations in their specific jurisdictions, as regulatory status can vary by country and product category.

Key Studies

While extensive clinical research on Luo Han Fruit Concentrate specifically is limited, studies on Siraitia grosvenorii and its compounds have been conducted. Research has primarily focused on characterizing the glycosides present in monk fruit and evaluating their organoleptic (taste and flavor) properties. Toxicological studies on the plant and its extracts have generally supported safety profiles.

The absence of reported adverse events in FDA databases, combined with the ingredient's extended use in food applications without documented safety concerns, provides practical evidence supporting continued safe use. Ongoing safety monitoring through the FDA's adverse event reporting system remains standard practice for all food additives.

Frequently Asked Questions

What is Luo Han Fruit Concentrate?

Luo Han Fruit Concentrate is a natural flavoring agent derived from the Siraitia grosvenorii plant, commonly known as monk fruit. It is used in food and beverage products primarily to provide sweetness and flavor characteristics.

Is Luo Han Fruit Concentrate safe?

Luo Han Fruit Concentrate 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 Luo Han Fruit Concentrate banned in any country?

Luo Han Fruit Concentrate 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.