Our Verdict: SAFE

Roselle (hibiscus Sabdariffa L.)

CAS977017-88-1

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

Roselle (hibiscus Sabdariffa L.) — food additive

Roselle (Hibiscus sabdariffa L.) is a plant-derived flavoring agent extracted from the hibiscus flower, commonly used to impart tart, cranberry-like flavor notes to beverages and food products. It is not currently on the FDA's GRAS (Generally Recognized As Safe) list but has no documented adverse events or recalls.

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
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
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 Roselle?

Roselle, scientifically known as Hibiscus sabdariffa L., is a tropical plant whose dried calyces (the leafy structure surrounding the flower) are used as a natural flavoring agent in the food industry. The plant is native to West Africa and is cultivated in tropical and subtropical regions worldwide. The extract produces a deep red color and distinctive tart, slightly acidic flavor profile reminiscent of cranberry or pomegranate. It has been used traditionally in beverages, teas, and food products for centuries, particularly in African, Caribbean, and Asian cuisines.

Common Uses

Roselle is primarily used in the beverage industry to flavor teas, juices, cordials, and ready-to-drink products. The ingredient provides both flavor and natural color to products, making it attractive to manufacturers seeking clean-label solutions. It appears in functional beverages marketed for their natural properties. Beyond beverages, roselle flavoring may be incorporated into desserts, jams, sauces, and confectionery products. The ingredient is particularly popular in natural and organic product formulations due to its botanical origin.

Safety Assessment

Roselle has an established history of traditional use in food and beverage applications across multiple cultures. The FDA's adverse event reporting system contains zero documented adverse events associated with roselle consumption through food products. Similarly, no FDA recalls have been issued for products containing roselle as a flavoring agent. The ingredient contains naturally occurring compounds including anthocyanins, flavonoids, and organic acids, which are characteristic of many plant-derived foods and beverages already in common consumption.

Toxicological data on roselle extract is limited compared to synthetic flavoring agents. Available safety literature does not indicate significant concerns at typical food use levels. Some studies have examined roselle's phytochemical composition and potential bioactive properties, but these do not represent safety concerns in the context of food flavoring applications at normal consumption levels.

Regulatory Status

Roselle is not on the FDA's GRAS (Generally Recognized As Safe) list for use as a flavoring agent, which means it has not undergone the formal GRAS notification process. However, this does not indicate the ingredient is unsafe; rather, it reflects that a formal GRAS petition has not been submitted or accepted. The ingredient is permitted in foods in several countries and is listed in various international food ingredient databases. In the European Union, similar hibiscus-derived ingredients are permitted for use in food applications. Manufacturers using roselle flavoring in the United States must comply with FDA regulations for food additives, and the ingredient should be listed by its common name on product labels.

Key Studies

Research on roselle has primarily focused on its phytochemical composition and potential biological activities rather than safety assessment. Studies have characterized the anthocyanin and polyphenol content of hibiscus extracts. A 2016 review in the Journal of Functional Foods examined the traditional uses and chemical composition of Hibiscus sabdariffa without identifying safety concerns relevant to food use. Traditional use data spanning multiple decades across different populations supports the safety profile at typical consumption levels in beverages and flavored foods. However, comprehensive toxicological safety studies specific to food-grade roselle extract at regulatory levels would strengthen the evidence base.

Frequently Asked Questions

What is Roselle (hibiscus Sabdariffa L.)?

Roselle (Hibiscus sabdariffa L.) is a plant-derived flavoring agent extracted from the hibiscus flower, commonly used to impart tart, cranberry-like flavor notes to beverages and food products. It is not currently on the FDA's GRAS (Generally Recognized As Safe) list but has no documented adverse events or recalls.

Is Roselle (hibiscus Sabdariffa L.) safe?

Roselle (hibiscus Sabdariffa L.) 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 Roselle (hibiscus Sabdariffa L.) banned in any country?

Roselle (hibiscus Sabdariffa L.) 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.