Our Verdict: RATING UNKNOWN

Hesperidin

CAS520-26-3

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

Hesperidin — food additive

Hesperidin is a naturally occurring flavonoid compound found in citrus fruits, used in food products as a flavor enhancer. It is not currently approved by the FDA as a Generally Recognized As Safe (GRAS) food additive in the United States.

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 Hesperidin?

Hesperidin (CAS Number 520-26-3) is a flavonoid glycoside naturally present in citrus fruits, particularly in orange and lemon peels. It consists of the flavonone hesperitin bonded to a disaccharide (rutinose). The compound has a bitter taste characteristic and is extracted or synthesized for use as a flavor enhancer in food and beverage applications. Hesperidin exists in different forms, including the natural glycoside and various derivatives, which may have different functional properties.

Common Uses

Hesperidin is primarily used in the food industry as a flavor enhancer, contributing to the bitter or citrus notes in products. It appears in some beverages, confectionery, and flavoring preparations, particularly those marketed with citrus or natural flavor profiles. The compound is also investigated for use in nutritional supplements and functional foods due to its natural origin from citrus sources. Additionally, hesperidin has been used in cosmetic and pharmaceutical formulations, though food applications remain its primary industrial use.

Safety Assessment

According to FDA records, there have been zero adverse events reported related to hesperidin consumption, and zero recalls have been issued involving this additive. The lack of reported adverse events suggests a generally safe profile at typical usage levels in food applications.

Hesperidin has been studied for potential health benefits in scientific literature, including cardiovascular and antioxidant properties, though such claims fall outside food additive safety evaluation. When evaluating hesperidin purely as a food additive for flavor enhancement purposes, the absence of safety signals in FDA monitoring systems is noteworthy. However, the compound's lack of GRAS status in the United States means it has not undergone the formal FDA review process that would allow its unrestricted use as a food ingredient.

The European Food Safety Authority (EFSA) has evaluated flavonoid compounds including hesperidin-like substances, generally recognizing their presence in traditional food sources at consumption levels considered safe. However, regulatory status varies by jurisdiction and specific application.

Regulatory Status

Hesperidin is not approved by the FDA as a GRAS food additive, which is a significant regulatory distinction. GRAS status requires documented evidence demonstrating that a substance is "generally recognized, among qualified experts, as having been adequately shown to be safe." Without GRAS approval, hesperidin cannot be legally added to foods in the United States without prior FDA approval through a food additive petition.

In the European Union, hesperidin may be used in food applications under different regulatory frameworks depending on the specific product category and intended use. Some countries permit its use in dietary supplements or functional foods under specific conditions.

The regulatory landscape for hesperidin reflects its status as a naturally occurring compound that requires formal safety documentation for food use, despite its long history of presence in citrus fruits consumed by humans.

Key Studies

Scientific research on hesperidin has primarily focused on its bioactive properties rather than food safety. Studies examining absorption, metabolism, and potential physiological effects have been conducted, though these fall outside the scope of additive safety evaluation. The compound's presence in traditional citrus-based foods and beverages has provided extensive human exposure data over centuries.

Any regulatory or safety decisions regarding hesperidin use in food applications should be based on toxicological studies, intended use levels, and evaluation by appropriate regulatory bodies rather than bioactivity research.

Frequently Asked Questions

What is Hesperidin?

Hesperidin is a naturally occurring flavonoid compound found in citrus fruits, used in food products as a flavor enhancer. It is not currently approved by the FDA as a Generally Recognized As Safe (GRAS) food additive in the United States.

Is Hesperidin safe?

Hesperidin 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 Hesperidin banned in any country?

Hesperidin 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.