Our Verdict: RATING UNKNOWN

Nootkatone

CAS4674-50-4

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

Nootkatone — food additive

Nootkatone is a naturally occurring organic compound classified as a flavoring agent used to impart grapefruit and citrus notes to food and beverages. It is derived from grapefruit peel and other botanical sources, and is used in very small quantities to enhance flavor profiles in commercial food products.

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
ApprovedHealth 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 Nootkatone?

Nootkatone (CAS Number: 4674-50-4) is a sesquiterpene ketone, an organic compound naturally found in grapefruit peel, other citrus fruits, and various plants. It is characterized by its distinctive grapefruit aroma and flavor profile. The compound can be isolated from natural sources or synthesized chemically for use in food and beverage applications. Nootkatone is colorless to pale yellow and belongs to the class of flavoring agents used in the food industry to enhance or modify taste and aroma.

Common Uses

Nootkatone is primarily used as a flavoring agent in the food and beverage industry. Its applications include:

- Flavoring in soft drinks and beverages, particularly those seeking citrus or grapefruit notes

- Ingredient in alcoholic beverages and spirits

- Component in flavored food products

- Use in confectionery and desserts

Because nootkatone provides a characteristic grapefruit flavor, it allows manufacturers to create or enhance grapefruit taste without using large quantities of actual grapefruit juice or concentrate. It is used in minimal quantities—typically measured in parts per million (ppm)—to achieve the desired flavor impact.

Safety Assessment

Nootkatone has been evaluated for safety in food applications. The FDA has not granted GRAS (Generally Recognized As Safe) status to nootkatone, meaning it has not undergone the formal GRAS notification process. However, this does not indicate the substance is unsafe; rather, it reflects that formal GRAS documentation or approval was not pursued through FDA channels.

According to FDA records, there have been zero reported adverse events associated with nootkatone consumption and zero product recalls linked to this ingredient. This absence of reported safety incidents suggests a benign safety profile in the context of food use.

The compound has been studied for potential insecticidal and other biological properties, with some research indicating activity against certain arthropods. However, these research findings relate to concentrated forms and do not apply to the trace quantities used in food flavoring applications.

Toxicological data on nootkatone is limited but has not revealed significant concerns at the exposure levels typical in food use. Most flavoring compounds in this chemical class are considered relatively safe when used at appropriate concentrations in food products.

Regulatory Status

Nootkatone's regulatory status varies globally:

- **United States (FDA)**: Not GRAS-designated, but permitted for use as a flavoring agent under FDA regulations for food additives. No specific restrictions have been implemented.

- **European Union (EFSA)**: Nootkatone may be regulated under the Flavouring Regulation (EC) 1334/2008, depending on classification and use levels.

- **International**: Accepted in various countries as a flavoring ingredient, though regulatory frameworks differ by jurisdiction.

Manufacturers using nootkatone must ensure compliance with local regulations regarding flavoring agents and food additives in their target markets.

Key Studies

Research on nootkatone has primarily focused on:

- Isolation and characterization studies from natural sources like grapefruit

- Chemical synthesis methods for commercial production

- Sensory and organoleptic properties for flavor applications

- Biological activity studies examining insecticidal properties (conducted at concentrations far exceeding food use levels)

The published literature on nootkatone toxicity in food-relevant contexts is limited, which contributes to its "unknown" regulatory classification in some jurisdictions. However, the absence of reported adverse events and the long history of use in flavor applications suggest an acceptable safety margin for typical food use.

Frequently Asked Questions

What is Nootkatone?

Nootkatone is a naturally occurring organic compound classified as a flavoring agent used to impart grapefruit and citrus notes to food and beverages. It is derived from grapefruit peel and other botanical sources, and is used in very small quantities to enhance flavor profiles in commercial food products.

Is Nootkatone safe?

Nootkatone 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 Nootkatone banned in any country?

Nootkatone 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.