Our Verdict: SAFE

Neroli, Bigarade Oil (citrus Aurantium L.)

CAS8016-38-4

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

Neroli, Bigarade Oil (citrus Aurantium L.) — food additive

Neroli, Bigarade Oil is an essential oil extracted from the bitter orange tree (Citrus aurantium L.) used as a natural flavoring agent in food and beverages. It imparts a distinctive floral, citrus aroma and is commonly found in confectionery, beverages, and baked goods.

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
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 Neroli, Bigarade Oil?

Neroli, Bigarade Oil is an essential oil derived from the flowers and leaves of Citrus aurantium L., commonly known as the bitter orange, sour orange, or Seville orange tree. The oil is obtained through steam distillation or expression of plant material and is characterized by its complex floral and citrus aromatic profile. The CAS number 8016-38-4 identifies this specific botanical extract. The name "neroli" historically refers to oils extracted from orange blossoms, while "bigarade" is another term for bitter orange varieties.

Common Uses

Neroli, Bigarade Oil functions as a flavoring agent and sensory adjuvant in the food industry. Its primary applications include:

- Confectionery and candy products, where it provides distinctive floral-citrus notes

- Alcoholic beverages, including liqueurs and spirits

- Non-alcoholic beverages such as soft drinks and flavored waters

- Baked goods and desserts

- Dairy products including yogurt and ice cream

- Chewing gum and breath fresheners

The oil is valued for its ability to provide authentic bitter orange character without the bitterness that might result from other extraction methods. Typical usage levels are minimal, often in the range of parts per million (ppm), as the oil is highly concentrated in flavor compounds.

Safety Assessment

Neroli, Bigarade Oil has not been formally designated as Generally Recognized as Safe (GRAS) by the FDA for all food applications, though related citrus-derived flavoring ingredients have achieved GRAS status. According to FDA adverse event reporting systems, there are no documented adverse events associated with this additive, and no FDA recalls have been issued for products containing it.

The European Food Safety Authority (EFSA) has evaluated related essential oils and citrus flavoring substances. Citrus aurantium and its derivatives have been used in food for centuries without documented safety concerns in typical culinary quantities. The lack of recorded adverse events combined with historical use suggests a favorable safety profile when used at standard flavoring concentrations.

As with all essential oils, concentrated forms should not be ingested undiluted. However, in the minute quantities used as food flavorings, the risk profile is substantially different. Individual sensitivity to citrus-derived compounds is possible but uncommon.

Regulatory Status

Neroli, Bigarade Oil operates under different regulatory frameworks globally. In the United States, while not designated as GRAS, it may be used under FDA's "Generally Recognized as Safe" provisions for substances with a history of safe use in food, or it may be listed under specific regulations for flavoring substances. The European Union permits citrus flavoring substances, including neroli oil, under specific listings with defined purity and compositional requirements.

The ingredient appears in the International Organization for Standardization (ISO) and European pharmacopoeia standards for essential oils, ensuring quality and composition specifications are met by manufacturers.

Key Studies

Limited peer-reviewed studies specifically address Neroli, Bigarade Oil as a food additive, reflecting its established historical use and favorable safety profile. Published research on Citrus aurantium and its essential oil components has focused primarily on:

- Chemical composition and identification of flavor compounds

- Antimicrobial properties of citrus essential oils (non-food applications)

- Sensory analysis and flavor profile characterization

- Stability of the oil under various storage conditions

The absence of toxicological literature specifically addressing this ingredient reflects the low concern in the regulatory and scientific communities. Broader reviews of citrus-derived flavoring substances by regulatory bodies have consistently found acceptable safety margins at typical food use levels.

Frequently Asked Questions

What is Neroli, Bigarade Oil (citrus Aurantium L.)?

Neroli, Bigarade Oil is an essential oil extracted from the bitter orange tree (Citrus aurantium L.) used as a natural flavoring agent in food and beverages. It imparts a distinctive floral, citrus aroma and is commonly found in confectionery, beverages, and baked goods.

Is Neroli, Bigarade Oil (citrus Aurantium L.) safe?

Neroli, Bigarade Oil (citrus Aurantium 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 Neroli, Bigarade Oil (citrus Aurantium L.) banned in any country?

Neroli, Bigarade Oil (citrus Aurantium 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.