# Orange Peel, Bitter, Oil (citrus Aurantium L.)

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**Safety rating:** SAFE
**CAS number:** 68916-04-1
**Category:** flavoring
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

Orange peel bitter oil (Citrus aurantium L.) is a natural flavoring extract derived from bitter orange peels, used to impart citrus flavor to food and beverages. It is not approved as a GRAS substance by the FDA but has no documented adverse events or recalls in the regulatory database.

## Regulatory status

| Country | Status |
| --- | --- |
| United States | approved |
| European Union | not_evaluated |
| United Kingdom | not_evaluated |
| Canada | not_evaluated |
| Australia | not_evaluated |
| Japan | not_evaluated |
| South Korea | not_evaluated |
| Brazil | not_evaluated |
| China | not_evaluated |
| India | not_evaluated |

## Detailed analysis

## What is Orange Peel, Bitter, Oil?

Orange peel bitter oil is an essential oil extracted from the peel of bitter oranges (Citrus aurantium L.), also known as Seville oranges or sour oranges. The oil is obtained through mechanical pressing or steam distillation of the dried peel material. This natural flavoring agent contains volatile compounds including limonene, myrcene, and other terpenes that contribute to its characteristic bitter citrus aroma and taste profile. The CAS number 68916-04-1 identifies this specific botanical ingredient in chemical databases.

## Common Uses

Orange peel bitter oil is primarily used as a flavoring agent in food and beverage manufacturing. Common applications include:

- Alcoholic beverages, particularly liqueurs and bitters
- Non-alcoholic beverages and soft drinks
- Confectionery and candies
- Baked goods and desserts
- Flavoring compounds and food additives
- Herbal and functional beverages

The bitter profile distinguishes this ingredient from sweet orange oil, making it valuable for applications where a more complex, mature citrus flavor is desired. Typical usage levels are low, as the potent flavor requires minimal quantities for desired effect.

## Safety Assessment

According to FDA data, there are zero documented adverse events or product recalls associated with orange peel bitter oil. The absence of regulatory action or safety concerns suggests a generally recognized safety profile when used as a flavoring agent.

As a natural botanical extract, orange peel bitter oil contains compounds that have been consumed traditionally in citrus-producing regions for centuries. Limonene, its primary volatile component, is widely recognized in the food industry and has been studied for safety in flavoring applications. However, it should be noted that essential oils are concentrated extracts and should not be confused with whole fruit consumption.

Persons with citrus sensitivities or those taking specific medications that interact with citrus compounds should be aware that concentrated citrus oils may trigger reactions more readily than fresh fruit. Some individuals may experience photosensitivity when applying citrus oils to skin, though this is less relevant for internal food use.

## Regulatory Status

Orange peel bitter oil is not FDA-approved as a GRAS (Generally Recognized As Safe) substance, meaning it has not undergone the formal GRAS notification process. However, the absence of GRAS status does not indicate the substance is unsafe; rather, it indicates the manufacturer has not submitted a GRAS determination petition to the FDA or the petition was not accepted.

In the European Union, orange peel oil bitter is listed in the Register of Flavoring Substances. The EFSA (European Food Safety Authority) has evaluated citrus peel oils, and they are permitted in food products in member states under specific conditions and use levels.

Manufacturers using this ingredient in FDA-regulated products are responsible for ensuring its safety and proper labeling. It may be declared as "natural flavor" or "orange oil" on ingredient lists, depending on regulatory and labeling guidelines.

## Key Studies

While specific peer-reviewed studies on bitter orange peel oil as a food additive are limited, related research on Citrus aurantium and its constituents provides relevant safety context:

- Studies on limonene and other orange oil components have been conducted by flavor and extract manufacturers for safety assessments.
- Traditional use of bitter orange peel in culinary and medicinal applications across Mediterranean and Asian cuisines provides historical safety data.
- EFSA evaluations of citrus peel oils have examined composition, use levels, and potential hazards, supporting their use in food applications at typical flavoring concentrations.

The lack of adverse event reports in FDA databases and regulatory acceptance in multiple jurisdictions suggest this ingredient has an established safety record when used appropriately as a flavoring agent.

## Sources

- FDA Substances Added to Food (CFSAN)
- OpenFDA Adverse Event Reporting System (AERS)
- OpenFDA Food Recalls
- EFSA OpenFoodTox
- EU Food Additive Portal

## Citation

Additive Facts. "Orange Peel, Bitter, Oil (citrus Aurantium L.) — Safety, regulation, and evidence." https://additivefacts.com/additives/orange-peel-bitter-oil-citrus-aurantium-l. Accessed 2026-05-19.