# Simaruba Bark (simaruba Amara Aubl.)

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**Safety rating:** UNKNOWN
**CAS number:** 977029-60-9
**Category:** other
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-04

## Summary

Simaruba bark is a botanical extract derived from the Simaruba amara tree, also known as paradise tree or bitterwood. Its function as a food additive is currently unknown, and it has not been approved by the FDA as Generally Recognized as Safe (GRAS).

## Regulatory status

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

## Detailed analysis

## What is Simaruba Bark?

Simaruba bark (Simaruba amara Aubl.) is a botanical material sourced from the Simaruba amara tree, a tropical hardwood tree native to Central and South America. The tree is traditionally known by several common names including paradise tree, bitterwood, and dysentery bark. The bark has been used in traditional medicine systems for centuries, particularly in Latin American and Caribbean folk remedies. Chemically, simaruba bark contains various phytochemical compounds including quassinoids, which are believed to contribute to its traditional properties.

## Common Uses

Historically, simaruba bark has appeared in traditional herbal preparations and folk medicine applications. However, its current use as a food additive in commercial food production is not well documented or established. The specific functional purpose it may serve in food formulations—whether as a flavoring agent, preservative, colorant, or other additive category—remains unclear and unstandardized. There is no widespread commercial application of simaruba bark as a food ingredient in major food manufacturing.

## Safety Assessment

The safety profile of simaruba bark as a food additive is inadequately characterized by modern food safety standards. The FDA has recorded zero adverse events associated with simaruba bark and zero product recalls, indicating either very limited use or no established incidents of harm. However, the absence of adverse reports does not constitute approval or confirmation of safety for food use. Traditional use in herbal remedies does not automatically translate to safety for addition to processed foods at potentially different exposure levels or in different populations.

The lack of comprehensive toxicological studies, pharmacokinetic data, and formal safety assessments specific to food additive applications represents a significant data gap. While some chemical constituents like quassinoids have been studied in limited contexts, systematic evaluation of simaruba bark specifically for food safety purposes has not been completed.

## Regulatory Status

Simaruba bark has not received FDA GRAS (Generally Recognized as Safe) determination, which means it does not have official recognition as safe for use in food. It does not appear on the FDA's list of approved food additives or permitted ingredients. The European Food Safety Authority (EFSA) has not published safety assessments for this botanical in food applications. Without regulatory approval from major food safety authorities, the use of simaruba bark in commercial food products in the United States or European Union would require specific authorization or would be considered non-compliant with food regulations.

The lack of regulatory status reflects the limited scientific evidence base and absence of formal safety dossiers submitted to regulatory agencies. Anyone seeking to use this ingredient would need to work with regulatory bodies to establish its safety profile through proper channels.

## Key Studies

Literature on simaruba bark exists primarily in ethnobotanical and traditional medicine contexts rather than food safety science. Published research is limited regarding its use specifically as a food additive. Most available information derives from historical accounts of traditional use and preliminary phytochemical analyses. The absence of indexed, peer-reviewed safety studies evaluating this botanical for food additive applications represents a notable limitation in the evidence base.

Further research including toxicity studies, allergenicity assessment, stability data, and appropriate exposure level determination would be necessary to establish a proper safety foundation for any potential food application.

## 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. "Simaruba Bark (simaruba Amara Aubl.) — Safety, regulation, and evidence." https://additivefacts.com/additives/simaruba-bark-simaruba-amara-aubl. Accessed 2026-05-20.