# Ox Bile Extract

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**Safety rating:** UNKNOWN
**CAS number:** 8008-63-7
**Category:** other
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-04

## Summary

Ox Bile Extract (CAS 8008-63-7) is a substance derived from bovine bile used as a surface-finishing agent in food processing. It functions to improve the appearance and texture of food products during manufacturing.

## 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 Ox Bile Extract?

Ox Bile Extract is a natural substance obtained from the bile of cattle (Bos taurus). Bile is a digestive fluid produced by the liver and stored in the gallbladder, containing bile salts, cholesterol, phospholipids, and bilirubin. The extract is processed to concentrate these components for industrial applications. In food manufacturing, it appears in ingredient lists by its INCI designation and CAS number 8008-63-7.

## Common Uses

Ox Bile Extract is primarily used as a surface-finishing agent in food production. Surface-finishing agents modify the appearance, texture, or handling properties of food products without significantly altering their nutritional composition. In this capacity, ox bile extract may be applied to confectionery, baked goods, or other processed foods to enhance gloss, improve texture uniformity, or facilitate manufacturing processes. The bile salts present act as natural emulsifiers and surfactants, helping to stabilize mixtures of fat and water-based ingredients.

## Safety Assessment

According to FDA records, there are zero adverse events and zero recalls associated with Ox Bile Extract. The substance has not been granted GRAS (Generally Recognized as Safe) status by the FDA, meaning it has not undergone formal GRAS affirmation. However, the absence of GRAS status does not indicate that a substance is unsafe; rather, it reflects the regulatory pathway and notification status. Many naturally-derived substances operate in food production without formal GRAS designation.

Bile constituents have been studied in biological systems, where bile salts are recognized as essential components of normal digestive function. When used as a food additive in small quantities as a processing aid or surface agent, exposure levels are generally minimal. The lack of adverse event reports suggests that current use levels have not raised safety concerns among consumers or regulatory agencies.

## Regulatory Status

Ox Bile Extract is not listed on the FDA's Color Additives Status List or explicitly prohibited for food use. Its regulatory status appears to be that of a processing aid or functional ingredient with no explicit authorization or prohibition in the United States. In the European Union, similar substances derived from animal sources are evaluated on a case-by-case basis under food additive regulations (EC 1333/2008), though ox bile extract does not appear on the EU's authorized food additives list as a standardized additive.

Manufacturers using this ingredient in the U.S. are responsible for ensuring its safety through their own compliance protocols and for accurate labeling. The use of animal-derived processing aids may require declaration on product labels depending on jurisdiction and specific application.

## Key Studies

No specific peer-reviewed food safety studies on ox bile extract as a food additive were identified in major scientific databases. The biological effects of bile salts are well-documented in medical and nutritional literature, where they are recognized as natural digestive components. However, targeted food safety toxicology studies evaluating this specific ingredient as a processing additive appear limited in the published literature. The absence of both adverse events and recalls, combined with its status as a naturally-derived substance with long historical use in various industries, suggests it has operated without identified safety concerns at current usage levels.

## 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. "Ox Bile Extract — Safety, regulation, and evidence." https://additivefacts.com/additives/ox-bile-extract. Accessed 2026-05-19.