# Albumin

> Source URL: https://additivefacts.com/additives/albumin
> Markdown URL: https://additivefacts.com/additives/albumin.md

**Safety rating:** SAFE
**CAS number:** 977005-72-3
**Category:** stabilizer
**FDA GRAS:** yes
**Adverse events (FDA AERS):** 39
**FDA recalls:** 4
**Last updated:** 2026-04-02

## Summary

Albumin is a naturally-occurring protein derived primarily from egg whites or blood plasma that functions as a stabilizer, thickener, and texturizing agent in food products. It is FDA GRAS (Generally Recognized As Safe) and serves multiple technological functions including firming, formulation aid, and nutrient supplementation in various food applications.

## Regulatory status

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

## Detailed analysis

## What is Albumin?

Albumin refers to a group of water-soluble proteins found naturally in egg whites, blood plasma, and other biological sources. In food manufacturing, albumin is typically derived from egg white (ovalbumin) or bovine blood plasma. The CAS number 977005-72-3 designates this substance for regulatory tracking purposes. Albumin is a colorless, odorless protein that remains stable across a wide pH range and temperature variations, making it valuable in food processing. The protein structure allows it to form films, gels, and foams, which explains its diverse technological applications in the food industry.

## Common Uses

Albumin functions as a multi-purpose additive across several food categories. It is commonly used in:

- **Baked goods**: As a binder and texturizer to improve structure and moisture retention
- **Processed meats**: As a binder and formulation aid to improve texture and water retention
- **Beverages**: As a clarifying agent and stabilizer in wine and beer production
- **Confectionery**: As a whipping agent and foam stabilizer in marshmallows and nougats
- **Dairy products**: As a stabilizer in yogurts and other fermented products
- **Nutritional supplements**: As a protein source due to its high nutritional content

The protein's ability to stabilize emulsions and suspensions makes it particularly useful in complex food formulations where ingredient separation would be problematic.

## Safety Assessment

Albumin has been designated as GRAS (Generally Recognized As Safe) by the FDA, indicating that it is widely recognized as safe for consumption based on scientific evidence and historical use. The designation reflects that albumin has a long history of safe use in foods, particularly from egg white in traditional cooking and manufacturing.

According to FDA records, there have been 39 adverse events associated with albumin and 4 recalls involving products containing this ingredient. These figures require context: adverse event reports do not establish causation and may reflect reporting of symptoms that coincided with consumption rather than direct cause-and-effect relationships. Given the widespread use of albumin in food products globally, the number of reported adverse events is relatively low. Many reported incidents likely involve allergic reactions in individuals with egg allergies, as egg-derived albumin is a known allergen.

Allergy considerations are the primary safety concern with albumin. Individuals with egg allergies must avoid egg-derived albumin products, as the protein can trigger allergic responses. Blood plasma-derived albumin presents a lower allergen risk for egg-allergic individuals but may carry other considerations. Products containing albumin derived from eggs must comply with allergen labeling requirements in most jurisdictions.

## Regulatory Status

Albumin is approved for use in food manufacturing in the United States, European Union, and most other developed nations. In the U.S., it is listed as a GRAS substance, allowing its use without specific pre-market approval, provided manufacturers follow established safety guidelines. The FDA permits its use in various food categories with specified limitations based on intended function.

In the European Union, albumin is approved as a food additive under Regulation (EC) 1333/2008 and is assigned the E number E524 when derived from blood plasma. Egg-derived albumin is recognized as a traditional ingredient rather than requiring formal additive status. Different countries may have varying specifications regarding source material and purity standards.

## Key Studies

Scientific literature supports albumin's safety profile when used at levels typical in food manufacturing. Research demonstrates that albumin's protein structure and functional properties remain stable during standard food processing conditions. Studies on egg white proteins, including ovalbumin, have consistently shown no toxicological concerns at food-use levels.

Allergenicity studies confirm that egg-derived albumin retains allergenic properties of egg proteins, making allergen labeling essential. Research on blood plasma-derived albumin indicates different allergen profiles with lower cross-reactivity to egg allergies. The European Food Safety Authority has reviewed albumin safety and confirmed its acceptable use in food production.

## Brands using Albumin

- Redcon1 LLC (2 products)
- Century Custom Molding, Inc. (1 product)

## 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. "Albumin — Safety, regulation, and evidence." https://additivefacts.com/additives/albumin. Accessed 2026-05-19.