# Lactalbumin

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

**Safety rating:** SAFE
**CAS number:** 9013-90-5
**Category:** nutrient
**FDA GRAS:** yes
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

Lactalbumin is a milk protein derived from whey that functions as a nutrient supplement and formulation aid in food products. It is Generally Recognized as Safe (GRAS) by the FDA and contains no reported adverse events or recalls.

## 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 Lactalbumin?

Lactalbumin (CAS Number 9013-90-5) is a naturally occurring protein extracted from milk whey, primarily consisting of alpha-lactalbumin and beta-lactalbumin. It is a complete protein containing all nine essential amino acids, making it nutritionally valuable for food fortification. The protein is isolated through ultrafiltration or other separation technologies and is used in powdered form in various food applications.

## Common Uses

Lactalbumin serves multiple functions in food manufacturing:

- **Nutrient Fortification**: Added to infant formulas, nutritional supplements, and protein-enriched beverages to increase protein content and amino acid profile
- **Formulation Aid**: Functions as a binding, emulsifying, or stabilizing agent in processed foods due to its protein properties
- **pH Control**: Contributes to pH buffering in food systems, particularly in dairy-based products
- **Sports Nutrition**: Incorporated into protein powders and meal replacement products
- **Bakery Products**: Used to improve texture and moisture retention

Typical use levels range from 1-10% depending on the specific food application and desired nutritional outcomes.

## Safety Assessment

Lactalbumin has an excellent safety profile based on available evidence:

- **FDA GRAS Status**: Lactalbumin is designated as Generally Recognized as Safe (GRAS), indicating qualified experts consider it safe for intended use
- **No Adverse Events**: The FDA has recorded zero adverse events associated with lactalbumin consumption
- **No Recalls**: No food recalls linked to lactalbumin have been documented in FDA databases
- **Natural Source**: As a milk-derived protein, it represents a naturally occurring substance with a long history of consumption in dairy products

**Allergen Consideration**: Since lactalbumin is derived from milk, it is unsuitable for individuals with milk allergies or lactose intolerance, though the protein itself is distinct from lactose. Products containing lactalbumin must be properly labeled to identify milk as an allergen.

## Regulatory Status

Lactalbumin is approved for use in food across multiple regulatory jurisdictions:

- **United States**: Confirmed GRAS by the FDA under 21 CFR Part 182
- **European Union**: Approved as a food ingredient under Regulation (EC) No 1333/2008
- **International**: Recognized by the Codex Alimentarius Commission as an acceptable food ingredient

Regulatory approval reflects the ingredient's long-standing use in food manufacturing and the absence of safety concerns in scientific literature.

## Key Studies

Research on whey proteins and lactalbumin demonstrates:

- Studies on whey protein consumption show positive outcomes for muscle protein synthesis and amino acid bioavailability
- Lactalbumin's amino acid composition, particularly high in branched-chain amino acids, supports its use in nutritional applications
- Research on infant formula containing lactalbumin shows normal growth and development outcomes
- Safety studies have not identified genotoxic, reproductive, or developmental concerns at food-use levels

The scientific consensus supports lactalbumin as a safe, nutritious food ingredient appropriate for diverse applications from infant nutrition to adult supplements.

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