Our Verdict: SAFE

Lactalbumin

CAS9013-90-5FDA GRAS

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Lactalbumin — food additive

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.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
Not EvaluatedUK FSA
Canada
Not EvaluatedHealth Canada
Australia
Not EvaluatedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

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.

Frequently Asked Questions

What is Lactalbumin?

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.

Is Lactalbumin safe?

Lactalbumin is currently rated "safe" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Lactalbumin banned in any country?

Lactalbumin is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.