Our Verdict: SAFE

Ammonium Caseinate

CAS9005-42-9FDA 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

Ammonium Caseinate — food additive

Ammonium caseinate is a food additive derived from casein, a milk protein, that has been granted GRAS (Generally Recognized As Safe) status by the FDA. While its specific function in food applications remains undocumented, it is utilized in various food formulations.

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
ApprovedHealth 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 Ammonium Caseinate?

Ammonium caseinate (CAS Number 9005-42-9) is a salt derivative of casein, the primary protein found in milk. It is produced through a chemical process where casein is treated with ammonia or ammonium compounds, resulting in a water-soluble protein ingredient. The ammonium salt form makes casein more soluble than its native state, allowing for broader application in food manufacturing. Ammonium caseinate appears as a white to off-white powder and is derived from milk sources, making it unsuitable for strict vegan applications but generally acceptable for vegetarian products.

Common Uses

While the specific functional role of ammonium caseinate in food products is not formally documented in FDA databases, caseinate derivatives are traditionally employed in the food industry for several potential purposes. These may include serving as a protein source, functioning as an emulsifier or stabilizer in complex food formulations, or acting as a binder in processed foods. The ingredient may appear in various product categories including nutritional supplements, processed meat products, dairy alternatives, and specialty food applications. Its solubility characteristics make it suitable for beverages and liquid-based formulations where protein incorporation is desired.

Safety Assessment

Ammonium caseinate has been designated as GRAS (Generally Recognized As Safe) by the U.S. Food and Drug Administration, indicating that qualified experts have concluded the ingredient is safe under its intended conditions of use. This classification is based on a history of common use in food and/or scientific procedures establishing safety. The FDA maintains no recorded adverse events associated with ammonium caseinate and has issued no recalls involving this ingredient. Since casein is a naturally occurring milk protein with extensive historical use in food products, ammonium caseinate inherits a substantial safety profile from its parent compound.

For individuals with milk allergies or casein sensitivities, ammonium caseinate would present the same allergenicity concerns as other milk-derived products. Proper labeling as a milk ingredient is essential for consumer protection. The ingredient does not appear on lists of substances of concern in major regulatory jurisdictions.

Regulatory Status

Ammonium caseinate holds GRAS status in the United States, permitting its use in food without pre-market approval requirements beyond proper documentation and notification procedures. The ingredient is accepted by the FDA as a food additive in various applications. In the European Union, caseinate derivatives fall under food additive regulations, though specific European regulatory documentation for ammonium caseinate may be limited. The ingredient is not classified as a restricted or banned substance in major food regulatory jurisdictions.

As a milk-derived ingredient, products containing ammonium caseinate must comply with allergen labeling requirements in jurisdictions with mandatory milk allergen declarations, including the United States and European Union.

Key Studies

Limited peer-reviewed scientific literature specifically addresses ammonium caseinate as an isolated ingredient. Most safety data derives from broader research on casein and caseinate derivatives, which have been studied extensively due to their widespread use in infant formula, nutritional products, and food applications. General toxicology studies on caseinate ingredients have not identified safety concerns at levels used in food. The GRAS determination for ammonium caseinate reflects the established safety of casein-based ingredients combined with the non-toxic nature of ammonium salts at food-use levels.

Frequently Asked Questions

What is Ammonium Caseinate?

Ammonium caseinate is a food additive derived from casein, a milk protein, that has been granted GRAS (Generally Recognized As Safe) status by the FDA. While its specific function in food applications remains undocumented, it is utilized in various food formulations.

Is Ammonium Caseinate safe?

Ammonium Caseinate 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 Ammonium Caseinate banned in any country?

Ammonium Caseinate 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.