About
Calcium caseinate is the calcium salt of casein, the principal phosphoprotein of bovine milk, produced by treating acid casein with calcium hydroxide and spray-drying the resulting product. It is used in food manufacturing as a high-quality protein source, emulsifier, and stabilizer in products such as coffee creamers, infant formulas, processed meats, and frozen desserts.
Safety summary
Calcium caseinate is derived from a natural milk protein and carries no significant toxicological risk at typical food-use levels; no Acceptable Daily Intake (ADI) has been established because regulatory bodies treat it as a conventional food ingredient rather than a synthetic chemical additive. The primary safety concern is its capacity to provoke allergic reactions in individuals with cow's milk protein allergy (CMPA), which is most prevalent among infants and young children. High-dose casein-based protein loading may also require monitoring in individuals with impaired renal function, where protein restriction is clinically indicated.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| FSANZ (Food Standards Australia New Zealand) (Australia) | Approved | Calcium caseinate is permitted as a food ingredient under the Australia New Zealand Food Standards Code. As a dairy-derived protein, it is not scheduled as a food additive and carries no numerical code or maximum limit; GMP applies.source |
| EFSA (European Food Safety Authority) (European Union) | Approved | Calcium caseinate is NOT classified as a food additive under Regulation (EC) No 1333/2008 and therefore has no E number. It is regulated as a food ingredient (dairy protein) under Council Directive 83/417/EEC on caseins and caseinates intended for human consumption, with compositional specifications including minimum protein content. No ADI established.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Permitted as a food ingredient under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 (FSS Act 2006). No specific maximum level established beyond GMP. Used in standardized dairy and processed food categories.source |
| FDA (Food and Drug Administration) (United States) | Approved | Listed as a food-standardized (FS) miscellaneous ingredient permitted in Frozen Desserts (21 CFR Part 135, except water ices) and Creamed Cottage Cheese (21 CFR Part 133). No ADI or maximum use level set; GMP applies. Treated as a prior-sanctioned food ingredient, not a synthetic additive. |
Who should approach with care
Research citations
- 1FDA. Food Additive Status List – Calcium Caseinate, 2026. fda.gov
- 2other. Codex Standard for Edible Caseins and Caseinates (CODEX STAN 290-1995, Revised 2019), 2019. fao.org
- 3PubMed. Cow's milk protein allergy (CMPA) across the ages: a clinical overview, 2014. pubmed.ncbi.nlm.nih.gov
- 4FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, 2011. fssai.gov.in
- 5other. Council Directive 83/417/EEC on the approximation of the laws of Member States relating to certain lactoproteins (caseins and caseinates) intended for human consumption, 1983. eur-lex.europa.eu
