Whole Milk Powder | whatsinit

About

What it is and where it shows up.

Whole milk powder is produced by filtering and pasteurizing raw cow's milk, partially removing water by evaporation, and then spray-drying the concentrate into a shelf-stable powder. It retains the full fat (~26–40% milk fat), protein (casein and whey at an 80:20 ratio), lactose, vitamins, and minerals of whole milk and is widely used in baked goods, confectionery, infant formula, and recombined dairy products.

Safety summary

The regulatory and scientific consensus.

Whole milk powder has a long, well-established history of safe human consumption and is approved by all major regulatory authorities worldwide without an established ADI, as it is a whole food ingredient rather than a functional additive. The principal safety concerns are cow's milk protein allergy—designated a major food allergen under FDA and EU labeling law—and lactose intolerance, both of which affect significant population subgroups. No IARC carcinogenicity classification exists for the ingredient itself; high saturated fat content warrants moderation for individuals with cardiovascular risk factors.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
FSANZ (Food Standards Australia New Zealand) (Australia)	Approved	Regulated as a dairy product under Australia New Zealand Food Standards Code, Standard 2.5.3 (Dried Milk, Evaporated Milk and Condensed Milk). Mandatory allergen declaration for milk required under Standard 1.2.3.source
EFSA (European Food Safety Authority) (European Union)	Approved	Regulated as a standard dairy product under Regulation (EU) No 1308/2013 (Common Market Organisation for agricultural products). Not a food additive; no E-number assigned. Compositional standards (minimum 26% milk fat, minimum 34% protein on fat-free dry matter basis) align with Codex STAN 207-1999. Allergen declaration mandatory under Regulation (EU) No 1169/2011.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Regulated under Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, Chapter 2.1 — Dairy Products and Analogues (version 01.09.2023). Products must comply with FSS (Contaminants, Toxins and Residues) Regulations, 2011, and microbiological requirements in Appendix B.source
MHLW (Ministry of Health, Labour and Welfare) (Japan)	Approved	Whole milk powder is permitted as a standard dairy food ingredient under Japan's Food Sanitation Act. Milk is a specified major allergen requiring mandatory labeling under MHLW allergen rules.

Who should approach with care

Whose guidance would steer them away.

Lactose Intolerance — Whole milk powder retains the full lactose content of cow's milk and will reliably trigger gastrointestinal symptoms (bloating, cramping, diarrhea) in lactose-intolerant individuals.

Other — Individuals with IgE-mediated or non-IgE-mediated cow's milk protein allergy must strictly avoid whole milk powder, which is classified as a major food allergen requiring mandatory declaration under FDA FALCPA and EU Regulation 1169/2011.

Infants — Whole cow's milk powder is not appropriate as a sole source of nutrition for infants under 12 months; FDA GRAS notices for dry whole milk in infant formula specify precise formulation conditions and whole cow's milk should not replace breast milk or approved infant formula without medical guidance.

Kidney Disease — Whole milk powder is high in protein and phosphorus; patients with chronic kidney disease on protein- or phosphorus-restricted diets should limit intake under clinical dietitian supervision.

Phenylketonuria — Milk proteins supply phenylalanine; individuals with phenylketonuria must carefully account for whole milk powder within their strictly controlled phenylalanine-restricted dietary regimen.

Research citations

The sources behind this verdict.

1FDA. Code of Federal Regulations, Title 21, Part 131.147 — Dry Whole Milk. accessdata.fda.gov
2FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 — Chapter 2.1: Dairy Products and Analogues (Version 01.09.2023), 2023. fssai.gov.in
3FDA. Agency Response Letter — GRAS Notice GRN 000894 (Nara Organics, Dry Whole Milk in Infant Formula), 2022. fda.gov
4FDA. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) — Major Food Allergen Requirements, FD&C Act Section 403(w), 2004. fda.gov
5other. Codex Standard for Whole Milk Powder, Partly Skimmed Milk Powder and Skimmed Milk Powder — CODEX STAN 207-1999, 1999. fao.org

Independently researched5 citations