About
Milk is a whole animal-derived food secreted by the mammary glands of cows, composed of water, lactose, casein and whey proteins, fat, calcium, and vitamins; it is used as a beverage and as a primary ingredient in baking, cooking, and the manufacture of dairy products. Its nutritional density makes it one of the most widely regulated and consumed food ingredients globally.
Safety summary
Milk is broadly safe for the healthy general population and is approved/standardised in all major food regulatory jurisdictions with no established Acceptable Daily Intake (ADI), as it is a whole food rather than a food additive. However, the FDA and EU Regulation 1169/2011 each classify milk as a major allergen requiring mandatory label declaration; individuals with a true IgE-mediated milk allergy (most common in infants and young children) must strictly avoid it. A substantial proportion of the global adult population is also lactose-intolerant, experiencing gastrointestinal symptoms from milk's lactose content.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| FSANZ (Food Standards Australia New Zealand) (Australia) | Approved | Milk is regulated as a standardised food under the Australia New Zealand Food Standards Code. It is listed as a mandatory allergen requiring declaration on food labels under Standard 1.2.3.source |
| EFSA (European Food Safety Authority) (European Union) | Approved | Milk is a traditional food approved for consumption in the EU without restriction under food law. Under Annex II of Regulation (EU) No 1169/2011 on food information to consumers, milk and products thereof are listed as one of 14 major allergens requiring mandatory declaration on food and beverage labels. EFSA evaluates milk-derived novel ingredients (e.g., human-identical milk oligosaccharides, bovine whey isolates) under Regulation (EU) 2015/2283.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Regulated under Chapter 2.1 (Dairy Products and Analogues) of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Standards specify composition, microbiological limits (pasteurised milk storage ≤8°C), contaminant limits under the FSS (Contaminants, Toxins and Residues) Regulations 2011, and mandatory labelling for pre-packaged milk. Total urea content in milk shall not exceed 700 ppm.source |
| FDA (Food and Drug Administration) (United States) |
Who should approach with care
Research citations
- 1FDA. Agency Response Letter GRAS Notice No. GRN 000633 — Milk-derived Ingredient Safety Review (21 CFR 184.1979). fda.gov
- 2FDA. Federal Food, Drug, and Cosmetic Act Section 403(w) — Major Food Allergen Declaration. fda.gov
- 3FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 — Chapter 2.1: Dairy Products and Analogues (Version 3, May 2025), 2025. fssai.gov.in
- 4PubMed. Trends in ingredients added to infant formula: FDA's experiences in the GRAS notification program, 2023. pubmed.ncbi.nlm.nih.gov
- 5other. Regulation (EU) No 1169/2011 of the European Parliament and of the Council — Annex II: Substances or Products Causing Allergies or Intolerances, 2011. eur-lex.europa.eu
