About
Lactose is a naturally occurring disaccharide sugar found in mammalian milk, composed of glucose and galactose. It is widely used in food manufacturing as a bulking agent, filler, carrier for flavourings, and mild sweetener in products such as baked goods, confectionery, infant formula, and pharmaceutical tablets.
Safety summary
Lactose is considered safe for the general adult population and carries GRAS status in the US (21 CFR 170.35) with no established ADI. Individuals with primary lactase deficiency (lactose intolerance) may experience gastrointestinal symptoms; EFSA notes that most such individuals tolerate up to 12 g as a single dose with no or minor symptoms. Persons with galactosaemia must strictly avoid lactose due to a genetic inability to metabolise galactose, which can cause serious organ damage if untreated.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Lactose is not assigned an E number as a food additive; it is a naturally occurring food ingredient and component of dairy products permitted without restriction under EU food law. EFSA issued a scientific opinion on lactose thresholds relevant to lactose intolerance and galactosaemia (EFSA Journal 2010;8(9):1777).source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Lactose is recognised under FSSAI Food Safety and Standards (Food Products Standards and Food Additives) Regulations as a natural component of milk and dairy products; seed lactose is also explicitly permitted in the manufacture of pre-crystallised whey powder. FSSAI advertising regulations set a threshold of ≤0.1% lactose content for 'lactose-free' claims.source |
| FDA (Food and Drug Administration) (United States) | Approved | Lactose is affirmed as GRAS under 21 CFR 184.1061 and 21 CFR 170.35; no maximum use level is specified for general food use.source |
Who should approach with care
Research citations
- 1FDA. Code of Federal Regulations Title 21, Section 184.1061 – Lactose. accessdata.fda.gov
- 2FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Regulations – Chapter 2.1: Dairy Products and Analogues, 2025. fssai.gov.in
- 3FDA. Agency Response Letter GRAS Notice No. GRN 001213 – Goat Milk Lactose, 2025. fda.gov
- 4FSSAI. Food Safety and Standards (Advertising and Claims) Regulations – Lactose-Free Labelling Threshold, 2022. fssai.gov.in
- 5EFSA. Scientific Opinion on lactose thresholds in lactose intolerance and galactosaemia, 2010. efsa.europa.eu
