lactose | whatsinit

About

What it is and where it shows up.

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

The regulatory and scientific consensus.

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

What food-safety regulators have decided.

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

Whose guidance would steer them away.

Lactose Intolerance — Individuals with primary lactase deficiency may experience bloating, flatulence, and diarrhoea; EFSA notes that most tolerate up to 12 g as a single dose but that individual thresholds vary widely.

Ibs — Lactose is a fermentable oligosaccharide, disaccharide, monosaccharide and polyol (FODMAP) that can exacerbate symptoms such as bloating and abdominal pain in individuals with irritable bowel syndrome.

Infants — Infants and neonates with galactosaemia must receive lactose-free formula, as dietary lactose provides galactose which cannot be metabolised and causes hepatic and renal damage; EFSA recommends lactose content ≤10 mg/100 kcal in formula for affected infants.

Other — Persons with any form of galactosaemia must strictly avoid all dietary sources of lactose, as unmetabolised galactose causes potentially fatal organ damage; EFSA recommends elimination of all galactose sources including lactose from the diet.

Research citations

The sources behind this verdict.

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

Independently researched5 citations