About
Lactase (β-galactosidase; EC 3.2.1.23) is a naturally occurring digestive enzyme that hydrolyses lactose into glucose and galactose; it is produced commercially from microbial sources such as Aspergillus oryzae and Kluyveromyces lactis and is used both as a food-processing enzyme to manufacture lactose-reduced dairy products and as a dietary supplement to assist lactose digestion.
Safety summary
Lactase has an extensive history of safe use, is GRAS-affirmed in the United States, and no Acceptable Daily Intake (ADI) has been established because the enzyme is typically denatured or inactivated during food processing, presenting no toxicological concern at intended use levels. Rare occupational allergies via inhalation of aerosolised β-galactosidase preparations have been documented in workers, and isolated case reports of allergic reactions (throat swelling, shortness of breath, difficulty swallowing) following ingestion of lactase supplement pills exist. Individuals with known hypersensitivity to the fungal or yeast production organisms (A. oryzae, K. lactis) should exercise caution with lactase supplement preparations specifically.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Regulated as a food enzyme—not a food additive—under Regulation (EC) No 1332/2008 (entered into force 20 January 2009); no E-number is assigned. Multiple strain-specific EFSA safety opinions published 2022–2024 for β-galactosidase from K. lactis (strain GAL, strain GD-YNL), A. oryzae (strains AE-LA, GL 470), and a GM B. licheniformis strain. All food enzymes on the EU market must be subjected to EFSA safety evaluation and authorised via a Community list being established by the European Commission under Regulation (EC) No 1331/2008.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Enzymes and enzyme preparations are regulated under the Food Safety and Standards Regulations (FSSR). Under FoSCoS product category 99.2, 'Enzymes and their preparations specified under FSSR' are recognised and require licensing/registration. Specific conditions of use for lactase in dairy processing are further governed by FSS (Food Products Standards and Food Additives) Regulations, 2011.source |
| FDA (Food and Drug Administration) (United States) | Approved | GRAS affirmed under 21 CFR §184.1388 (Kluyveromyces lactis source) and 21 CFR §184.1387 (Candida pseudotropicalis source). At least nine additional strain-specific GRAS notifications (GRN 88, 132, 485, 510, 572, 579, 649, 743, 825) have all received 'no questions' letters from FDA; GRN 1039 (A. oryzae strain GD-FAL) is the most recent (2022). Intended use: hydrolysis of lactose in milk, milk powder, whey, fermented milk products, yogurt, fresh cheese, baked goods, confectionery, cereal bars, soft drinks, and non-exempt infant formula.source |
Who should approach with care
Research citations
- 1FDA. Lactase Enzyme Preparation from Kluyveromyces lactis — GRAS Affirmation (21 CFR §184.1388). accessdata.fda.gov
- 2EFSA. Safety evaluation of the food enzyme β-galactosidase from the genetically modified Bacillus licheniformis strain DSM 34099, 2024. efsa.europa.eu
- 3FDA. GRAS Notice GRN 1039 — Lactase Enzyme Preparation (GODO-FAL) Derived from Aspergillus oryzae Strain GD-FAL, 2022. fda.gov
- 4EFSA. Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified Kluyveromyces lactis strain GAL, 2022. efsa.europa.eu
- 5EFSA. Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified Aspergillus oryzae strain AE-LA, 2022. efsa.europa.eu