Lactase
Lactase is an enzyme that splits lactose into glucose and galactose. Commercial lactase is made by fermenting yeasts such as Kluyveromyces lactis, which give a neutral lactase suited to milk, or molds such as Aspergillus oryzae or Aspergillus niger, which give an acid lactase. Brands buy liquid neutral lactase for lactose-reduced dairy and powdered acid lactase for supplements and chewables.
Suppliers sell different products under the same name. Specify the one you need.
Yeast lactase (Kluyveromyces lactis) in a glycerol-stabilized liquid, used to make lactose-reduced milk and dairy products.
Fungal lactase (Aspergillus oryzae or niger) standardized in FCC acid lactase units (ALU) per gram for tablets, capsules and chewables.
Lactase supplied sterile for adding to UHT milk after heat treatment.
Grades with production strain, carrier and certification documented for specific markets.
Compare each result with your own specification when the lot arrives.
Liquid lactase is usually kept refrigerated and sealed; powders are kept sealed in a cool, dry place away from humidity. Shelf life is set by the supplier's specification as a minimum activity to a date, and older lots are retested for activity before use. Supplier safety data sheets call for dust control when handling the powder.
Record the measured activity and unit (ALU or NLU) for each lot, since acid and neutral lactase are not interchangeable. Note the production organism and carrier, and rotate stock first-expired, first-out.
Facts from regulators and standards bodies, each linked to its source.
21 CFR 184.1388 affirms lactase enzyme preparation from Kluyveromyces lactis as GRAS, used to convert lactose to glucose and galactose.
Source: ecfr.gov (opens in a new tab)21 CFR 184.1387 affirms lactase enzyme preparation from Candida pseudotropicalis as GRAS, limited to reducing lactose in milk and milk-derived foods where standards allow.
Source: ecfr.gov (opens in a new tab)FDA's GRAS Notice Inventory lists GRN 132, for lactase enzyme preparation from Aspergillus niger notified by the Enzyme Technical Association for dairy uses; FDA had no questions.
Source: hfpappexternal.fda.gov (opens in a new tab)Health Canada's List of Permitted Food Enzymes includes lactase (item L.1), with sources including Aspergillus niger, Aspergillus oryzae and Kluyveromyces lactis.
Source: canada.ca (opens in a new tab)This is general information, not regulatory advice. Status differs by country and by how the ingredient is used, so check the rules for your product and market.
Manufacturers and distributors whose own websites say they sell it.
Manufacturer · Thane, India
Indian maker of enzymes and probiotics produced by fermentation, with a human nutrition range of digestive and systemic enzymes plus Saccharomyces boulardii for supplement makers.
Manufacturer · Nagoya, Japan
Japanese enzyme maker founded in 1899 that supplies digestive enzymes for dietary supplements and processing enzymes for food and beverage production.
Manufacturer · Troy, VA
Virginia-based enzyme and Bacillus probiotic company that formulates and blends ingredients for supplement, food and animal nutrition brands. Its news page says it has joined the Lallemand group.
Manufacturer · Scranton, PA
US enzyme supplier founded in 1953 that produces papain at its Scranton, Pennsylvania plant and sells food-grade proteases, carbohydrases and lipases for supplements and food processing.
Suppliers are in alphabetical order and none pays to appear. Each claim is checked against the supplier’s own website on the date shown. Ask for the specification sheet and a recent COA before you order, and confirm details with the supplier.
Common forms include neutral liquid lactase, acid lactase powder, sterile-filtered liquid and non-GMO and kosher or halal grades. Ask each supplier for the specification sheet of the exact grade they quote.
Expect lactase activity, production strain, side activities, heavy metals, microbiology and sterility, each with its method, specification and result for that lot.
Liquid lactase is usually kept refrigerated and sealed; powders are kept sealed in a cool, dry place away from humidity. Shelf life is set by the supplier's specification as a minimum activity to a date, and older lots are retested for activity before use. Supplier safety data sheets call for dust control when handling the powder.
21 CFR 184.1388 affirms lactase enzyme preparation from Kluyveromyces lactis as GRAS, used to convert lactose to glucose and galactose. 21 CFR 184.1387 affirms lactase enzyme preparation from Candida pseudotropicalis as GRAS, limited to reducing lactose in milk and milk-derived foods where standards allow. FDA's GRAS Notice Inventory lists GRN 132, for lactase enzyme preparation from Aspergillus niger notified by the Enzyme Technical Association for dairy uses; FDA had no questions. Health Canada's List of Permitted Food Enzymes includes lactase (item L.1), with sources including Aspergillus niger, Aspergillus oryzae and Kluyveromyces lactis.
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