Fungal protease
Fungal protease is a protein-splitting enzyme preparation made by fermenting a mold, most often Aspergillus oryzae or Aspergillus niger, and recovering the enzyme from the culture. The broth is filtered to remove the organism, then concentrated, and the enzyme is spray-dried onto a carrier or sold as a liquid. Grades differ by the pH where they work best (acid, neutral or alkaline) and are sold to a stated activity for supplements, baking and protein hydrolysis.
Suppliers sell different products under the same name. Specify the one you need.
Protease at a stated activity, usually in hemoglobin units on a tyrosine basis (HUT) or spectrophotometric acid protease units (SAP) per gram, on a maltodextrin or similar carrier.
Separate products defined by their working pH range; supplement blends often combine several to cover a wider range.
Stabilized liquid for food processing, such as protein hydrolysis and dough work, where dosing by pump is easier.
Grades from non-genetically modified strains, with carriers and processing aids chosen for use in products labeled organic.
Compare each result with your own specification when the lot arrives.
Enzyme powders lose activity with heat and moisture, so keep them sealed in the original lined container in a cool, dry place, and refrigerate liquid preparations if the supplier says to. Shelf life is set by each supplier's specification, usually as a guaranteed minimum activity to a stated date, and older stock is retested for activity before use. Supplier safety data sheets for enzyme powders call for dust control and respiratory protection when weighing and blending.
Activity varies from lot to lot, so record the measured activity per gram and adjust the dose to the label claim. Record the production organism, carrier and any allergen in the carrier for each lot, and rotate stock first-expired, first-out.
Facts from regulators and standards bodies, each linked to its source.
FDA's GRAS Notice Inventory lists GRN 90, from the Enzyme Technical Association, which covers a protease enzyme preparation from Aspergillus oryzae for use in foods in general; FDA had no questions.
Source: hfpappexternal.fda.gov (opens in a new tab)Health Canada's List of Permitted Food Enzymes includes protease (item P.11), with sources including Aspergillus melleus, Aspergillus niger and Aspergillus oryzae.
Source: canada.ca (opens in a new tab)Health Canada's Digestive Enzymes natural health product monograph lists fungal protease from Aspergillus oryzae and Aspergillus niger, with a daily maximum of 680,000 FCC HUT.
Source: webprod.hc-sc.gc.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 · Darmstadt, Germany
German enzyme company, part of ABF Ingredients, that develops and produces enzymes for baking, juice, brewing, protein hydrolysis and oil processing.
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 · 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 standardized powder, acid, neutral and alkaline types, liquid concentrate and non-GMO and organic-compliant. Ask each supplier for the specification sheet of the exact grade they quote.
Expect protease activity, production strain, mycotoxins, heavy metals, microbiology and loss on drying, each with its method, specification and result for that lot.
Enzyme powders lose activity with heat and moisture, so keep them sealed in the original lined container in a cool, dry place, and refrigerate liquid preparations if the supplier says to. Shelf life is set by each supplier's specification, usually as a guaranteed minimum activity to a stated date, and older stock is retested for activity before use. Supplier safety data sheets for enzyme powders call for dust control and respiratory protection when weighing and blending.
FDA's GRAS Notice Inventory lists GRN 90, from the Enzyme Technical Association, which covers a protease enzyme preparation from Aspergillus oryzae for use in foods in general; FDA had no questions. Health Canada's List of Permitted Food Enzymes includes protease (item P.11), with sources including Aspergillus melleus, Aspergillus niger and Aspergillus oryzae. Health Canada's Digestive Enzymes natural health product monograph lists fungal protease from Aspergillus oryzae and Aspergillus niger, with a daily maximum of 680,000 FCC HUT.
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