Bacillus subtilis
Bacillus subtilis is an aerobic, spore-forming bacterium found in soil and on plants, and the organism used to make natto from soybeans. Probiotic strains are grown by fermentation, induced to form spores, then harvested and dried. Because spores tolerate heat and dry storage, it goes into baked goods, drinks and shelf-stable foods as well as capsules, bought as a named strain at a stated CFU per gram. The species is also a common production host for food enzymes, which are separate ingredients.
Suppliers sell different products under the same name. Specify the one you need.
Dried spores of a named strain at a high count stated in billions of CFU per gram.
Spores diluted with maltodextrin or another carrier to a fixed lower count for easier dosing in foods and capsules.
Grades offered for baked goods, hot drinks and other heat-processed foods, with the supplier's data on count retention through the process.
Spores of B. subtilis var. natto sold to inoculate cooked soybeans; a culture for food fermentation rather than a counted probiotic.
Compare each result with your own specification when the lot arrives.
Spore powders are more stable than freeze-dried lactobacilli and are usually stored sealed at room temperature, cool and dry, away from humidity; follow the supplier's stated conditions. Keep containers closed between uses to keep moisture out. Shelf life is set by the supplier from spore count stability data, and aged stock is retested for count.
Record the actual spore count, strain and carrier for each lot, and check that the count method (heat-shock temperature, medium and incubation) matches the one in your specification, since methods change results. Rotate stock FEFO.
Facts from regulators and standards bodies, each linked to its source.
FDA's GRAS Notice Inventory lists GRN 831 for Bacillus subtilis DE111, notified by Deerland Probiotics and Enzymes; it closed on August 13, 2019 with FDA having no questions. The notice covers that notifier's substance and intended use only.
Source: hfpappexternal.fda.gov (opens in a new tab)FDA's GRAS Notice Inventory lists GRN 969 for a Bacillus subtilis Bss-19 spore preparation, notified by Danisco USA; it closed on October 6, 2021 with FDA having no questions. The notice covers that notifier's substance and intended use only.
Source: hfpappexternal.fda.gov (opens in a new tab)Health Canada's Probiotics monograph lists Bacillus subtilis among the live microorganisms excluded from the monograph, so a natural health product with it cannot use the compendial route.
Source: webprod.hc-sc.gc.ca (opens in a new tab)The EU Novel Food Catalogue entry for Bacillus subtilis (POL-NF-13361) gives it the status not novel in food supplements.
Source: ec.europa.eu (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 · 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.
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 spore powder concentrate, standardized dilution, food-processing grade and natto starter. Ask each supplier for the specification sheet of the exact grade they quote.
Expect spore count (CFU/g), identity, bacillus cereus group check, contaminant microbiology, moisture and heavy metals, each with its method, specification and result for that lot.
Spore powders are more stable than freeze-dried lactobacilli and are usually stored sealed at room temperature, cool and dry, away from humidity; follow the supplier's stated conditions. Keep containers closed between uses to keep moisture out. Shelf life is set by the supplier from spore count stability data, and aged stock is retested for count.
FDA's GRAS Notice Inventory lists GRN 831 for Bacillus subtilis DE111, notified by Deerland Probiotics and Enzymes; it closed on August 13, 2019 with FDA having no questions. The notice covers that notifier's substance and intended use only. FDA's GRAS Notice Inventory lists GRN 969 for a Bacillus subtilis Bss-19 spore preparation, notified by Danisco USA; it closed on October 6, 2021 with FDA having no questions. The notice covers that notifier's substance and intended use only. Health Canada's Probiotics monograph lists Bacillus subtilis among the live microorganisms excluded from the monograph, so a natural health product with it cannot use the compendial route. The EU Novel Food Catalogue entry for Bacillus subtilis (POL-NF-13361) gives it the status not novel in food supplements.
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