Bacillus clausii
Bacillus clausii is an alkali-tolerant, spore-forming soil bacterium, reclassified as Alkalihalobacillus clausii in 2020 and later as Shouchella clausii, though trade still uses the old name. It is grown by aerobic fermentation, induced to sporulate, and sold as dried spores or as spore suspensions in water for oral vials, a common format in Europe and Asia. Brands buy a named strain at a stated CFU per gram or per milliliter, and the strain designation belongs on the specification.
Suppliers sell different products under the same name. Specify the one you need.
Dried spores of a named strain at a stated count in billions of CFU per gram.
Spores suspended in purified water for single-dose vials, counted per milliliter.
Spores diluted with a carrier to a fixed lower count for capsules and foods.
A specific strain with its deposit number and documentation, sometimes sold as a mix of several B. clausii strains.
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 971 for a Bacillus clausii strain 088AE spore preparation, notified by Advanced Enzyme Technologies Ltd.; it closed on March 3, 2022 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 1214 for a Bacillus clausii UBBC-07 spore preparation, notified by Unique Biotech Limited; it closed on May 7, 2025 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 clausii 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 clausii (POL-NF-15101) 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 · Hyderabad, India
Indian probiotic manufacturer in Hyderabad’s Genome Valley that supplies spore-forming and other probiotic strains in bulk and as contract-made finished formats.
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, aqueous spore suspension, standardized dilution and named strain. 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 971 for a Bacillus clausii strain 088AE spore preparation, notified by Advanced Enzyme Technologies Ltd.; it closed on March 3, 2022 with FDA having no questions. The notice covers that notifier's substance and intended use only. FDA's GRAS Notice Inventory lists GRN 1214 for a Bacillus clausii UBBC-07 spore preparation, notified by Unique Biotech Limited; it closed on May 7, 2025 with FDA having no questions. The notice covers that notifier's substance and intended use only. Health Canada's Probiotics monograph lists Bacillus clausii 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 clausii (POL-NF-15101) gives it the status not novel in food supplements.
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