Bifidobacterium longum subsp. infantis
Bifidobacterium longum subsp. infantis is an anaerobic bacterium, a subspecies of B. longum that is often still labeled Bifidobacterium infantis. Commercial strains are grown by anaerobic fermentation, concentrated, mixed with cryoprotectants and freeze-dried. It is used mainly in infant formula and infant supplement drops or powders, and is sensitive to oxygen, heat and moisture. Brands buy a named strain at a stated CFU per gram.
Suppliers sell different products under the same name. Specify the one you need.
Pure B. infantis powder at a high count stated in billions of CFU per gram, sold for dilution or blending by the buyer.
Concentrate diluted with a carrier such as maltodextrin, microcrystalline cellulose or potato starch to a fixed lower count, which is easier to dose in capsules, sachets and powders.
A specific strain identified by a culture-collection deposit number or a trade designation, sold with that strain's own documentation; the strain designation belongs on the specification.
Grades produced for infant formula and infant powders, with tighter contaminant microbiology specifications, including Cronobacter, than general supplement grades.
Compare each result with your own specification when the lot arrives.
Bifidobacteria are sensitive to oxygen and moisture, so freeze-dried powder is kept frozen or refrigerated in sealed oxygen- and moisture-barrier packs, often nitrogen-flushed with desiccant. Bring packs to room temperature before opening, limit air exposure during weighing and reseal at once. Shelf life is set by the supplier from real-time stability counts at a stated temperature, and aged stock is retested for viable count.
Record the actual CFU/g, strain designation and carrier for each lot, since counts vary between lots and decline with time and temperature. Rotate stock FEFO, track any warm excursions in shipping, and size the overage from your own finished-product stability data.
Facts from regulators and standards bodies, each linked to its source.
Health Canada's Probiotics monograph for natural health products lists Bifidobacterium longum subsp. infantis as a medicinal ingredient, and the licence application and label must give the strain designation.
Source: webprod.hc-sc.gc.ca (opens in a new tab)FDA's GRAS Notice Inventory lists GRN 985 for Bifidobacterium longum subsp. infantis strain ATCC SD 6720 for use in powdered infant and toddler formula, notified by Danisco USA; it closed on December 21, 2021 with FDA having no questions. The notice covers that notifier's strain and intended use only.
Source: hfpappexternal.fda.gov (opens in a new tab)FDA's draft guidance on dietary supplements containing live microbials states its intent to exercise enforcement discretion so that firms may declare live microbial quantity in colony forming units (CFUs), in addition to the weight declaration required by regulation.
Source: fda.gov (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 · Novara, Italy
Italian probiotic company that isolates, produces and blends bacterial strains, sold as raw materials or as finished and private-label products.
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 freeze-dried concentrate, standardized dilution, named strain and infant formula grade. Ask each supplier for the specification sheet of the exact grade they quote.
Expect viable count (CFU/g), identity, water activity, contaminant microbiology, heavy metals and allergen statement, each with its method, specification and result for that lot.
Bifidobacteria are sensitive to oxygen and moisture, so freeze-dried powder is kept frozen or refrigerated in sealed oxygen- and moisture-barrier packs, often nitrogen-flushed with desiccant. Bring packs to room temperature before opening, limit air exposure during weighing and reseal at once. Shelf life is set by the supplier from real-time stability counts at a stated temperature, and aged stock is retested for viable count.
Health Canada's Probiotics monograph for natural health products lists Bifidobacterium longum subsp. infantis as a medicinal ingredient, and the licence application and label must give the strain designation. FDA's GRAS Notice Inventory lists GRN 985 for Bifidobacterium longum subsp. infantis strain ATCC SD 6720 for use in powdered infant and toddler formula, notified by Danisco USA; it closed on December 21, 2021 with FDA having no questions. The notice covers that notifier's strain and intended use only. FDA's draft guidance on dietary supplements containing live microbials states its intent to exercise enforcement discretion so that firms may declare live microbial quantity in colony forming units (CFUs), in addition to the weight declaration required by regulation.
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