Bifidobacterium longum
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Science
Bifidobacterium longum

GRAS Notice No. GRN 000268
The notice informs FDA of the view of Morinaga Milk Industry Co., Ltd. that B. longum
strain BB536 is GRAS, through scientific procedures, for use as an ingredient in
breads/baked goods, cereals, dairy products/dairy-based foods and dairy substitutes,
fruit products, candy, chewing gum, cocoa powder, condiment sauces, flavored beverage
syrups, fruit flavored powder beverage mixes, gelatin desserts, gravies, margarine,
peanut and other nut butter/spreads, snack foods, weaning foods at a maximum level of
1x1010 colony forming units (cfu) per serving1 and in milk based powdered infant formula
at a level of 1x1010 cfu per gram of infant formula powder that is intended for consumption
for term infants aged 9 months and older.

Morinaga states that Bifidobacteria are naturally occurring bacteria and are a normal part
of the human gut microflora. Bifidobacteria comprise up to 25 percent of the cultivatable
fecal bacteria in adults and up to 80 percent in infants. Morinaga further states that B.
longum strain BB536 was initially isolated from a healthy infant. Morinaga states that B.
longum strain BB536 is nonpathogenic, nontoxigenic, lacks any antibiotic resistance
genes, does not contain any plasmids, does not display harmful metabolic activities, and
is non-hemolytic. Morinaga also discusses the organism’s taxonomy, physiology, and
prior use in food in other countries.

Morinaga describes the inoculating and subculturing methods used to prepare the starter
cultures needed to produce the variety of B. longum strain BB536 formulations. Morinaga
states that after fermentation, the B. longum strain BB536 cultures are concentrated,
washed with sterilized cooled water, reconcentrated, mixed, frozen, and powdered. The
powder is then mixed with either corn starch, tapioca starch, or potato starch as a carrier.
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