About
What it is and where it shows up.
Bifidobacterium bifidum is a Gram-positive, anaerobic, non-motile probiotic bacterium naturally found in the human gastrointestinal tract. It is used as a functional food ingredient in dairy products, fermented foods, infant formulas, and dietary supplements to support gut health and modulate the intestinal microbiota.
Safety summary
The regulatory and scientific consensus.
B. bifidum has an extensive history of safe use in food and has been assessed as non-hemolytic, non-toxigenic, and non-pathogenic in healthy adults by multiple regulatory bodies. EFSA grants it Qualified Presumption of Safety (QPS) status, and multiple strains hold FDA GRAS status. Rare adverse events have been reported almost exclusively in severely immunocompromised individuals.
Regulatory landscape
What food-safety regulators have decided.
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | B. bifidum is listed on the EFSA Qualified Presumption of Safety (QPS) register, meaning strains are presumed safe for food/feed use subject to absence of transferable antibiotic resistance genes.source |
| FDA (Food and Drug Administration) (United States) | Approved | Multiple strains (e.g., BGN4, CBT BF3, OLB6378) hold GRAS status for use in dairy products, infant formulas, and other conventional foods under 21 CFR Part 170, Subpart E. Dose typically up to 1×10⁹ CFU per serving.source |
Who should approach with care
Whose guidance would steer them away.
Other — Immunocompromised individuals (e.g., those undergoing chemotherapy, organ transplant recipients, or patients with severe underlying illness) should consult a doctor before consuming live probiotic bacteria, as rare cases of bacteremia have been reported almost exclusively in this population.
Infants — While certain B. bifidum strains (e.g., BGN4, CBT BF3) have FDA GRAS status for use in term infant formulas, premature infants or those with compromised immunity should only receive probiotic-containing products under medical supervision.
Research citations
The sources behind this verdict.
- 1FDA. GRAS Notice GRN 001078: Bifidobacterium bifidum CBT BF3 (KCTC 12199BP), 2022. fda.gov
- 2FDA. GRAS Notice GRN 000875 – Bifidobacterium species history of safe use in food, 2019. fda.gov
- 3FDA. GRAS Notice GRN 000814: Bifidobacterium bifidum BGN4, 2019. fda.gov
- 4PubMed. Safety Evaluations of Bifidobacterium bifidum BGN4 and Bifidobacterium longum BORI, 2018. pmc.ncbi.nlm.nih.gov
- 5PubMed. Consumption of a Bifidobacterium bifidum Strain for 4 Weeks Modulates Dominant Intestinal Bacterial Taxa and Fecal Butyrate in Healthy Adults, 2016. pmc.ncbi.nlm.nih.gov
Independently researched5 citations