Bifidobacterium longum subsp. infantis

About

What it is and where it shows up.

Bifidobacterium longum subsp. infantis is a gram-positive, anaerobic probiotic bacterium naturally dominant in the gut microbiome of breastfed infants. It is used as a food ingredient and dietary supplement to support gut microbiota balance, immune function, and intestinal barrier integrity.

Safety summary

The regulatory and scientific consensus.

Multiple safety assessments demonstrate no mutagenicity, genotoxicity, or acute/sub-chronic toxicity in standard models, and several strains have achieved GRAS status in the US for term infants and the general population. The FDA has raised serious safety concerns about use in pre-term infants, including a documented fatality linked to sepsis caused by B. infantis EVC001, and the American Academy of Pediatrics does not endorse routine use of live microorganisms in pre-term infants. Immunocompromised individuals should consult a physician prior to use, as rare systemic infections from probiotic use have been reported in the scientific literature.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Bifidobacterium longum (including subsp. infantis) holds Qualified Presumption of Safety (QPS) status granted by EFSA, indicating it is considered safe for use in food and feed applications. Strain-specific safety assessments are required per EFSA guidelines including antibiotic susceptibility, hemolysis, and toxigenic gene analysis.source
FDA (Food and Drug Administration) (United States)	Approved	GRN 950: B. infantis DSM 33361 granted GRAS status for use in non-exempt term infant formula, dairy products, beverages, shelf-stable bars, cereals, and confectionery at up to 2.8×10^10 CFU/serving.source

Who should approach with care

Whose guidance would steer them away.

Infants — FDA has determined that use of B. infantis EVC001 in food for pre-term infants lacks GRAS basis and constitutes an unsafe food additive; a fatality from sepsis was linked to its use in a pre-term infant, and the American Academy of Pediatrics does not endorse routine probiotic use in this population.

Other — Immunocompromised individuals (e.g., those on immunosuppressive therapy, with HIV/AIDS, or undergoing chemotherapy) face elevated risk of systemic probiotic infections, as rare cases of bacteremia/sepsis from Bifidobacterium have been reported in the scientific literature.

Research citations

The sources behind this verdict.

1FDA. GRAS Notice 950: Bifidobacterium longum subsp. infantis DSM 33361. fda.gov
2PubMed. Early Probiotic Supplementation of Healthy Term Infants with Bifidobacterium longum subsp. infantis M-63 Is Safe and Leads to the Development of Bifidobacterium-Predominant Gut Microbiota: A Double-Blind, Placebo-Controlled Trial. ncbi.nlm.nih.gov
3PubMed. Safety and Tolerance of Bifidobacterium longum subsp. Infantis YLGB-1496 in Toddlers with Respiratory Symptoms. ncbi.nlm.nih.gov
4PubMed. Safety Assessment and Probiotic Potential Comparison of Bifidobacterium longum subsp. infantis BLI-02, Lactobacillus plantarum LPL28, Lactobacillus acidophilus TYCA06, and Lactobacillus paracasei ET-66, 2023. pmc.ncbi.nlm.nih.gov
5FDA. Regulatory Status of Live Microorganisms When Used or Intended for Use in Food, 2023. fda.gov
6FDA. Regulatory Status of Infinant Health Bifidobacterium longum subsp. infantis EVC001 (EVIVO with MCT Oil) for Pre-Term Infants, 2023.

Independently researched6 citations