Bifidobacterium animalis subsp. lactis

About

What it is and where it shows up.

Bifidobacterium animalis subsp. lactis (commonly called B. lactis) is a gram-positive, anaerobic, non-spore-forming probiotic bacterium naturally occurring in the human gastrointestinal tract and in fermented dairy foods such as yogurt. It is widely used as a live culture ingredient in fermented milks, infant formulas, beverages, and dietary supplements to support intestinal barrier function, gut motility, and immune health.

Safety summary

The regulatory and scientific consensus.

Multiple FDA GRAS notices and EFSA Qualified Presumption of Safety (QPS) status since 2007 confirm a strong safety consensus for B. lactis across all age groups including infants, children, and the elderly, with no significant adverse effects reported in controlled clinical trials. No ADI has been established as it is a live microorganism rather than a chemical additive. Immunocompromised individuals face a theoretical risk of opportunistic infection and should consult a physician before use.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
FSANZ (Food Standards Australia New Zealand) (Australia)	Approved	Australian Therapeutic Goods Administration includes Bifidobacterium animalis subsp. lactis in the list of approved substances that can be used as active ingredients in 'listed' therapeutic goods.source
Health Canada (Canada)	Approved	B. animalis subsp. lactis is listed in Health Canada's 2009 Guidance Document on Probiotic Microorganisms in Food as eligible for generic structure/function claims supporting gastrointestinal health; confirmed in the Probiotics Monograph (May 26, 2015).source
EFSA (European Food Safety Authority) (European Union)	Approved	Bifidobacterium animalis (including subsp. lactis) has held EFSA Qualified Presumption of Safety (QPS) status since 2007 and is listed in the Inventory of Microbial Food Cultures with Safety Demonstration in Fermented Food Products. Strains must demonstrate absence of acquired antibiotic resistance on transferable elements.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Listed as an approved probiotic strain under Schedule X of the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations (No. 1-4/Nutraceutical/FSSAI-2013). Minimum viable count requirement: ≥10⁸ CFU per recommended daily serving size.

Who should approach with care

Whose guidance would steer them away.

Other — Immunocompromised individuals (e.g., HIV/AIDS patients, organ transplant recipients, or those on immunosuppressants) face a theoretical risk of opportunistic infection from live probiotic bacteria, as explicitly noted in FDA GRAS documentation for B. animalis subsp. lactis (GRN 856).

Infants — While B. lactis is approved and studied in infant formulas (GRN 49, GRN 445), premature or critically ill neonates should only receive probiotic supplementation under direct medical supervision given rare reports of Bifidobacterium bacteremia in extremely vulnerable neonatal populations.

Research citations

The sources behind this verdict.

1PubMed. Bifidobacterium animalis subsp. lactis HN019 Effects on Gut Health: A Review, 2022. pmc.ncbi.nlm.nih.gov
2FSSAI. Compendium: Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations – Version I, 2021. fssai.gov.in
3FDA. GRAS Notice 856: Bifidobacterium animalis subsp. lactis strain DSM 15954 (Chr. Hansen A/S), 2020. fda.gov
4PubMed. Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt in healthy children, 2017. pmc.ncbi.nlm.nih.gov
5PubMed. Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study, 2015. pubmed.ncbi.nlm.nih.gov

Independently researched5 citations