Regulatory and safety documentation.
Bacospore® is manufactured under WHO-GMP, ISO 9001 and FSSC 22000 systems, and the strain is deposited with MTCC (India) as MTCC 25308 and with ATCC as PTA-126364, establishing identity and traceability at strain level. Regulatory classification varies by market; our regulatory team confirms the current position for your jurisdiction and supplies the supporting dossier.
Non-clinical safety.
Acute and sub-chronic toxicity evaluations of Bacillus coagulans in rodents showed no adverse effects at recommended probiotic doses. Full study protocols, dose ranges and histopathology reports are available to qualified evaluators on request.
A 2026 in-vitro investigation in 3T3-L1 cells reported comparatively high cellular viability for MTCC 25308 among four Bacillus strains tested, with no significant cytotoxicity under the experimental conditions, supporting cellular compatibility.
Bacospore® 300B contaminant limits.
| Parameter | Specification | Method |
|---|---|---|
| Lead | ≤ 3.0 ppm | ICP-MS |
| Arsenic | ≤ 1.0 ppm | ICP-MS |
| Cadmium | ≤ 1.0 ppm | ICP-MS |
| Mercury | ≤ 0.1 ppm | ICP-MS |
| Total yeast & mould | ≤ 100 CFU/g | USP <2021> |
| Salmonella | Absent/g | USP <2022> |
| E. coli | Absent/g | USP <2022> |
| Staphylococcus aureus | Absent/g | USP <2022> |
| Pseudomonas aeruginosa | Absent/g | USP <62> |
Allergen and dietary status.
- ◆GMO-free (per 300B specification)
- ◆BSE/TSE-free (per 300B specification)
- ◆Non-irradiated
- ◆Not treated with ethylene oxide
- ◆Tapioca-derived maltodextrin excipient
- ◆Country of origin: India
The Bacospore® 300B specification carries Kosher and Halal certification marks. Current certificates and allergen documentation are available from our quality team for finished-product label review.
Regulatory status by region.
India
Manufactured by Star Hi Herbs, Unit-2 (SEZ), Hassan, Karnataka. Bacospore® 300B specifies ≥300B viable spores/g.
United States
Strain deposited with ATCC as PTA-126364. Our regulatory team supplies the current US dossier, including the GRAS and NDI position, on request.
EU & other markets
Novel-food and permitted-use position confirmed with our regulatory team ahead of market entry, supported by full manufacturing and specification documentation.
Publisher note.
Bacospore® is supplied as a B2B probiotic ingredient. Regulatory classifications, permitted claims and maximum use levels vary by jurisdiction. Information is presented for technical evaluation and is not intended to diagnose, treat, cure or prevent any disease.