Title : Regulatory and safety considerations for Bacillus subtilis strain DG101: Aligning innovation with global and regional compliance
Abstract:
The increased incorporation of spore-forming probiotics such as Bacillus subtilis into health and wellness products highlights the critical need for harmonized safety and regulatory frameworks. Strain DG101 exemplifies the importance of early-stage evaluation of genomic integrity, absence of virulence and antibiotic resistance genes, and preclinical safety indicators to support regulatory readiness.
This presentation outlines the core components of a regulatory and safety assessment strategy for DG101 within global and regional contexts. Emphasis is placed on compliance with major frameworks including the U.S. Food and Drug Administration (GRAS notification), the European Food Safety Authority (Qualified Presumption of Safety), and the Singapore Food Agency (SFA) guidelines for novel ingredients and microbial cultures. Additional reference is made to the ASEAN Guidelines on Health Supplements, which shape probiotic market entry strategies across Southeast Asia.
As demand for stable, spore-based formulations grows—particularly in tropical and high-mobility regions—strain-specific positioning becomes increasingly important. This session also addresses regulatory considerations for health claims, cross-border product registration, and label conformity under regional schemes.
By presenting DG101 as a case within this evolving landscape, the discussion provides a framework for aligning scientific, regulatory, and market objectives in the development of next-generation probiotics for global and Asia-Pacific markets.
