Table 4. Regulatory status of postbiotics across major countries and regions

Region / Country	Regulatory category	Ingredient approval	Health / functional claims	Quality control indicators
Korea	Health functional food	Strain identity, manufacturing process, heat-treatment conditions, and safety data required	Subject to MFDS review and approval	Inactivated cell counts, cell wall components
EU (EFSA)	Food / feed / additive	QPS-listed strains; no specific legal definition for postbiotics	Health claims require EFSA scientific substantiation	Process verification, indicator components
USA (FDA / FTC)	Food / dietary supplement / GRAS	GRAS status based on strain identity and manufacturing process	Claims must be scientifically substantiated; advertising overseen by the FTC	Strain identity, compositional markers
Canada	Natural health product (NHP)	Product-specific safety and efficacy data required	Claims reviewed by Health Canada	Strain and product characterization
Japan (MHLW)	Foods with function claims / supplements	Scientific evidence required for safety assessment	Claims require regulatory review	Strain identity, indicator markers