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HealthBiome is going to contribute to the promotion of human
health through continuous research and development
HealthBiome is going to contribute
to the promotion of human health through
continuous research and development

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Name 헬스바이옴 Date26-10-16 16:26 View65 Re.0

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HealthBiome's Jeonju plant has been certified to FSSC 22000 (Food Safety System Certification 22000), effective October 12, 2026. Building on the plant's existing health functional food GMP framework by MFDS Korea, the certification provides further, internationally recognized evidence of the food safety standards applied on our production floor.

FSSC 22000 combines ISO 22000, the international standard for food safety management systems, with prerequisite programmes (PRPs) covering hygiene and facility controls at the manufacturing site, plus additional scheme-specific requirements. Recognized by the Global Food Safety Initiative (GFSI), it is one of the benchmarks that leading food and dietary supplement companies worldwide use when qualifying ingredient suppliers. The audit spans the entire production process — hazard analysis and control, traceability from raw materials to shipment, prevention of foreign matter and cross-contamination, change management, and food fraud and food defense — and certified sites must maintain these standards through regular surveillance audits.

The strict-anaerobic human commensal bacteria at the core of HealthBiome's work are hard-to-culture organisms that struggle to survive even trace amounts of oxygen, demanding tight process control at every step from cultivation through inactivation, purification and drying. This certification confirms, through an independent third-party certification body, that the food safety management system of the Jeonju plant — which runs these demanding postbiotic production processes — meets internationally accepted standards.

HealthBiome's lead ingredient, HB05P (Akkermansia muciniphila HB05P), holds two US FDA New Dietary Ingredient acknowledgments (NDI No. 1363 and No. 1438) and an MFDS-authorized muscle-strength functional claim in Korea, and is on the market as Samyang Foods' SPINDLE in Korea. With international certification of the manufacturing site now complementing the regulatory clearances for the ingredient itself, we expect supplier-qualification reviews and audits by overseas partners to become more straightforward, and our position as a trusted supplier in global ingredient partnerships to strengthen.

Going forward, HealthBiome will continue to advance its quality and safety systems on the foundation of FSSC 22000 and GMP, and expand the global supply of strict-anaerobic postbiotic ingredients, including HB05P.