GenMont functional probiotic GM-080 (Lactobacillus paracasei) has a safe consumption history of over 20 years. Whole-genome sequencing has confirmed that GM-080 carries no pathogenic factors or antibiotic resistance genes, ensuring its absolute safety. Furthermore, GM-080 possesses excellent gastric acid and bile salt resistance, allowing it to remain in the intestinal tract for a longer duration to exert its efficacy.Backed by extensive international animal and human clinical literature, GM-080 has achieved New Dietary Ingredient (NDI) notification from the US FDA, New Food Raw Material authorization from China, and multiple invention patents across various countries, with numerous international papers published. Clinical trials demonstrate that GM-080 can promote IFN-γ secretion to inhibit the hyperactive immune response of Th2 (T-helper 2) cells. Meanwhile, it enhances the secretion of the anti-inflammatory cytokine IL-10 and activates regulatory T cells (Tregs) to modulate allergic reactions. Its most representative commercial application, "eN-Lac Capsule," has been granted the dual-efficacy certification for "assisting in adjusting allergic constitution" and "immune regulation" under the Taiwan Health Food Regulations.

GenMont has successfully obtained international quality management and food safety certifications, including GHP、TQF、ISO 22000、HACCP and HALAL certification. Functional probiotic GM-080 has achieved New Dietary Ingredient (NDI) notification from the US FDA and New Food Raw Material authorization from China. It has also been granted multiple patents across various countries, with numerous international papers published.

Lactobacillus paracasei

Lactobacillus paracasei≧1×10^11 CFU/g

• Raw materials undergo testing for total viable count (TVC), Coliforms, E. coli, mold, and yeast. They are approved and transferred to the warehouse only after meeting all compliance standards.

• Raw materials are issued and dispatched based on production requisitions.

• The production process is carried out through fermentation, freeze-drying, pulverization, sifting, and metal detection.

• In the final packaging stage, the bulk probiotic powder is filled into PE bags and then sealed within aluminum foil bags. Final product clearance is granted upon verification of the finished product inspection results.

Food Safety and Hygiene Testing

Items Mandatory Testing: Heavy metals (Testing items: Arsenic, Lead, Cadmium, Mercury; Heavy metals calculated as Lead) (Testing lab: SGS) / Microorganisms (Testing items: Coliforms, E. coli) (Testing lab: SGS)/ In-house Testing: Phthalate plasticizers (Testing lab: SGS).

• Risk Control in the Inbound Phase: Supplier management (evaluation, classification, and compliance testing reports for raw materials and ingredients); In-house inspection of raw materials.

• Risk Control in the Production Phase: Execution in accordance with SOPs; In-process inspection, where production personnel perform autonomous checks and maintain production records according to regulations; Sifting and blending monitoring; Magnetic rod verification.

• Risk Control in the Finished Product Phase: Finished product inspection (compliance with all specifications); Retention sample management.

• Risk Control in the Post-Market Phase: Customer complaint management, establishing procedures for handling customer complaints and reporting adverse events, with investigation, analysis, and corrective actions for anomalous cases; Product traceability and recall mechanism management.

L. paracasei as the active health ingredient, eN-Lac® APF Probiotic Capsules have been scientifically proven to provide dual benefits: assisting in adjusting allergic constitution and immune regulation.

• EK Lin et al. (2023). L. paracasei GM-080 Ameliorates Allergic Airway Inflammation in Children with Allergic Rhinitis From an Animal Model to a Double-Blind, Randomized, Placebo-Controlled Trial. Cells. 2023 Feb 28;12(5):768.

• DJ Costa et al. (2014). Efficacy and safety of the probiotic Lactobacillus paracasei LP-33 in allergic rhinitis: a double-blind, randomized, placebo-controlled trial (GA2LEN Study). Eur J Clin Nutr. 2014 May;68(5):602-7.

• Peng & Hsu (2005). The efficacy and safety of heat-killed Lactobacillus paracasei for treatment of perennial allergic rhinitis induced by house-dust mite. Pediatr Allergy Immunol. 2005 Aug;16(5):433-8.

• M. F. Wang, Lin, Wang, & Hsu (2004).Treatment of perennial allergic rhinitis with lactic acid bacteria. Pediatr Allergy Immunol. 2004 Apr;15(2):152-8.

Use of Lactobacillus paracasei GM-080 for modulating immune function:TW Ⅰ 802177、IT 102022000005717、US 12648974 B2