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. Author manuscript; available in PMC: 2023 Dec 1.
Published in final edited form as: Regul Toxicol Pharmacol. 2022 Oct 4;136:105266. doi: 10.1016/j.yrtph.2022.105266

Box 1.

Essential Parameters of a Comprehensive Safety Assessment for a Probiotic.

Basic Safety Information - all probiotics
  • Genomic Analysis - whole genome sequencing
    • Strain identification
    • Identification of any virulence factors, hemolytic activity, toxin production
    • Genotypic assessment of antimicrobial resistance genes

  • Antibiotic resistance testing - Minimum Inhibitory Concentration (MIC) determination and assessment of potential transferable antimicrobial resistance genes

  • History of safe use (Genus, species, and strain levels)

 Additional Safety Information - case-by-case basis

  • D(−)-lactate production

  • Mucin degradation

  • Animal toxicity studies
    • Repeated dose studies (length of study may vary)

  • Human clinical studies tracking safety endpoints

  • Biogenic amine production