| 1 | Strain identification | Each microorganism should be identified by genus, species, and strain—not only by genus or species. | Strain-level identification records using appropriate phenotypic and genotypic methods. | Confirm that the identity is specific, documented, and consistent across technical and product records. |
| 2 | Strain characterization | Check that the strain has been characterized and can be distinguished from related microorganisms. | Characterization data and a traceable link between the tested strain and the strain supplied. | Require documentation that supports strain identity and traceability. |
| 3 | Safety assessment | Review the safety basis for the specific strain and its intended use, including relevant history of use and safety studies. | Strain-specific safety assessment, relevant study reports, and information on the intended population and use. | Assess safety for the proposed use; do not rely on species-level information alone. |
| 4 | Antimicrobial resistance | Evaluate resistance characteristics and whether any resistance raises a safety concern, including potential transferability. | Antimicrobial susceptibility results and supporting investigation of any clinically relevant resistance traits. | Request a documented scientific assessment of detected resistance. |
| 5 | Potentially undesirable metabolic activity | Consider metabolic properties relevant to safety, including production of substances that could be undesirable in the intended use. | Relevant strain-specific metabolic studies or other scientific evidence. | Check that identified risks have been assessed for the intended dose and consumer group. |
| 6 | Toxin, hemolytic, and pathogenic potential | Review evidence relevant to toxin production, hemolytic activity, and other indicators of potential pathogenicity or infectivity. | Appropriate laboratory and safety-assessment data for the specific strain. | Require clear results and documented follow-up for any safety-relevant finding. |
| 7 | Functional characterization | Confirm that any claimed probiotic function has been investigated for the specific strain or strain combination. | Relevant in vitro, in vivo, or other scientifically appropriate studies, with methods and results available for review. | Distinguish demonstrated strain-specific properties from general claims about probiotics. |
| 8 | Human efficacy evidence | Check whether human studies support the stated health benefit for the relevant strain, dose, population, and use. | Human study reports, including study design, population, dosage, outcomes, and limitations. | Match the evidence to the exact product formulation and proposed claim; avoid extrapolating beyond the data. |
| 9 | Label identity and viable count | Check for genus, species, and strain designation, plus the minimum viable amount of each probiotic strain through the end of shelf life. | Proposed label and supporting count or stability data through the stated expiry date. | Verify that the declared identity and viable count are clear and supported at the end of shelf life. |
| 10 | Use, storage, and consumer information | Review the suggested serving size, relevant health claim, storage conditions, and consumer contact information. | Proposed label, serving-size rationale, storage instructions, and contact details. | Check that instructions and claims are consistent with the evidence and that storage directions support product quality. |