BPOM Regulation No. 17 of 2025: Guidelines for the Assessment of Health Supplement Products Containing Probiotics

On July 18, 2025, the Indonesian National Agency of Drug and Food Control (BPOM) officially issued Regulation No. 17 of 2025, providing detailed technical guidelines for the registration and assessment of health supplement products containing probiotics. This regulation became effective on the same day and repeals the previous Regulation No. 17 of 2021.

Key Provisions:

  1. Scope and Purpose
    This regulation applies to the assessment of health supplement products containing probiotics, aiming to provide technical guidance for industry stakeholders and BPOM evaluators during the registration process.
  2. Product Categorization and Self-Assessment
    Businesses are required to perform a self-assessment to categorize their products as health supplements, processed foods, or other categories using the flowchart provided in Appendix I. If a new strain or combination is used, a strain evaluation application must be submitted to BPOM as per the regulation.
  3. Documentation and Data Requirements
    • Strain Identification: Identification using both phenotypic and genotypic methods, with deposits in recognized culture collections.
    • Safety Data: In vitro and, if necessary, in vivo safety data.
    • Efficacy Data: Clinical evidence, especially for strains claiming benefits beyond general digestive health.
    • Product Quality and Stability: Data including colony-forming units (CFU), shelf life, and microbial purity controls.
  4. Assessment Timelines and Review
    For new strain evaluations, BPOM must issue a decision within 85 working days after dossier acceptance. BPOM may also re-evaluate already-registered probiotic supplement products in light of scientific or technological advances.
  5. Transitional Clause
    Existing registration permits for probiotic health supplement products issued before the effective date remain valid until their expiry. The previous Regulation No. 17 of 2021 is formally repealed upon the enactment of this regulation.
  6. Appendices and Attachments
  7. Appendix I: Flowchart for product categorization.
  8. Appendix II: Basic principles for evaluating new probiotic strains and products.
  9. Appendices III/IV: Forms for strain evaluation applications, classification of supporting data, registration procedures, and technical procedural guidelines.