BPOM New Guidelines for Probiotic Health Supplements

    Indonesia’s Food and Drug Authority (BPOM) has issued new Guidelines, PerBPOM 17/2025, for Assessment of Probiotics in Health Supplements. 

    These new guidelines replace the previous rules established in 2021 and, unlike the 2021 version, create now an extensive system for evaluating registered probiotic strains, as well as new or combined strains.

    According to the new Guideline:

        • The term “probiotic” applies only to products containing live microorganisms that have proven health benefits, when using specific strains at specific doses.  

        • New strains, novel combinations, or products making claims other than maintaining digestive health, must undergo scientific evaluation, This includes validated strain identification, safety studies and evidence of efficacy. Probiotic strains that are already registered can proceed through standard registration.

        • Claims: the claims related to digestive health may be supported by foreign studies. However, all other claims – or changes to the existing approved claims – must be substantiated by clinical trials. These studies must be conducted in Indonesia or, under specific conditions and under BPOM approval, in countries with similar public health and dietary profiles (namely Malaysia, Thailand, or Vietnam). Post-market surveillance data must be submitted as well.

        • Labelling: labels must clearly indicate:

              – The strain’s genus, species and identification;

              – CFU counts at the end of shelf life;

              – Usage instructions based on clinical trial results;

              – Storage conditions.

        • Quality standards: proof of strain viability throughout shelf life, compatibility in multi-strain products, and stability data are required. 

    All probiotic supplements must be registered with BPOM, which will decide within 85 working days. Previously authorised products remain valid until their expiration date, but renewals and new applications must comply with the newly published guideline.