In October 2025, Indonesia’s National Agency for Drug and Food Control (BPOM) issued Regulation No. 26/2025 on Risk Assessment of Raw Materials used in traditional medicines, health supplements, quasi drugs, and certain cosmetics.
This move signals a new era of upstream compliance where ingredient safety becomes just as critical as finished product registration.
Why Does This Regulation Matter?
The regulation was born from tragedy. After the 2022 ethylene glycol and diethylene glycol contamination cases that caused fatal acute kidney injuries in children, BPOM recognized that product safety cannot rely solely on end-stage testing.
Contamination often begins at the raw-material stage, where oversight had previously been inconsistent. Regulation 26/2025 now requires that any raw material posing potential health risks be supported by a formal risk assessment—covering hazard identification, exposure, and risk characterization—and, when necessary, use pharmaceutical-grade inputs.
The assessment framework follows BPOM’s four-step model:
- Hazard Identification — recognizing substances or conditions that may cause harm.
- Hazard Characterization — defining dose–response relationships (e.g., ADI, TDI, NOAEL).
- Exposure Assessment — estimating the amount, frequency, and duration of human exposure.
- Risk Characterization — integrating all data to determine acceptable safety margins.
The outcome determines whether a material must comply with Farmakope Indonesia, another recognized pharmacopoeia, or the Kodeks Kosmetika Indonesia for cosmetics.
What’s New Compared to Before?
Previously, BPOM regulations focused mainly on finished-product dossiers, labeling, and prohibited ingredients. Risk assessment of raw materials was largely left to internal company practices.
For instance, under Peraturan BPOM No. 32 Tahun 2022 (for health supplements) and No. 23 Tahun 2019 / 17 Tahun 2022 (for cosmetics), product evaluations primarily covered formulation compliance and manufacturing GMP. Regulation No. 26/2025 expands that scope to include raw material provenance, documentation of toxicological data, and qualification of suppliers, effectively creating a new layer of pre-market due diligence.
Now, it’s mandatory. BPOM will evaluate not only the dossier but also the safety of the ingredients behind it, referencing the Farmakope Indonesia or Kodeks Kosmetika Indonesia.
This change aligns Indonesia with global best practice, shifting from reactive testing to proactive risk prevention.
What Does It Mean for Businesses?
For manufacturers, importers, and brand owners, this is both a challenge and an opportunity:
- Higher compliance expectations: Raw material sourcing, supplier qualification, and toxicology documentation must now follow a structured framework.
- Rising operational costs: Pharmaceutical-grade materials and risk assessments increase compliance costs and lead times.
- Competitive advantage: Companies that adopt these standards early can position themselves as premium, trustworthy brands in an increasingly regulated market.
- Regulatory risk: Non-compliance may lead to delays, recalls, or suspension of marketing authorizations.
Practically, BPOM expects industry players to maintain a Risk Assessment Dossier (RAD) or equivalent documentation during registration and market surveillance. Key technical expectations include:
- Certificates of analysis for impurities such as ethylene glycol (EG) and diethylene glycol (DEG), especially for glycerin, sorbitol, propylene glycol, and similar excipients.
- Verification that raw materials used in oral and topical dosage forms meet pharmaceutical-grade monographs.
- Integration of these assessments into Good Manufacturing Practice (GMP) or CDAKB/CPKB quality systems.
Non-pharma-grade ingredients in risk-sensitive formulations may now trigger rejection or post-market recall.
The Bigger Picture of The BPOM Regulation No. 26/2025
BPOM’s shift reflects Indonesia’s ambition to strengthen public health protection while raising the quality benchmark for its health and wellness industries. It will likely drive industry consolidation, filtering out low-quality players and rewarding those committed to transparent, science-based manufacturing.
From a regulatory perspective, this also operationalizes Pasal 406 ayat (5) of PP No. 28/2024, which implements the Health Law No. 17/2023. It confirms BPOM’s authority to issue lists of approved pharmaceutical raw materials and to enforce risk-based monitoring throughout the product’s life cycle from
importation, formulation, to post-market control.
At Product Registration Indonesia, we see this not merely as new paperwork, but as a turning point. For serious manufacturers and importers, Regulation 26/2025 is a strategic upgrade toward safer products, stronger consumer trust, and sustainable market access in Indonesia.
