,"Indonesia's National Agency of Drug and Food Control (BPOM) introduced Regulation No. 26 of 2025, establishing a mandatory risk assessment framework for raw materials utilized in health supplements, traditional medicines, quasi-drugs, and specific cosmetic preparations. The regulation, effective immediately, comprises a four-step process: hazard identification, risk assessment, risk control, and risk communication.
This initiative responds to the 2022 crisis involving Ethylene Glycol (EG) and Diethylene Glycol (DEG) contamination, which led to numerous cases of acute kidney injury and fatalities. The new regulation aims to prevent such incidents by ensuring that raw materials meet stringent safety and quality standards before product registration.
Manufacturers and importers are now required to submit comprehensive risk assessment documentation for each raw material used in their products. This move underscores BPOM's commitment to safeguarding public health and enhancing consumer confidence in health-related products."
Consumer News Region