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On November 11, 2024, the Indonesian Food and Drug Supervisory Agency (BPOM) released a draft Regulation concerning Risk Assessment of Ingredients Used in Natural Medicines, Health Supplements, Quasi-drugs, and Certain Cosmetics for public consultation. 1 On October 3, 2025, BPOM officially issued and enforced the finalized version. 2
The regulation requires that ingredients used in certain dosage forms of natural medicines, health supplements, quasi-drugs, and cosmetics comply with the standards and quality requirements applicable to pharmaceutical ingredients. These “specific dosage forms” refer to products that, based on BPOM’s risk assessment, may pose potential health hazards if pharmaceutical-grade ingredients are not used.
BPOM conducts risk assessments according to the procedures outlined in the regulation’s Appendix. Industry stakeholders may also use this Appendix as a reference to perform their own risk assessments, ensuring product compliance during registration and market circulation.
The Appendix provides a four-step risk assessment framework:
Step 1: Hazard Identification: The first step requires companies to conduct a thorough scientific investigation to determine if a raw material has any inherent potential to cause harm. This involves gathering and analyzing data on the material's physicochemical properties, the impact of human exposure, and findings from existing epidemiological studies.
Step 2: Hazard Characterization: Once a potential hazard is identified, this step evaluates the relationship between the dose of the substance and its adverse health effects. Manufacturers must collect extensive toxicological data, including studies on long-term toxicity, carcinogenicity, and reproductive toxicity, to establish a definitive safe level of intake. The goal is to determine a specific value, such as the NOAEL (No Observed Adverse Effect Level), which is the highest dose at which no negative effects are seen.
Step 3: Exposure Assessment: This crucial stage focuses on how consumers interact with the product in the real world. Companies must now calculate the amount of a substance a person will be exposed to by considering frequency and duration of product use, the target user, as well as dosage forms.
Step 4: Risk Characterization: In the final step, the data from the previous stages are integrated to make a concluding assessment of the risk to the public. This involves comparing the calculated consumer exposure level (from Step 3) with the established safe toxicological level (from Step 2) to characterize the final risk. If this assessment reveals a significant risk, the regulation mandates a clear follow-up action: the Ingredient in question must be pharmaceutical-grade and meet the standards and/or quality requirements specified in the Indonesian Cosmetic Codex, or other recognized international standards if not listed in the Codex.
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