Indonesia Consults on Risk Assessment Regulation for Ingredients in Certain Cosmetics

On November 11, 2024, the Indonesian Food and Drug Supervisory Agency (BPOM) released a draft Regulation concerning Risk Assessment of Ingredients Used in Certain Natural Medicines, Health Supplements, Quasi-drugs, and Cosmetics for public consultation. ¹

This regulation mandates that ingredients in specific dosage forms of natural medicines, health supplements, quasi-drugs, and cosmetics meet the standards and quality requirements as pharmaceutical ingredients. These specific dosage forms refer to products that, based on BPOM’s risk assessment, may pose adverse health effects if pharmaceutical-grade ingredients are not used.

BPOM will conduct risk assessments following the steps and requirements outlined in Appendix 1 of this regulation. Relevant businesses in the sector can also refer to Appendix 1 to perform their own risk assessments, ensuring their products comply with regulatory requirements before or during distribution. Appendix 1 outlines the risk assessment process, including hazard identification, hazard characterization, exposure assessment, and risk characterization.

Additionally, Appendix 2 of the regulation includes a list of pharmaceutical-grade ingredients used in dental and oral care products.

Further Reading

• Indonesia Updates Implementation Regulation of Halal Product Assurance

• Indonesia Proposes to Update Cosmetic GMP Certification Application and Renewal Requirements

• Indonesia Proposes to Amend Cosmetic Labeling, Promotion and Advertising Requirements