Indonesia Details Pharmaceutical-Grade Ingredient Requirements for Dental and Oral Care Products

On January 27, 2026, the Indonesian Food and Drug Supervisory Agency (BPOM) released a draft regulation on the List of Pharmaceutical Ingredients Used in Natural Medicines, Health Supplements, Quasi-drugs, and Certain Cosmetic Products. ¹ The draft sets out specific ingredients that must comply with pharmaceutical-grade standards when used in designated natural medicines, health supplements, quasi-drugs, and certain cosmetic products. Stakeholders may submit comments via https://bit.ly/KP-SKBB by February 10, 2026.

Regulatory Background

The draft decree follows BPOM Regulation No. 26 of 2025 on the Risk Assessment of Ingredients Used in Natural Medicines, Health Supplements, Quasi-drugs, and Certain Cosmetic Products, which entered into force on October 3, 2025. That regulation requires ingredients used in certain high-risk dosage forms to meet pharmaceutical-grade standards. For cosmetics, pharmaceutical-grade standards refer to the quality requirements set out in the Indonesian Cosmetics Codex, or other recognized standards where the Codex does not apply.

Ingredients Listed in the Draft

The draft regulation specifies the ingredients and applicable product categories that trigger the pharmaceutical-grade requirement. Notably, the appendix lists 14 ingredients used in dental and oral care products that are required to meet pharmaceutical-grade standards.

Further Reading

• Indonesia Releases Risk Assessment Regulation for Ingredients in Certain Cosmetics

• Indonesia Clarifies Ingredient Origin and Halal Labeling Requirements for Cosmetics

• Indonesia Specifies Cosmetic Test Parameters for Import Certificate Applications