Indonesia Consults on Risk Assessment Regulation for Ingredients in Dental and Oral Care Products

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

This Regulation requires that ingredients in natural medicines, health supplements, quasi-drugs, and certain cosmetic preparations (i.e. dental and oral care products) meet the standards and quality requirements as pharmaceutical ingredients.

Any ingredients listed in the following table are subject to a risk assessment when used in dental and oral care preparations. If ingredients not listed are utilized, supporting data and a risk assessment are necessary.