On July 27, 2026, the Indonesian Food and Drug Supervisory Agency (BPOM) issued Decision No. 366 of 2026, promulgating the List of Pharmaceutical Ingredients Used in Natural Medicines, Health Supplements, Quasi-drugs, and Certain Cosmetic Preparations, which clarifies that ingredients used in certain cosmetics (particularly dental and oral care products) must meet pharmaceutical-grade standards. The regulation took effect immediately upon its issuance. CIRS Group has summarized the key points of this regulation relevant to cosmetics (especially dental and oral care products) as follows.
Regulatory Background
Decision No. 366 follows the Regulation on the Risk Assessment of Ingredients Used in Natural Medicines, Health Supplements, Quasi-drugs, and Certain Cosmetics, which took effect on October 3, 2025. The 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; where the Codex does not apply, other recognized standards shall be referenced.
Core Requirements for Cosmetics
Decision No. 366 sets out, in its annex, the ingredients that must meet pharmaceutical-grade standards and the applicable product categories. Notably for cosmetic companies, the annex specifically lists 14 ingredients used in dental and oral care products that are required to meet pharmaceutical-grade standards.
This means that, in ingredient procurement, formula design, and product notification, companies concerned must ensure that the above ingredients meet pharmaceutical-grade quality requirements, rather than merely satisfying general cosmetic ingredient specifications; accordingly, they must obtain from their suppliers ingredient certificates demonstrating compliance with pharmaceutical-grade specifications.
14 Ingredients Involved in Dental and Oral Care Products
The 14 ingredients listed in the annex to Decision No. 366 that are used in dental and oral care products and must meet pharmaceutical-grade standards are as follows:
| No. | Ingredient Name |
| 1 | Diethylene Glycol Monoethyl Ether |
| 2 | Diethylene Glycol Stearate |
| 3 | Glycerin |
| 4 | Lactitol |
| 5 | Maltitol |
| 6 | Maltitol Solution |
| 7 | Polyethylene Glycol |
| 8 | Polyethylene Glycol Monomethyl Ether |
| 9 | Propylene Glycol |
| 10 | Propylene Glycol Dilaurate |
| 11 | Sorbitol |
| 12 | Sorbitol Solution |
| 13 | Sorbitol Sorbitan Solution |
| 14 | Non-Crystallizing Sorbitol Solution |
Note: The ingredient names above are provided for reference; the official BPOM regulation text shall prevail.
CIRS Reminder
Decision No. 366 has a direct impact on companies exporting dental and oral care cosmetics to Indonesia. CIRS Group offers the following reminders:
- Accurately define “pharmaceutical-grade standards”: the pharmaceutical-grade standard for cosmetic ingredients is governed by the Indonesian Cosmetics Codex, with other recognized standards referenced where the Codex does not apply. Companies should verify whether their formulas contain any of the 14 listed ingredients and confirm whether their suppliers can provide ingredients and corresponding certificates meeting pharmaceutical-grade specifications.
- Pay attention to product classification boundaries: under Indonesia’s regulatory system, dental care products such as toothpaste may be registered as quasi-drugs, while others are notified as cosmetics; regardless of classification, any product involving listed ingredients must meet pharmaceutical-grade requirements. Companies should apply the rules accurately according to their own product category.
- Trace the regulatory basis: Decision No. 366 is the supporting list to Decision No. 26 of 2025 (ingredient risk assessment). Companies are advised to review both instruments together to strengthen their ingredient compliance records and quality management systems.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Our Services
- Indonesian Companies License Holding Services
- BPOM Account Registration
- Formula and Packaging Review
- Cosmetic Product Notification
- PIF/DIP File Preparation and Compilation
- Product Testing Services
- Logistics and Customs Clearance
- HALAL Certification Services
Further Information:
