Regulation Watch · Tourism and Health · Indonesia. The decision applies nationally to specified natural medicines, health supplements, quasi-drugs and cosmetics that use any of the listed raw materials. It affects product registration or notification and products already circulating under BPOM oversight.
BPOM Requires Pharmaceutical-Grade Inputs for Selected Oral and Dental Products
BPOM Decision 366/2026 identifies 14 excipients that must meet pharmaceutical raw-material standards when used in specified oral liquids, mouthwash and dental-care cosmetics.
- Published
- Established by the Head of BPOM in Jakarta on 27 July 2026. The official BPOM JDIH metadata records no separate promulgation date or State Bulletin publication because the instrument is a Head of BPOM decision. Regulation Watch first recorded the decision on 24 October 2026 as a late-discovered instrument.
- Effective
- 27 July 2026, the date of establishment stated in the decision. The decision contains no transition period.
- Added to Watch
- 24 October 2026
Who is affected
PT PMA and PT PMDN manufacturers, product owners, importers and distributors of natural medicines, health supplements, quasi-drugs and dental or oral-care cosmetics; foreign raw-material manufacturers and suppliers; shareholders and directors; and regulatory, quality, procurement, formulation, laboratory, warehouse and distribution teams.
Practical impact
Decision 366/2026 implements the risk framework in PerBPOM 26/2025 by listing 14 raw materials that must meet pharmaceutical raw-material standards when used in the specified dosage forms. The list covers diethylene glycol monoethyl ether, diethylene glycol stearate, glycerin, lactitol, maltitol, maltitol solution, polyethylene glycol, polyethylene glycol monomethyl ether, propylene glycol, propylene glycol dilaurate, sorbitol, sorbitol solution, sorbitol sorbitan solution and non-crystallising sorbitol solution. The rule applies to liquid oral natural medicines, oral liquid health supplements, external liquid quasi-drugs that may include mouthwash, and dental or oral-care cosmetics. For natural medicines, supplements and quasi-drugs, the material must satisfy the Indonesian Pharmacopoeia, another internationally applicable pharmacopoeia or another recognised standard where the Indonesian Pharmacopoeia has no standard. For cosmetics, the material must satisfy the Indonesian Cosmetic Codex or another recognised standard where the Codex has no standard.
The Head of BPOM established Decision 366/2026 on 27 July 2026, and the decision took effect that day. It completes an implementation step required by PerBPOM 26/2025, which created a risk-based framework for raw materials used in natural medicines, health supplements, quasi-drugs and specified cosmetics.
The decision lists 14 raw materials: diethylene glycol monoethyl ether, diethylene glycol stearate, glycerin, lactitol, maltitol, maltitol solution, polyethylene glycol, polyethylene glycol monomethyl ether, propylene glycol, propylene glycol dilaurate, sorbitol, sorbitol solution, sorbitol sorbitan solution and non-crystallising sorbitol solution.
For each listed material, the decision identifies the same covered uses: liquid oral natural medicines, oral liquid health supplements, external liquid quasi-drugs that may include mouthwash, and dental or oral-care cosmetics. The list is therefore dosage-form and product-type specific. A business should not apply the decision to every use of the ingredient without first mapping the actual product and route of exposure.
PerBPOM 26/2025 supplies the controlling quality standard. For covered natural medicines, supplements and quasi-drugs, the material must comply with the Indonesian Pharmacopoeia, another internationally applicable pharmacopoeia or another recognised standard where the material is absent from the Indonesian Pharmacopoeia. For covered cosmetics, the reference is the Indonesian Cosmetic Codex or another recognised standard where the material is absent from that Codex.
The framework is designed to control health risks across the product life cycle, including contamination and exposure. It is relevant during registration or notification and while the finished product remains on the market. Supplier approval should therefore connect the actual manufacturer, grade, specification, analytical evidence and batch record to the Indonesian finished product rather than stopping at a commercial ingredient name.
Affected companies should immediately reconcile formulations, BPOM files and circulating stock. Priority should go to oral products, products for children or other higher-risk users, materials purchased through intermediaries, imported inputs and any file that relies on a food, industrial or generic cosmetic grade without clear evidence of the required pharmaceutical raw-material standard.
Late discovery: the decision took effect in July 2026 but was not previously recorded in the Regulation Watch ledger. BPOM JDIH now provides the official metadata and signed text needed to publish the update without changing the instrument's true legal dates.
Required action
- Inventory every formulation, registration, notification and circulating product that uses one of the 14 listed materials, and map the ingredient to the covered dosage form or cosmetic product type.
- Confirm that the purchased grade is a pharmaceutical raw material rather than relying only on a generic, food, industrial or cosmetic trade description.
- Reconcile specifications, certificates of analysis, test methods, supplier qualification and incoming-release criteria with the Indonesian Pharmacopoeia, an internationally applicable pharmacopoeia or another recognised standard; use the Indonesian Cosmetic Codex route for covered cosmetics.
- For imported materials, obtain traceable evidence from the actual manufacturer and confirm that the foreign standard relied on is applicable and recognised for the material and intended use.
- Update BPOM registration or notification files, product information and post-market quality records where the current file does not demonstrate the required raw-material standard.
- Add contractual change-control, batch traceability, deviation, complaint and recall cooperation clauses for listed-material suppliers, and reassess the material when the manufacturer, process, grade, specification or source changes.
- Preserve the risk assessment, approved specification, supplier evidence, certificate of analysis, incoming-test record, release decision and finished-product link for BPOM inspection or product review.