On July 27, 2026, the Indonesian Food and Drug Supervisory Agency (BPOM) issued Decision No. 366 of 2026, establishing a list of pharmaceutical ingredients used in natural medicines, health supplements, quasi-drugs and certain cosmetic preparations. The decision took effect immediately.
For the cosmetics sector, one of the most relevant aspects is the inclusion of 14 ingredients commonly used in dental and oral care products that must comply with pharmaceutical-grade quality standards.
The measure has implications not only for formulation, but also for raw material sourcing, supplier documentation and product notification in Indonesia.
Why has BPOM introduced these requirements?
Decision No. 366 follows Indonesia’s broader framework for assessing the risks associated with ingredients used in certain regulated products.
Under the Regulation on the Risk Assessment of Ingredients Used in Natural Medicines, Health Supplements, Quasi-drugs, and Certain Cosmetics, which entered into force in October 2025, ingredients used in certain higher-risk dosage forms are required to meet pharmaceutical-grade quality requirements.
For cosmetic ingredients, “pharmaceutical-grade” does not necessarily mean that the material must comply with a foreign pharmacopoeia. The applicable quality requirements are primarily those established in the Indonesian Cosmetics Codex. Where the Codex does not provide a relevant specification, other recognized standards may be used.
Decision No. 366 now provides a more concrete reference by identifying the ingredients and product categories to which these requirements apply.
Fourteen oral care ingredients are specifically covered
The annex to Decision No. 366 identifies 14 ingredients used in dental and oral care products that must meet the applicable pharmaceutical-grade specifications:
- 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
- Non-Crystallizing Sorbitol Solution
The list is particularly relevant to manufacturers of oral hygiene products because several of these substances are widely used for functions such as humectancy, solvent systems and formulation stability.
The important point for manufacturers is that the requirement concerns the quality grade of the ingredient, not simply whether the ingredient itself is permitted for use in cosmetics.
What does “pharmaceutical grade” mean in practice?
For companies supplying these products to Indonesia, the new requirements mean that conventional cosmetic raw material specifications may not always be sufficient.
Where a listed ingredient is used, manufacturers should verify that the material supplied meets the applicable pharmaceutical-grade specification. This should be supported by appropriate supplier documentation and quality certificates.
This makes supplier management an important part of regulatory compliance. Companies may need to review existing raw material specifications, certificates of analysis and other quality documents to determine whether the materials currently used in their formulations meet the Indonesian requirements.
The assessment should ideally take place before product notification or registration, rather than after a compliance issue has been identified.
Product classification also matters
Indonesia has several regulatory categories for products used in and around the mouth. Depending on their characteristics and intended use, dental products such as toothpaste may fall under the quasi-drug framework, while other oral care products may be regulated as cosmetics.
This distinction can affect the applicable regulatory pathway. However, companies should not assume that classification alone removes the ingredient-quality requirement.
Where one of the ingredients covered by Decision No. 366 is present in a relevant product, manufacturers need to determine the applicable quality standard based on the product’s regulatory category and the requirements established by BPOM.
For international companies, this makes accurate product classification particularly important when preparing an Indonesian market-entry strategy.
What should manufacturers do?
The immediate priority for companies selling oral care cosmetics in Indonesia should be an ingredient-level review.
Manufacturers should first identify whether their formulas contain any of the 14 substances listed in Decision No. 366. They should then confirm the applicable pharmaceutical-grade specification and check whether their suppliers can provide documentation demonstrating compliance.
It is also advisable to review the product’s Indonesian classification at the same time. A toothpaste, mouthwash or other dental product may not necessarily follow the same regulatory pathway as a conventional cosmetic, even though both may contain some of the same ingredients.
Finally, companies should consider Decision No. 366 together with the underlying ingredient risk-assessment framework. Reviewing the two measures together can help manufacturers build a more complete compliance file covering ingredient selection, quality specifications, supplier qualification and product notification.
