{"id":7459,"date":"2026-08-21T13:20:52","date_gmt":"2026-08-21T06:20:52","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/"},"modified":"2026-08-21T13:20:54","modified_gmt":"2026-08-21T06:20:54","slug":"product-category-determination","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/zh\/product-category-determination\/","title":{"rendered":"Product Category in Indonesia: Cosmetic, Quasi-Drug, or Something Else?"},"content":{"rendered":"

This guide is for regulatory and market-entry teams preparing to register a product in Indonesia where the correct product category<\/strong> is not obvious: oral care, antiseptic and hygiene products, topical preparations with an active ingredient, or anything whose marketing makes a functional promise. After reading, you will know how BPOM defines a cosmetic, where a quasi-drug classification applies instead, and which product groups most often get misclassified before a submission is filed.<\/p>\n\n\n\n

Here is the detail a first read of the regulation will not tell you. <\/em><\/p>\n\n\n\n

In our own project work, the products that go wrong are rarely ones where the formula is unclear. They are products where Indonesian-language marketing copy was translated from a home-market claim sheet without a claims review, and that translation alone pushed a compliant cosmetic formula into a therapeutic claim it could no longer carry under its original product category. That failure mode sits entirely outside the statute and shows up only in submissions we have had to rebuild.<\/p>\n\n\n\n

What Determines Product Category Under BPOM Rules?<\/h2>\n\n\n\n
\"Product<\/figure>\n\n\n\n

Under Indonesian regulation, a cosmetic is a material or preparation intended for external use on the body: the epidermis, hair, nails, lips, and external genital organs, or the teeth and the mucous membranes of the oral cavity, principally to clean, perfume, alter appearance, improve body odour, or protect and maintain the body in good condition. This is the cosmetic definition Indonesia BPOM<\/strong> applicants work from, established through Peraturan Menteri Kesehatan Nomor 1176\/MENKES\/PER\/VIII\/2010 tentang Notifikasi Kosmetika<\/a>, and it is the starting point for every product category determination.<\/p>\n\n\n\n

The definition carries one hard limitation. A cosmetic is not a medicine and is not intended to treat a condition. Where a preparation is intended to treat, it sits outside the cosmetic product category however it is applied and however it is packaged. This single line decides most of the borderline cases foreign applicants bring to us.<\/p>\n\n\n\n

The Short Answer<\/h3>\n\n\n\n

A product is a cosmetic in Indonesia when its intended purpose is limited to cleaning, perfuming, altering appearance, addressing body odour, or maintaining the body in good condition, applied externally including the teeth and oral mucosa, with no claim to treat a named condition. If any one of those conditions fails, cosmetic product category should not be assumed without a review.<\/p>\n\n\n\n

Toothpaste and Oral Care: Which BPOM Category Applies?<\/h2>\n\n\n\n

Toothpaste sits in the toothpaste BPOM category<\/strong> of cosmetics in Indonesia. The statutory definition under Permenkes 1176\/2010 expressly extends to the teeth and the mucous membranes of the oral cavity, and BPOM’s notification framework under Peraturan Badan Pengawas Obat dan Makanan Nomor 21 Tahun 2022 tentang Tata Cara Pengajuan Notifikasi Kosmetika processes oral hygiene products, including cosmetic tooth-whitening preparations, through the same cosmetic notification pathway.<\/p>\n\n\n\n

Applicants from Japan, Korea, and several European markets, where oral care sits under a separate quasi-drug or medicated category, frequently expect a different Indonesian pathway. Mouthwash and cosmetic tooth-whitening products follow the same toothpaste BPOM category placement, subject to the claims analysis set out below.<\/p>\n\n\n\n

Obat Kuasi: Where Quasi-Drug Indonesia Rules Take Over<\/h2>\n\n\n\n

The adjacent category to cosmetics is the quasi-drug, known in Indonesian as obat kuasi. BPOM defines an obat kuasi <\/strong>product as a preparation containing an active ingredient with a local or non-systemic pharmacological effect, intended to address minor complaints, with topical rubs, medicated balms, and inhalant oils as the familiar examples.<\/p>\n\n\n\n

Labelling for this category is governed separately, under Peraturan Badan Pengawas Obat dan Makanan Nomor 10 Tahun 2024 tentang Penandaan Obat Bahan Alam, Obat Kuasi, dan Suplemen Kesehatan. A formulation containing a pharmacologically active substance does not automatically fall into this category, but it does mean the product classification cosmetic or drug<\/strong> question has to be established through analysis rather than assumed from the finished product’s appearance or intended retail aisle.<\/p>\n\n\n\n

The Two Determinants That Decide a Borderline Case<\/h2>\n\n\n\n

Every borderline product category decision we have reviewed comes down to two factors, and they do not always point the same direction.<\/p>\n\n\n\n

Composition. <\/strong>The presence of an active substance with a pharmacological effect points toward obat kuasi rather than cosmetic. Composition alone is not decisive; it is a signal that the classification needs to be worked through rather than defaulted.<\/p>\n\n\n\n

Claims. <\/strong>Because the cosmetic definition excludes treatment, a product marketed as treating a condition places itself outside the cosmetic product category regardless of formula. Cosmetic claims Indonesia<\/strong> rules sit in Peraturan Badan Pengawas Obat dan Makanan Nomor 3 Tahun 2022 tentang Persyaratan Teknis Klaim Kosmetika, and labelling, promotion, and advertising sit under Peraturan Badan Pengawas Obat dan Makanan Nomor 18 Tahun 2024 tentang Penandaan, Promosi, dan Iklan Kosmetik, which replaced Peraturan BPOM Nomor 30 Tahun 2020 and Peraturan BPOM Nomor 32 Tahun 2021.<\/p>\n\n\n\n

The table below sets out how these two determinants combine in practice, and which regulation governs each outcome.<\/p>\n\n\n\n

Determinant<\/strong><\/td>Points Toward Cosmetic<\/strong><\/td>Points Toward Obat Kuasi<\/strong><\/td><\/tr>
Active ingredient<\/td>Absent, or present only for a cosmetic purpose (e.g. UV filter)<\/td>Present, with a local pharmacological effect<\/td><\/tr>
Site of application<\/td>Skin, hair, nails, lips, teeth, oral mucosa, purpose limited to the cosmetic list<\/td>Same sites, paired with a treatment claim<\/td><\/tr>
Label \/ marketing claim<\/td>Clean, perfume, beautify, protect, maintain<\/td>Treat, cure, relieve a named minor complaint<\/td><\/tr>
Governing regulation<\/td>Permenkes 1176\/2010; PerBPOM 21\/2022; PerBPOM 3\/2022<\/td>PerBPOM 10\/2024 and related quasi-drug rules<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
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Cosmetic Ingredient Review in Indonesia: Applying PerBPOM 25\/2025 Before Submission<\/a><\/blockquote>