Foreign brands often assume registering traditional cosmetics in Indonesia means the same heavy dossier process required for pharmaceuticals or medical devices. We see this mistake constantly with kohl eyeliners, henna hair colorants, and mineral nail treatments.
Clients frequently arrive expecting months of clinical documentation, similar to drug registration. This guide is written for cosmetic brand owners, distributors, and compliance teams who need to register traditional cosmetics in Indonesia and want an accurate picture before they commit to a launch timeline.
By the end of this guide, you will understand the real notification pathway, why heavy-metal testing applies specifically to kohl, henna, and nail formats, and how Indonesia’s requirements compare to a stricter market such as the United States.
The most important fact to understand upfront is this. Indonesia does not register traditional cosmetics in Indonesia the way it registers drugs or medical devices. Kohl, henna, and nail products move through BPOM’s notification system, a self-declared compliance pathway rather than a pre-market dossier review.
What Is the BPOM Notification Pathway for Traditional Cosmetics?
Cosmetic notification in Indonesia is governed by Peraturan Menteri Kesehatan No. 1176/MENKES/PER/VIII/2010 tentang Notifikasi Kosmetika and Peraturan BPOM No. 21 Tahun 2022 tentang Tata Cara Pengajuan Notifikasi Kosmetika. A locally established company submits product data through BPOM’s online notification system.
Under this system, BPOM does not pre-approve the formula before the product reaches shelves. The notification holder self-declares that the product meets safety, labeling, and ingredient requirements, then receives a Notification Number once the submission clears administrative verification (in accordance with BPOM Regulation No. 25 of 2025 on Technical Requirements for Cosmetic Ingredients).
This differs sharply from drug or medical device registration, where BPOM evaluates a full technical dossier before issuing market authorization. For traditional cosmetics like kohl, henna, or nail treatments, the compliance burden shifts toward accurate self-declaration, not upfront government approval of the formula.
The notification holder stays legally responsible for every ingredient and safety claim submitted. BPOM can request or audit the underlying Product Information Document, known as DIP, at any point after notification, under Peraturan BPOM No. 17 Tahun 2023 tentang Pedoman Dokumen Informasi Produk Kosmetik.
Why Heavy-Metal Testing Matters for Kohl, Henna, and Nail Products
These three product categories draw more heavy-metal scrutiny than typical skincare because of how they are traditionally formulated. Kohl is historically made from ground galena, a lead sulfide mineral, which can carry naturally high lead content if not reformulated.
Henna powders sourced from open markets sometimes carry contamination from soil, processing equipment, or metallic salts added to darken the color. Traditional nail treatments and mineral-based nail hardeners can likewise carry trace heavy metals from unrefined mineral inputs.
BPOM sets contamination ceilings for all cosmetics under Peraturan BPOM No. 12 Tahun 2019 tentang Cemaran Dalam Kosmetika. This regulation caps lead, or timbal, at 20 mg per kilogram and cadmium, or kadmium, at 5 mg per kilogram, regardless of product category.
| Contaminant | Indonesia limit (BPOM No. 12/2019) | Testing method typically used |
| Lead (Pb) | 20 mg/kg (20 ppm) | Atomic Absorption Spectrophotometry (AAS) or ICP |
| Cadmium (Cd) | 5 mg/kg | AAS or ICP |
| Mercury (Hg) | Not permitted as an added ingredient | AAS or ICP |
| Arsenic (As) | Regulated under the same standard | AAS or ICP |
Under BPOM Regulation No. 25 of 2025 concerning the Technical Requirements for Cosmetic Ingredients (Peraturan BPOM No. 25 Tahun 2025 tentang Persyaratan Teknis Bahan Kosmetik) — the regulation currently governing prohibited cosmetic ingredients — heavy metals such as lead, cadmium, mercury, and arsenic, along with their compounds, all appear in Annex V (Lampiran V), the list of substances banned from use in cosmetics, namely:
- Lead and its compounds (No. 875 / CAS 7439-92-1)
- Cadmium and its compounds (No. 180 / CAS 7440-43-9)
- Mercury and its compounds (No. 903 / CAS 7439-97-6)
- Arsenic and its compounds (No. 79 / CAS 7440-38-2)
In our experience, kohl and unrefined henna are the two formats most likely to fail this testing on first submission. This usually happens when the manufacturer sources raw mineral or plant material without a validated heavy-metal control step in production.
BPOM’s WHO Listed Authority Status: What It Covers, and What It Does Not
Since December 2025, BPOM has held World Health Organization Listed Authority status, making Indonesia the first developing country to receive this recognition. Clients sometimes read this as proof that Indonesian cosmetic standards now match FDA-level rigor.
That reading is incorrect. BPOM’s WLA designation applies specifically to its regulatory function over medicines and vaccines, not cosmetics. The cosmetic notification pathway described above remains unchanged by this status, and heavy-metal limits for cosmetics still sit under a separate, cosmetic-specific regulation.
We flag this distinction directly with clients because conflating the two creates false confidence. A WLA-recognized authority for pharmaceuticals does not mean every cosmetic notification receives the same depth of pre-market scrutiny that a drug dossier does.
How the US FDA Treats Kohl-Based Products: A Useful Comparison
Clients preparing kohl products for Indonesia often ask whether the heavy-metal testing requirement here is unusually strict. It is not. The comparison with the United States actually shows Indonesia’s approach is more permissive in one specific respect.
The FDA classifies kohl, kajal, surma, and related names as illegal color additives under the Federal Food, Drug and Cosmetic Act, and enforces Import Alert 53-13 against these products. Under this alert, kohl-labeled eyeliners can be detained at US ports regardless of lead content.
| Aspect | Indonesia (BPOM) | United States (FDA) |
| Legal status of “kohl” as labeled | Permitted if within contamination limits – | Prohibited as an unapproved color additive |
| Lead limit | 20 mg/kg (20 ppm) | 10 ppm in externally applied cosmetics |
| Market pathway | Self-declared notification | No lawful pathway for kohl-labeled products |
| Enforcement point | Post-market audit of DIP | Import Alert, port detention |
Traditional, lead-based kohl formulated from unrefined galena cannot lawfully enter the United States at all, notification or not. The heavy-metal check under Indonesian law is not a local peculiarity. It reflects a global pattern of scrutiny toward this specific product category.
When “Kohl” Is a Color Name, Not an Ingredient
Here is a distinction we regularly walk clients through that is easy to miss when reading the regulation text alone. On many modern product labels, “kohl” describes a color and finish, not a declared ingredient made from galena.
A significant share of kohl-branded eyeliners sold internationally today use conventional cosmetic colorants, such as iron oxides, to achieve the traditional dark, smoky look, without any lead-bearing mineral in the formula. The name is marketing language carried over from tradition.
For brands in this position, a lead-free reformulation paired with accurate labeling is a realistic path to register traditional cosmetics in Indonesia. The key is ensuring the Product Information Document reflects the actual formula, not just the traditional product name on the label.
This is where formulation review before submission matters most. Confirming what is actually in the product, independent of what the name suggests, determines whether heavy-metal testing becomes a routine pass or an unexpected rejection.
Common Mistakes We See When Clients Register Traditional Cosmetics in Indonesia
- Assuming the notification pathway requires the same dossier depth as drug registration
- Sourcing raw kohl or henna material without a validated heavy-metal control step
- Treating BPOM’s WHO Listed Authority status as proof of cosmetic-grade equivalence with the FDA
- Submitting a Product Information Document that does not match the product’s actual formulation
- Leaving halal certification planning until after notification, instead of building it into the timeline.
- Using lead, cadmium, mercury, arsenic, or their compounds as a deliberate ingredient — for example unrefined galena in kohl — rather than treating them only as a contamination-limit issue, when Peraturan BPOM No. 25 Tahun 2025 Lampiran V bans these substances outright”
- Assuming an existing Notification Number is grandfathered indefinitely, when Pasal 15 Peraturan BPOM No. 25 Tahun 2025 requires existing notification holders to adjust their formulation within 12 months of the regulation’s promulgation.”
Key Acronyms Used in This Article
- BPOM: Badan Pengawas Obat dan Makanan, Indonesia’s Food and Drug Authority
- DIP: Dokumen Informasi Produk, the Product Information Document BPOM can audit after notification
- NA: Notification Number, the market authorization code issued after successful cosmetic notification
- CPKB: Cara Pembuatan Kosmetik yang Baik, Indonesia’s Good Cosmetic Manufacturing Practice standard
- WLA: WHO Listed Authority, the World Health Organization’s recognition of a national regulator
How We Help You Register Traditional Cosmetics in Indonesia Safely
Traditional cosmetic formats carry real reputational and legal exposure if heavy-metal contamination surfaces after a product reaches Indonesian shelves. A notification that later fails a BPOM audit can mean recalls, notification revocation, and lost distribution relationships.
This is not a category where a do-it-yourself submission is worth the risk. Our regulatory team reviews formulations against BPOM’s contamination limits before submission, prepares the Product Information Document to match your actual formula, and manages the notification filing end to end.
If you are preparing to register traditional cosmetics in Indonesia, get in touch with our Cosmetic Product Registration team using the contact form below to book a formulation risk review before you file. Our team can also coordinate Heavy-Metal Compliance Testing alongside your notification process so you can go to market with complete confidence.
Don’t leave your market entry to chance, reach out today and let us help you navigate BPOM compliance smoothly, safely, and successfully.
