Export Documents and Certificates for Japan-Made Cosmetics

An importer’s email often asks for “a free sale certificate, a GMP certificate, a CoA and the full formula” in one line. Each of those is a different document from a different issuer, proving a different thing, and one of them depends on a decision made months before production: whether the product is also notified for the Japanese market. A brand that knows the Japan-side document set at the brief stage can match it to the importer’s list early, instead of discovering a gap when the goods are ready to ship.

💬 Sunsho Trade manages own-brand cosmetics made in Japan for brands outside Japan, including the Japan-side documents, with a GMP-certified partner factory in Japan. Send us your importer’s document list and we will map each item to a Japanese document.

The document set at a glance

Japan-side export documents fall into three groups: domestic filings the factory makes, certificates issued through the Japan Cosmetic Industry Association or the Ministry of Health, Labour and Welfare, and technical documents from the factory; each proves something narrower than importers often assume.

Sources for this article are JETRO’s Q&A on exporting cosmetics from Japan (last updated August 2025) and MHLW’s notice of 27 July 2026 on export cosmetics certificates. Checked against the published texts of the Ministry of Health, Labour and Welfare, JETRO and the Japan Cosmetic Industry Association on 17 October 2026.

The export manufacturing notification

If a product is made with export-only labels or to an export-only specification, a licensed manufacturer must file an export manufacturing notification (輸出用化粧品製造届) before manufacture starts; it is a Japanese filing, not a document your importer receives.

Under the PMD Act (Japan’s Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices), as JETRO’s Q&A explains, putting export labels on a cosmetic or making it to an export specification counts as manufacturing. Why that is, and how it affects the order of work, is covered in the export and shipping flow. Here, the point is what the filing is and is not as a document. It is made by the licensed manufacturing side in Japan, it must be in place before manufacture starts, and your importer does not receive it as evidence of anything.

The notification goes to the Minister of Health, Labour and Welfare through PMDA, under Article 74 of the PMD Act Enforcement Order and Article 265 of the Enforcement Regulations. For an own-brand product made for an overseas market, this is the normal case. The notification does have one direct link to the certificates below: for a Form 3 certificate (described below) that names the product by its export name, for example in English, the export manufacturing notification is among the documents required.

Certificates under the July 2026 notice

Under MHLW’s notice of 27 July 2026, export cosmetics certificates are applied for through the Japan Cosmetic Industry Association and are in principle issued by it in its own formats; MHLW issues a certificate itself only where the destination’s laws require a government certificate.

The notice (医薬薬審発0727第4号 / 医薬安発0727第6号) replaced the notice of 2 August 2021. Its main points for an exporter:

• One route in. Applications go through JCIA, whether the certificate is JCIA’s or the Ministry’s.
• JCIA formats first. Certificates are in principle JCIA certificates in JCIA’s formats.
• Government certificate only when required. MHLW issues its own certificate only when the destination country’s laws require a government certificate. JCIA still receives the application and checks the documents, and the applicant must attach the relevant part of the destination regulation, with a Japanese translation of that part.
• Electronic certificates. New in July 2026, certificates can be issued as electronic PDF files, with the date and a document ID inserted in the signature frame, delivered through a shared cloud folder designated by MHLW. Paper remains available, normally through JCIA.

The electronic option matters if your importer’s authority accepts electronic documents, because it removes the courier step. Ask your importer whether the authority accepts a PDF certificate of this kind, and whether it wants any further authentication of the document.

The practical consequence of the government-certificate rule is that your importer must tell you, early and precisely, whether their authority requires a certificate from a government body or will accept an industry association’s certificate, and which regulation says so. Without that text, the Ministry route cannot start.

💬 Does your importer’s authority want a government certificate or an industry one? Send us the requirement as they wrote it and we will tell you which Japanese certificate answers it.

Why Form 3 depends on a Japanese notification

A certificate that a product is manufactured and sold in Japan presupposes that it is notified for the Japanese market, so decide at the brief stage whether your product will be notified in Japan if your importer expects that kind of certificate.

Among the documents required for Form 3 are copies of the marketing authorisation holder licence, the manufacturing licence, and the product’s Japanese notification (化粧品製造販売届) or equivalent. If the product name to be certified is an export name, for example in English, the export manufacturing notification is needed as well.

This is the point that catches export-only projects. Many importers ask for a “free sale” type certificate, meaning proof that the product is legally sold in the country of origin. If your product is made only for export and never notified for the Japanese market, the “manufacture and sale” certificate is not a straightforward option. Two questions follow:

1. Does the destination accept a manufacturing certificate instead? Forms 4-1 and 4-2 certify manufacture of a named product, without the sale element. Ask your importer whether that, or a JCIA-format certificate, satisfies the authority.
2. Should the product also be notified in Japan? That requires a licensed marketing authorisation holder and Japanese labelling for any product sold there. The requirements are set out in the licences you need to sell cosmetics in Japan.

Whichever route applies, note that Forms 3, 4-1 and 4-2 certify the product name only, not the ingredients. If your importer expects a certificate to confirm the formula, it will not.

The GMP statement: what ISO 22716 covers

JCIA issues its members certificates stating that products are made in line with ISO 22716, the cosmetics GMP standard that JCIA adopted as the industry’s voluntary standard in April 2008.

MHLW abolished its 1988 cosmetics manufacturing technical guideline in June 2008, in response to JCIA’s adoption of ISO 22716. A GMP statement tells your importer that manufacture follows a recognised quality system: controlled premises, trained staff, documented production and records. It does not certify that the formula is safe, that it meets the destination’s ingredient rules, or that the claims on the label are permitted there. Those questions are answered by the formula check, the ingredient list and your importer’s own review.

For our own projects, the factory is described in one way only: a GMP-certified partner factory in Japan. Which GMP document can be issued for a given project is confirmed with the factory when your importer’s list is known.

CoA, ingredient list and SDS

The certificate of analysis, the ingredient list with INCI names and the safety data sheet come from the factory; agree their content early, because each one answers a different question from your importer.

Certificate of analysis. A CoA reports a production batch’s results against the specification agreed for that product: typically appearance, odour, pH, viscosity and microbiological items, but the actual list is whatever the specification contains. If your importer wants a particular item on the CoA, it has to be in the specification before production. Stability results, which describe the formula over time rather than one batch, are a separate document; see stability and compatibility testing.

Ingredient list with INCI names. The factory’s ingredient list is written in Japanese labelling names. Most export markets use INCI names, so the list has to be converted and the conversion checked; the two systems do not map automatically. How this works is explained in full-ingredient labelling and INCI names. Some authorities also ask for percentages. Whether the factory discloses them, and to whom, should be agreed at the start, as part of who owns what in the project.

Safety data sheet. The SDS describes hazards, handling and, in section 14, the transport classification. It matters most for alcohol-rich products and aerosols, which may be dangerous goods for transport. It is a handling document, not a statement about consumer safety.

What to ask your importer first

Before production, get your importer’s list of required documents in writing, with the authority’s exact wording, and match each item to a Japanese document.

A short exchange at the brief stage saves a long one at shipment. Ask your importer:

• which documents the destination authority requires for the notification, and which it may ask for later;
• whether a certificate must come from a government body, and which regulation says so;
• whether electronic certificates are accepted;
• whether the authority wants any certificate further authenticated, for example by an embassy;
• which items the CoA must show;
• whether the ingredient list must include percentages.

For Vietnam, the filing side is covered in Vietnam’s cosmetics import notification. For general Japanese export customs paperwork, such as invoices and packing lists, see export from Japan: documents and flow.

💬 Want the document set settled before production? See how our Japan cosmetics OEM service works, browse the Japan cosmetics OEM guide, or send us your importer’s list.

Frequently asked questions

1. Can I get a free sale certificate for a cosmetic made only for export?
The MHLW certificate of manufacture and sale (Form 3) requires, among other documents, the product’s Japanese notification or equivalent. A product never notified for the Japanese market is therefore not a straightforward case. Ask your importer whether a manufacturing certificate or a JCIA-format certificate is accepted instead.

2. Who issues export certificates for cosmetics in Japan?
Under MHLW’s notice of 27 July 2026, applications go through the Japan Cosmetic Industry Association, which in principle issues certificates in its own formats. MHLW issues a certificate itself only when the destination’s laws require a government certificate.

3. Does an export certificate confirm my product’s ingredients?
No. MHLW Forms 3, 4-1 and 4-2 certify the product name only. Ingredient information comes from the ingredient list, which should be given in the names your destination uses, usually INCI.

4. Are electronic certificates available?
Yes, since the July 2026 notice. Certificates can be issued as PDF files with the date and a document ID in the signature frame, through a shared cloud folder designated by MHLW. Paper certificates remain available. Check that your destination authority accepts the electronic form.

5. What does the export manufacturing notification do for my importer?
Nothing directly. It is a filing on the Japanese side, needed when a product is made with export labels or to an export-only specification, and it must be filed before manufacture starts. It is, though, among the documents required when a Form 3 certificate names the product by an export name.