Japan-made cosmetics OEM

Your own-brand cosmetics, made in Japan

For brands outside Japan that want “Made in Japan” on the pack. We check your concept against Japanese cosmetic rules, arrange production at a GMP-certified partner factory in Japan, and prepare the documents your market asks for — in English.

Send us your brief Product types Rules, development and export guides

The first decision: cosmetic or quasi-drug

In Japan, what the label claims decides the regulatory category — and the category decides how the product is made, approved and documented.

Japan’s Act on Pharmaceuticals and Medical Devices defines a cosmetic as something applied to the body to clean, beautify, add attractiveness, change the appearance or keep the skin or hair healthy, with a mild action on the body (Article 2(3)). Products that claim certain active effects — the quasi-drug wording for whitening, acne prevention as an active effect, anti-dandruff medicated shampoo, deodorants, hair growth — are quasi-drugs (医薬部外品) instead. A cosmetic is notified; a quasi-drug needs product-by-product approval and a manufacturing site licensed for quasi-drugs.

Many overseas briefs mix the two without knowing it: a “brightening serum” or a “wrinkle cream” is an ordinary cosmetic in some markets and a quasi-drug claim in Japan. We settle the category with you before any formula work. See how to decide between a cosmetic and a quasi-drug.

The formula check: Japan’s Standards for Cosmetics

Japan controls cosmetic ingredients through positive lists and limits, so a formula that sells elsewhere can still fail in Japan.

The Standards for Cosmetics (Ministry of Health and Welfare Notification No. 331 of 29 September 2000, applied from 1 April 2001) prohibit medicinal ingredients and a list of named substances, set maximum amounts for restricted ingredients — often different for rinse-off and leave-on products — and allow preservatives and UV filters only from positive lists. Tar colours follow a separate ministerial ordinance. We run that check ingredient by ingredient before samples, and suggest a compliant alternative where one exists. See the formula check in detail.

What a Japanese label may say

A cosmetic in Japan may claim only effects from a fixed list of 56 items, and must list every ingredient.

The efficacy range covers wording such as “moisturises the skin”, “prevents rough skin” and “prevents sunburn”. The 56th item, “makes fine lines caused by dryness less noticeable”, was added on 21 July 2011 and may be used only after the effect has been confirmed by testing. Since April 2001 every cosmetic has had to list all ingredients, in Japanese label names and in descending order of amount, with ingredients at 1% or less and colourants allowed in any order. For export, the same list has to be prepared in INCI names for your market. See the 56-item efficacy range.

Documents your importer will ask for

The Japan side can provide the manufacturing and product documents; what the destination authority wants is confirmed with your importer first.

Document	What it shows	Who issues it
Export manufacturing notification	A product made to an export-only specification, notified before production starts	Filed with the Minister of Health, Labour and Welfare through PMDA
Certificate of manufacture and sale (Form 3)	A named product is manufactured and sold in Japan — product name only, not ingredients	Ministry of Health, Labour and Welfare, where the destination’s law requires it; applied for through JCIA
Industry certificates	Licence status, manufacture, and manufacture in line with ISO 22716	Japan Cosmetic Industry Association
Ingredient list in INCI	The full formula in the names your market uses	Prepared from the factory’s formula
Certificate of analysis, SDS	Batch test results; hazard and transport information	The factory

Checked against the Ministry of Health, Labour and Welfare notice on certificates for export cosmetics of 27 July 2026, JETRO’s Q&A on exporting cosmetics from Japan and the published pages of the Japan Cosmetic Industry Association on 17 October 2026. See the export documents guide.

Manufacturing quality in Japan

Japanese cosmetic manufacturing works to good manufacturing practice based on ISO 22716, which the industry adopted as its own standard in April 2008.

The Japan Cosmetic Industry Association adopted ISO 22716 as the industry’s voluntary cosmetics GMP standard in April 2008, and the Ministry withdrew its older technical guideline in response. Our production takes place at a GMP-certified partner factory in Japan. If you want to sell in Japan itself as well, the licence route is different — see the licences needed to sell cosmetics in Japan.

From brief to shipment

Six steps, each agreed in writing before the next starts.

01 Brief and target market Product type, texture, a reference product if you have one, the packaging you have in mind and the countries you will sell in. The market decides the label and the documents.
02 Cosmetic or quasi-drug What you want the label to say decides the regulatory category in Japan. That decision comes before any formula work.
03 Formula check against Japanese rules Every ingredient is checked against Japan’s Standards for Cosmetics — the prohibited and restricted lists and the positive lists for preservatives, UV filters and tar colours.
04 Formula route and samples Start from a base formula the factory already makes, or develop one for you. Samples are made against a written specification and approved in writing.
05 Containers, stability and labels Container and outer box, compatibility and stability testing, and the ingredient list prepared both in Japanese label names and in INCI for your market.
06 Production and export documents Production at a GMP-certified partner factory in Japan, the batch documents, and the certificates your importer’s authority asks for.

Product types at a glance

What you decide for each product type, and what to watch on the label. Each guide sets out the manufacturing and labelling points in detail.

Product	What you decide	Label and rules to watch
Toner and lotion	Texture (watery to milky), alcohol or alcohol-free, and the preservative system for a high-water formula.	Moisture and skin-conditioning wording within the cosmetic range; alcohol-rich formulas may change the shipping classification.
Serum and essence	The featured ingredients and how much of the story rests on them, the texture and a container that protects the formula.	Brightening and wrinkle wording — in Japan those are quasi-drug claims needing an approved active ingredient.
Cream and gel	Emulsion type and finish, jar or airless pump, and whether it is an all-in-one product.	Fine-lines wording is limited to the one item in the cosmetic range, and only after the required testing.
Sunscreen	Target SPF and PA, chemical or mineral filters, texture and water resistance.	SPF, PA and water resistance are measured and shown under ISO methods and JCIA standards; UV filters must be on Japan’s positive list.
Cleansing oil and face wash	Oil, balm, gel or foam; how it rinses; and whether it is a rinse-off product for ingredient limits.	Rinse-off and leave-on products have different ingredient limits; acne wording is tied to cleansing in the cosmetic range.
Shampoo and hair care	Cleansing base, conditioning level, fragrance and the bottle and pump.	Anti-dandruff medicated shampoo is a quasi-drug; ordinary shampoo keeps to the hair items in the cosmetic range.

These are the most requested types, not a limit. Body care, lip and hand care, make-up, hair styling and other products follow the same steps. Have a different idea? Send it to us.

Guides: rules, development and export

Each decision in a Japan-made cosmetics project, written as a procedure with the rules and dates we checked.

Japanese rules

The category, the formula check, the ingredient list and the wording a Japanese label may use.

Cosmetic or quasi-drug The claim you want decides the Japanese category, and the category decides licences, approval and the brief. Formula check How an overseas formula is checked against Japan's prohibited, restricted and positive lists before samples. Ingredient labelling and INCI Japanese label names, order rules, fragrance and extracts, and how to build a checked INCI list for export. Claims and the 56 items What a cosmetic label may claim in Japan, how item 56 works, and how to build a claims sheet for export.

Products

What to decide, and what to watch on the label, for each product type.

Toner and lotion Briefing a Japanese toner or lotion for export, from naming and alcohol content to claims, labels and shipping. Serum and essence Building a serum or essence in Japan, from active ingredients and preservatives to the claims its label may carry Face cream and gel Creams, gels and all-in-one gels made in Japan, from texture and jar or tube to what the label may claim Sunscreen, SPF and PA Planning a Japan-made sunscreen, from UV filters and SPF and PA testing to water resistance and label wording Cleansing oil and face wash Cleansing oils, balms, gels and face washes made in Japan, from rinse-off limits to sample tests and label wording Shampoo and hair care Shampoo, conditioner and treatments made in Japan, and where a medicated shampoo becomes a quasi-drug

Development and production

Formula route, samples, containers and the testing that sits behind a shelf life.

Stock or custom formula Choosing between a factory base formula and custom development, writing the brief and agreeing who owns what Containers and packaging Choosing containers and boxes, deciding who supplies them and planning label space for several markets Stability and compatibility What stability, compatibility and challenge tests cover, the Japanese expiry-date rule and the data to request

Export

The Japan-side documents and the order in which the shipment comes together.

Export documents Japan-side export documents and certificates for cosmetics, who issues them and what each one proves From sample to shipment The sequence from an approved sample to a shipment leaving Japan, and what has to be ready at each step

Frequently asked questions

Can a Japan-made cosmetic be sold under my own brand in my country?

Yes. The product is made at a GMP-certified partner factory in Japan and labelled with your brand. Your importer handles the notification or registration your own market requires, and we prepare the Japan-side documents and the ingredient list your importer will need.

Is a whitening or wrinkle cream a cosmetic in Japan?

Not if the label claims those effects as active effects. In Japan, claims such as suppressing melanin production or improving wrinkles belong to quasi-drugs, which need an approved active ingredient and product-by-product approval. A cosmetic may only use the 56 effects in Japan’s efficacy range, including “makes fine lines caused by dryness less noticeable” after the required testing. We settle this before any formula work.

Why might a Japanese factory change my existing formula?

Japan controls cosmetic ingredients through its Standards for Cosmetics. Preservatives, UV filters and tar colours must come from positive lists, and many other ingredients have limits that differ for rinse-off and leave-on products. An ingredient that is allowed in another market, or allowed at a higher level, can fail that check.

Do I need a Japanese product notification if I only export?

Not always. A product made to an export-only specification needs a cosmetics manufacturing licence at the factory and an export manufacturing notification filed before production. But a certificate stating that a product is manufactured and sold in Japan presupposes the Japanese market notification, so if your importer needs that kind of certificate, plan for it from the start.

Who issues export certificates for Japanese cosmetics?

Under the Ministry of Health, Labour and Welfare notice of 27 July 2026, applications go through the Japan Cosmetic Industry Association, which in principle issues the certificates. The Ministry itself issues a certificate only where the destination country’s law requires a government certificate, and since that notice it can issue them as electronic PDF files.

Do you publish a minimum order quantity or a price?

No. Both depend on the product type, the formula, the container and the packaging, so any number given before the specification exists would be misleading. Send us the brief and we come back with the real figures for your product.

Cosmetics are not medicines. The wording quoted on this page describes what Japanese rules allow a label to say; it is not a promise of any result, and claims in your market are governed by your market’s own rules.

Contact

Tell us what you want to buy or sell — in Vietnam or Japan

Selling into Vietnam or Japan, sourcing from either, or a product made under your own brand. One Japanese-managed team in Ho Chi Minh City, working in English, Japanese and Vietnamese.

Email us Write to us in English — we reply in English Send an enquiry Send an enquiry any time

Email Enquiry