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Private label cosmetics for Japan, made in India
In Japan, cosmetics are regulated under the PMD Act. Only a business holding a marketing licence for cosmetics may market them, so a Japanese marketing authorisation holder notifies each product in advance and takes responsibility for it. Formulas must meet the MHLW Standards for Cosmetics, and label particulars must be in Japanese. Products with active ingredients are usually quasi-drugs needing approval. We supply formulas, documents and artwork.
Japan at a glance
| Regulator | Ministry of Health, Labour and Welfare (MHLW), with PMDA and prefectural governments |
|---|---|
| Main framework | PMD Act and the MHLW Standards for Cosmetics |
| Responsible person | Japanese marketing authorisation holder with a cosmetics marketing licence, not the manufacturer |
| Pre-market step | Advance marketing notification for each product by the marketing authorisation holder |
| Label language | Japanese |
Summary for planning only. Requirements change; confirm with your importer or regulatory adviser.
Japan regulates cosmetics under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, usually called the PMD Act. The Ministry of Health, Labour and Welfare (MHLW) sets the rules, and the Pharmaceuticals and Medical Devices Agency (PMDA) and prefectural governments carry out parts of the process. Products must also meet the MHLW Standards for Cosmetics. We make private label products in our own facility in Ambala, Haryana, India. A Japanese company holding the right licence places them on the market.
Who is legally responsible when you sell cosmetics in Japan?
Under the PMD Act, only a business holding a marketing licence for cosmetics may market cosmetics in Japan. In practice this is a Japanese company, often called the marketing authorisation holder (MAH). It may be your own Japanese entity, your importer or a specialist firm that acts for foreign brands. The MAH is responsible for quality control and post-marketing safety, and its name and address go on the label.
We are the manufacturer in India. We do not hold a Japanese licence, and the MAH does not need to be us. PMDA's guidance for overseas companies is to confirm the requirements of each procedure with the designated MAH in Japan, and to direct questions about marketing licences to the prefectural government where the business is based.
What has to happen before products go on sale?
PMDA states that ordinary cosmetics do not need a marketing approval application, but each product must comply with the Standards for Cosmetics. The usual sequence is:
- Confirm the product is a cosmetic. PMDA notes that products containing active ingredients are generally classified as quasi-drugs in Japan, and those do need a marketing approval application. MHLW decides classification questions.
- Check the formula against the Standards for Cosmetics. The Standards include a list of substances cosmetics must not contain and a list of substances limited to maximum amounts. Preservatives and UV absorbers must come from permitted lists, and tar colours follow their own rules.
- Marketing notification. The PMD Act requires the MAH to notify the authorities in advance for each cosmetic it intends to market, as directed by MHLW ordinance.
- Labelling and release. The MAH approves Japanese labelling and releases the product to market. Ask your MAH whether any final labelling, packing or storage done in Japan needs a separate manufacturing licence, and whether any import-stage filings apply.
Cosmetic or quasi-drug?
Japan has a category between cosmetics and medicines, known as quasi-drugs. Products presented with specific active effects can fall into it, and quasi-drugs go through an approval process rather than a notification. If you want a product positioned as a quasi-drug in Japan, raise it in the brief and agree the route with your MAH before any formula work, because the approval route needs more data. For most private label projects, a cosmetic formula with cosmetic claims is the simpler path.
Labelling: language and what typically goes on the label
The PMD Act lists the particulars that go on a cosmetic's immediate container or wrapper. The Enforcement Regulation requires them to be written in Japanese. They include:
- Name and address of the marketing authorisation holder
- Product name
- Manufacturing number or code
- Ingredient names, as designated by MHLW
- Expiry date for cosmetics MHLW designates
- Any other items MHLW specifies
The Act also requires label information to be easy to see and written in terms a general consumer can understand. Your MAH will usually prepare or check the Japanese ingredient names from our INCI list. Japanese text can be printed on the pack or applied as a sticker. Agree the approach with your MAH before anything goes to print. Keep claims within cosmetic wording.
Documents your importer will usually ask us for
A Japanese MAH needs enough information to confirm the product meets the Standards for Cosmetics and to manage quality. Expect requests for some or all of these:
- Full formula with INCI names and percentages, so restricted ingredients and permitted lists can be checked
- Composition information for fragrance and colourants from their suppliers
- Product specification and safety data sheet (SDS)
- Stability and pack compatibility information
- Certificate of analysis for each batch shipped
- Manufacturing process outline and facility information
- Label artwork with space for the Japanese label or sticker
- Commercial invoice, packing list and certificate of origin
Our testing and documents service prepares the product paperwork. Share the MAH's own checklist with us, because Japanese partners often have a set format.
Which ranges suit Japan?
A range is easier to place in Japan when the formula is clearly cosmetic and the ingredient list is easy to check against the Standards for Cosmetics.
- Toners and mists and cleansers, which are everyday skincare steps.
- Moisturisers with cosmetic claims rather than active-ingredient positioning.
- Hair care, such as shampoo and conditioner.
If a formula relies on an ingredient with a specific active effect, check early whether it would be a quasi-drug in Japan.
How an order to Japan works with us
- Brief. Name your Japanese MAH and the products you plan.
- Formula check. We share the full formula so your MAH can check it against the Standards for Cosmetics.
- Samples and approval. Samples are available on request. Ready formulas start from 500 units per product.
- Labels and documents. We prepare artwork and the document set. Your MAH completes the notification and Japanese labelling.
- Production and shipping. Our fulfilment and export service packs and ships to your MAH or importer.
The how it works page explains our process, and our guide to exporting cosmetics from India covers export documents in general. Our facility is ISO certified and GMP-compliant. These are facts about how we manufacture, not approvals for sale in Japan.
Next step
Send your product list through the inquiry form for Japan. Rules and their interpretation change, so confirm current requirements with your Japanese MAH or a regulatory adviser in Japan before you order.
Official sources
- PMDA – Frequently Asked Questions (FAQ)
- Japanese Law Translation – Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
- Japanese Law Translation – Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
- MHLW – Standards for Cosmetics (provisional English translation)
Checked . Made by Anadoris is the manufacturer; registration, notification and listing in Japan are carried out by the brand owner, importer or responsible person.
Exporting to Japan: questions
Can Anadoris sell our cosmetics directly into Japan?
No. Under the PMD Act, only a business holding a marketing licence for cosmetics may market them in Japan. That is a Japanese company acting as marketing authorisation holder, which may be your own entity or a partner. We manufacture in India and supply the formula, documents, artwork and shipment. The holder files the notification and takes responsibility in Japan.
Do cosmetics need approval in Japan?
Ordinary cosmetics do not need a marketing approval application, according to PMDA, but each product must meet the Standards for Cosmetics and be notified in advance by the marketing authorisation holder. Products containing active ingredients are generally quasi-drugs, which do need approval. Confirm the classification of each product with your holder or MHLW.
What is a quasi-drug?
A quasi-drug is a Japanese category between cosmetics and medicines. PMDA says products containing active ingredients are generally classified as quasi-drugs and need a marketing approval application rather than a notification. If you want a product positioned this way, agree the route with your Japanese partner first, because it needs more data and time than a cosmetic.
Does the label have to be in Japanese?
Yes. The PMD Act sets out what must appear on a cosmetic's container, such as the holder's name and address, product name, manufacturing number and designated ingredient names. The Enforcement Regulation requires these to be written in Japanese. Whether Japanese text is printed or applied as a sticker should be agreed with your holder before printing.
What will our Japanese partner need from the manufacturer?
Usually the full formula with INCI names and percentages, fragrance and colourant information, a specification, safety data sheet, stability and compatibility information, a certificate of analysis per batch and facility details. These let the holder check the product against the Standards for Cosmetics and manage quality. Share their checklist with us early.