A finished cosmetic arrives at a Japanese port with nobody in Japan licensed to put it on the market. Unlike a quasi-drug, a cosmetic in Japan does not need a product-by-product approval — but it does need a licensed marketing authorisation holder to take responsibility for it, a licensed site to repackage and relabel it if that is done in Japan, and a notification filed before the first sale. None of those three steps has to be visible to the exporter, but if any one of them is missing, the product sits at the port with a compliant formula and nowhere to go.
💬 Sunsho Trade is a Japanese-managed trading company in Ho Chi Minh City, acting as sales agent and distributor for Japan for cosmetics and other products from any country. Send us the formula and packaging and we will map what Japan requires.
The two licences, and why a cosmetic does not need product approval
Under Japan’s Act on Pharmaceuticals and Medical Devices, a cosmetic marketed in Japan needs a licensed marketing authorisation holder (製造販売業許可) who takes legal responsibility for it, and a licensed manufacturing site (製造業許可) wherever the cosmetic is actually made, packaged, or labelled — but the item itself is notified, not individually approved.
This is the point that differs from a quasi-drug (医薬部外品) or a drug, both of which need item-by-item approval before sale. A cosmetic is instead notified to the prefectural governor where the marketing authorisation holder is located, and the notification is accepted on the basis that the formula meets the standards below — there is no waiting period for a government approval decision on the specific product.
| Role | Licence needed | What it covers |
|---|---|---|
| The company that places the cosmetic on the Japanese market and carries legal responsibility for it | Marketing authorisation holder licence (化粧品製造販売業許可) | Quality assurance, safety oversight (GQP/GVP obligations), the item notification |
| A site that carries out the full manufacturing process | Manufacturing licence, category 1 (化粧品製造業許可、一般) | The formulation and manufacture of the cosmetic itself |
| A site that only packages, labels or stores a finished cosmetic made elsewhere | Manufacturing licence, category 2 (化粧品製造業許可、包装等) | Repackaging, relabelling or storage only, with no change to the formula |
If the finished cosmetic is packaged and labelled entirely outside Japan and imported ready for sale, the manufacturing licence obligation attaches to the site abroad rather than to a site inside Japan, through the foreign manufacturer registration route described below. If the product arrives in bulk and is filled, packaged or labelled in Japan, whoever does that work needs the category 2 licence for that activity.
Registering the overseas factory, or repackaging in Japan instead
A factory outside Japan that manufactures the finished cosmetic can be registered with Japan’s regulator as a foreign manufacturer, which lets the marketing authorisation holder in Japan notify the item without a separate Japanese manufacturing licence for that factory’s own processes.
This registration is what allows a cosmetic finished overseas — filled, capped and labelled at origin — to be imported and sold without the factory itself holding a Japanese manufacturing licence. It does not replace the marketing authorisation holder’s licence in Japan, and it does not remove the need for a category 2 licence if any packaging, labelling or storage step still happens on Japanese soil after import. Two practical routes therefore exist for a product finished overseas:
- Finished and labelled at origin. The factory is registered as a foreign manufacturer; the Japanese marketing authorisation holder notifies the item and handles the sale. No Japanese-side manufacturing licence is needed for the factory’s own work.
- Shipped in bulk, finished in Japan. A Japanese site holding a category 2 licence fills, packages, or applies the Japanese label after import. This is common where Japanese-language labelling and local packaging formats are easier to apply after arrival than to produce at the country of origin.
Which route suits a given product is a commercial and logistical decision, not a legal preference — both are valid under the Act.
💬 Not sure whether your factory should be registered as a foreign manufacturer, or whether relabelling in Japan is the simpler route for your product? Tell us the packaging format and we will lay out both options.
Ingredient standards: a list of banned substances, and separate lists of what may be used
Japan’s Standards for Cosmetics set a negative list of substances that must never be used in a cosmetic, and separate positive lists — for preservatives, UV absorbers and coal-tar colourants — naming the only substances permitted in those three categories, each with its own maximum concentration.
The negative list covers ingredients considered unsuitable for cosmetic use at any concentration, including a number of substances that are otherwise regulated as active pharmaceutical ingredients. The positive lists work the other way round: for preservatives, UV absorbers and colourants, only a substance actually named on the relevant list may be used, at or below the concentration limit set for it. An ingredient not on a positive list cannot be added to that function class by substitution or by a supplier’s own safety data — it has to actually appear on Japan’s list. For every other ingredient outside those three positive-list categories, the general safety obligation applies without a fixed list: the marketing authorisation holder must be able to support that the ingredient and its level are safe for cosmetic use.
| Ingredient category | Type of list | Practical meaning for a formula |
|---|---|---|
| Substances generally unsuitable for cosmetics | Negative list | Presence at any level blocks the notification |
| Preservatives | Positive list | Only listed substances, at or under the listed concentration |
| UV absorbers | Positive list | Only listed substances, at or under the listed concentration |
| Coal-tar colourants | Positive list | Only listed substances, at or under the listed concentration |
| Everything else in the formula | General safety obligation, no fixed list | Marketing authorisation holder must support the ingredient’s safety for cosmetic use |
Before a formula is finalised for the Japanese market, check every preservative, UV filter and colourant against the current Japanese positive lists — a preservative system approved elsewhere is not a guide to what Japan permits, and a reformulation discovered after manufacturing has started costs far more than one checked against the list first.
Japanese labelling: what has to be on the container, in Japanese
The Act requires a defined set of items on the container or the package of every cosmetic sold in Japan, in Japanese, including the full ingredient list, the name and address of the marketing authorisation holder, and the manufacturing lot number.
The label obligations sit with the marketing authorisation holder, whether the physical labelling is done at the overseas factory or at a Japanese site holding a category 2 licence. Getting the label right before shipment avoids a hold at the notification stage for a formula that was otherwise compliant.
- Product name
- Name and address of the marketing authorisation holder
- Full list of ingredients, in the order and form Japan’s labelling rules require
- Manufacturing lot number or a mark that identifies it
- Net content
- Any period of use or expiry information the product category requires
- Directions for use and precautions, where applicable to the product type
A product that already carries full multilingual packaging is not automatically compliant — Japan’s rule is that these items appear in Japanese, not merely that equivalent information exists somewhere on the pack. For how imported foods handle a parallel labelling obligation, see Japan’s food labelling rules for imported products; the categories differ, but the underlying discipline — check the Japanese-language label before the container is sealed, not after — is the same.
Where Sunsho Trade fits, and where it does not
We take products to Japanese buyers and support the compliance check on formula and labelling before shipment; who holds the marketing authorisation holder licence and files the item notification is agreed case by case for each brand.
Sunsho Trade’s Japanese management negotiates with buyers in Japanese and works from Ho Chi Minh City with manufacturers on the export side. On the compliance side, we help check a formula against Japan’s positive and negative lists and a label against the Japanese labelling requirements before a shipment is booked, so a licensing or ingredient problem is found while it can still be fixed. The marketing authorisation holder licence itself, and the decision on foreign manufacturer registration versus finishing in Japan, is settled with the Japanese-side partner for each brand — we will say plainly if that arrangement is not yet in place for a product you bring to us. For what a Japanese buyer generally wants to see before committing to a new supplier, see what Japanese buyers check before they commit.
💬 Have a formula and packaging ready and want to know what Japan’s licensing route looks like for it? Send the ingredient list and label artwork, or see how we sell into Japan.
Frequently asked questions
1. Does a cosmetic need government approval before it can be sold in Japan?
No. Unlike a quasi-drug or a drug, a cosmetic is notified to the prefectural governor where the marketing authorisation holder is located, on the basis that its formula meets Japan’s cosmetic standards. There is no separate item-by-item approval decision.
2. Who has to hold the marketing authorisation holder licence?
A company in Japan that takes legal responsibility for the cosmetic’s quality and safety and files the notification. It does not have to be the manufacturer, and for an imported cosmetic it is agreed case by case which Japanese-side party holds this role.
3. Can a factory outside Japan manufacture a cosmetic for the Japanese market without a Japanese manufacturing licence?
Yes, if it is registered with Japan’s regulator as a foreign manufacturer and the product is finished and labelled at that factory. If any packaging, labelling or storage step happens in Japan after import, whoever does that step needs a category 2 manufacturing licence for it.
4. Are all cosmetic ingredients checked against a fixed list?
No. Only preservatives, UV absorbers and coal-tar colourants are checked against positive lists naming the permitted substances and concentrations. A separate negative list bans certain substances outright. Every other ingredient is covered by a general safety obligation rather than a fixed list.
5. Is English packaging enough if the ingredient list is included?
No. Japan’s labelling requirements call for the specified items — including the ingredient list, the marketing authorisation holder’s name and address, and the lot number — in Japanese on the container or package, not merely present in another language elsewhere on the pack.
Checked on 25 September 2026.
Sources: Act on Pharmaceuticals and Medical Devices, Ministry of Health, Labour and Welfare cosmetics licensing guidance (mhlw.go.jp); prefectural cosmetics licensing guidance describing manufacturing licence categories (Kanagawa, Tokyo, Miyagi, Kagoshima prefectural health authorities); Standards for Cosmetics, positive and negative ingredient lists.