In Japan, putting a label on a box counts as manufacturing

Two licences, not one

Conversations about Japan often stop at "our partner holds a marketing authorisation." That sentence only covers half the picture. Japan licenses the company that sells and the site that handles the goods as two separate things.

The marketing authorisation comes from the prefectural governor under Article 12(1) of the PMD Act. It runs for five years, and it simply lapses if the renewal is not filed in time. Fees are set locally — Yamaguchi Prefecture publishes ¥66,330 for a new application and ¥53,300 for renewal.

None of that lets you open a carton and apply a Japanese sticker. That work needs the second licence.

Labelling is manufacturing

Japan's definition of manufacturing is wider than most exporters expect. It takes in mixing raw materials and filling containers, and it also takes in applying the statutory label, repacking into smaller units, and holding finished stock before the market-release decision. Swapping a foreign label for a Japanese one sits in the same box.

That is why imports pull in a manufacturing licence under the "packaging, labelling and storage" category. The category permits packaging, labelling, storage and inspection, and stops short of bulk manufacture or filling. Repacking or filling needs the general category instead. Since 1 August 2021 a lighter registration exists for sites that only store goods, though a site that performs market release does not qualify.

The last row is the structure most Korean brands end up using. The trade-off is that the name and address printed on the label become the partner's. Change distributor and the print plates go back to the start.

Three named officers

The conditions for a marketing authorisation are no disqualifying grounds, a quality control system (GQP) and a post-marketing safety system (GVP). "System" here does not mean a binder of procedures. It means three people on the payroll.

The marketing supervisor is appointed under Article 17(1). For cosmetics the qualifying routes are: a pharmacist; someone who completed a specialised pharmacy or chemistry course at high school level or above; or someone who took those subjects and then worked three years or more in quality control or post-marketing safety for drugs, quasi-drugs or cosmetics. Quasi-drugs raise the bar to university or technical college, while cosmetics carry no degree requirement at all. The quality assurance and safety management officers have no educational requirement, but they must sit outside the sales function.

The manufacturing side appoints its own responsible engineer. The routes look similar, except the experience route reads "three years or more in manufacturing work" rather than quality control — a different box. Worth asking a prospective partner whether one person is covering both seats.

Two notifications, no review

Once the licences are issued, two notifications follow. The first is the foreign manufacturer notification, filed through the PMDA to the Minister of Health, Labour and Welfare for an overseas site with no Japanese legal entity. It goes in as one original and two copies.

The second is the per-product cosmetics marketing notification, filed in duplicate with the prefectural pharmaceutical affairs office before market release, with no approval review attached. That is the line separating cosmetics from quasi-drugs, which are approved. What it does carry is nine rules on the product name: names identical to an existing drug or quasi-drug, names built from a specific ingredient, names written in Roman letters alone and names inconsistent with the dosage form all fail. Customs wants a copy of this notification at clearance, so a rejected name holds the shipment.

Full ingredient labelling is standard for cosmetics, using the ingredient-name list published by the Japan Cosmetic Industry Association. Formulation follows the Standards for Cosmetics (MHW Notification No. 331 of 2000): Appendix 1 lists prohibited ingredients, Appendix 2 sets limits per 100 g, and Appendices 3 and 4 are the permitted lists for preservatives and UV absorbers. For those two groups, only what is on the list may be used.

Samples move before the licences do

You do not need the licences in hand to send samples. Goods for a domestic exhibition, in-house samples and research materials clear on a regional health bureau import confirmation certificate instead. In-house samples are limited to one unit per product as a rule, and applications go to the Kanto-Shinetsu or Kinki bureau depending on the port.

Personal imports for own use have their own ceilings. Standard sizes are capped at 24 units per item — for lipstick that is 24 in total regardless of brand or shade. Items of 60 g or 60 ml and under stretch to 120 units per item, though foundations, lip products and fragrances are excluded from that allowance. Anything brought in this way cannot be sold or transferred.

Which category to send first is a different question, and today's ingredient signal shows where the Korean shelf is moving right now, while the product planner lets you test size and price combinations. Then put these four questions to your partner.

• Do they hold both licences, and under which manufacturing category?
• When does each one expire (both run five years)?
• Is the marketing supervisor the same person as the responsible engineer?
• Is the site that applies the Japanese label the address on that manufacturing licence?

In short

• Japan licenses the seller and the site separately. Both licences run five years and need renewing.
• Applying the Japanese label falls inside the legal definition of manufacturing, so finished imports still need the packaging, labelling and storage licence.
• A marketing authorisation needs three officers, and the cosmetics marketing supervisor does not have to be a pharmacist.
• The per-product notification carries no approval review. The real obstacle is the set of nine product-name rules.
• Exhibition and in-house samples can ship on an import confirmation certificate, with in-house samples capped at one unit per product as a rule.

*Sources: the Article 12(1) basis, the five-year term, the licensing conditions, the four qualifying routes for the marketing supervisor and the fees (¥66,330 new, ¥53,300 renewal) are from Yamaguchi Prefecture, "Applying for a cosmetics marketing authorisation" (updated 7 Oct 2026). The four licensing requirements, the manufacturing licence categories and the definition of manufacturing, the responsible engineer's qualifications (Enforcement Regulations Article 91(2)), the storage-only registration introduced on 1 Aug 2021 and the table of licences by import structure are from Ibaraki Prefecture, "For those manufacturing, marketing or importing cosmetics for the first time" (updated 6 Feb 2025). The five-year term for both licences, the scope of the packaging/labelling/storage category, the marketing supervisor's qualifications, the copy counts for the foreign manufacturer notification, the filing office and the nine product-name rules for the per-product notification, the structure of the Standards for Cosmetics (MHW Notification No. 331 of 2000) and the import confirmation certificate and personal-import ceilings are from MIPRO, "Manual for Importing and Selling Cosmetics and Quasi-drugs 2024" (information as of December 2023). Fees are as published by Yamaguchi Prefecture and differ by prefecture. The manufacturing licence fee and the notification fees were not confirmed within this check.*