Japan cosmetics regulation: how to sell skincare legally in Japan

The PMD Act and the regulators

Cosmetics, quasi-drugs, drugs and medical devices are all governed by one law: the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (医薬品医療機器等法, the PMD Act or 薬機法, Act No. 145 of 1960). Three bodies apply it:

• MHLW, the Ministry of Health, Labour and Welfare, writes the standards and receives the foreign manufacturer filings and safety reports.
• PMDA, the national review body for drugs and devices, receives foreign manufacturer filings on MHLW's behalf and reviews quasi-drug approvals.
• Prefectures (the pharmaceutical affairs division of each prefecture) grant the marketing and manufacturing licenses for cosmetics and receive the product notifications.

Article 2 of the Act defines a cosmetic as something applied to the body by rubbing, spraying or similar means to cleanse, beautify, increase attractiveness, alter appearance or keep the skin or hair healthy, with a mild action on the body. Products with a mild action used for purposes listed in the Act (such as preventing heat rash or hair loss), or designated by MHLW, are quasi-drugs, not cosmetics; medicated cosmetics fall in this group.

Cosmetic or quasi-drug

Most Korean skincare launched in Japan goes in as a cosmetic and keeps its claims within the 56. A brightening serum can be a cosmetic if it says only, for example, "prevents spots and freckles caused by sunburn" where permitted, and never "whitening" in the medicated sense. Our cosmetic vs drug claims guide compares this line across markets.

The marketing license holder

Article 12 of the PMD Act says no one may market cosmetics as a business without the cosmetics marketing license. The license holder (製造販売業者, often translated marketing authorization holder) takes responsibility for the product's quality and safety once it ships to the market. Prefectural guidance lists four conditions for the license:

1. No disqualifying grounds

   The applicant and its officers must not fall under the Act's grounds for refusal.

2. Three named managers

   A general marketing compliance officer (総括製造販売責任者), who must be a pharmacist, or have completed a pharmacy or chemistry course at high school level or above, or have studied pharmacy or chemistry and worked 3 or more years in quality or post-market safety work, or be recognized by MHLW as equivalent; plus a quality assurance manager and a safety management manager.

3. GQP compliance

   A quality management system under the GQP ministerial ordinance (Good Quality Practice), covering release decisions, supplier control and complaints.

4. GVP compliance

   A post-market safety system under the GVP ministerial ordinance (Good Vigilance Practice), covering collection and evaluation of safety information.

The license is applied for at the prefecture where the general marketing compliance officer works and must be renewed at the intervals set by cabinet order. A foreign company cannot hold it from abroad. In practice a foreign brand either works with a Japanese importer or distributor that already holds the license, or sets up a Japanese company and obtains one. The license holder's name and address go on the label.

Manufacturing license too. Japanese law treats packaging, labeling and storage in Japan as manufacturing. If the license holder applies Japanese labels or stores goods before shipping them to the market, the site needs a cosmetics manufacturing license (化粧品製造業許可) in the packaging, labeling and storage category, with a responsible technical manager. Prefectural guidance lists both licenses even for imports that arrive fully labeled, because storage before release counts too; a license holder can also contract a licensed site to import and store for it.

Step by step: from formula to legal sale

The example is a ceramide cream and a hydrating toner made in Korea, sold on Qoo10 Japan and Rakuten by a Japanese partner.

1. Choose the license holder

   Agree with a Japanese company that holds the cosmetics marketing license (and a manufacturing license for labeling and storage), or plan your own Japanese entity. Agree who keeps the product records.

2. Confirm both products are cosmetics

   Screen every claim against the 56 permitted claims. Anything about whitening, acne prevention or treating rough skin as a medical effect makes it a quasi-drug.

3. Check the formula against the Standards for Cosmetics

   No prohibited ingredients, restricted ingredients within limits, and preservatives, UV filters and tar colors only from the positive lists.

4. Prepare the Japanese label

   Every ingredient by its Japanese label name, the license holder's name and address, product name, lot number and contents. Approve a proof.

5. File the foreign manufacturer notification

   The license holder notifies MHLW through PMDA of the name and address of the Korean manufacturer and its factory.

6. File the product notification

   For each product, the license holder files the cosmetic marketing notification (化粧品製造販売届書) with its prefecture before shipping it to the market.

7. Import and release

   The license holder clears customs, showing its license and the notification copies, and releases the goods to the market under GQP.

8. Run post-market safety

   Collect complaints and side effect reports under GVP, report to MHLW where required, and update the notification within 30 days of a change.

The filings before import

The foreign manufacturer notification is based on Article 76(2) of the PMD Act Enforcement Order and Article 267 of the Enforcement Regulations, and is made when the Korean maker sells to Japan without its own Japanese entity. Prefectural guidance is clear that every filing must be complete before the goods clear customs. Article 14 approval is needed only for cosmetics containing ingredients MHLW designates; a cosmetic that meets the Standards for Cosmetics and lists all ingredients goes the notification route.

The Standards for Cosmetics

The Standards for Cosmetics (化粧品基準, MHW Notification No. 331 of 2000) are the ingredient rules. They combine a negative list and positive lists:

• Prohibited ingredients: substances that must not be used in cosmetics.
• Restricted ingredients: substances allowed only within set limits or product types.
• Preservatives: a positive list with maximum amounts, split by product type (rinse-off, leave-on, mucous membrane).
• UV filters: a positive list with maximum amounts.
• Tar colors: only those allowed by the separate ministerial ordinance on tar colors for drugs and cosmetics.

Prefectural guidance adds that even for allowed ingredients, the license holder must confirm safety on its own responsibility and collect, prepare and keep safety data for the ingredients and the product. A preservative or UV filter allowed in Korea or the EU is not automatically on the Japanese positive lists, so check each one.

The 56 permitted efficacy claims

Cosmetics may claim only effects within the range of cosmetic efficacy (化粧品の効能の範囲) set by MHLW notice. The list grew to 56 items on July 21, 2011, when MHLW added item 56, "乾燥による小ジワを目立たなくする" (makes fine lines due to dryness less noticeable). That claim is allowed only when its effect has been confirmed by testing under the Japanese Cosmetic Science Society's guideline for evaluating cosmetic functions. Examples from the list:

Claims outside the list, such as "reduces wrinkles", "removes dark spots", "anti-aging" in a physiological sense or "repairs the skin barrier", are not allowed for cosmetics. Advertising is also checked against the PMD Act's ban on false or exaggerated advertising (Article 66) and the industry's Fair Advertising Guidelines from the Japan Cosmetic Industry Association. Read the full official list before writing Japanese copy.

Quasi-drugs: approval and foreign manufacturer accreditation

A medicated product (薬用化粧品) such as a whitening serum, an acne-preventing cleanser or a medicated cream for rough skin is a quasi-drug. That route means:

• a quasi-drug marketing license for the Japanese company;
• product-by-product approval (製造販売承認) of the formula, active ingredient, efficacy, usage and specifications;
• accreditation of the foreign manufacturer (外国製造業者認定) by MHLW, applied for through PMDA under Article 13-3 of the Act; accreditation is a condition of the approval;
• quasi-drug labeling rules and the approved efficacy wording.

Approval takes far longer than a cosmetic notification and needs data on the active ingredient at an accepted level. Many brands launch the cosmetic version first and add a quasi-drug version later.

Japanese labeling summary

Article 61 of the PMD Act requires the direct container or wrapper of a cosmetic to show:

• the name and address of the marketing license holder;
• the product name;
• the lot number or code;
• for cosmetics containing ingredients MHLW designates, the ingredient names (under MHLW's notice this means all ingredients, the full ingredient labeling in force since 2001);
• for cosmetics MHLW designates, the expiry date, which in practice applies to products whose quality may change within 3 years of manufacture or import under proper storage;
• other items set by ministerial ordinance, such as contents (weight or volume).

The information must be in Japanese and easy to read. Ingredient names follow the Japanese label names published by the Japan Cosmetic Industry Association (化粧品の成分表示名称リスト), and the industry's Fair Competition Code on cosmetic labeling adds items such as the country of origin and a contact point. Full label details are in our label requirements by country, and our label proof check covers Japan.

Import and customs

Each time goods clear customs, the license holder shows its business license and copies of the product notifications (or approvals) for the items imported. Questions on import procedures go to the Regional Bureau of Health and Welfare for the license holder's area. Duty depends on the tariff classification and origin; ask the license holder's customs broker, and see our guide to importing skincare from Korea for the export documents from Korea. Selling on Japanese marketplaces still needs the licensed company behind the listing; see our Qoo10 guide.

Post-market duties

• Safety information. Under Article 68-10, the license holder must report to MHLW suspected side effects and other safety information specified by ministerial ordinance, on the timelines the ordinance sets. GVP requires a system to collect and evaluate this information.
• Recalls. Under Article 68-11, a license holder that recalls a product must report the start and progress of the recall.
• Changes. A change to notified information is notified within 30 days (Article 14-9).
• Advertising. False or exaggerated advertising is banned, and the Act includes administrative fines for certain advertising violations.

Our recalls and adverse events guide covers complaint handling in more depth.

What the license holder does and what we provide

Frequently asked questions

Can a Korean brand sell cosmetics in Japan without a Japanese company?

No. The PMD Act lets only a company holding a cosmetics marketing license market cosmetics in Japan, and the license cannot be held from abroad. Foreign brands work with a licensed Japanese importer or distributor, or set up a Japanese company that obtains the license.

What filings are needed before importing cosmetics into Japan?

After the license, the license holder files a foreign manufacturer notification with MHLW through PMDA and a product notification for each product with its prefecture. Both must be done before the goods clear customs for sale.

What is the difference between a cosmetic and a quasi-drug in Japan?

A cosmetic has a mild effect, is notified to the prefecture and may use only the 56 permitted claims. A quasi-drug, such as a medicated whitening or acne-preventing product, needs product approval, a quasi-drug license and accreditation of the foreign manufacturer.

What are the 56 cosmetic claims in Japan?

They are the range of cosmetic efficacy set by MHLW notice, such as conditioning the skin, moisturizing and preventing rough skin. Item 56, making fine lines due to dryness less noticeable, was added on July 21, 2011 and needs supporting tests.

Does a Japanese cosmetic label need every ingredient?

Yes. Full ingredient labeling has applied since 2001, using the Japanese label names, together with the license holder's name and address, the product name, the lot number and the contents. Products whose quality may change within 3 years also show an expiry date.

Is whitening allowed as a claim in Japan?

Only for an approved quasi-drug, using the approved wording, such as preventing spots and freckles by suppressing melanin production. A cosmetic cannot claim whitening as a medicated effect.

Can I relabel Korean products in Japan?

Yes, but labeling and storage in Japan count as manufacturing, so the site needs a cosmetics manufacturing license in the packaging, labeling and storage category.

What does KoreanOEM do for a Japan launch?

We develop and produce the formula in Korea, screen it against the Standards for Cosmetics, prepare the documents the license holder files (full INCI list after the NDA, COA, MSDS, specification, stability data, Certificate of Free Sale) and check the Japanese label before printing.

Sources

• e-Gov: PMD Act (医薬品医療機器等法), Articles 2, 12, 13-3, 14, 14-9, 61, 66, 68-10, 68-11
• MHLW: Cosmetics and quasi-drugs (化粧品・医薬部外品等)
• Ibaraki Prefecture: For first-time cosmetic manufacturers, marketers and importers (licenses, managers, GQP, GVP, Standards, efficacy range)
• Toyama Prefecture: Importing and selling cosmetics (foreign manufacturer notification, product notification)
• Fukuoka Prefecture: Cosmetic marketing notification
• JETRO: Import procedures for cosmetics in Japan
• MIPRO: Importing and selling cosmetics (customs documents)
• Fukuoka Prefecture: Range of cosmetic efficacy (56 claims) and JCIA: Fair advertising guidelines for cosmetics
• Japan Customs: PMD Act import checks at customs

Checked against these sources in October 2026. Rules and fees change; check with the authority or your importer before you sell.