Exporting Cosmetics to Japan: Licences, Notification and Labels

Who must hold the licences

The cosmetics marketing licence is issued by the prefecture where the company's general marketing compliance officer works. That officer must be full-time and qualified (for example a pharmacist or chemistry-trained), and the company must run quality (GQP) and post-market safety (GVP) systems. A foreign brand therefore sells through a Japanese licence holder, such as its importer or a subsidiary.

Applying Japanese labels, repacking or storing imported goods counts as manufacturing, so the site needs a cosmetics manufacturing licence in the packaging, labelling and storage category (包装・表示・保管区分). Since 1 August 2021 some storage-only sites can register instead, but not sites storing finished products for release to market.

Notifications before the first shipment

Each product is notified to the prefecture before it is marketed, and the name on the label must match the notified name.

For imports, the MAH also files a foreign manufacturer notification (化粧品外国製造業者届) through PMDA, or a foreign marketer notification if it buys from a brand owner or trader rather than the maker. There is no fee, and it replaces the accreditation needed for approval-route products.

The separate import notification (輸入届) was abolished from 1 January 2016.

Ingredients: the Standards for Cosmetics

The MAH must check each formula against the Standards before notifying. Otherwise, individual product approval is needed.

• Annex 1: prohibited ingredients; medicinal ingredients are also barred unless listed in Annexes 2 to 4 or used only as additives
• Annex 2: restricted ingredients, with maximum amounts per 100 g
• Annex 3: preservatives, positive list only
• Annex 4: UV filters, positive list only
• Tar colours: only those allowed by MHLW ordinance

Japanese labels

Under Article 61 of the PMD Act the container or wrapping shows the MAH's name and address, the notified name, a batch number or code, and all ingredients. An expiry date is needed for products containing ascorbic acid, its esters or salts, or enzymes, or that may change in quality within 3 years.

Labels must be in Japanese, using the Japan Cosmetic Industry Association (JCIA) ingredient names in descending order; ingredients at 1% or less and colourants may be in any order. Containers of 50 g or 50 mL or less may list ingredients on the box, a tag or a leaflet.

The industry Fair Competition Code adds product type, net contents, country of origin, precautions where required and a contact point.

Quasi-drugs and claims

Products with active ingredients claiming, for example, to prevent spots and freckles by suppressing melanin (whitening) or to prevent acne are quasi-drugs (医薬部外品). They need a quasi-drug marketing licence and product approval (by MHLW after PMDA review or, for some categories, by the prefecture), and may advertise only approved claims.

Cosmetics may use only MHLW's 56 permitted claims, such as moisturising skin or preventing sunburn, plus makeup effects. The claim of making fine lines from dryness less noticeable needs supporting tests.

The advertising rules cover all media, including social media. Since 10 March 2025, highlighting an ingredient on packs or in ads requires stating its purpose, objectively substantiated.

Customs clearance and other rules

For business imports, customs checks copies of the importer's licence and the product notification. Personal imports of up to 24 standard-size units per item for own use are outside these rules.

Cosmetics fall mainly under HS headings 3304, 3305, 3307 and 3401; customs offers advance rulings. Triplicate's free HS code lookup and invoice and packing list generator can help keep descriptions consistent.

Aerosols also need a test report showing they meet the High Pressure Gas Safety Act exemption, such as 1 litre or less and 0.8 MPa or less. Rules change, so confirm with the prefecture, PMDA, customs or a licensed customs broker or regulatory consultant before shipping.