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Selling cosmetics and beauty products in Japan

In Japan, cosmetics fall under the Pharmaceuticals and Medical Devices Act. Only a holder of a cosmetics marketing licence may place them on the market, and each product is notified in advance. Ingredients follow the Standards for Cosmetics, labels are in Japanese, and products with mild active effects, such as deodorants, are quasi-drugs needing approval.

Updated · Each section links to the official source it comes from

Main law
Pharmaceuticals and Medical Devices Act (医薬品医療機器等法)
Regulator
MHLW, with prefectures
Who answers
The holder of a cosmetics marketing licence (化粧品製造販売業許可)
Before sale
Advance notification for each product
Ingredients
Standards for Cosmetics (化粧品基準), MHW Notification No. 331 of 2000
Label language
Japanese

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is it a cosmetic, or a quasi-drug that needs approval? Read more
  2. 2Who holds the marketing licence, and is the factory licensed or accredited? Read more
  3. 3Is each ingredient allowed under the Standards for Cosmetics? Read more
  4. 4Has the product been notified before marketing? Read more
  5. 5What must the Japanese label show? Read more
  6. 6Do the claims stay within what a cosmetic may say? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Cosmetic or quasi-drug

Where a beauty product sits in the law.

  • A cosmetic is an item used on the body by rubbing, sprinkling or similar means to clean, beautify, increase attractiveness, alter the appearance or keep the skin or hair in good condition, with mild effects on the body (Article 2(3)).
  • Quasi-pharmaceutical products (医薬部外品) are items with mild effects used, for example, to prevent bad breath, deodorise the body, prevent heat rash, prevent hair loss, promote hair growth or remove hair (Article 2(2)).
  • Quasi-drugs, and cosmetics containing components specified by MHLW, need approval for each item, unless the item falls under standards designated by the Minister (Article 14(1)).

How we help: Compliant Always records whether each product is filed as a cosmetic or a quasi-drug, with the reasoning and the documents behind it. Ask about this

Marketing licence and notification

Who may place cosmetics on the Japanese market.

  • Only a person holding a cosmetics marketing licence from MHLW may market cosmetics; the licence lapses unless renewed within a period of at least three years set by Cabinet Order (Article 12).
  • Manufacturing cosmetics needs a manufacturing licence (Article 13); a foreign manufacturer making cosmetics for export to Japan may be accredited by MHLW (Article 13-3).
  • A marketing licence holder notifies MHLW in advance of each cosmetic it intends to market that does not need item approval (Article 14-9).
  • The licence holder appoints a person meeting MHLW's standards to oversee quality control and post-marketing safety control (Article 17).
  • Applications, notifications and reports to the authorities are written in Japanese (Regulation for Enforcement, Article 283).

How we help: Compliant Always keeps the licence holder's details and each product's notification with the product file, and shows when a licence comes up for renewal. Ask about this

Standards for Cosmetics

What may go into a cosmetic, and how much.

  • Cosmetics must not contain anything, including impurities, that may cause infection or make their use a potential health hazard.
  • Medical drug ingredients, substances not meeting the Standards for Biological Materials, Class I and Class II specified chemical substances, and the substances in Appendix 1 are prohibited.
  • Ingredients in Appendix 2 may be used only below the maximum amount per 100 g set there.
  • Preservatives must be among those in Appendix 3 and UV absorbers among those in Appendix 4; tar colours follow the ordinance on tar colours, with Red No. 219 and Yellow No. 204 allowed only in hair and nail products.
  • Glycerin in cosmetics must contain less than 0.1 g of diethylene glycol per 100 g.

How we help: Compliant Always reads your formula against the Appendices of the Standards for Cosmetics and keeps the supplier's specification for each ingredient with the product. Ask about this

Labelling

What the container or wrapper must show.

  • The immediate container or wrapper shows the marketing licence holder's name and address, the product name, the manufacturing number or code, and the names of components where MHLW designates (Article 61).
  • Cosmetics designated by MHLW also show an expiry date, and products under standards show what those standards require.
  • These particulars are written in Japanese (Regulation for Enforcement, Articles 218 and 221-3).
  • For containers of 50 g or 50 ml or less, the component names may be shown on the outer packaging or attached documents instead (Article 221-2).

How we help: Compliant Always sets the Japanese label beside the Article 61 particulars and the ingredient list in the formula, so a mismatch shows up before print. Ask about this

Claims and advertising

What a cosmetic may say about itself.

  • No one may advertise, describe or circulate false or exaggerated statements about the name, manufacturing process, efficacy or effects of cosmetics, explicitly or implicitly (Article 66).
  • MHLW publishes the range of efficacy claims for cosmetics (化粧品の効能の範囲), last revised by notice of 21 July 2011.
  • A cosmetic must not be intended for the uses of a medicine, such as diagnosing, treating or preventing disease or affecting the body's structure or functions (Article 2(3)).

How we help: Compliant Always reads your claims and marketing copy against the rules for cosmetics, and keeps each version of the wording with the product. Ask about this

Safety reports and recalls

What the licence holder reports after a product is on sale.

  • The marketing licence holder reports to MHLW cases of disease, disability or death suspected to be caused by its cosmetics, and other safety information specified by ordinance (Article 68-10).
  • A licence holder that recalls a cosmetic reports the start and progress of the recall to MHLW (Article 68-11).
  • Cosmetics are excluded from the Consumer Product Safety Act's serious incident reporting, since they are covered by this Act.

How we help: Compliant Always ties each document to the batch it covers, so a report or a recall can be scoped from the record. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Marketing licence holderPlacing the product on the market, the notification, quality and post-marketing safety, the label and safety reports.The product file, notification and safety records kept together and dated.
ManufacturerA manufacturing licence in Japan, or accreditation as a foreign manufacturer.Licences and batch records kept with each product.
BrandThe formula, the claims and the choice of licence holder.Formula and claims checked against the Standards and the Act.
Ingredient supplierSpecifications showing the ingredient meets the Standards for Cosmetics.Specifications collected once and shown to each customer that asks.

National law, prefectural enforcement

Product law in Japan is national. Ministries and the Consumer Affairs Agency set the standards; prefectural governors and cities with public health centres license food businesses, receive food recall notifications and carry out inspections.

Imports are checked at the border: food and food contact articles at MHLW quarantine stations, and liquor licences are granted by the tax office for each place of sale.

Questions businesses ask

Do I need a licence to sell cosmetics in Japan?
Placing cosmetics on the market needs a cosmetics marketing licence from MHLW under Article 12 of the Pharmaceuticals and Medical Devices Act. The licence must be renewed within a period of at least three years.
Do I need to register my cosmetics in Japan?
Each cosmetic that does not need item approval is notified to MHLW in advance by the marketing licence holder (Article 14-9). Cosmetics containing components specified by MHLW need approval.
What is a quasi-drug in Japan?
A product with mild effects for purposes such as preventing bad breath, deodorising the body, preventing heat rash or hair loss, promoting hair growth or removing hair. Quasi-drugs generally need approval for each item.
Which ingredients are banned in Japanese cosmetics?
Medical drug ingredients, substances not meeting the Standards for Biological Materials, Class I and II specified chemical substances, and the substances in Appendix 1 of the Standards for Cosmetics.
Are preservatives and UV filters restricted?
Yes. Preservatives must be listed in Appendix 3 and UV absorbers in Appendix 4 of the Standards for Cosmetics.
Must cosmetic labels be in Japanese?
Yes. The particulars required by Article 61, including the licence holder, name, batch number and component names, are written in Japanese.
Can a foreign manufacturer make cosmetics for Japan?
A foreign manufacturer making cosmetics for export to Japan may be accredited by MHLW under Article 13-3. A marketing licence holder in Japan places them on the market.
Can cosmetics make medical claims in Japan?
No. Cosmetics have mild effects and exclude medicinal uses, and false or exaggerated statements about efficacy are prohibited (Article 66). MHLW sets the range of efficacy claims for cosmetics.
What must be reported after a cosmetic is on sale?
Suspected adverse effects such as disease, disability or death, and the start and progress of any recall, reported to MHLW by the marketing licence holder.
Do small cosmetic containers need a full ingredient list?
For containers of 50 g or 50 ml or less, the component names may be shown on the outer packaging or attached documents instead of the container (Regulation for Enforcement, Article 221-2).
How does Compliant Always help with selling in Japan?
Our team reads the rules for the markets you sell in, including the Japanese-language sources. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in Japan and what your paperwork needs to show.

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