When you import cosmetics and sell them in Japan, the list of ingredient names on the container cannot simply be a translation of the overseas ingredient list. The issue is not only wording: which name you use, what order you write them in, and what you leave out are all fixed by a ministerial notice and by administrative notifications.

Getting this wrong means scrapping labels that have already been printed. It is an avoidable kind of loss if you know the shape of the rule first, so here it is, article by article.

Where the full-ingredient rule actually comes from

What must appear on a cosmetic container is set by Article 61 of the Pharmaceuticals and Medical Devices Act. On ingredients, item (4) says only this.

For cosmetics containing ingredients designated by the Minister of Health, Labour and Welfare: the names of those ingredients.

The statute itself never says "all ingredients". Its structure is that you write the ingredients the Minister has designated. That designation is Ministry of Health and Welfare Notification No. 332 of September 2000, and for cosmetics it designated, as a rule, every ingredient in the formulation. That is the legal basis of the full-ingredient declaration.

Before it, only 102 designated ingredients had to be declared, as information helping consumers avoid skin reactions (医薬発第990号). The present system came out of a trade: the category-by-category approval system was abolished, and in exchange every ingredient is disclosed. It is part of the same deregulation, on the same day, as the Cosmetics Standard (Notification No. 331) covered in the previous article.

Quasi-drugs are still limited to designated ingredients. A product labelled 薬用 ("medicated") is a quasi-drug, so no full-ingredient declaration is required. Manufacturers often publish the full list voluntarily, but having the information and owing the duty are different things. For two products on the same shelf, what you have to verify swaps over.

One more point: an ingredient whose name a company wants to omit under item (4) is designated as a non-disclosed ingredient, and a cosmetic containing one needs product-by-product ministerial approval. An ingredient already publicly known cannot be withheld, so it is more realistic to choose formulations on the assumption that everything will be disclosed.

Three exceptions to the order

The order is set by notification (医薬審発第163号 and 医薬監麻発第220号, 6 March 2001). The rule is descending order of quantity in the product. There are three exceptions.

  • Ingredients at 1% or less — may be listed in any order among themselves
  • Colourants — may be listed in any order among themselves
  • Fragrance used as a perfuming agent — may be written collectively as 香料 ("fragrance") instead of naming each component

The first exception is the one that bites. Ingredients above 1% are in descending order, but once the list enters the band at 1% or below, the order carries no information. And the boundary of that band is invisible from outside. Read any ingredient list on the understanding that you cannot infer concentrations from the declaration alone.

What you leave out, and what you break apart

The same notification sets out what need not be declared.

Ingredients incidental to a blended ingredient (including impurities) that are present in the product in a quantity smaller than that at which their effect is exerted — so-called carry-over ingredients — need not be declared.

Conversely, two things must be broken apart. A premix must be declared by each of its constituent ingredients. You do not write one line using the trade name you bought from the raw-material supplier; you expand its contents.

An extract must be declared with the extracted substance separated from the extraction or dilution solvent (unless no solvent remains in the finished product). Formulations heavy in botanical extracts gain lines here, so estimate the container area from the expanded line count, not from the line count of your raw-material sheet.

The name is not a translation but a prescribed display name

The notification requires ingredient names in Japanese, and asks companies to use the "List of Cosmetic Ingredient Display Names" compiled by the 日本化粧品工業連合会 (Japan Cosmetic Industry Federation) and similar sources, so that consumers are not confused. That body was reorganised in 2023 as the 日本化粧品工業会 (Japan Cosmetic Industry Association).

Rendering an INCI name in katakana is not enough; you have to map it to the display name actually used in Japan. Korean and English notations often do not map one-to-one, and the reconciliation takes time. For ingredients with no listed name, the 日本化粧品工業会 operates a display-name creation service, so a formulation containing new raw materials must budget schedule time for obtaining a name.

Small containers have an allowance

As the line count grows, it stops fitting on a small container. Article 221-2 of the Enforcement Regulation sets out when the item (4) particulars — the ingredient names — may be omitted from the immediate container.

  • when they are stated on the outer container or outer packaging
  • when they are stated on a tag or display card affixed to the immediate container or immediate packaging
  • for cosmetics in an immediate container of 50 g or 50 mL or less, and for small-container samples having neither of the above: on a document attached to it
  • for cosmetics that have an outer box and sit in an immediate container of 10 g or 10 mL or less: on a document attached to the outer box, or on a document attached to the immediate container together with a display card

The attached document need not be affixed to the container, but it must be something the customer can take home with the product at the time of purchase, and a display card must be positioned so the ingredients can be checked at the time of purchase (医薬発第990号).

One further condition: where the full-ingredient declaration is made on a non-affixed attached document, the immediate container and packaging must state that an attached document exists (医薬審発第163号). If you handle a lot of samples or mini sizes, check this one early.

The order to check in

To avoid stalling at the label stage, working in this order reduces rework.

  • Confirm the category — cosmetic or quasi-drug (the scope of the duty changes)
  • List every ingredient with premixes and extracts already expanded
  • Check whether each ingredient has a Japanese display name, and arrange for one where it does not
  • Re-sort around the 1% line, move colourants to the end, collapse fragrance into 香料
  • Check the net content, and if you use the allowance, build the "an attached document exists" statement into the design

Where the Cosmetics Standard in the previous article decided whether the formulation has to change, almost everything here can be absorbed by reprinting. It can be absorbed, however, only if you notice before the print run.

Primary sources

* This article outlines the system. Individual determinations rest with the competent prefectural pharmaceutical affairs division.

We import and wholesale cosmetics and quasi-drugs, verifying whether a product can be handled in Japan from both the formulation and the labelling side. We are glad to be consulted from the ingredient-screening stage onwards.