When checking whether an overseas formulation can be brought into Japan as it is, the usual method is to put the list of prohibited ingredients next to the ingredient declaration. If nothing prohibited appears, the formulation is assumed to be fine.

That method is only half right. Japan’s Cosmetics Standard regulates some ingredients through a prohibition list and others through a permission list. For the second group, confirming that something is “not on the banned list” tells you nothing. It may be used only if it is on the list.

The notification behind it

Ingredient regulation for cosmetics is set by the Cosmetics Standard (MHW Notification No. 331 of 29 September 2000). Issued under Article 42(2) of the former Pharmaceutical Affairs Act, it has applied since 1 April 2001. The earlier Cosmetics Quality Standard and Cosmetics Ingredient Standard were abolished at that point, and the system changed so that ingredients not in breach of the Standard may be used once the company has confirmed their safety on its own responsibility.

In other words, approval is not obtained item by item; the company itself judges whether a formulation sits inside the Standard. Because the responsibility for that judgement rests with the business, the shape of the boundary has to be known precisely.

Two methods coexist

Paragraphs 2 to 4 of the Notification each take a different approach.

1. Ingredients other than preservatives, UV absorbers and tar colours — prohibition list

Paragraph 2 provides that pharmaceutical ingredients, substances not conforming to the Standards for Biological Ingredients, Class I and Class II Specified Chemical Substances under the Chemical Substances Control Act, and the substances listed in Appended Table 1 may not be blended. Paragraph 3 then limits the ingredients in Appended Table 2 to the maximum amount shown per 100 g.

Within this range, reading the rule as “if it is not on the list, it may be used” does hold.

2. Preservatives and UV absorbers — permission list

Paragraph 4 runs the other way.

A preservative blended into a cosmetic (meaning a substance blended into a cosmetic for the purpose of inhibiting the growth of micro-organisms in the cosmetic) must be one of those listed in Appended Table 3.

UV absorbers follow the same construction: they must be among those listed in Appended Table 4. Anything not listed cannot be used. No amount of reading the prohibition list will reveal this restriction.

3. Tar colours — governed by a separate ministerial ordinance

For tar colours, Article 3 of the Ministerial Ordinance Designating Tar Colours That May Be Used in Pharmaceuticals and Related Products (MHW Ordinance No. 30 of 1966) applies by analogy. There is one exception: Red No. 219 and Yellow No. 204 may be blended only into cosmetics used solely on hair and nails.

Where things usually stop

The most common failure is a preservative in everyday use overseas that does not appear in Japan’s Appended Table 3. Even where the rest of the formulation raises no issue, a single preservative forces a choice between reformulating or dropping that product.

The same happens with UV absorbers. For sunscreens, or base products that claim UV protection, this one point can put an entire product out of scope.

With colours, the same colour name does not settle whether that particular number may be used in Japan. And as with the two colours above, some are limited to specific parts of the body.

One provision reaches as far as impurities

Paragraph 5 requires glycerin to contain no more than 0.1g of diethylene glycol per 100 g. The provision regulates not the blended ingredient itself but the quantity of an impurity within it.

Paragraph 1, the general rule, likewise states that raw materials — “including impurities contained therein” — must not be substances liable to cause a risk to public health and hygiene. The design assumes that checking a list of ingredient names does not finish the job.

The order of checking

In practice, working through the following order reduces rework.

  • Preservatives — are they in Appended Table 3? (if not, start from considering reformulation)
  • UV absorbers — are they in Appended Table 4?
  • Colours — is the specific number usable in Japan, and is any site-of-use limit attached?
  • Other ingredients — absent from Appended Table 1, and within the ceiling in Appended Table 2?
  • Raw-material specifications — do they touch the impurity provisions?

The order matters because only the first two lead to a decision that changes the formulation itself. Separating the points that can be absorbed by adjusting labelling from those that require the formulation to be rebuilt is worth doing at the outset.

If a new ingredient is needed

Where a preservative or UV absorber not in the appended tables is genuinely required, there is a procedure for requesting an amendment to the Notification: a written request with safety documentation is submitted to the Minister of Health, Labour and Welfare, under the procedure set out in a notice (医薬審発第325号, March 2001). The 2006 amendment by Notification No. 371 did in fact add prohibited ingredients and add permitted preservatives.

The lists are not fixed. They do move, but not at a speed that fits a product launch schedule, and should be planned for on that basis.

Primary sources consulted

This article outlines the regulatory framework. Whether a specific product may be handled is a matter for the competent authorities.

We import and wholesale cosmetics and quasi-drugs, and check 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 stage onwards.