A brand’s marketing team writes a front-of-pack line, a product name and six bullet points for a new cream. The Japanese factory reads them and asks which of the 56 items each line belongs to. Nobody on the brand side has heard of the 56 items. In Japan, a cosmetic may claim only effects from a fixed list, and the factory, the responsible company and the Japanese-side documents all work from that list — even when the product is going abroad.
This article shows you how to read the list, how to test your own claims against it, and how to build a claims sheet that survives translation into your export languages.
💬 Sunsho Trade manages own-brand cosmetics made at a GMP-certified partner factory in Japan for brands outside Japan. Send us your draft claims and we will map them against Japan’s efficacy range, or see the Japan cosmetics OEM guide.
How the efficacy range works
A cosmetic in Japan may claim only effects that appear in a list of 56 items (化粧品の効能の範囲), and only the items that fit the product — anything outside the list is not a cosmetic claim.
The efficacy range is a closed list. It is not a set of examples. If a claim is not on it, a cosmetic cannot make it. The list is also not a menu that every product can use in full: a product may only use the items applicable to it. A shampoo does not claim lip effects; a lip balm does not claim scalp effects.
The current list has 56 items. The range was reorganised into 55 items in December 2000. Item 56 was added by a Ministry of Health, Labour and Welfare notice of 21 July 2011 (薬食発0721第1号), the first new item since that reorganisation.
Checked against the published texts of the Ministry of Health, Labour and Welfare, Fukuoka Prefecture’s list of the 56 items and the Tokyo Metropolitan Government’s guidance on 17 October 2026.
What the list allows: examples you can use
The items describe modest, everyday effects — cleaning, moisturising, preventing dryness and rough skin, softening, giving lustre, preventing sunburn — and the exact wording matters.
The table groups examples from the list. The English is a faithful rendering of the Japanese item; when you write a label, keep the meaning, not a stronger paraphrase.
| Area | Examples from the 56 items |
|---|---|
| Hair and scalp | ”cleans the scalp and hair”, “gives hair body and firmness”, “removes / suppresses dandruff and itching” |
| Skin care | ”moisturises the skin”, “keeps the skin healthy”, “prevents rough skin”, “tightens the skin”, “prevents dryness of the skin”, “softens the skin”, “gives the skin firmness”, “gives the skin lustre”, “makes the skin smooth” |
| Face washes | ”(by cleansing) prevents acne and heat rash” |
| Sun | ”prevents sunburn”, “prevents spots and freckles caused by sunburn” |
| Lips | ”protects the lips / prevents dryness of the lips” |
| Item 56 | ”makes fine lines caused by dryness less noticeable” |
Three reading notes from the list itself are worth knowing:
- Wording variants. Where an item says “replenishes and keeps”, the label may also say just “replenishes” or just “keeps”.
- “Skin” and 肌. The two Japanese words for skin may be used interchangeably.
- Words in brackets. Bracketed words are limits that come from the product’s form, not part of the claim. “(By cleansing) prevents acne” belongs to face washes because the effect comes from washing.
Notice what the sun items say and do not say. “Prevents spots and freckles caused by sunburn” is about preventing sunburn-related marks. It is not a whitening claim. Whitening, in Japan’s quasi-drug wording — suppressing melanin production to prevent spots and freckles — belongs to quasi-drugs, which need an approved active ingredient and product approval. The boundary is explained in cosmetic or quasi-drug.
Item 56 and fine lines: the condition that comes with it
Item 56 lets a cosmetic say “makes fine lines caused by dryness less noticeable”, but only if the responsible company confirms the effect on its own responsibility through testing — and wrinkle prevention or removal stays outside the range.
Item 56 is the only item that carries an explicit testing condition. According to the 2011 notice, the marketing authorisation holder must confirm the effect on its own responsibility through testing, such as testing following the Japanese Society of Cosmetic Chemists’ guideline for evaluating anti-wrinkle products.
Three practical points follow:
- The claim is narrow. It is about fine lines caused by dryness, and about making them less noticeable. It is not about wrinkles in general, and not about removing anything.
- It needs evidence. Plan the testing before you plan the artwork. If the test has not been done for your formula, the claim is not available.
- Neighbouring claims are outside. Prefectural guidance treats wrinkle prevention, wrinkle removal and sagging removal as outside the efficacy range. Wrinkle-improvement claims exist in Japan only for approved quasi-drugs.
If item 56 matters to your brand, say so in the brief. It changes the development plan.
Makeup effects and sensory feel
Separately from the 56 items, a label may describe makeup effects and how a product feels, as long as the description is true and does not guarantee a result.
Tokyo Metropolitan Government guidance allows makeup effects — for example “makes fine lines look less noticeable” because a product covers them — and descriptions of sensory feel, provided they are true and do not guarantee results. This is a different basis from item 56. A makeup effect comes from covering, colouring or light; it says nothing about changing the skin.
Two cautions:
- Keep the mechanism visible. “Covers fine lines for a smoother look” makes the makeup basis clear. A sentence that drops the covering mechanism can read like an item-56 claim or a wrinkle claim.
- Feel is not effect. “Light, non-sticky texture” describes feel. “Light texture that repairs the skin” attaches an effect that is outside the range.
Out of range: what to strike from a draft
Strike any line that promises a change in the skin beyond the list, uses medical language, borrows quasi-drug wording, or guarantees a result.
| Draft line type | Status for a cosmetic in Japan | What to do |
|---|---|---|
| Moisturising, preventing dryness, softening, lustre | Within the range | Keep, in list wording |
| ”Makes fine lines caused by dryness less noticeable” | Within the range, with testing | Keep only if the testing is done |
| Wrinkle prevention, removal, sagging removal | Outside the range | Strike, or reconsider as a quasi-drug project |
| Whitening in the melanin-suppression sense | Quasi-drug wording | Strike, or reconsider as a quasi-drug project |
| Medical words: treats, cures, heals, repairs | Outside the range | Strike |
| ”Clinically proven”, guaranteed results | Not a claim the range supports | Strike or rewrite as a factual feel or makeup description |
| Product name that carries any of the above | Treated as a claim | Rename |
The product name is the line brands forget. A name is part of how the product is presented. If the name says something the label may not, the name is the problem.
💬 Want your product name and claim list checked line by line before samples? Send the draft to us and we will mark each line against the efficacy range.
Why Japanese claims matter even for an export product
The product is made under a Japanese licence and described in Japanese documents, so keeping its claims inside the Japanese range avoids a product that is a cosmetic in one set of papers and reads like something else in another.
What an export label may say is governed by the destination market. Your importer files the destination notification and should tell you its claim rules. So why should a brand that never sells in Japan care about the 56 items?
- The factory works in Japanese categories. A Japanese factory makes the product as a cosmetic under a cosmetics manufacturing licence. A claim list that describes quasi-drug effects puts the product in a different Japanese category from the one being manufactured. Expect the factory to ask how your claims fit.
- Export labelling in Japan is manufacturing. When export-specific labels are applied in Japan, that work is manufacturing and needs an export manufacturing notification (輸出用化粧品製造届) filed before manufacture starts. The labels and their wording are part of what is being manufactured.
- Certificates rest on Japanese status. If you later need a certificate that a named product is manufactured and sold in Japan, it presupposes that the product is notified for the Japanese market — where the Japanese claim rules apply. See Japan-side export documents and certificates.
- Selling in Japan later. If you ever want to sell in Japan, the claims are already compliant. The Japanese-market route is described in importing cosmetics into Japan.
None of this means the export label must copy the Japanese wording. It means the Japanese-range wording is the safe base, and each translation is checked to make sure it has not grown stronger.
Build a claims sheet before the brief
A one-page claims sheet — each claim, its list item, the evidence needed, and each translation — is the tool that keeps marketing, the factory and your importer aligned.
Set out four columns:
- The claim as you want it on the pack, in English.
- The item from the efficacy range it relies on, or “makeup effect” or “feel”.
- The evidence needed, if any — for item 56, the testing.
- Each export-language version, checked against the meaning of column 1.
Send the sheet with your brief. It also feeds the product pages that follow: for example, the typical claim set for a toner is covered in Japanese toner and lotion OEM, and sun claims in Japanese sunscreen OEM.
💬 Prefer to have the claims sheet, formula check and export documents handled together in English? See our own-brand OEM service, or send your product brief.
Frequently asked questions
1. Is the 56-item list a set of examples or a complete list?
It is a complete list. A cosmetic in Japan may claim only effects within it, and only those applicable to the product.
2. Can a cosmetic in Japan say anything about wrinkles?
It can use item 56, “makes fine lines caused by dryness less noticeable”, if the responsible company has confirmed the effect through testing. Makeup effects from covering may also be described if true. Wrinkle prevention, removal and improvement are outside the cosmetic range; wrinkle-improvement claims exist in Japan only for approved quasi-drugs.
3. Does “prevents spots and freckles caused by sunburn” mean whitening?
No. That item is about sunburn. Whitening in Japan’s quasi-drug sense — suppressing melanin production to prevent spots and freckles — is a quasi-drug claim.
4. My product is only for export. Do I still need to follow the 56 items?
The export label follows the destination market’s rules, which your importer should confirm. But the product is manufactured in Japan as a cosmetic and described in Japanese documents, so keeping claims within the Japanese range avoids a mismatch.
5. Is the product name checked as a claim?
Yes, in practice. A product name is part of how the product is presented. If the name states an effect outside the range, rename it.