Japan's Standards for Cosmetics Explained: MHLW Negative, Restricted and Positive Lists

Japan does not regulate cosmetic ingredients the way the EU does. There is no single annex of thousands of named substances. Instead, cosmetics sold in Japan sit under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices — commonly called the PMD Act — and a much shorter ministerial notification: the Standards for Cosmetics, issued by the Ministry of Health, Labour and Welfare (MHLW) as Notification No. 331 of 2000, effective from April 2001. This article explains how that notification is structured, why it is short compared with the EU annexes, why 'quasi-drugs' are a separate legal category rather than a subset of cosmetics, and what a formulator or regulatory reader actually finds when they look up a Japanese entry on cosingchecker.com/regulations/jp/.

The self-responsibility principle behind a short list

The MHLW Standards for Cosmetics negative list, MHLW cosmetics negative list, and the restricted and positive lists inside the same notification work under what industry guidance calls the self-responsibility principle: an ingredient not named anywhere in the Standards is not automatically approved, and it is not automatically banned either. The manufacturer that places the product on the Japanese market is responsible for verifying and documenting the safety of every ingredient it uses, named or not. The Standards only carve out the ingredients MHLW has decided need an explicit prohibition, a use limit, or a closed approved list. That is why the notification runs to a few dozen appendix entries rather than thousands of annex rows — it is not a shorter version of the EU system, it is a differently shaped one.

The four appendices: negative list, restricted list, two positive lists

The Standards for Cosmetics are organised into four appendices, each with its own regulatory role:

• Appendix 1 — the negative list. Around 30 entries, each an outright prohibition covering a substance or a class (for example mercury and its compounds, boric acid, formalin, hormones and their derivatives except specified estrogens, chloroform). No concentration is permitted; the entry simply forbids the material in cosmetics.
• Appendix 2 — a restricted list for named ingredients that are neither preservatives nor UV absorbers, split into sections, each carrying its own maximum concentration or use condition (examples on the site include aluminum chlorhydroxy allantoinate and cantharides tincture in one section, and botanical or biochemical extracts such as jujube extract, thioctic acid and ubidecarenone in another).
• Appendix 3 — a positive list for preservatives, split into two sections. Nothing outside this list may be used as a preservative in a Japanese cosmetic; each listed preservative carries a maximum percentage, typically expressed as a maximum amount per 100 g of product.
• Appendix 4 — a positive list for UV absorbers, also split into two sections. Many entries here carry a three-column use matrix rather than one flat limit: separate maximum percentages for rinse-off products, leave-on products, and products intended for use near mucous membranes.

That structure — one negative list, one general restricted list, and two closed positive lists for specific functional classes — is the answer to how the standard organises prohibited, restricted and permitted-with-limits ingredients. Tar (coal-tar) colourants are handled outside these four appendices, under a separate instrument, the Ministerial Ordinance on Coal-Tar Colours (MHW Ordinance No. 30 of 1966), which is why a search for a tar colour will not turn up a match inside the site's Standards-for-Cosmetics dataset even though colourants remain fully regulated in Japan.

Why quasi-drugs are a separate category, not stricter cosmetics

Japan quasi-drug cosmetics is a genuinely separate legal bucket under the PMD Act, not a stricter tier of the cosmetics category. The PMD Act splits personal-care-type products into cosmetics and quasi-drugs (iyakubugaihin). A product becomes a quasi-drug when it is formulated and labelled to deliver a specific, MHLW-recognised effect — skin whitening, acne prevention, anti-dandruff, deodorising, or hair growth promotion, among others — through a designated 'active ingredient' (yuko seibun). Typical medicated-cosmetic and whitening quasi-drug actives include compounds such as arbutin and specified vitamin C derivatives, used at concentrations tied to the claimed effect.

Because quasi-drugs make an efficacy claim backed by a named active, MHLW requires product-level approval or notification for each quasi-drug formulation, reviewed with scientific input from the Pharmaceuticals and Medical Devices Agency (PMDA). Ordinary cosmetics, by contrast, are covered by the Standards for Cosmetics and the self-responsibility principle described above, with no active-ingredient approval step. That is the practical reason quasi-drug ingredients fall under different rules: they are evaluated and approved as part of a specific product's efficacy claim, not screened against a general cosmetics negative or positive list. Industry references describe a distinct compilation of approved quasi-drug actives (often called the Japanese Standards of Quasi-drug Ingredients) that sits alongside, not inside, the Standards for Cosmetics — cosingchecker.com's Japan records track the cosmetics-side Standards, not the separate quasi-drug approval track.

How the structure compares with the EU annexes

The EU Cosmetics Regulation (EC) No 1223/2009 uses the same broad idea — banned substances, restricted substances, and positive lists for specific functional classes — but at a different scale and with a different default. EU Annex II (banned substances) alone lists more than 1,700 named entries in the CosIng data behind cosingchecker.com/regulations/eu/; EU Annex III (restricted substances) holds several hundred more, each with its own conditions; and Annexes IV, V and VI are the EU's closed positive lists for colourants, preservatives and UV filters respectively. The EU default is the opposite of Japan's: an ingredient not listed as permitted in an EU positive-list annex (colourants, preservatives, UV filters) may not be used for that function at all, and general ingredients are governed by a safety-assessment duty under the same regulation rather than a name-by-name negative list of comparable length to Annex II.

Japan's negative list is short by comparison because it exists to name specific prohibitions, not to enumerate every substance a formulator might consider. A formulator moving a product between the two markets cannot assume that silence in one system maps to permission or prohibition in the other — cosingchecker.com/market-divergence/ and cosingchecker.com/market-compare/ are built for exactly that side-by-side check, ingredient by ingredient, rather than for reading either country's rule as a stand-in for the other's.

Four worked examples from the site's Japanese records

These four entries are drawn directly from cosingchecker.com's published Japan dataset, each traceable to its appendix and entry number in the MHLW Standards for Cosmetics.

The pattern is consistent with the structure above: a negative-list entry carries no percentage at all because the substance is simply not allowed; positive-list preservative entries carry one flat cap; and UV-absorber entries often carry the three-column rinse-off / leave-on / mucosal matrix rather than a single number, because Appendix 4 sets different exposure-based limits for different product types.

Why the site holds 117 Japanese records, not thousands

cosingchecker.com currently publishes 117 Japan records, confirmed directly from the site's own jurisdictions endpoint. That is not a gap in coverage — it is the shape of the underlying notification. Appendix 1 names roughly 30 prohibited substances or classes, and the rest of the site's 117 Japan records - about 87 - are restricted or positive-list entries from Appendices 2 to 4 for preservatives, UV absorbers and other named restricted materials. Everything else permitted in Japanese cosmetics is governed by the self-responsibility principle rather than by a named entry, so there is no long tail of thousands of individually listed 'approved' ingredients to publish, the way there is for the EU's Annex II. A short Japan record count reflects how few substances MHLW chose to name in this particular notification, not an absence of regulation, and it should not be read as 'Japan permits more' or 'Japan checks less' — the country's underlying safety obligations sit elsewhere in the PMD Act framework, outside the appendices this dataset tracks.

As with every jurisdiction on the site, a Japanese record here is identity and sourcing evidence for that entry in the MHLW notification — it confirms what the Standards for Cosmetics say about a named substance, not a safety verdict on any product. The controlling text is the Japanese-language notification; the English translation MHLW hosts is provisional, and cosingchecker.com's records note that translation status alongside the entry. Anyone making a compliance decision for the Japanese market should check the current Japanese text and, where a quasi-drug or medicated-cosmetic claim is involved, confirm the product's approval status with MHLW/PMDA directly rather than relying on any secondary source, including this one.

Sources

• MHLW Standards for Cosmetics, Notification No. 331 of 2000 (provisional English translation) — https://www.mhlw.go.jp/content/001257665.pdf
• cosingchecker.com Japan jurisdiction data — https://cosingchecker.com/api/v1/jurisdictions/
• cosingchecker.com Japan rules (Appendix 1-4 entries) — https://cosingchecker.com/api/v1/jurisdictions/jp/rules/
• cosingchecker.com EU statistics (Annex II/III/IV counts) — https://cosingchecker.com/api/v1/stats/
• Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Japanese Law Translation) — https://www.japaneselawtranslation.go.jp/en/laws/view/3213
• Japan Cosmetics & Quasi-Drugs: PMD Act Compliance Guide — https://en.reach24h.com/service/cosmetic/japan-quasi-drugs-and-cosmetics-compliance
• Cosmetics and Quasi-drug Notification in Japan — https://www.cirs-group.com/en/cosmetics/jp-cosmetics-and-quasi-drug-notification
• Japanese Standards of Quasi-drug Ingredients (JSQI) — https://cosmetic.chemlinked.com/cosmepedia/japanese-standards-of-quasi-drug-ingredients-jsqi
• EU Cosmetics Regulation (EC) No 1223/2009 annex overview — https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-ingredient-database_en