Product Compliance And Certification For Hair Dye In Japan

Scope and evidence must be confirmed before any paid tests or filings.

A hair dye cannot be cleared for Japan by choosing a generic ‘cosmetics certificate’. The decisive question is how this particular product colors, bleaches or removes color from human scalp hair, what its formula contains, and what the Japanese label promises. Japanese rules distinguish quasi-drug senmōzai (染毛剤) from cosmetic senmōryō (染毛料). A product’s approval status abroad does not decide its Japanese route.

Use the decision matrix to assign a provisional route, then confirm it with the prospective Japanese marketing authorization holder (MAH) and, for borderline products, the competent prefectural pharmaceutical affairs office. This is a national product route map, not a certificate or approval for any particular formula.

Classify the dye by mechanism and claims

Check whether color forms by oxidative or another chemical reaction, whether the item bleaches or removes hair color, or whether pigment is deposited through simple physical action. The 2021 MHLW hair-color approval standard expressly excludes direct coloring by simple physical means (cosmetics) from its quasi-drug scope. Non-oxidative chemical dyes can still be quasi-drugs; ‘peroxide-free’ is not a classification test. Record all on-pack, online and salon-use claims before deciding.

Regulatory route matrix: five hair-color situations

Actual product / claimed function	Likely Japanese route	What to verify first
Two-part oxidative permanent dye, including grey coverage	Quasi-drug: hair-color product approval route	Each agent, approved active dyes, developer concentration, mixing instructions and allergy warnings
Bleach or hair-color remover sold for scalp hair	Quasi-drug, even if it adds no color	The stated bleaching/removal effect, active ingredients and component arrangement
Non-oxidative chemical colorant	Potential quasi-drug: do not assume ‘cosmetic’	Mechanism and whether MHLW's non-oxidative hair-color category applies
Acid-color hair manicure, color treatment or direct-deposit mask	Often cosmetic where effect is purely physical	Cosmetics Standards, permitted colorants and no quasi-drug claims
Wash-out spray, mascara or color stick for hair	Often cosmetic; aerosol adds a separate packaging question	Actual use, ingredients, claims and, if pressurized, applicable high-pressure-gas requirements

Ingredient and mixing gates that can block a launch

For quasi-drug dye, compare every active substance and its use concentration with the 2021 Hair Coloring Agents Standards (Tables 1, 2 and 2-2) and the separate additives requirements. The standard distinguishes one-, two- and three-agent arrangements, and sets a maximum of 6.0% hydrogen peroxide in the product for hydrogen-peroxide preparations. The applicable limits must be checked for the specific category and formula; 6% is not a blanket permission. A product outside the standards is not automatically prohibited, but may require a fuller efficacy, safety and formulation review.

Additional hair-dye limit: where two or more actives from Column I-A or I-C of Table 2 are used, their combined concentration at use must not exceed 5.0%. Check each individual dye limit separately. This combined 5.0% limit and the 6.0% hydrogen-peroxide limit address different calculations.

Do not stop at the 2021 dye-approval tables. The hair-dye additives list was revised in December 2022, and the Japanese Standards of Quasi-Drug Ingredients 2021 were amended in March 2025. For affected ingredient specifications and test methods, the March 2025 implementation notice provides a transition ending on 30 September 2026: from 1 October 2026 the revised specifications generally apply. For an already-approved product to continue using a former affected specification, the relevant minor-change notification establishing a separate specification had to be filed by 30 September 2026. Check the actual approval record; the notice is not a general exemption. Have the MAH check the exact ingredient and approval record before release.

Maintain ingredient names, specifications and percentage by each agent, plus concentrations at the prescribed use ratio; check impurity and stability evidence.
For cosmetic coloring, screen the Japanese Cosmetics Standards, including restricted/prohibited substances and the special rules for tar colors; a foreign INCI list alone is insufficient.
Confirm whether changing an oxidant, dye precursor, coupling agent or shade creates a new regulatory submission or falls within an accepted series/variation procedure; do not presume one approval covers every color.

Japanese hair-dye MAH and manufacturing-site responsibilities

Separate three legal layers: authorization of the Japanese MAH responsible for market quality and safety, authorization or notification of manufacturing and packaging sites, and the product-specific route. For quasi-drugs, PMDA's August 2025 procedure describes MAH licensing, product marketing approval, manufacturing-site arrangements and foreign-manufacturer accreditation, with GMP inspection where applicable. The competent approval body may be MHLW or a prefecture depending on the case. Cosmetic marketing generally follows a MAH license and product notification rather than routine product pre-approval when full ingredients are declared and the Cosmetics Standards are met.

Foreign brand: appoint and contract with an appropriately licensed Japanese MAH before assuming the importer or distributor can place goods on the market.
Japan-based MAH: establish supplier oversight, quality/safety responsibilities, requisite product filing and release controls; review the approved or notified product scope.
Site or repacker: identify whether local filling, labeling, packing or storage requires manufacturing authorization; check foreign-site steps specifically for quasi-drug supply.

For imported cosmetic hair colors, distinguish the cosmetic product notification to the MAH’s prefecture from the additional foreign manufacturer/foreign marketer notification submitted to PMDA, as applicable. These are not interchangeable with foreign-manufacturer accreditation in the quasi-drug route. Verify the manufacturing, packaging, labeling and storage site arrangements separately.

Hair-dye evidence file: documents to request

Ask for a shade-by-shade, component-by-component evidence pack before artwork or production orders are locked. This is a practical dossier checklist, not a claim that every listed study is always a mandatory statutory attachment:

A formula and complete quantitative bill of materials for every agent, developer and shade, including colorant identity and impurities.
Mechanism of action, intended human use, application method, mixing ratio, contact time, rinse instructions and efficacy claims.
Ingredient compliance mapping: quasi-drug active/additive rules or Cosmetics Standards and permitted colorants.
Specifications, batch and supplier traceability, stability and compatibility data; fit-for-purpose microbiological and chemical safety evidence.
Risk assessment for oxidative-dye sensitization, scalp/eye exposure and misuse; proposed patch-test instructions where relevant.
Identity, license/accreditation status and functions of MAH, production sites, labeler, importer and logistics operator.
Japanese label and leaflet drafts, every shade identifier, pack size, intended channel and source evidence for advertising claims.

Japanese labels, warnings and other regulatory layers

Do not print Japanese artwork from an EU/US pack without a route-specific check. Quasi-drugs must be identified and labeled in line with applicable Japanese provisions and the approved use; cosmetics generally require full ingredient labeling. Relevant product name, MAH identification, batch/lot, quantities, directions, warnings and required particulars must be checked on the actual pack or accompanying documentation. Japan's misleading-representation rules also affect e-commerce and salon claims. Industry advice on a patch test 48 hours before each use is particularly important for oxidative dyes; check current applicable warnings rather than copying a cosmetic color-mask leaflet.

Compare Japan-approved or notified names, indications, use instructions and every component label with final artwork.
Ensure warnings distinguish oxidative-dye sensitization, eye exposure, prior reactions, patch testing and prohibited uses as applicable.
Review physical pack, outer carton, inserts, online listing and salon instruction sheet as one consistent claims set.
For aerosol hair color, separately assess gas/pressure classification and transport/packaging duties; PMD compliance alone may not close the issue.

Edge cases: henna, salons, sprays and mixed kits

Natural-sounding marketing terms are unreliable classification shortcuts. Japan's National Consumer Affairs Center reported in 2026 anaphylaxis incidents involving oxidative dyes in henna products intended for wigs, highlighting the danger of treating ‘henna’ or ‘for wigs’ as proof of suitability for people.

‘Henna’ or ‘plant-based’: verify all color-forming chemicals, intended application surface and claims; never imply a wig-only product is safe for human hair.
‘Professional/salon-only’: this does not by itself remove a product from the PMD Act or replace the appropriate marketing route.
‘Made in EU’, ‘FDA registered’, ‘peroxide-free’ or ‘certified’: none alone substitutes for Japanese classification, MAH responsibilities and required approvals/notices.

Hair-dye launch gates: formula, shade and label changes

Treat these as sequential release gates: a failed earlier gate blocks the commercial launch rather than being fixed by a certificate obtained later.

Freeze intended scalp-hair use, chemical mechanism, claims, each shade and the one-/two-/three-agent configuration.
Obtain a written preliminary cosmetic-versus-quasi-drug assessment and resolve borderline questions with the intended Japanese MAH/prefecture.
Map formula against the correct standard and establish responsible entities, site qualifications and the product approval/notification route.
Compile product-specific safety/quality evidence, then finalize Japanese labeling and advertising against that exact route.
Only after applicable authorizations, filings, import and release checks are complete, distribute; reevaluate on ingredient, claims, supplier, component, shade or label changes.

Official sources and related routes

For the broader Japanese cosmetics framework. For comparison only: hair-dye obligations in the United States: For comparison only: hair-dye obligations in the United States.

Selected official and authoritative sources:

Frequently asked questions

Is every hair dye in Japan a quasi-drug?

No. Chemically acting dyes and hair bleaches may follow the quasi-drug route, while purely physically depositing hair colors can be cosmetics. Non-oxidative chemistry also needs review.

Can one approval cover all shades and developers?

Do not assume so. Document each shade, active ingredient, developer and agent arrangement; have the MAH check the 2021 standards and series/application rules before filing.

Is a 6% peroxide developer automatically compliant?

No. The 2021 quasi-drug standard contains a 6.0% product-concentration limit for hydrogen peroxide, but the whole formula, component structure, active substances, use and label must also comply.

May we import EU-compliant hair dye directly for resale?

Foreign compliance does not replace the Japanese MAH, site and product requirements. Commercial imports must satisfy the PMD Act and customs checks; personal-use exemptions are not a resale route.

Can ‘natural henna’ or salon-only branding avoid authorization?

Neither phrase determines classification. Verify the ingredients, use on human hair and mechanism, especially possible oxidative dyes in products marketed as henna.