Cosmetics Imports and Sales — PMD Act, Labeling and Notification Requirements
Interlink編集部What Are Cosmetics?
Cosmetics are products used for cleaning the human body, beautifying it, enhancing attractiveness, changing appearance, and maintaining healthy skin and hair.
Under the Pharmaceuticals and Medical Devices Act (PMD Act), cosmetics are defined as products with mild effects on the human body.
In import operations, even products commonly sold overseas such as skincare items, makeup products, hair care products, perfumes, sunscreens, and nail products need to be checked to determine whether they fall under the definition of cosmetics or if they qualify as quasi-drugs or pharmaceuticals when sold within Japan.
Although cosmetics are familiar products, they are regulated under the PMD Act. Products freely sold overseas require confirmation of ingredients, labeling, advertising, permits, and notifications when imported and sold in Japan.
Scope Covered in This Article
| Scope | Contents Organized in This Article | Items to Check Separately |
|---|---|---|
| Basics of Cosmetics | Organized as products intended for cleaning, beautifying, enhancing attractiveness, changing appearance, and maintaining healthy skin and hair. | The final classification under the PMD Act for individual products should be confirmed considering ingredients, efficacy claims, labeling, advertising, and sales methods. |
| Differences from Pharmaceuticals and Quasi-Drugs | Clarifies boundaries between cosmetics, quasi-drugs, and pharmaceuticals based on purpose, efficacy claims, ingredients, and labeling. | Approvals, permits, and sales regulations for pharmaceuticals and quasi-drugs should be checked separately. |
| Relation to Medicinal Cosmetics | Organizes products close to quasi-drugs such as medicinal whitening cosmetics, medicated shampoos, medicated toothpaste, and hair growth agents. | Approval or permit for quasi-drugs is necessary when medicinal efficacy claims are made and requires expert verification. |
| Ingredient Regulations | Organizes cosmetic standards, prohibited ingredients, restricted ingredients, preservatives, UV absorbers, and tar-based colorants. | Use, concentration, application, and labeling names for individual ingredients should be checked against the latest standards and expert references. |
| Full Ingredient Labeling | Organizes Japanese language labeling, Japanese product names, order of ingredients, manufacturer/importer name, address, net content, lot numbers, etc. | Whether overseas labels can be used as-is should be checked against domestic labeling rules. |
| Import and Sales Procedures | Organizes cosmetic manufacturing and marketing authorization, manufacturing permits, marketing notifications, and foreign notifications. | Whether permits or notifications are required, where to submit, and timing of procedures should be confirmed with prefectural authorities, PMDA, or experts. |
| Freight Forwarder and Customs Practice | Organizes points to check when seeing cargo descriptions such as cosmetics, skin care products, sunscreen, beauty serum in logistics operations. | Freight forwarders should not definitively judge applicability under the PMD Act or necessity of permits/notifications but encourage importers to verify. |
Overview
Cosmetics, like pharmaceuticals and quasi-drugs, are regulated under the PMD Act.
However, they are characterized by not being intended for the treatment or prevention of diseases but for cleansing, beautifying, enhancing attractiveness, changing appearance, and maintaining healthy skin and hair.
On the other hand, if labeling or advertising claims pharmaceutical-like efficacy, the product may not be treated as a cosmetic.
It is important to check not only the product itself but also labels, outer packaging, package inserts, product descriptions, e-commerce sites, advertising wording, social media postings, and video explanations.
Purpose and Background of the System
Cosmetics are daily use products applied to the human body—skin, hair, oral cavity, nails—making safety, quality, labeling, and advertising controls essential.
Even if sold as general products overseas, it is necessary to confirm whether they comply with Japanese cosmetic standards, contain no prohibited ingredients, and do not exceed usage limits for restricted substances.
Furthermore, when claims extend beyond cosmetics' scope—to treatment, prevention, improvement of diseases, or effects on body functions—it may require classification as pharmaceuticals or quasi-drugs.
In import sales, not only whether customs clearance is possible but also responsibility for market shipment, domestic storage, packaging, labeling operations, product notifications, foreign manufacturer information, and post-sale quality and safety management need to be confirmed.
Applicable Products
Products potentially classified as cosmetics include those related to everyday beauty and hygiene care.
| Product Examples | Main Uses | Points to Confirm | Notes |
|---|---|---|---|
| Lotion, Emulsion, Cream, Beauty Serum | Used to keep the skin healthy, moisturized, and beautified. | Ingredients, full ingredient list, advertising claims, presence of medicinal effects | Avoid expressions such as "heals inflammation" or "improves atopic dermatitis." |
| Foundation, Lipstick, Eye Makeup Products | Used to enhance and beautify appearance. | Pigments, tar pigments, preservatives, labeling, advertising | Pigments permitted for use overseas may not be allowed in Japan. |
| Shampoo, Rinse, Treatment | Used to cleanse and maintain healthy hair and scalp. | Medicinal labeling, dandruff/itch prevention claims, hair growth claims | If medicinal effects are claimed, confirmation of quasi-drug status is necessary. |
| Soap, Facial Cleanser, Body Soap | Used to clean the body and face. | Applications, ingredients, antibacterial/disinfectant claims, quasi-drug applicability | Strong claims of antibacterial or disinfectant effects may exceed the scope of cosmetics. |
| Perfume, Eau de Cologne | Used to add fragrance and enhance attractiveness. | Fragrances, alcohol, labeling, dangerous goods classification for transport | Not only Pharmaceutical and Medical Device Law but also transport-related dangerous goods must sometimes be confirmed. |
| Sunscreen | Used to protect skin from ultraviolet rays. | UV absorbers, UV scattering agents, labeling, SPF claims | Formulations intended for overseas markets may not be immediately suitable for sale in Japan. |
| Nail Products, Lip Balm, Hand Cream | Used to beautify and maintain health of nails, lips, and hands. | Ingredients, applications, medicinal labeling, advertising claims | Beware of claims related to treatment, repair, or regeneration. |
List of Situations Where Regulations Apply
| Situation | Reason Regulations Become an Issue | Materials to Check | Common Causes of Delays |
|---|---|---|---|
| When importing and selling overseas-made cosmetics | Need to confirm cosmetic applicability, ingredients, labeling, permits, and notifications for sale in Japan. | Product catalogs, full ingredient lists, specifications, COA, sales pages | Judging solely by the fact the products are sold overseas as cosmetics. |
| When importing products that claim medicinal effects | They may be classified as medicated cosmetics, quasi-drugs, or pharmaceuticals. | Advertising texts, overseas labels, efficacy claims, ingredient data | Using expressions like anti-acne, whitening, medicated directly without adaptation. |
| When applying labels in domestic warehouses | Packaging, labeling, and storage fall under this, potentially requiring cosmetic manufacturing permits. | Work details, warehouse information, label drafts, manufacturing permit documents | Assuming it is just logistics work and failing to check manufacturing permits under Pharmaceutical and Medical Device Law. |
| When using overseas labels as-is for sales | May not comply with Japan’s mandatory full ingredient labeling, manufacturers’ details, and usage warnings. | Overseas labels, draft Japanese labels, full ingredient lists, labeling name documentation | Attempting to sell products simply by sticking English labels. |
| When advertising strong efficacy claims | Claims may exceed cosmetic effect range and be regarded as medicinal advertisements. | EC pages, landing pages, SNS posts, video ads, pamphlets | Using expressions such as "cures," "disappears," or "regenerates." |
| When domestically selling products imported via personal import | Distinction between import for personal use and for business; sales require permits, notifications, and labeling checks. | Quantities, sales destinations, EC listing info, import purposes, product data | Attempting to resell items obtained via personal import as-is. |
| When importing sunscreen, colored cosmetics, or perfumes | UV absorbers, tar pigments, fragrances, alcohol, and transport regulations often cause issues. | Full ingredient lists, content amounts, SDS, COA, hazardous materials documentation | Confusing cosmetic regulations with transport dangerous goods confirmation. |
Differences from Pharmaceuticals and Quasi-Drugs
Cosmetics are primarily intended for beauty and maintaining cleanliness.
Pharmaceuticals, on the other hand, are intended for diagnosing, treating, or preventing diseases, or for acting on the structure or functions of the body.
Quasi-drugs have effects that are less strong than pharmaceuticals but aim for certain efficacy such as preventing bad breath, body odor, heat rash, or inflammation; promoting hair growth; removing hair; preventing acne; or other medicinal benefits.
For example, a regular shampoo might be considered a cosmetic, but if marketed as a "medicated shampoo" claiming to prevent dandruff or itchiness, confirmation as a quasi-drug may be required.
Similarly, a standard cream may be treated as a cosmetic, but if claims like "cures eczema", "reduces inflammation", or "improves atopic dermatitis" are made, it may be viewed as having pharmaceutical effects and cause regulatory issues.
Comparison with Other Systems
| Category | Main Purpose | Difference from Cosmetics | Documents to Check | Practical Notes |
|---|---|---|---|---|
| Cosmetics | Cleanliness, beautification, enhancement of attractiveness, changes in appearance, maintaining healthy skin and hair. | Has mild effects on the human body and is not intended for the treatment or prevention of diseases. | Complete ingredient list, compliance documents with cosmetic standards, labeling drafts, advertising drafts, notification documents | Avoid advertising that exceeds the efficacy and effectiveness range of cosmetics. |
| Quasi-Drugs | Intended for certain efficacy effects with milder effects than pharmaceuticals. | Includes medicated cosmetics, medicated shampoos, medicated toothpaste, hair growth agents, etc. | Approval documents, efficacy claims, ingredients, active ingredients, labeling drafts | If advertising medicinal effects, confirm whether it can be sold as a cosmetic. |
| Pharmaceuticals | For diagnosis, treatment, prevention of diseases, or affecting bodily functions. | Claims related to treatment, improvement, prevention, regeneration, hair growth may be considered pharmaceutical claims. | Ingredients, efficacy claims, dosage and administration, advertising, approval documents | Even if imported as cosmetics, advertising medicinal efficacy may cause issues. |
| Health Foods | Foods consumed with the expectation of maintaining health or nutritional supplementation. | Application methods differ from cosmetics applied or scattered on the body. | Ingredient lists, food labeling, advertising, food sanitation law documents | Do not confuse foods for ingestion with topical cosmetics even if promoting beauty benefits. |
| Miscellaneous Goods / Beauty Accessories | Beauty tools, accessories, and miscellaneous items. | May not be products containing ingredients for application or scattering on the body. | Intended use, materials, advertising, usage instructions, import documents | It is necessary to verify the boundary with medical devices or cosmetics for beauty equipment and patches. |
| Personal Imports | Items purchased overseas for personal use. | Different from imports for domestic sales, resale, or distribution. | Quantity, purpose, purchaser, planned sales, delivery address | Personal import goods cannot be diverted to domestic sales. |
Relationship with Medicated Cosmetics
In practice, the term “medicated cosmetics” is sometimes used.
Medicated cosmetics generally have the form of cosmetics but are treated as quasi-drugs with certain active ingredients and efficacy claims.
Products like medicated whitening cosmetics, medicated shampoos, medicated toothpaste, and medicated hair growth agents often raise issues.
Products labeled overseas with whitening, anti-acne, medicated, anti-dandruff, hair growth, etc., may not always be allowed to be sold simply as cosmetics in Japan.
It is necessary to clarify before import whether they will be imported and sold as cosmetics or approved/authorized as quasi-drugs.
Applicable Requirements and Items Outside Scope
| Category | Concept | Documents to Check | Notes |
|---|---|---|---|
| Items possibly treated as cosmetics | Intended for cleanliness, beautification, enhancement of attractiveness, changes in appearance, maintaining skin and hair health with mild effects. | Product descriptions, usage instructions, complete ingredient lists, advertising drafts, labeling drafts | Avoid claims of disease treatment, prevention, or improvement. |
| Items possibly falling under quasi-drugs | Claims of medicinal effects, active ingredients, acne prevention, whitening, hair growth, dandruff prevention, etc. | Efficacy claims, ingredients, active ingredients, overseas labeling, advertising texts | May require approval or authorization as medicated cosmetics. |
| Items possibly classified as pharmaceuticals | Claims of disease treatment, prevention, improvement, or strong effects on bodily functions. | Efficacy claims, advertising, ingredients, dosage and administration, sales materials | May not be importable or sellable as cosmetics. |
| Items possibly treated as miscellaneous goods | Not ingredient products applied or spread on the body, treated as beauty devices or miscellaneous goods. | Materials, intended use, usage instructions, advertising, import documents | Verify boundaries with medical devices and cosmetics. |
| Items limited to personal import | Imports limited to a certain range for personal use. | Quantity, purpose, purchaser, presence or absence of sales plans | If diverted to domestic sales, resale, or distribution, considered import for business purposes. |
| Items imported for business purposes | Imported domestically for sale, resale, distribution, or business use. | Sales plan, delivery destination, e-commerce page, quantity, frequency | Requires confirmation of permits, notifications, labeling, and advertising under the Pharmaceutical and Medical Device Act. |
Ingredient Regulations for Cosmetics
Ingredient confirmation is very important for cosmetics.
Even if a product is sold overseas as a cosmetic, it may not comply with Japanese cosmetic standards.
In Japan, it is necessary to check for prohibited ingredients, restricted ingredient amounts, preservatives, UV absorbers, tar dyes, and other regulated substances.
| Check Items | Main Content | Common Causes for Delays in Import Operations | Reference Documents | Practical Measures |
|---|---|---|---|---|
| Prohibited Ingredients | Confirm that no ingredients prohibited in cosmetics are included. | Ingredients allowed overseas may be prohibited for use in Japan. | Complete ingredient list, specification sheet, COA, ingredient standard documents | Check all ingredients and their amounts before procurement. |
| Restricted Ingredients | Verify compliance with restrictions on concentration, usage area, and product type. | Ingredients may be permitted but the concentration or usage may exceed standards. | Concentration data, formulation sheets, product specification documents | Check usage, area, and concentration. |
| Preservatives | Confirm the allowed preservatives and their concentration ranges. | Preservatives in overseas formulations may not meet Japanese standards. | Complete ingredient list, concentration, formulation data | Confirm conformity to Japanese standards. |
| UV Absorbers | Verify the types and concentration of UV absorbers used in sunscreens, etc. | Formulations for overseas sunscreens may be used as-is without adjustment. | Formulation sheets, concentration, SPF labeling documents | Verify ingredients and concentrations permitted for use in Japan. |
| Coal Tar Dyes | Check whether the dyes used are permitted. | Dyes in overseas cosmetics may not be allowed for use in Japan. | Dye name, CI number, concentration, product application | Confirm whether the dyes can be used in Japan. |
| Raw Material Information | Check INCI names, Japanese labeling names, content amounts, specifications, and COA. | Difficulty obtaining ingredient lists or specifications from foreign manufacturers. | INCI list, Japanese labeling names documents, COA, specification sheets | Obtain necessary documents from the manufacturer before shipment. |
Ingredient verification requires more than just product names or overseas labels.
Importers need to confirm the full ingredient list, INCI names, concentration, specification sheets, COAs, manufacturer information, and Japanese labeling names.
Notes on Full Ingredient Labeling
When selling cosmetics in Japan, full ingredient labeling is generally required.
You cannot always use the labeling from overseas products as-is.
Japanese labeling must display ingredient names in Japanese and generally in order of decreasing concentration.
Additionally, specific labeling rules apply to ingredients less than 1%, colorants, fragrances, and carry-over ingredients.
Importers must confirm not only translations of overseas labels but also full ingredient lists compliant with Japanese rules, the name and address of the manufacturer or seller, usage cautions, lot numbers, net contents, and more.
Main Procedures for Import Sales
When importing cosmetics for commercial purposes and selling them domestically in Japan, it is necessary to check not only customs clearance but also the permits and notifications required under the Pharmaceutical and Medical Device Act (PMD Act).
When importing and selling overseas cosmetics, relevant permits and notifications may include cosmetic manufacturing and marketing authorization, manufacturing permits, per-item cosmetic marketing notifications, foreign manufacturing marketing notifications, and foreign manufacturing notifications.
In practice, the term "cosmetic import sales business license" may be used, but current practice requires checking the importer’s role in market distribution, whether manufacturing and marketing authorization and manufacturing permits are necessary, and the status of item notifications.
| Check Items | Main Content | Common Causes for Delays | Reference Documents | Practical Measures |
|---|---|---|---|---|
| Cosmetic Classification | Confirm if the product qualifies as a cosmetic, quasi-drug, or pharmaceutical product. | Relying solely on the fact that the product is labeled as cosmetics overseas. | Product description, ingredient list, efficacy claims, advertising materials | Check classification based on sales purpose and labeling in Japan. |
| Manufacturing and Marketing Authorization | Confirm whether authorization as a cosmetic manufacturer and marketer is required as the party responsible for market release. | Importer only acts as seller without a manufacturing and marketing structure. | Cosmetic manufacturing and marketing authorization certificate, outsourcing contracts, sales structure documents | Confirm who will be the marketing authorization holder before import. |
| Manufacturing Permit | Confirm permits for facilities performing domestic storage, packaging, labeling, and attaching labels. | No confirmation of manufacturing permit when labeling or storing in domestic warehouses. | Manufacturing permit certificate, warehouse information, work details | Determine whether logistics operations or manufacturing acts under PMD Act apply. |
| Manufacturing Notification | Check whether item-specific cosmetic manufacturing notifications are required. | Misunderstanding that permit alone allows sales. | Cosmetic manufacturing notifications, item information, planned sales lists | Confirm notification status per item. |
| Foreign Notifications | Verify notifications related to foreign manufacturers and foreign marketing authorization holders. | Not obtaining manufacturer information until immediately before customs clearance. | Foreign manufacturing marketing notification, foreign manufacturing notification, overseas manufacturer information | Obtain overseas manufacturer information early. |
| Ingredients and Labeling | Check cosmetic standards, full ingredient labeling, and Japanese language labeling. | Attempting to sell by applying overseas labels as-is. | Complete ingredient list, Japanese labeling draft, INCI names, Japanese labeling names | Prepare Japan-compliant labeling. |
System Application Flow
- Do not judge based on the product name alone; check the intended use, efficacy, ingredients, and sales method.
- Organize the possibilities whether it falls under cosmetics, quasi-drugs, pharmaceuticals, or miscellaneous goods.
- If it is sold as a cosmetic, confirm compliance with cosmetic standards.
- Check for prohibited ingredients, restricted ingredients, preservatives, UV absorbers, and tar dyes.
- Obtain the full ingredients list, INCI names, Japanese display names, formulation amounts, specification sheets, and COA.
- Confirm who will ship as the cosmetic manufacturer and marketing authorization holder.
- Confirm that the location for domestic storage, packaging, labeling, and affixing of labels holds a cosmetic manufacturing license.
- Confirm the cosmetic manufacturing and marketing notifications for each item, foreign marketing authorization holder notifications, and foreign manufacturer notifications.
- Check the Japanese labeling, full ingredient display, manufacturer/marketer name and address, lot number, net content, and usage precautions.
- Check efficacy and effect expressions on EC sites, SNS, landing pages (LP), brochures, and advertisements.
- Before customs clearance, confirm with the importer, customs broker, pharmaceutical affairs personnel, and experts as needed.
Import Procedures Flow
| Stage | Main Points to Confirm | Common Causes of Delays |
|---|---|---|
| Before Purchasing | Check product usage, efficacy, ingredients, countries of sale labeling, and advertisement expressions. | Assuming that because it is sold generally overseas, it can also be sold in Japan. |
| Before Import Arrangement | Confirm classification among cosmetics, quasi-drugs, pharmaceuticals; permits; notifications; and foreign notifications. | Proceeding with overseas shipment before confirming compliance with the Pharmaceutical and Medical Device Act. |
| At Customs Declaration | Organize product name, usage, ingredients, sales purpose, and importer’s permit/notification status. | When the invoice just states "cosmetics" without details. |
| Domestic Storage and Labeling | Check label affixing, full ingredient display, Japanese labeling, and need for manufacturing license. | Affixing labels in a warehouse without checking required permit category. |
| Before Sales Start | Confirm efficacy and effect expressions in EC sites, advertisements, SNS, and brochures. | Claims exceeding the scope of cosmetics’ permitted efficacy in advertisements. |
| After Sales | Check quality control, safety management, complaint handling, side effect information, and recall measures. | Not establishing quality and safety control systems after sales. |
Notes on Labeling and Advertising
In cosmetics, the scope of permitted efficacy and effect claims is limited.
Expressions claiming treatment, prevention, or improvement of diseases, or those strongly impacting bodily functions, may be problematic as drug-like efficacy claims.
For example, phrases like “removes spots,” “cures atopy,” “promotes hair growth,” “heals inflammation,” “treats acne,” “regenerates cells,” “fundamentally improves skin texture,” or “has medical-level effects” require caution.
Moreover, not only direct expressions but also testimonials, before-and-after photos, endorsements by doctors or experts, citations of research data, rankings, and reviews that collectively imply drug-like effects should be carefully checked.
Importers and sellers need to verify expressions not just on product labels, but also in advertisements, sales pages, SNS posts, brochures, video explanations, landing pages, and email marketing.
Difference Between Personal and Business Imports
In cosmetics, it is necessary to distinguish between imports for personal use and imports for commercial sale.
The regulations to be confirmed differ between individuals purchasing overseas cosmetics for personal use and imports intended for domestic sale, resale, distribution, or business use.
Cosmetics imported for personal use may not be sold domestically.
Imports for commercial sale require permits, notifications, ingredient checks, labeling checks, and advertisement checks under the Pharmaceutical and Medical Device Act.
Checkpoints for Freight Forwarders and Customs Practices
Freight forwarders and customs-related personnel should confirm the product details, intended use, ingredients, and sales purpose even when the cargo is described as "cosmetics," "skin care products," "makeup," "hair care," "sunscreen," or "beauty serum."
Freight forwarders are not in the position to make the final determination whether a product is subject to the Pharmaceutical and Medical Device Act or requires permits/notifications.
However, if based on the cargo name, product description, sales materials, or advertisements the cargo appears to require such confirmation, freight forwarders should encourage the importer to confirm and share information early with the customs broker.
When customs requests confirmation, freight forwarders collect from the importer the product catalog, full ingredients list, specification sheets, COA, intended use description, sales pages, and relevant permit/notification documents, and relay these to the customs broker.
Freight forwarders should avoid categorically stating "It’s a cosmetic, so there is no problem," or "It’s not a pharmaceutical."
Scope of Freight Forwarder Involvement
| Situation | What Support Can Be Provided | What Should Not Be Asserted | Practical Measures |
|---|---|---|---|
| When the cargo name includes cosmetics, etc. | You can encourage the importer to confirm product content, usage, ingredients, and sales purpose. | Do not assert that there is no problem as a cosmetic or that it is not a pharmaceutical product. | Share information promptly with the customs broker. |
| When ingredient documentation is insufficient | You can request the acquisition of a full ingredient list, INCI names, specifications, and COA. | Do not judge ingredient compliance with insufficient documents. | List the missing documents and request them from the importer. |
| When medicinal claims are present | You can inform that confirmation is needed whether it qualifies as quasi-drugs or pharmaceuticals. | Do not independently decide that it can be sold as a cosmetic. | Encourage confirmation with the importer's regulatory affairs staff. |
| When labels will be affixed at a domestic warehouse | You can advise that confirmation of the work content and manufacturing business permit is required. | Do not assert that permission is unnecessary just because it is a simple logistics task. | Confirm the scope of work with the importer, warehouse, and regulatory affairs staff. |
| When customs confirmation is requested | You can collect product documents, permits/notification documents, and usage explanations from the importer. | Do not independently respond that it is outside the scope of regulations. | Share the importer's explanatory and supporting documents with the customs broker. |
| When consulted about advertising expressions | You can indicate that advertising review is the responsibility of the importer's regulatory affairs, labeling, and legal departments. | You are not in a position to approve efficacy or effect expressions on sales pages. | Encourage expert review, and avoid mixing customs documents with advertising materials. |
Common Practical Issues
| Case | What Causes Issues | Documents to Check | Practical Measures |
|---|---|---|---|
| Directly importing and selling overseas cosmetics | Issues arise regarding ingredients not allowed in Japan, formulation restrictions, Japanese labeling, and notification requirements. | Full ingredient list, INCI names, specifications, COA, overseas labels | Conduct ingredient verification, label creation, and confirm permits and notifications. |
| Importing products claiming medicinal effects as cosmetics | They may qualify as quasi-drugs or pharmaceuticals. | Advertising texts, product descriptions, ingredients, active ingredients, overseas labeling | Limit labeling to cosmetics or verify status as quasi-drugs. |
| Labeling performed at a domestic warehouse | This may be considered an operation requiring a cosmetic manufacturing business permit. | Work procedures, warehouse permits, label drafts, outsourcing contracts | Confirm whether it constitutes storage, packaging, or labeling operations under the Pharmaceutical and Medical Device Act. |
| Advertising claims medicinal effects | This could exceed the permitted scope of cosmetic efficacy claims. | EC pages, SNS, landing pages, brochures, video ads | Revise advertising expressions before starting sales. |
| Reselling individually imported goods domestically | The distinction between self-use imports and imports for commercial purposes becomes an issue. | Quantities, sales destinations, EC listings, purchase history, delivery destinations | Confirm permits, notifications, and labeling for imports intended for commercial use. |
| Using overseas sunscreen formulations as-is | UV absorbers or concentration levels may not comply with Japanese standards. | Formulation sheets, concentration data, SPF documentation, ingredient standard documents | Confirm ingredients and concentrations allowed for use in Japan. |
| Unclear pigments in colored cosmetics | Use of tar dyes or colorants and their permissibility can be an issue. | Pigment names, CI numbers, concentrations, product usage | Confirm whether pigments are permitted for use in Japan. |
| Mistaken belief that manufacturing and sales permits alone allow sales | Notifications by item, foreign notifications, manufacturing permits, and labeling confirmation may remain incomplete. | Permits, manufacturing and sales notifications, foreign notifications, work location information | Separately verify permits, notifications, labeling, and storage/work operations. |
Required Documents
| Documents | Details to Confirm | Purpose in Practice |
|---|---|---|
| Product Catalog | Product overview, intended use, efficacy claims, labeling in the sales country | Used to verify classification of cosmetics, quasi-drugs, and pharmaceutical products. |
| Full Ingredient List | Formulated ingredients, INCI names, order of ingredients, composition | Used to verify cosmetic standards and full ingredient labeling. |
| INCI Name List / Japanese Labeling Name Reference | Correspondence between overseas ingredient names and Japanese labeling names | Used to prepare full ingredient lists for Japan. |
| Specifications / COA | Quality standards, analysis results, ingredient confirmation, raw material information | Used to verify ingredients and quality. |
| Manufacturer Information | Overseas manufacturer name, location, manufacturing site information | Used to verify foreign notifications and import procedures. |
| Overseas Label / Japanese Label Draft | Labeling details, usage precautions, content volume, lot number | Used to prepare labeling for domestic sales. |
| Advertising Copy / Sales Page Draft | Efficacy claims, testimonials, before-and-after, SNS expressions | Used to verify presence or absence of pharmaceutical efficacy claims. |
| Cosmetics Manufacturing and Marketing Authorization Documents | Person responsible for market shipment, license number, license expiration | Used to confirm who will act as the marketing authorization holder. |
| Cosmetics Manufacturing License Documents | Permission for domestic storage, packaging, labeling, and label attachment location | Used to verify legality of domestic operations. |
| Cosmetics Manufacturing and Marketing Notification / Foreign Notification Documents | Product notifications, foreign manufacturing and marketing business operator and foreign manufacturer information | Used to verify notification status required for import sales. |
4-Column Decision Checklist
| Confirmation Stage | Person to Confirm With | Details to Confirm | Actions if Problems Are Found |
|---|---|---|---|
| Before Procurement | Importer, Overseas Manufacturer | Product use, efficacy claims, full ingredients, labeling in sales countries | Confirm before shipment if there are any medicinal claims or unknown ingredients. |
| During Ingredient Verification | Importer, Regulatory Affairs Personnel, Overseas Manufacturer | Prohibited ingredients, restricted ingredients, preservatives, UV absorbers, colorants | Review import and sales plans if product does not comply with Japanese standards. |
| When Confirming Licenses / Notifications | Importer, Marketing Authorization Holder, Regulatory Affairs Personnel | Manufacturing and marketing authorization, manufacturing license, manufacturing and marketing notification, foreign notification | If not completed, verify status before import and sales. |
| At Customs Declaration | Customs Broker, Importer | Product name, use, ingredients, sales purpose, licensing and notification documents | Prepare to submit detailed documentation beyond just "cosmetics". |
| When Applying Domestic Labels | Importer, Warehouse, Manufacturer | Work location, work details, manufacturing license, Japanese labeling | Confirm that packaging and labeling are not performed at locations without the required permits. |
| When Creating Advertising | Importer, Advertising Staff, Regulatory & Legal Personnel | Disease names, treatment effects, pharmaceutical efficacy, regeneration, hair growth, before-and-after expressions | Revise to ensure expressions stay within allowable cosmetic efficacy claims. |
| When Confirming Personal Import | Importer, Consignee, Customs Broker | Use for self-consumption or for sales/resale/distribution, quantity, frequency | If for sales purposes, handle as commercial import. |
| After Sales Follow-up | Marketing Authorization Holder, Importer, Seller | Quality control, safety management, complaints, side effect information, recall response | Clarify responsibility system after product shipment to market. |
Practical Scenario 1: Case of Importing and Selling Overseas Cosmetics As-Is
There are cases where an importer procures a popular overseas skincare product and plans to sell it via e-commerce domestically in Japan.
While sold as general cosmetics overseas, the product may include ingredients that cannot be used in Japan or ingredients subject to upper concentration limits.
Furthermore, overseas labels are in English and do not comply with Japanese full ingredient labeling or manufacturing and marketing authorization holder labeling requirements.
In such cases, the importer needs to verify ingredients, conformity to cosmetic standards, full ingredient labeling, Japanese labels, and licenses/notifications before proceeding with import and sales.
Practical Scenario 2: Case Where Cosmetics Claiming Medicinal Effects Are Classified as Quasi-Drugs
There are cases where importers bring in overseas products such as "anti-acne cream," "whitening lotion," or "anti-dandruff shampoo."
Even if these are sold as cosmetics overseas, if they claim medicinal effects like "prevents acne," "whitens skin," or "prevents dandruff and itching" in Japan, they may require confirmation as quasi-drugs.
If the importer attempts to clear customs and sell as mere cosmetics, there may be issues related to advertising expressions and product classification.
In this case, it is necessary to decide whether to limit advertising to expressions allowed for cosmetics or to confirm approval and permits as quasi-drugs.
Practical Scenario 3: Case of Labeling at a Domestic Warehouse
An importer may import overseas cosmetics and apply Japanese labels at a domestic warehouse before shipment.
If storage, packaging, labeling, or label application of cosmetics is conducted domestically, a cosmetics manufacturing license for that location may be required.
If the importer checks only the manufacturing and marketing authorization but not the warehouse’s license category, problems may arise with domestic post-import operations.
Freight forwarders and warehouse operators need to confirm with importers whether these are simply logistics storage activities or operations subject to packaging, labeling, and storage under the Pharmaceuticals and Medical Devices Act.
Practical Scenario 4: Case Where Advertising Claims Pharmaceutical-Like Efficacy
When importers sell overseas cosmetics in Japan, there are cases where they directly translate the product pages from overseas and post them on their e-commerce sites.
If the overseas pages include expressions such as "removes spots," "heals inflammation," "regenerates cells," or "promotes hair growth," these claims may cause problems under Japanese cosmetics advertising regulations.
Even if the goods can be imported as cosmetics from a customs clearance perspective, the advertising expressions used during domestic sales may violate the Pharmaceutical and Medical Device Act (PMD Act).
Importers need to review Japanese advertising text, product descriptions, social media posts, landing pages (LP), and brochures before importation.
Practical Scenario 5: Cases where personal imports are redirected for domestic sales
There are cases where individuals purchase cosmetics from overseas e-commerce sites and then attempt to sell them within Japan.
Self-use personal imports and commercial import sales are handled differently.
If selling domestically, permissions such as the cosmetics manufacturing and marketing authorization, manufacturing authorization, notifications, ingredient checks, full ingredient labeling, and advertising compliance are required.
Reselling products obtained as personal imports without modification may cause issues under the PMD Act.
Impact When Customs Clearance or Sales Are Stopped
If cosmetics imports are subject to checks, delays in customs clearance, storage charges, delivery postponements, sales launch delays, label correction costs, advertising correction costs, and ingredient verification fees may be incurred.
If the required licenses, notifications, ingredient documentation, full ingredient labeling, and Japanese labeling cannot be confirmed, domestic sales may be prohibited even after customs clearance.
Also, if sales pages or advertising expressions violate the PMD Act, the products may be flagged during domestic sales or advertising phases even if customs clearance succeeded.
Importers need to verify not only customs clearance but also post-import storage, labeling, advertising, sales destinations, quality control, and safety management in advance.
Common Misconceptions
| Misconception | Correct Understanding | Practical Points |
|---|---|---|
| If it’s cosmetics overseas, it can be sold as cosmetics in Japan too | Overseas classification and Japanese PMD Act classifications differ. | Check ingredients, labeling, efficacy claims, and required permits/notifications for Japan. |
| Cosmetics are not pharmaceuticals, so they are not regulated by the PMD Act | Cosmetics are regulated under the PMD Act. | Verify manufacturing and marketing authorizations, notifications, labeling, and advertising. |
| If you have a manufacturing and marketing authorization, product notifications are unnecessary | Authorizations and product-specific notifications are separate requirements. | Confirm notification status for each product planned for sale. |
| Labeling at a domestic warehouse is just a logistics task | If it involves packaging, labeling, or storage, cosmetics manufacturing authorization may be required. | Confirm the work location and content ahead of time. |
| Translating overseas labels is sufficient for Japanese labeling | Must comply with Japan’s full ingredient labeling, manufacturer labeling, and usage precautions. | Cross-check INCI names with Japanese listed ingredient names. |
| Simply avoiding the use of the word “medicinal” means no problems | Even without the word “medicinal,” product efficacy claims may lead to classification as quasi-drugs or pharmaceuticals. | Assess the overall impression of advertising. |
| Clearance means you’re free to sell domestically | Customs clearance and domestic sale/advertising approvals are separate matters. | Check labeling, advertising, notifications, and quality control before sales launch. |
| If the forwarder states the goods are cosmetics, there's no issue | Forwarders do not have final authority under the PMD Act. | Collect documents from the importer and confirm with customs brokers and regulatory specialists. |
Practical Points
Cosmetics are relatively common products in import operations but are regulated under the PMD Act.
Even if sold as general products overseas, importers must confirm ingredients, intended use, labeling, advertising, and the presence of required authorizations or notifications before importing and selling in Japan.
Particularly with overseas cosmetics, ingredients not permitted in Japan, restricted ingredient concentrations, preservatives, UV absorbers, dyes, full ingredient labeling, and medicinal effect claims tend to cause issues.
Although forwarders are not PMD Act decision-makers, if cargo descriptions include cosmetics, skin care, beauty serum, sunscreen, etc., they should confirm with the importer and share information with the customs broker.
Summary
Cosmetics are regulated products under the PMD Act, used to clean, beautify, enhance attractiveness, alter appearance, and maintain the health of skin and hair.
Even cosmetics commonly sold overseas must be classified correctly in Japan as cosmetics, quasi-drugs, or pharmaceuticals before import and sale.
Importers must check cosmetics standards, prohibited and restricted ingredients, preservatives, UV absorbers, full ingredient disclosure, manufacturing and marketing authorizations, product notifications, foreign notifications, labeling, and advertising expressions.
Forwarders are not regulatory decision-makers but must encourage importers to verify doubtful cargo and coordinate with customs brokers.
Cosmetics regulations directly affect customs clearance and sales eligibility regarding ingredient restrictions, full ingredient labeling, authorizations, notifications, advertising claims, and domestic storage and labeling operations. Confirming regulatory compliance and preparing Japan-specific labeling before import is the most critical preventive measure.
