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Handbook for Consumer ProductsImport Regulations 2010

October 2010

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Copyright 2010 JETRO. All rights reserved.

Contents

FASHION ............................................................................................................................................... 2LEATHER FOOTWEAR ......................................................................................................................... 2EYEWEAR........................................................................................................................................... 3BAGS.................................................................................................................................................. 4

INTERIOR AND HOUSEHOLD GOODS ................................................................................................ 5CARPETS ............................................................................................................................................ 5TABLEWARE ....................................................................................................................................... 6GAS LIGHTERS................................................................................................................................... 7TOYS .................................................................................................................................................. 8

VEHICLES, ETC. ................................................................................................................................. 10BICYCLES......................................................................................................................................... 10MOTORCYCLES................................................................................................................................. 12HELMETS ......................................................................................................................................... 14PASSENGER VEHICLES..................................................................................................................... 16YACHTS AND MOTORBOATS .............................................................................................................. 18

HEALTH AND BEAUTY ....................................................................................................................... 20COSMETICS ...................................................................................................................................... 20AROMA PRODUCTS........................................................................................................................... 23HARBAL AND NATURAL MEDICINES................................................................................................. 25

HOBBIES ............................................................................................................................................. 28MUSICAL INSTRUMENTS.................................................................................................................. 28MOUNTAINEERING EQUIPMENT ...................................................................................................... 30VIDEO SOFTWARE ............................................................................................................................ 31

OTHER ................................................................................................................................................ 33WHEELCHAIRS................................................................................................................................. 33CRIBS............................................................................................................................................... 35

OUTLINE OF RELEVANT LAWS ......................................................................................................... 37ACT AGAINST UNJUSTIFIABLE PREMIUMS AND MISLEADING REPRESENTATIONS ........................... 37ACT ON THE PROMOTION OF SORTED COLLECTION AND RECYCLING OF CONTAINERS AND PACKAGING/ACT ON THE PROMOTION OF EFFECTIVE UTILIZATION OF RESOURCES........................................................ 39INDUSTRIAL STANDARDIZATION ACT (JISMARK LABELING SYSTEM)............................................. 41HOUSEHOLD GOODS QUALITY LABELING ACT ................................................................................ 43ACT ON CONTROL OF HOUSEHOLD PRODUCTS CONTAINING HARMFUL SUBSTANCES .................... 45ELECTRICAL APPLIANCES AND MATERIAL SAFETY ACT................................................................... 47CONSUMER PRODUCT SAFETY ACT.................................................................................................. 49

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Fashion

Leather FootwearLeather footwear (HS 6403 - 6405) is subject to the Tariff Quota (TQ) System.

1. Customs Tariff Law (Tariff Quota)Under the Ministerial Ordinance on the Tariff Quota (TQ) System, a lower tariff rate (primary rate) is

assessed on quantities of imports within the limits of the annual tariff quota and a higher tariff rate(secondary rate) is assessed on imports in excess of that quota.

Methods of applying for a tariff quota certificate are announced by the Ministry of Economy, Trade andIndustry (METI) and the Regional Bureau of Economy, Trade and Industry.

2. Import Trade Control Order (CITES)Products made from wild flora and fauna regulated under the Convention on International Trade in

Endangered Species of Wild Fauna and Flora (CITES, Washington Convention) require certificationsuch as an export certificate or a certificate of origin issued by an agency of the government of theexporting country and an import authorization issued by the Minister of Economy, Trade and Industryshowing that importation of the product is not prohibited, based on the categories of the appendices tothe Convention. Since it is difficult to judge from general names whether an animal is subject to theConvention or has been raised as livestock, it is instructed that formal scientific names be shown on theinvoices for leather products.

For products subject to Appendix I, there is a need to confirm whether the import is for purposes ofacademic research or is of products from plants or animals bred for commercial or non-commercialtrading purposes, and whether it is an import of products acquired prior to application of the Convention,and to obtain import authorization. For products subject to Appendices II and III, if made from flora,fauna, etc. produced in countries or regions subject to strict restriction of international trading (such asprohibition of exports), there is a need to attach a copy of the export permit issued by regulators in theexporting country and to obtain prior confirmation by the MITI. If the product is not subject to priorconfirmation, for products subject to Appendix II submit to customs during customs clearance theoriginal export permit issued by regulators in the exporting country, and for products subject to AppendixIII submit the original re-export certificate or certificate of origin issued by regulators in the exportingcountry.

Also use care concerning articles infringing on intellectual property rights (import of articles such ascounterfeit brand-name goods infringing on trademark rights, design rights, etc.), products withfraudulent or mistaken labeling of origin (import of which is prohibited under the Customs Law and saleof which is prohibited under the Act against Unjustifiable Premiums and Misleading Representations).

Outline of Import Control (Ministry of Economy, Trade and Industry)http://www.meti.go.jp/english/information/data/outline.htmlCITES; Convention on International Trade in Endangered Species of Wild Fauna and Florahttp://www.cites.org/

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Eyewear:Spectacle lenses of materials other than glass (9001.50), Frames and mountings for spectacles of

plastics (9003.11), Sunglasses (9004.10), Spectacles, goggles and the like, corrective, protective or other,other than sunglasses (9004.90).

Particular care is required concerning corrective spectacles and contact lenses, since these qualify asmedical devices under the Pharmaceutical Affairs Law.

1. Pharmaceutical Affairs LawSince corrective spectacle frames and corrective lenses qualify as general medical devices (class I),

a type-3 medical devices manufacturing and marketing business license is required. While there is noneed for approval on a per-article basis, a notice of manufacture and sale must be submitted to thePharmaceuticals and Medical Devices Agency.

Incidentally, since contact lenses (including fashion color contacts) qualify as specially controlled

medical devices (class III), a type-1 medical devices manufacturing and marketing business license andthe approval of the Minister of Health, Labour and Welfare are required for import.

2. Household Goods Quality Labeling ActWhen selling subject products to ordinary consumers in Japan, labeling pursuant to the Household

Goods Quality Labeling Act is required. Labeling must be affixed by the party with responsibility for thecontent of the labeling (e.g., importers or the seller in Japan) and the labeling must be clearly visible toand easily understandable by consumers and in the Japanese language.

Sunglasses (exclude that with corrective lenses) are required with the information of labeling requiredunder theMiscellaneous Manufactured Goods Quality Labeling Regulations (i.e., product name, lensmaterial, frame materials, visible ray transmission, ultraviolet ray transmission, handling precautions).

3. Other relevant laws

(1) Act against Unjustifiable Premiums and Misleading RepresentationsThe Eyeglass Industry Fair-Trade Council has established Fair competition code regarding labeling

of eyeglasses as autonomous industry regulations under this Act.

(2) Customs Law (articles infringing on intellectual property rights)Import of articles infringing on intellectual property rights (i.e., goods infringing on trademark rights,

copyright, neighboring rights, patent rights, utility model rights, or design rights) including counterfeitbrand-name goods is prohibited. Import will be suspended even if the importer is not aware that thegoods are counterfeit.

(3) CITES: Import Trade Control Order (such as tortoiseshell frame materials)

Customs confirmation requirement concerning import restrictions in accordance with the PharmaceuticalAffairs Law (Japan Customs)http://www.customs.go.jp/english/c-answer_e/imtsukan/1805_e.htmPharmaceuticals and Medical Devices Agency, Japan (PMDA)http://www.pmda.go.jp/english/index.htmlConsumer Affairs Agencyhttp://www.caa.go.jp/en/index.htmlImporting or Bringing Medication into Japan for Personal Use (Ministry of Health, Labour and Welfare)http://www.mhlw.go.jp/english/topics/import/index.html

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BagsWhile bags are classified under HS 4202, tariff rates vary according to materials and other factors.In particular, bags made of certain types of leather may be subject to regulation under the Washington

Convention (CITES).

1. Import Trade Control Order (CITES)While in principle importation of plant and animal species and genera subject to the Washington

Convention, and of their parts and of products made from them (including bags) is prohibited, or somesubjects are items to need to approval or prior confirmation by the MITI, and/or to confirmationapplications or confirmation during customs clearance.

In such case, the importer being required such as an import license or confirmation issued by theMITI, an export permit, certificate of origin, re-export certificate, or processing certificate issued byregulators in the exporting country, and customs clearance is available only at certain air and sea ports.

2. Other relevant laws

(1) Customs Law (articles infringing on intellectual property rights)Import of articles infringing on intellectual property rights (i.e., goods infringing on trademark rights,copyright, neighboring rights, patent rights, utility model rights, or design rights) including counterfeitbrand-name goods is prohibited. Import will be suspended even if the importer is not aware that thegoods are counterfeit.

(2) Household Goods Quality Labeling ActBags using cowhide, horsehide, pigskin, sheepskin, or goatskin require labeling showing the type of

leather, care and storing method, and name and address or telephone number of the party responsiblefor labeling, under the Miscellaneous Manufactured Goods Quality Labeling Regulations.

(3) Act against Unjustifiable Premiums and Misleading RepresentationsImport and sale of products with fraudulent or mistaken labeling of origin is prohibited, as is sale with

excessive premiums. For golf caddy bags, Fair competition code for sporting goods labeling havebeen established as autonomous industry regulations under this Act.

CITES; Convention on International Trade in Endangered Species of Wild Fauna and Florahttp://www.cites.org/IPR Protection (Japan Customs)http://www.customs.go.jp/mizugiwa/chiteki/ipr_p.pdfConsumer Affairs Agencyhttp://www.caa.go.jp/en/index.html

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Interior and Household Goods

CarpetsTextile floor coverings such as carpets are grouped into the classification HS57, according to factors suchas type of fibers used.When fabrics or raw materials are exported from Japan and then imported in the form of textile productsprocessed overseas within one year from the authorized export date, the Duty Reduction for Re-importsystem can be used to reduce import tariffs by the amount corresponding to customs tariffs on theexported raw materials, through the procedures of submitting an Application for Duty Reduction forRe-import to Customs upon export for confirmation.

1. Household Goods Quality Labeling ActFloor coverings for household use (limited to those with piles) require labeling showing the

composition of fibers, name and address or telephone number of the party responsible for labeling, andother information under the Textile Goods Quality Labeling Regulations.

2. Act on Control of Household Products Containing Harmful SubstancesSale of articles not confirming the standard values established for designated chemical substances

that could be harmful to human health among chemical substances used in textiles, such as insectrepellents, is prohibited.

3. Fire Service ActFloor coverings used in facilities such as theaters and hotels must be flame retardant in satisfaction

of flame-retardance standards. Articles conforming to these standards must have flame-retardancelabels, and those without such labels may not be sold as flame-retardant articles.

4. Secondhand Articles Dealer ActIn some cases, handling of carpets qualifying as antiques may require a secondhand dealer's permit.

Outline of the duty reduction system for re-importing processed goods (Japan Customs)http://www.customs.go.jp/english/c-answer_e/imtsukan/1605_e.htmConsumer Affairs Agencyhttp://www.caa.go.jp/en/index.html

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Tableware:Tableware and kitchenware of plastics (3924.10), Tableware and kitchenware of wood (4419.00), Trays,

dishes, plates, cups and the like, of paper or paperboard (4823.69), Tableware and kitchenware, ofporcelain or china (6911.10), Ceramic tableware, kitchenware, other household articles and toilet articles,other than of porcelain or china (6912.00), Table or other household articles & parts thereof, of iron orsteel (7323), Other table, kitchen or household articles and parts thereof, of copper (7418.19), Table,kitchen or other household articles and parts thereof, of aluminum (7615.19). Other customsclassifications include articles of goldsmiths, or silversmiths, wares and parts thereof, of precious metal orof metal clad with precious metal (7114), Table knives having fixed blades (8211.91), and spoons andforks (8215).

1. Food Sanitation ActWhen importing these products for purposes of sale or business use, Notice must be submitted to the

imported food inspector of the Quarantine Station of the Ministry of Health, Labour and Welfare for the

air and sea ports where the cargo clears customs by submitting the Notification Form for Importation ofFoods, etc with the relevant documents attached. Import is permitted for articles judged to satisfy thislaw after examination and inspection.

Since under this act tableware is considered an apparatus whose standards are establishedconcerning materials and other matters, there is a need to check conformity with these standards inadvance. This applies to disposable tableware of materials such as paper and plastic as well.

While sanitary inspection by the Quarantine Station may be omitted if the importer submitsdocuments such as results of inspection by an inspection agency designated by the Minister of Health,Labour and Welfare or an official inspection agency of the exporting country, it must be noted thatsample inspection certification system, used in past custom procedures, has been abolished - in thissystem, the results of inspection of articles that were imported as samples before the actual import (forpurposes of sale or business) could have been submitted as that of articles actually imported.

This abolishment is due to the difficulty of confirming identification of beforehand-imported samples

and articles actually imported. Thus now it is required to undergo the inspection of the actually importedarticles themselves.

2. Household Goods Quality Labeling ActPlastic tableware qualifies as Tableware and kitchen utensils under the Plastic Manufactured

Goods Quality Labeling Regulations, and as such it requires labeling of material plastic, heat resistanttemperature, and other matters. Similarly, Glass products (Tempered glass, Borosilicate glass, orGlass-ceramics) and Tableware coated with lacquer or cashew resin coating also are subject to labelingrequirements under the Miscellaneous Manufactured Goods Quality Labeling Regulations (productname, type of suface painting, base material handring precautions, etc.).

Other relevant regulations that must be noted include the Act against Unjustifiable Premiums and

Misleading Representations (Prohibiting acts such as exaggerated or fraudulent labeling that couldmislead consumers), those concerning intellectual property rights (Prohibiting import of infringing productssuch as counterfeit brands), and, for disposable tableware, the Act on the Promotion of Sorted Collectionand Recycling of Containers and Packaging and the Act on the Promotion of Effective Utilization ofResources.

Customs confirmation requirements concerning import restrictions in accordance with the FoodSanitation Law (Japan Customs)http://www.customs.go.jp/english/c-answer_e/imtsukan/1802_e.htmFood Safety (Ministry of Health, Labour and Welfare)http://www.mhlw.go.jp/english/topics/foodsafety/index.html

The Food Safety Commissionhttp://www.fsc.go.jp/english/index.html

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Gas LightersImport of lighters (HS 9613) requires procedures for exemption from application of the High Pressure GasSafety Act.

1. High Pressure Gas Safety ActIn import customs clearance for aerosol products exempted from this act (e.g., spray cans, lighters,

gas cartridges for portable cooker, etc.), however, a Japanese or foreign inspecting agency, or the gaslighter manufacturer who filled the product with liquefied gas, or the importer must preparedocumentation of the test results and it must be confirmed that the products satisfy the requirementsestablished in notification by the Minister of Economy, Trade and Industry. If no such documentation issubmitted or the results for any item are "fail," an inspection by the competent prefectural governor (tosubmit the import inspection application) is required.

2. Customs Law (articles infringing on intellectual property rights), etc.Import of articles infringing on intellectual property rights such as counterfeit character merchandise

and unauthorized use of misleading names (e.g., goods infringing on trademark rights, copyright,neighboring rights, patent rights, utility model rights, or design rights) is prohibited. Under the UnfairCompetition Prevention Act and other laws, import will be suspended even if the importer is not awarethat the goods are in violation of the law.

Also, under the Act against Unjustifiable Premiums and Misleading Representations acts such assale with excessive premiums and exaggerated or fraudulent labeling that could mislead consumers areprohibited.

3. Consumer Product Safety ActIn case of any serious product accident, importers of consumer products are required to submit a

report to the Prime Minister on the name and model of the product, the details of the accident, and thequantity of relevant products imported and sold, within 10 days from the day business operatorsincluding importers came to know the fact of the accident (Article 35). All importers of consumer

products in Japan, regardless of their size or type of business, are required to submit this report onaccidents.

There have been reports of incidents such as lighters suddenly bursting into flame while placed onvehicle dashboards, fire damage from large fires ignited by lighters, etc.

The SG mark authorized by the Consumer Product Safety Association is a voluntary certificationawarded to products recognized to satisfy the required standards for safe products established underthe SG mark system. SG mark applies to pocket gas lighters.

4. Product Liability Act, Industrial Standards, etc.Care also must be given to compliance with the Product Liability Act and other regulations.The Japan Smoking Articles Corporate Association has established consumer safety standards for

injection gas lighters manufactured and sold by its members (including licensed brands). It issues a

"passed" seal, like the SG mark, as a product-liability guarantee to products that have satisfied its safetystandards in inspection conducted by official inspection agencies.

In addition, care must be given to the fact that in some cases lighters are subject to the Fire ServiceAct, fire regulations, and other restrictions depending on the volume handled and their type.

IPR Protection (Japan Customs)http://www.customs.go.jp/mizugiwa/chiteki/ipr_p.pdfConsumer Product Safety Association (CPSA)http://www.sg-mark.org/english/english20100810.pdf

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ToysWhile in general toys are grouped in the classification HS95, in recent years matters such as functionsand performance of toys have grown more varied and diverse, so that it is conceivable that relevant laws

and regulations could vary by product. Only the main laws and regulations are provided below. Particularcare is required concerning toys for use by infants.

1. Food Sanitaton ActStandards and testing methods are established under this act for toys specified by the Minister of

Health, Labour and Welfare (Article 78 of the Ordinance for Enforcement of the Act). Specifically, theseinclude (i) toys which are or might be used by infants principally by putting them in their mouths (ex.Pacifier, harmonica), (ii) accessory toys (include rings, necklaces, pendants and brooches), transferpictures, okiagari(daruma doll made so as to right itself when knocked over), masks, origami, rattles,educational toys, building blocks, toy phones, toy animals, dolls, clay, toy vehicles, balloons, blocks,balls, toys for playing house, and (iii) toys which are played with in combination with those toys listed in(ii) above. Toys not meeting these standards and testing methods may not be imported. Notice must be

submitted to the imported food inspector of the Quarantine Station of the Ministry of Health, Labour andWelfare for the air and sea ports where the cargo clears customs by submitting a form of the ImportNotification of Food with the relevant documents attached. Import is permitted for articles judged tosatisfy this act after examination and inspection.

2. Electrical Appliance and Material Safety LawSince many toys include electric parts, caution is required concerning whether toys are subject to this

law (ex.: Toy circuit board, other toys with electronic applications).All persons engaged manufacturing or importing electrical appliances in Japan shall notify the

Ministry of Economy, Trade and Industry (Regional Bureau of Economy, Trade and Industry) of theirbusiness commencement within 30 days from the date of starting business (hereinafter referred to as aNotifying Supplier). The Notifying Suppliers have the obligation to secure the conformity of electricappliances and materials they import and sell to the mandatory technical standards.

The enforcement regulations to this law groups subject products into the categories of SpecifiedElectrical Appliances and Materials (115 items / Category A) and Other Electrical Appliances andMaterials (339 items / Category B). Category A products must pass the third-party conformityassesment by an inspection agency registered with national government and receive a certificate ofconformity. Self-confirmation of conformity is required for Categories A and B (all regulated ElectricalAppliances and Materials) whose methods are designated by the government. Also this self-inspectionmay be subcontracted to a registered inspection bodies. The Notifying Supplier may sell the productsonly after they satisfy these standards, have been subjected to inspection and other tasks, and havebeen labeled with the marking required such as the PSE mark, the company name, rated current, etc.

The Notifying Supplier also is required to report any serious accidents after sale of the products.Many toys include Category A (such as transformers, electrically heater, electric vehicles, etc. for toy)

as well as many Category B (such as internal components, lithium-ion batteries, etc.), and in either case

advance preparations are needed.


report to the Prime Minister on the name and model of the product, the details of the accident, and thequantity of relevant products imported and sold, within 10 days from the day business operatorsincluding importers came to know the fact of the accident (Article 35). All importers of consumerproducts in Japan, regardless of their size or type of business, are required to submit this report onaccidents.

The SG mark authorized by the Consumer Product Safety Association is a voluntary certificationawarded to products recognized to satysfy the required standards for safe products established underthe SG mark system. Among products for infants, this mark applies to tricycles, foot-operated toy cars,

swings, slides, and horizontal bars.

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4. Industrial Regulation (ST Mark)The ST Mark authorized by the Japan Toy Association is a voluntary certification awarded to toys

recognized to satysfy the Toy Safety Standards (ST Standards). In case such as injury to a consumerdue to a defect in a product with the ST Mark, compensations are paid up to a certain amount, and at thesame time the seller is required to recall the product.

As part of efforts to strengthen safety measures for imported toys, which have been a topic ofparticular concern recently, the term of validity of the ST Mark has been shortened to two years andefforts such as shifting to new standards (ST2007) are underway.

The Japan Toy Association also certifies the guide dog mark and Rabbit Mark, which signify"Universal-use toys" that give consideration to their use at ease in play with children visually or hearingimpaired.

5. Other relevant laws(1) Customs Law

Import of articles infringing on intellectual property rights (i.e., goods infringing on trademark rights,copyright, neighboring rights, patent rights, utility model rights, or design rights) including counterfeitbrand-name goods is prohibited. Import will be suspended even if the importer is not aware that the

goods are counterfeit. While parallel importing is not prohibited, in some cases the original rights holdersapply to Customs for suspension of importing.

(2) Act against Unjustifiable Premiums and Misleading RepresentationsActs such as exaggerated or fraudulent labeling that could mislead consumers are prohibited, as is

sale with excessive premiums. In addition, depending on the character and function of toys (such aselectric products, cameras, musical instruments, and sporting goods), it should be preferable to refer tolabeling suited to the fair competition code established by individual industry groups based on this act.

(3) Household Goods Quality Labeling Act (for products which may be subject to the TextileGoods Quality Labeling Regulations)

Other laws and regulations that must be noted include those related to the Radio Act(Radio-controlled toys) and those related to recycling (such as compact secondary batteries, which maybe subject to the Act on the Promotion of Effective Utilization of Resources).

Food Safety Information (Ministry of Health, Labour and Welfare)http://www.mhlw.go.jp/english/topics/foodsafety/index.htmlElectrical Appliance and Material Safety Law (Ministry of Economy, Trade and Industry)http://www.meti.go.jp/english/policy/economy/consumer/pse/index.htmlJapanese Industrial Standards Committee (JISC)http://www.jisc.go.jp/eng/index.htmlConsumer Affairs Agency

http://www.caa.go.jp/en/index.htmlConsumer Product Safety Association (CPSA)http://www.sg-mark.org/english/english20100810.pdfThe Japan Toy Associationhttp://www.toys.or.jp/IPR Protection (Japan Customs)http://www.customs.go.jp/mizugiwa/chiteki/ipr_p.pdf
http://www.jisc.go.jp/eng/index.htmlhttp://www.jisc.go.jp/eng/index.html

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Vehicles, etc.

Bicycles

While the customs classification for bicycles is HS 8712.00 (8711.90 for bicycles fitted with auxiliarymotors), the parts and accessory classification (8714) checking details with the customs counselorsoffices is recommended.

Due to the nature of the product, in cases such as accidents resulting from defects in bicycles importersmay be held liable for compensations.

1. Road Traffic Act (TS mark)Standards are established for ordinary bicycles, bicycles fitted with auxiliary electric motors, and

businesses assembling, or selling them may label the traffic safety (TS) mark certifying compliance withstandards on products covered by voluntary insurance after the products have received type certificationfrom the National Public Safety Commission. Type certification inspection is conducted by the JapanTraffic Management Technology Association.

2. Industry standard (BAA mark) / Industrial Standardization Act (JIS standards)Bicycles certified through types testing under the bicycle safety standards of the Bicycle Association

(Japan) may label the Bicycle Association (Japan) Approved (BAA) mark. However, product-liability (PL)insurance is required. Type testing is conducted by the Japan Vehicle Inspection Association and theJapan Bicycle Technical Center.

Also, since October 2008 new standards established for the purpose of reducing use of sixsubstances with high levels of environmental impact (such as lead, mercury, and cadmium) have appliedin principle to all bicycle parts.

JIS standards also include a variety of standards concerning bicycles, bicycle parts, and other related

products. These include JISD9301 (bicycles for general use) and JISD9302 (bicycles for youngchildren).


report to the Prime Minister on the name and model of the product, the details of the accident, and thequantity of relevant products imported and sold, within 10 days from the day business operatorsincluding importers came to know the fact of the accident (Article 35). All importers of consumerproducts in Japan, regardless of their size or type of business, are required to submit this report onaccidents. Compliance with the Product Liability (PL Law) also is required separately.

The SG mark authorized by the Consumer Product Safety Association is a voluntary certificationawarded to products recognized to meet the required standards for safe products established under the

SG mark system. In case of an accident due to a defect in a product with the SG mark, liability insuranceis provided up to a certain amount.

The following bicycle products and related accessories are eligible for the SG mark: Bicycles Helmets for bicycles, electric powered wheelchairs, and moving playground equipment Bicycle seats for children Bicycle air pumps

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4. Other relevant laws(1) Industrial Safety and Health Act / Foreign Exchange and Foreign Trade Act

Bicycles and parts containing asbestos may not be imported. Specifically, for safety's sake, care isrequired concerning abrasive materials used in bicycle clutches or brakes (i.e., clutch facings, clutchlinings, brake pads, and brake linings).

Since an announcement concerning imports under the Foreign Exchange and Foreign Trade Actfollowing enactment of the Industrial Safety and Health Act (October 2004), certification that nocomponents including asbestos are used is required.

(2) Act on the Promotion of Effective Utilization of Resources (Bicycles fitted with auxiliarymotors)Under this act, bicycles fitted with auxiliary motors are considered Specified Reuse-Promoted

Products (products for which efforts to promote the utilization of recyclable resources or reusable partsare required) and Specified Resources-Recycled Products (products using sealed batteries ascomponents). As such, importers and sellers of these products in certain quantities (1,000 units or more)are required to carry out "three-R" (reduce, reuse, recycle) efforts.

(3) Customs Law (articles infringing on intellectual property rights), etc.Import of articles infringing on intellectual property rights such as counterfeit character merchandise

and use of misleading or unauthorized names (e.g., goods infringing on trademark rights, copyright,neighboring rights, patent rights, utility model rights, or design rights) is prohibited. Under the UnfairCompetition Prevention Act and other laws, import will be suspended even if the importer is not awarethat the goods are in violation of the law.

Care is also required concerning matters such as compliance with recycling and industrial-wastedisposal regulations under local ordinances, etc.

Japan Traffic Management Technology Associationhttp://204.227.185.48/en/index2.htmlJapanese Industrial Standards Committee (JISC)http://www.jisc.go.jp/eng/index.htmlConsumer Affairs Agencyhttp://www.caa.go.jp/en/index.htmlConsumer Product Safety Association (CPSA)http://www.sg-mark.org/english/english20100810.pdf3R Policies (Ministry of Economy, Trade and Industry)http://www.meti.go.jp/policy/recycle/main/english/index.htmlIPR Protection (Japan Customs)http://www.customs.go.jp/mizugiwa/chiteki/ipr_p.pdf

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MotorcyclesCustoms classifications for motorcycles and sidecars (HS8711) are subdivided according to enginedisplacement.

:Mopeds with engine displacement of 50 cc or less (8711.10), motor scooters with engine displacement of50 - 250 cc (8711.20), and large motorcycles with engine displacement of more than 800 cc (8711.50)

In addition to the above customs classifications, motorcycles also are categorized based on the RoadTransport Vehicle Act (which categorizes two-wheeled vehicles with engine displacement of 125 cc orless as motorized bicycles and permits only light two-wheeled vehicles with engine displacement of morethan 125 cc and small two-wheeled motor vehicles to drive on expressways) and the Road Traffic Act(which categorizes those with engine displacement of 50 - 400 cc as standard motorcycles and those withengine displacement of 401 cc or more as large motorcycles).

Due to the wide range of laws and regulations, concerning import and sale, this section focuses on the

Road Transport Vehicle Act.

1. Road Transport Vehicle ActStandards are categorized as shown below, based on total engine displacement and vehicle size.

Inspection, submittal of notification, and other procedures are required.

(1) For motorcycles with total engine displacement of 126 250 cc, and up to 2.5m in length, 1.3m inwidth, and 2m in height, submittal of notification to the District Transport Bureau of the Ministry ofLand, Infrastructure, Transport and Tourism and the prefectural land transportation bureau is required,subject to the condition that the vehicle satisfy the safety standards for a Light two-wheeled motorvehicle. Type certification is sufficient for confirmation of safety standards, and official vehicleinspection is not needed.

(2) For motorcycles with total engine displacement of 251 cc or more and larger than those describedunder paragraph (1) above, submittal of notification to the District Transport Bureau of the Ministry ofLand, Infrastructure, Transport and Tourism is required, subject to the condition that the vehiclesatisfy the safety standards for a Small two-wheeled motor vehicle. Type certification is required forconfirmation of safety standards, and official vehicle inspection is required as well.

(3) Motorcycles with total engine displacement of 125 cc or less and smaller than those described underparagraph (1) above are categorized as Motorized bicycles and further subcategorized into type I(50 cc or less) and type II (51 - 125 cc), although the regulations applying to both subcategories areidentical. Submittal of notification to the municipal government is required, subject to the conditionthat the vehicle satisfies safety standards. Type certification is sufficient for confirmation of safetystandards, and official vehicle inspection is not needed.

There are three types of certification systems for imported vehicles in Japan: a. Formal designationsystem, b. New-vehicle notification system, and c. System for small quantities treatment. Each issummarized below.

a. Formal designation system:Vehicle inspection is conducted by submitting a sample vehicle and documents in advance, and the

system for ensuring uniformity among the vehicles is inspected as well. For two-wheeled motor vehiclesthat have undergone formal designation, during new inspection presenting an actual vehicle can beomitted. The formal designation system is used for imported vehicles planned for mass sale in Japan.

b. New-vehicle notification system:

Vehicle inspection is conducted by presenting a sample vehicle in advance. New inspection isconducted by merely confirming that the actual vehicle is the same as the sample vehicle, withsystematic inspection of product uniformity omitted. This system is used to trucks and buses, which

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have large numbers of specifications and vehicle types, also for small two-wheeled motor vehicles insome cases.

c. System for small quantities treatmentThis system is applied only to imported vehicles planned for sale in small quantities in Japan (up to

2,000 units per year), presenting a sample vehicle is omitted and the documents submitted are

simplified as well.

However, in inspection at the Transport Branch Office of the District Transport Bureau or the Office ofmotor-vehicle inspection and registration, while under the system described under paragraph (a) abovethere is no need to present the actual vehicle if an inspection certificate issued by the manufacturer orother party is available, under the systems described under paragraphs (b) and (c) above a license platewill not be issued until the actual vehicle has been checked to confirm that it matches the advancecertification.

Furthermore, the above motor-vehicle certification systems do not apply to private importing,reimportation, or parallel importing. In these cases, conformity with safety standards needs to beconfirmed through inspection of the individual vehicle. Since vehicles configured to overseasspecifications differ on various points from Japanese specification vehicles, for example in headlight

optical axes, meter displays, and exhaust measures, a variety of modifications are required to satisfysafety standards.

Application documents for a new vehicle inspection:Certificate of conformity to safety standards / Certificate of completion of completed-vehicle inspection(for formal designation) / Certificate of completion of exhaust inspection (for formal permit and formalcertification) / Certificate of transfer / Motor-vehicle customs clearance certificate / Parallel importmotor-vehicle certificate (for parallel import) / Certificate of liability insurance / Certificate of payment ofautomobile weight tax / The user's certificate of residence, etc.

2. Act against Unjustifiable Premiums and Misleading Representations / Fair competition codeThe motorcycle fair competition code of the Automobile Fair Trade Council, based on this act,

establishes standards on representation in sale of new and used vehicles.

Other laws and regulations apply to motorcycles such as handling recalls and other measures ofproduct liability as well as recycling.

Also, when importing a motorcycle for personal use in connection with moving to Japan fromoverseas, to be eligible for the special-purpose exemption there is a need to certify to the Customs officein charge of the import place that the motorcycle is intended for the personal use, that it already hasbeen used by that person (for example by showing a vehicle registration certificate, insurance policy, ortransfer certificate from the foreign country).

Import Clearance Procedures for Vehicles (Japan Customs)http://www.customs.go.jp/english/c-answer_e/imtsukan/1109_e.htmMotor Vehicle Inspection and Registration System in Japan (Ministry of Land, Infrastructure andTransport)http://www.mlit.go.jp/english/inspect/index1e.htmlJapanese Automobile Recycling Promotion Center (JARC)http://www.jarc.or.jp/en/motorcycle/

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HelmetsHelmets (HS6506) are not only the purposes for use in vehicles. Due to the nature of the product, incases such as accidents resulting from defects in helmets importers may be held liable for reparations.

1. Industrial Safety and Health ActThis act establishes standards for protective headgear (used to prevent risks from flying or falling

objects or from falls) and prohibits use of the products that has not passed type certification by aregistered type-testing agency. Its standards cover the following matters:

Materials used in each component of protective headgear Designs of protective headgear Resistance performance of protective headgear to penetration Head dummies used in performance testing, conical strikers and jigs for use in testing Shock-absorption performance of protective headgear Labeling requirements of protective headgearSince under this act helmets (protective headgear) are subject to type testing, when undergoing

testing for the procedures are conducted by relevant documents such as a design of the protectiveheadgear, an outline of manufacturing and testing equipment, other matters (for imported articles,documents on the overseas manufacturer's manufacturing and testing equipment are required) withsamples to the application for testing and submitting it to the Technology Institution of Industrial Safety.

2. Consumer Product Safety Act(1) PSC mark system (Product Safety of Consumer Products)

Helmets for motor vehicle users, which are designated as Specified products under a ministerialordinance based on this act, a Notice of Import of Specified products needs to be submitted to theRegional Bureau of Economy, Trade and Industry with jurisdiction (or the Minister of Economy, Tradeand Industry if the applicant's business facilities are in multiple districts) and compatibility testing by thedesignated testing agency (the Japan Vehicle Inspection Association) is required. The applicant may sellthe product on which the labeling required, such as the PSC mark, has been affixed.

(2) SG mark systemThe SG mark authorized by the Consumer Product Safety Association is a voluntary certification

awarded to products recognized to satisfy the required standards for safe products established underthe SG mark system. In case of an accident due to a defect in a product with the SG mark, liabilityinsurance is provided up to a certain amount. The following helmets are eligible for the SG mark: Baseball helmets Helmets for baseball played with rubber balls and softball helmets Baseball and softball catcher's helmets Baseball pitcher's headgear Helmets for bicycles, electric powered wheelchairs, and moving playground equipment users Helmets for motor vehicle users

(3) System for report and publication of product accident informationIn case of any serious product accident, importers of consumer products are required to submit a

report to the Prime Minister on the name and model of the product, the details of the accident, and thequantity of relevant products imported and sold, within 10 days from the day business operatorsincluding importers came to know the fact of the accident (Article 35). All importers of consumerproducts in Japan, regardless of their size or type of business, are required to submit this report onaccidents.

Compliance with the Product Liability Act (PL Act) also is required separately.

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3. Other relevant laws(1) Industrial Standardization Act (JIS standards) / Road Traffic Act

JIS standards include standards concerning protective helmets for motor vehicle users (JIST8133)and protective helmets for bicycle users (JIST8134).

While the Road Traffic Act does not restrict sale of protective helmets for motor vehicle users directly,

the detailed regulations for enforcement of the Act establishes the standards on helmets (e.g., theweight up to 2kg).

(2) Household Goods Quality Labeling Act / Act against Unjustifiable Premiums and MisleadingRepresentationsWhen selling subject products to ordinary consumers in Japan, labeling pursuant to the Household

Goods Quality Labeling Act is required. Labeling must be affixed by the party with responsibility (e.g., animporter with a sales facility in Japan or the seller of the product) and the labeling must be clearly visibleto and easily understandable to consumers and in the Japanese language.

Under the Act against Unjustifiable Premiums and Misleading Representations acts such as sale withexcessive premiums and exaggerated or fraudulent labeling that could mislead consumers areprohibited.

(3) Customs Law (articles infringing on intellectual property rights), etc.Import of articles infringing on intellectual property rights such as counterfeit character merchandise

and use of misleading or unauthorized names (e.g., goods infringing on trademark rights, copyright,neighboring rights, patent rights, utility model rights, or design rights) is prohibited. Under the UnfairCompetition Prevention Act and other laws, import will be suspended even if the importer is not awarethat the goods are in violation of the law.

(4) Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.(Chemical Substances Control Law)

Import of helmets made of plastics or other materials using chemical substances categorized asClass I Specified Chemical Substances under this act is prohibited.

Caution is required concerning other regulations related to chemical substances as well.

Japan Advanced Information center of Safety and Health (JAISH)http://www.jaish.gr.jp/eng/index.htmlConsumer Affairs Agencyhttp://www.caa.go.jp/en/index.htmlConsumer Product Safety Association (CPSA)http://www.sg-mark.org/english/english20100810.pdfJapanese Industrial Standards Committee (JISC)http://www.jisc.go.jp/eng/index.htmlIPR Protection (Japan Customs)

http://www.customs.go.jp/mizugiwa/chiteki/ipr_p.pdfChemical Management (Ministry of Economy, Trade and Industry)http://www.meti.go.jp/english/policy/mono_info_service/kagaku/index.htmlNational Institute of Technology and Evaluation (NITE)http://www.safe.nite.go.jp/english/index.html

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Passenger VehiclesDue to the wide range of laws and regulations concerning import and sale of passenger vehicles, only themain laws and regulations are outlined below for reference.

1. Road Transport Vehicle ActActually driving a vehicle on public roads requires obtaining a vehicle license number after

conducting domestic procedures such as official vehicle inspection and registration.

(1) When the importer is an agent:There are three types of vehicle certification systems for prior inspection to ensure imported vehicles

satisfy safety standards based on this act, grouped by type.

a. Formal designation system:Vehicle inspection is conducted by submitting a sample vehicle and documents in advance, and the

system for ensuring uniformity among the vehicles is inspected as well. For motor vehicles that have

undergone formal designation, during new inspection presenting an actual vehicle can be omitted. Theformal designation system is used for imported vehicles planned for mass sale in Japan.

b. New-vehicle notification system:Vehicle inspection is conducted by presenting a sample vehicle in advance. New inspection is

conducted by merely confirming that the actual vehicle is the same as the sample vehicle, withsystematic inspection of product uniformity omitted. This system is used to trucks and buses, whichhave large numbers of specifications and vehicle types.

c. System for small quantities treatmentThis system is applied only to imported vehicles planned for sale in small quantities in Japan (up to

2,000 units per year), presenting a sample vehicle is omitted and the documents submitted aresimplified as well.

However, in inspection at the Transport Branch Office of the District Transport Bureau or the Office ofmotor-vehicle inspection and registration, while under the system described under paragraph (a) abovethere is no need to present the actual vehicle if an inspection certificate issued by the manufacturer orother party is available, under the systems described under paragraphs (b) and (c) above a license platewill not be issued until the actual vehicle has been checked to confirm that it matches the advancecertification.

(2) Private importing and parallel importing:Furthermore, the above motor-vehicle certification systems do not apply to private importing,

reimportation, or parallel importing. In these cases, conformity with safety standards needs to beconfirmed through receiving a vehicle customs clearance certificate during import customs clearance

and then inspection of each individual vehicle as it leaves the bonded area. Since vehicles configured tooverseas specifications differ on various points from Japanese specification vehicles, for example inheadlight optical axes, meter displays, and exhaust measures, a variety of modifications are required tosatisfy safety standards.a. Modifications to exhaust measures and other equipment to satisfy safety standards are conducted

at a car maintenance workshop.b. Exhaust testing and other testing is conducted at an official agency authorized by the Ministry of

Land, Infrastructure, Transport and Tourism.c. The vehicle is inspected at a land transportation bureau.

When importing for personal use in connection with moving to Japan from overseas, to be eligible forthe special-purpose exemption there is a need to certify to the Customs office in charge of the place thatthe car is intended for the personal use, that it already has been used by that person (for example by

showing a vehicle registration certificate, insurance policy, or transfer certificate from the foreigncountry).

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2. Act on Recycling, etc. of End-of-Life VehiclesUnder this act, automakers or importers are required to take responsibility for recycling (appropriate

processing and recycling, or disposal for CFCs) shredder dust, CFCs, airbags, etc. resulting when avehicle they manufactured or imported reaches the end of its life, either themselves or throughsubcontracting.

Also, under the Act on the Promotion of Effective Utilization of Resources, motor vehicles areconsidered Specified Resources-Saved Products (products for which efforts to restrain generation ofused articles, such as rationalization of use of raw materials and promoting long-term use, are required)and Specified Reuse-Promoted Products (products for which efforts to promote the utilization ofrecyclable resources or reusable parts are required). As such, importers and sellers of these productsare required to carry out "three-R" (reduce, reuse, recycle) efforts.

3. Act on the Rational Use of EnergyIn addition to the requirements for improvements to energy-conservation performance and labeling

for energy efficiency, motor vehicles are subject to the "top-runner system" under which importers ofvehicles at or above a certain quantity are required to conform at least to the energy efficiency of thebest-performing product currently commercially available.

4. Other relevant lawsUnder the Act against Unjustifiable Premiums and Misleading Representations, The Automobile Fair

Trade Council has established the fair competition code regarding motor-vehicle labeling.Other laws and regulations apply to motor vehicles such as recalls and other measures of product

liability as well as the Automotive NOx and PM Law for some vehicles and JIS standards.

Import Clearance Procedures for Vehicles (Japan Customs)http://www.customs.go.jp/english/c-answer_e/imtsukan/1109_e.htmMotor Vehicle Inspection and Registration System in Japan (Ministry of Land, Infrastructure and

Transport)http://www.mlit.go.jp/english/inspect/index1e.html3R Policies (Ministry of Economy, Trade and Industry)http://www.meti.go.jp/policy/recycle/main/english/index.htmlJapanese Automobile Recycling Promotion Center (JARC)http://www.jarc.or.jp/en/recycling/Act on Recycling, etc. of End-of-Life Vehicleshttp://www.japaneselawtranslation.go.jp/law/detail/?id=127&vm=04&re=01&new=1Act on the Rational Use of Energyhttp://www.japaneselawtranslation.go.jp/law/detail/?id=1855&vm=04&re=01&new=1
http://www.japaneselawtranslation.go.jp/law/detail/?id=127&vm=04&re=01&new=1http://www.japaneselawtranslation.go.jp/law/detail/?id=127&vm=04&re=01&new=1

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Yachts and MotorboatsActual sailing of yachts or motorboats (HS8903) in Japan requires vessel inspection (including inspectionfor legally required equipments) and vessel registration. Sale of yachts and motorboats is regulated under

the Ship Safety Act, the Act on Registration, etc. of Small-Sized Vessels, and the Ship Act.

1. Ship Safety ActUnder this act, technical standards on the structures and equipment of small vessels included among

vessels for which national inspection (vessel inspection) is required are established in the Small-VesselSafety Regulations and vessel inspection of craft with tonnage of less than 20 tons is conducted by theJapan Craft Inspection Organization (District Transport Bureaus and other organizations inspect largevessels with tonnage of more than 20 tons). Small crafts satisfying certain requirements, such as lengthsof less than 3 meters and propulsion engines with maximum output of less than 1.5 kW or with nopropulsion engines are exempted from vessel inspection.

Vessel inspection covers matters including manufacturing specifications and various specs,structural inspection using data of testing results and other documents, and durability testing of the

vessel body and equipment. Since other tests including testing on the sea may be conducted as well,individual matters need to be checked in advance with the testing agency.While in principle, vessel inspection is conducted for each body individually, preparations vary with

the conditions of the vessel to be imported, for example in cases such as those of mass-producedoutboard motors and legally required equipment for which the importer of other party has undergoneformal approval (for legally required equipment such as life jackets, life rings, fire extinguisher, andnautical equipment, testing systems such as preparatory inspection at the manufacturing stage apply)and when documentation of testing results need to be checked by a classification society.

A Vessel Inspection Certificate, Vessel Inspection Handbook, and Vessel Inspection Stub aredelivered to vessels that have passed vessel inspection. The Vessel Inspection Stub (showing thevessel inspection number, year of passing periodic inspection, number of the department awarding thestub, passing number and other information) must be affixed to both sides of the vessel in locationseasily visible from outside.

2. Act on Registration, etc. of Small-Sized VesselsImporters of small vessels (those with tonnage of less than 20 tons, not including fishing boats) must

notify to the Minister of Land, Infrastructure, Transport and Tourism within 15 days from the importingdate that the state of inscription of the vessel identification number on the vessel itself and the followingmatters prescribed by ministerial ordinance. Also the vessel must undergo measurement (Article 6 of theact) by the Japan Craft Inspection Organization and registration (the registers are operated by theOrganization) before actual sailing. The information to be registered is shown below.(1) Type of vessel (steam or sail)(2) Port of registry (municipality where the vessel usually anchoring)(3) Length, width, depth (figures from measurement)(4) Tonnage

(5) Vessel identification number (inscribed by the manufacturer or importer; under JIS standards, thisnumber consists of 15 alphanumeric characters)

(6) Type of propulsion engine (outboard motor, inboard motor, or inboard/outboard motor)(7) Name and address of owner (and shares if more than one owner)(8) Date of registration(9) Vessel number (assigned to each registered small vessel)

3. Ship ActThis act specifies that for vessels with tonnage of 20 tons or more, the owner must designate a port

of registry, undergo measurement and registration by the District Transport Bureau with jurisdiction, andattain a country of registry (not required if the vessel will not be sailed). Through this process, a VesselCountry of Registry Certificate and a Vessel Registry Stub are issued.

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4. Other relevant laws(1) Act on Prevention of Marine Pollution and Maritime Disaster

Based on the MARPOL Convention (International Convention for the Prevention of Pollution FromShips), restrictions on emissions volume from diesel engines on vessels with output over 130 kW, aswell as preparation of motor handling manual and approval by the Minister of Land, Infrastructure,

Transport and Tourism, are required under this law.

(2) Industrial Standardization Act (JIS standards)JIS standards relate to vessels, including standards concerning inscription of the vessel identification

number as described in 2. Act on Registration, etc. ofabove, and those providing an outline ofpreparation of the motor handling manual for diesel engines based on 4. (1) Act on Prevention ofMarine Pollutionabove(JISF0406).

Japan Customshttp://www.customs.go.jp/english/index.htm

Japan Craft Inspection Organizationhttp://www.jci.go.jp/english/01.htmlNippon Kaiji Kyokai (ClassNK)http://www.classnk.or.jp/hp/en/index.aspxIncorporation of ISO standards into Japanese Boat Safety Regulations (Ministry of Land, Infrastructureand Transport)http://www.mlit.go.jp/english/2006/j_maritime_bureau/index.html

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Health and Beauty

Cosmetics

Cosmetics are regulated under the Pharmaceutical Affairs Law.Checking HS classifications with the customs counselors offices is recommended.:Beauty or make-up preparations and preparations for the care of the skin (HS3304)

The procedures mentioned below are not necessary for personal consumption and not intended for sale.However, on the whole such items must be in standard sizes of no more than 24 pieces per an item (ex.24 lipstics regardless brand or color).

1. Pharmaceutical Affairs LawWhen importing cosmetics for business purposes, (i) a Manufacture Permit is required. When

purchasing imported products in Japan and then packaging, labeling, storing and selling them to market,(ii) a Manufacture/Sale Permit is required. When importing a product yourself and selling it in Japan,both permits (i) and (ii) are required. Also, the cosmetics to be imported must conform to the Standardsfor Cosmetics established by the Ministry of Health, Labour and Welfare (MHLW).

After obtaining the permits above, prior to import the following notices also must be submitted foreach product: (iii) Notice of Foreign Manufacturer / Seller of Cosmetics etc. (Pharmaceuticals andMedical Devices Agency), (iv) Notice of Manufacture / Sale of Cosmetics (the prefecture department incharge of pharmaceuticals), and (v) Notice of Import of Cosmetics for Manufacture/Sale(Kanto-Shinetsu or the Kinki Regional Bureau of Health and Welfare).

(1) Manufacture Permit, Manufacture/Sale Permit, and Approval of Manufacture/Sale (approval ofeach product)

First, (i) the Manufacture Permit Application is submitted to the prefecture department in charge ofpharmaceuticals, and a permit is awarded for each manufacturing facility after inspection of the state ofthe manufacturer's structure and equipment, human-resources aptitude, and other conditions, to ensurethat manufacture (or import) of the product would not present any health or hygiene problems. A generalresponsible technician with necessary qualifications such as those of a pharmacist must be appointedon a permanent basis.

(ii) The Manufacture/Sale Permit Application also is submitted to the prefecture department in chargeof pharmaceuticals for the location of the business planning to sell the product (i.e., the facility at whichthe person with general responsibility for manufacture and sale are posted), together with the followingdocuments: the copy of corporate registry, a doctor's medical certificate stating that the applicant doesnot have any mental disorder or similar condition, an organizational chart, documents certifying that thepermanently posted persons with general responsibility for manufacture and sale have necessary

qualifications such as those of a pharmacist, documents on systems for quality control and control ofsafety after manufacture and sale, and other documents. When both (i) a Manufacture Permit and (ii) aManufacture/Sale Permit are held, the person with general responsibility for manufacture on theManufacture/Sale Permit may be the same as the responsible technician on the Manufacture Permit,subject to the condition that his or hers is a permanent post. Inquire of each prefecture for details.

Next, approval of manufacture and sale of each product is based on comprehensive judgmentfollowing inspection of the cosmetic or other product to be imported; ingredients and quantities,manufacturing methods, dosage and administration, efficacy and effects, storage methods andexpiration dates, its standards and testing methods, and other required information, either through theprefecture* or at the Pharmaceuticals and Medical Devices Agency, by submitting the requireddocuments to that agency. However, if the product satisfies the Standards for Cosmetics established by

the MHLW and all ingredients are labeled, this approval is not necessary.* On applying for the approval through the prefecture, consult with the prefecture department in charge ofpharmaceuticals on matters such as checking whether the product qualifies as a cosmetic or a quasi-drug.

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(2) Notice of Foreign Manufacturer/Seller of Cosmetics etc.,Notice of Manufacture/Sale of CosmeticsPrior to import of the products by the Japanese manufacturer/seller (ii), a foreign manufacturer of

cosmetics not requiring approval* must submit (iii) a Notice of Foreign Manufacturer/Seller of Cosmeticsetc. (Form 115) to the Minister of Health, Labour and Welfare through the Pharmaceuticals and Medical

Devices Agency and (iv) a Notice of Manufacture/Sale of Cosmetics (Form 39) to the prefecturalgovernor. Notices (iii) and (iv) may be submitted to the prefecture department in charge ofpharmaceuticals at the same time.*Article 14 of the Pharmaceutical Affairs Law, Article 76 of the enforcement ordinance

(3) Notices of importFurthermore, when importing for business purposes (v) a Notice of Import with the required items

filled in, such as name and address of manufacturer/seller, type of permission, permit number, permitdate of Manufacture/Sale Permit, and name of the product to be imported, must be submitted to theKanto-Shinetsu Regional Bureau of Health and Welfare (East Japan) or the Kinki Regional Bureau ofHealth and Welfare (West Japan excluding Okinawa. In Okinawa, the Narcotics Control Office.) forchecking, by the time of customs clearance. After the checking, the MHLW Checked Import Notice, will

be returned with a confirmation mark, and importer should attach it to the import customs clearancedocuments and submit it to Customs.

If that within certain quantity ranges, import may be permitted in some cases for items such asproduct samples, items for personal use by doctors, and items for testing and clinical trials, throughsubmittal of the required documents. However, quantities exceeding a certain amount requirecertification of pharmaceuticals inspection through conducting procedures with the pharmaceuticalsdepartment of the Regional Bureau of Health and Welfare.

Consulting with Customs or the Bureau of Health and Welfare in advance is recommended.

(4) Standards for Cosmetics and labeling requirementsImport and sale of products requires conformity with Standards for Cosmetics, which establishes

rules concerning prohibited or restricted ingredients (the Negative List) and specific permittedingredients (the Positive List).

The required items under the law, such as the name of the manufacturer/seller, product name, lotnumber or code, must be labeled directly on the container or package, and in principle all ingredientsmust be labeled. Other regulations include prohibition of fraudulent or misleading labeling.

2. Other relevant laws(1) Act against Unjustifiable Premiums and Misleading Representations / Fair competition code

As for the products with fraudulent or incorrect labeling of country of origin, import is prohibited underthe Customs Law and sale is prohibited under the Act against Unjustifiable Premiums and MisleadingRepresentations. Sale with excessive premiums also is prohibited. As a voluntary industry standardbased on this act, the Codes of Fair Competition regarding the representations of cosmetics, formulatedby the Cosmetic Fair Trade Council Japan, apply to products considered cosmetics under the

Pharmaceutical Affairs Law. These regulate matters such as labeling and advertising.

(2) Customs Law (articles infringing on intellectual property rights), etc.Import of articles infringing on intellectual property rights such as counterfeit brand names (e.g.,

goods infringing on trademark rights, copyright, neighboring rights, patent rights, utility model rights, ordesign rights) is prohibited. Import will be suspended even if the importer is not aware that the goods arecounterfeit.

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(3) High Pressure Gas Safety ActRegarding containers, import of spray and aerosol products requires a certificate showing that the

products are exempt from application of this act. The product is approved exempt when the importeritself prepares the required documentation of testing results and it is confirmed that the productssatisfies the requirements established in notificartion by the Minister of Economy, Trade and Industry

(container no larger than 1 liter in capacity, with internal pressure no more than 0.8 megapascals).If no such documentation is submitted or the results for any item are "fail," an inspection by the

prefecture governor (import inspection application) is required.

Compliance with other laws and regulations, such as those recycling of containers and packaging,also is required.

Customs confirmation requirement concerning import restrictions in accordance with the PharmaceuticalAffairs Law (Japan Customs)http://www.customs.go.jp/english/c-answer_e/imtsukan/1805_e.htm

Standards for Cosmetics (Ministry of Health, Labour and Welfare)http://www.mhlw.go.jp/english/topics/cosmetics/index.htmlPharmaceuticals and Medical Devices Agency, Japan (PMDA)http://www.pmda.go.jp/english/index.htmlOutline of other relevant laws and ordinances referred to by Costoms (Japan Customs)http://www.customs.go.jp/english/c-answer_e/imtsukan/1801_e.htmPrivate importation of drugs, cosmetics, etc. (Japan Customs)http://www.customs.go.jp/english/c-answer_e/imtsukan/1806_e.htmCodes of Fair Competition regarding the representations of cosmetics (Cosmetic Fair Trade CouncilJapan)http://www.cftc.jp/english/index.html

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Aroma ProductsSince there is not specific HS classification for aroma products, the HS code needs to be confirmed bychecking with the customs counselors offices, based on detailed information of the actual product to be

imported such as analysis of their ingredients. Use of the Advance Classification Ruling System isrecommended.This section covers only general notes on importing aroma products from that standpoint that aroma is notonly intended for purposes of relaxation or healing but also sometimes included in the classification ofpharmaceuticals or health products for beauty effects, etc.So the miscellaneous goods such as oils, candles, and incense with no effect on the human body andenjoyed merely for their scents may be imported with no particular regulations.

1. Pharmaceutical Affairs LawThe key point is whether or not the specific product to be imported is subject to this law. Cosmetics: soap, lotion, perfumes, etc. Quasi-drugs: medicinal cosmetics, medicinal soaps, bath preparations (with effects such as

treatment of eczema), etc. Medical devices: acupuncture and moxibustion implements, massage devices, magnetic therapy

devices, etc.While in general products applied directly to the skin can be considered subject to the law, check withthe prefecture department in charge of pharmaceuticals.

Import and sale of products subject to the Pharmaceutical Affairs Law requires authorization such asa Manufacture Permit and a Manufacture/Sale Permit from the prefectural governor, and the importermust appoint on a permanent basis a person with general responsibility, such as a pharmacist, and havecertain required equipment and structures at its business facility, among other requirements, forpurposes such as quality checking and control of safety after sale.

Furthermore, depending on the product Manufacture/Sale Approval (acquired by applying to theMinister of Health, Labour and Welfare through Pharmaceuticals and Medical Devices Agency andundergoing the required inspection) may be required for each product. A Notice of Manufacture/Sale isrequired even if the product does not need approval.

For quasi-drugs and medical devices, application procedures for Foreign Manufacturer Certificationare required, and for cosmetics a Notice of Foreign Manufacture/Sale or Manufacturer must besubmitted to the Minister of Health, Labour and Welfare through Pharmaceuticals and Medical DevicesAgency.

When import customs clearance, a Notice of Import also must be submitted after the RegionalBureau of Health and Welfares checking.

2. Plant Protection ActProducts made from plants (ex. medicinal herbs) may be subject to quarantine, depending on their

form and the degree of processing. In recent years, cases have been uncovered of illegal drugs such as

stimulants and hallucinogens disguised as aroma products, so that monitoring of aroma products isincreasing in strictness.

3. Consumer Product Safety ActThere are no particular import regulations on miscellaneous goods not subject to the Pharmaceutical

Affairs Law (ex. oils, candles, and incense enjoyed merely for their scents). However, in case of anyserious product accident, importers of the products are required to submit a report to the Prime Ministeron the name and model of the product, the details of the accident, and the quantity of products importedand sold, within 10 days from the day business operators (importer) came to know the fact of theaccident (Article 35). All importers of consumer products in Japan, regardless of their size or type ofbusiness, are required to submit this report on accidents.

Compliance with the Product Liability Act (such as civil indemnity) also is required separately.

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4. Other relevant laws(1) Act against Unjustifiable Premiums and Misleading Representations, etc.

With fraudulent labeling of country of origin or labeling that could mislead consumers are prohibited.In some cases of products subject to the Pharmaceutical Affairs Law, fair competition code andguidelines apply to them, as voluntary industry standards regulating matters such as labeling and

advertising. Products imported as miscellaneous goods exempt from the Pharmaceutical Affairs Lawmay not be labeled as having medicinal effects. As for essential oils the voluntary certification system forconformity to labeling industry standards is established by the Aroma Environment Association of Japan.

(2) Customs Law (articles infringing on intellectual property rights)Import of articles infringing on intellectual property rights such as counterfeit brand names (e.g.,

goods infringing on trademark rights, copyright, neighboring rights, patent rights, utility model rights, ordesign rights) is prohibited. Import will be suspended even if the importer is not aware that the goods arecounterfeit.

Depending on the product, regulations may apply under other laws.Compliance with other laws and regulations, such as those concerning recycling of containers and

packaging, also is required.

Japan Customshttp://www.customs.go.jp/english/index.htmAdvance Classification Ruling System (Japan Customs)http://www.customs.go.jp/english/c-answer_e/imtsukan/1202_e.htmCustoms confirmation requirement concerning import restrictions in accordance with the PharmaceuticalAffairs Law (Japan Customs)http://www.customs.go.jp/english/c-answer_e/imtsukan/1805_e.htmPharmaceuticals and Medical Devices Agency, Japan (PMDA)

http://www.pmda.go.jp/english/index.htmlConsumer Affairs Agencyhttp://www.caa.go.jp/en/index.html

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Harbal and Natural MedicinesSince HS classifications vary with factors such as whether the product is a raw material or formulation foruse in manufacture of pharmaceuticals and the sources of ingredients, checking with the customs

counselors offices, based on details of the ingredients of the product information, is recommended.:Materials of animal origin (HS0510), Materials of plant origin (1211), Organ therapeutic uses (3001),Mixtures of formulations not for retail sale (3003), and Mixtures of formulations for retail sale (3004)

However, these classifications include products not subject to the Pharmaceutical Affairs Law such asmaterials for perfumery use (which are included in HS 1211) and many products belonging to otherclassifications, such as plant extracts (2106), seeds and fruit for extraction of fixed oils (1201 - 1207), andcitrus peels (0814), which can qualify as natural medicines depending on how they are used. Caution alsois required concerning the fact that formulations may belong to HS 3303 - 3307 or 3808 case by case.

While in this section combinations of natural medicines are, on the whole, considered herbal medicines,

this does not necessarily mean that all natural plant and animal materials primarily supplied topharmacies are considered medicaments.While the term medicaments in HS code 3003 or 3004 refers only to articles with therapeutic or preventiveuses, the term pharmacy also includes products that do not necessarily have such uses (such asnutritional drinks). Also, classifications such as spices include some natural medicines as well (ex. redpepper, hydrangea, jasmine, etc.).

1. Pharmaceutical Affairs LawProducts belonging to the following categories are defined as pharmaceuticals under the law.

(1) Those covered in the Japanese Pharmacopoeia(2) Those intended for use in diagnosis, treatment, or prevention of human or animal illness or injury,

other than implements or machines (except quasi-drugs)(3) Those intended to affect the structure or functions of human or animal bodies, other than

implements or machines (except quasi-drugs and cosmetics)Products in category (1), those covered in the Japanese Pharmacopoeia, include many naturalmedicines.

Differentiation between pharmaceuticals and food is based on the "Judgment Criteria on the Scopeof Pharmaceuticals"(Ministry of Health and Welfare Pharmaceuticals Bureau Director Notice No. 476).Since these criteria are revised frequently by the Ministry of Health, Labour and Welfare, the businessoperator must check for the latest information.

When importing for business purposes, (i) Manufacture Permit is required. When purchasingimported products in Japan and then packaging, labeling, storing and selling them to Japanese market,(ii) Manufacture/Sale Permit is required. When importing a product yourself and selling it in Japan,

both permits (i) and (ii) are required.After obtaining the permits above, if (iii) Approval of Manufacture/Sale is needed for each product

then it must be obtained, and then the following notices also must be submitted for each product: (iv)Notice of Foreign Manufacturer/Seller etc.(Pharmaceuticals and Medical Devices Agency), (v) Noticeof Manufacture/Sale of Pharmaceuticals(the prefectural department in charge of pharmaceuticalswhere the Manufacture/Sale Permit was obtained), and (vi) Notice of Import of Pharmaceuticals forManufacture/Sale (Kanto-Shinetsu or Kinki Regional Bureau of Health and Welfare).

When applying for (iii) Approval of Manufacture/Sale, a foreign manufacturer planning to export toJapan needs to receive (vii) Foreign Manufacturer Certification. However, it also may appoint abusiness partner who has (ii) Manufacture/Sale Permit in Japan and apply for (iii) Approval to theMinister of Health, Labour and Welfare through the (ii) business pertner.

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2. Industry standardsThe Japan Kampo Medicines Manufacturers Association has established standards including the

Industry Standards on Residual Agricultural Chemicals and the GMP* for Kampo Products to ensurethe safety of herbal medicine. * GMP: Good Manufacturing Practice

3. Plant Protection Act / Act on Domestic Animal Infectious Diseases ControlDepending on the degree of processing as natural medicine or herbal medicine, products made from

plants may require plant quarantine (in principle, all are subject to quarantine, and plants may not beimported with soil attached) and those made from animals may require animal quarantine (only for thosedesignated for quarantine). In these cases, checking with the Plant Protection Station or the AnimalQuarantine Service, based on details of the ingredients of the product information, is recommended.Either quarantine requires an inspection certificate issued by a government quarantine station of theexporting country or a certifiable agency.

4. Import Trade Control Order (CITES)Under the Import Trade Control Order based on the Washington Convention (CITES), products made

from endangered wild flora and fauna as well as their body parts and derivative products may be

prohibited from import or their import may require documents depending on the type of products, suchas an import license, a confirmation issued by the Ministry of Economy, Trade and Industry, or an exportcertificate or a certificate of origin issued by an agency of the government of the exporting country.

5. Narcotics and Psychotropics Control Act / Import Trade Control OrderIf the imported products include poppy husk or other ingredients covered by this act, each business

facility requires a license* from the Minister of Health, Labour and Welfare or the prefectural governor.Also obtaining a permit and other relevant procedures are required for each import.

Furthermore, since these products are subject to import approval under the Import Trade ControlOrder, they require application procedures for approval to the Ministry of Economy, Trade and Industryand confirmation with Customs during customs clearance.* Article 3 (Licensing)

Minister of Health, Labour and Welfare:Importer (qualification: Pharmaceutical Manufacture/Sale Permit), Pharmaceutical firm (qualification:Pharmaceuticals Manufacture/Sale Permit and Manufacture Permit), Manufacturer of exempt narcoticpreparations (qualification: Manufacture Permit), Principal wholesaler (qualification: a business facilitywith a pharmacist and licensed as a pharmacy or seller), etc.

Prefectural Governor:Wholesaler (same qualification with principal wholesaler), Pharmacy, Doctor, Pharmacist, etc.

* Article 13 (Imports) - 16Import by other than qualified narcotic importers is prohibited. Each import requires obtaining an importpermit from the Minister of Health, Labour and Welfare. When imported, an export certificate issued bythe exporting country must be submitted within 10 days from the date of import, and if not imported theimport permit should be returned.

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Outline of other relevant laws and ordinances referred by Customs (Japan Customs)http://www.customs.go.jp/english/c-answer_e/imtsukan/1801_e.htmCustoms confirmation requirement concerning import restrictions in accordance with the PharmaceuticalAffairs Law (Japan Customs)

http://www.customs.go.jp/english/c-answer_e/imtsukan/1805_e.htmPharmaceuticals and Medical Devices Agency, Japan (PMDA)http://www.pmda.go.jp/english/index.htmlFood Safety Information (Ministry of Health, Labour and Welfare)http://www.mhlw.go.jp/english/topics/foodsafety/index.htmlPlant Protection Stationhttp://www.pps.go.jp/english/index.htmlAnimal Quarantine Servicehttp://www.maff.go.jp/aqs/english/index.htmlCITES; Convention on International Trade in Endangered Species of Wild Fauna and Florahttp://www.cites.org/Consumer Affairs Agency

http://www.caa.go.jp/en/index.htmlImporting or Bringing Medication into Japan for Personal Use (Ministry of Health, Labour and Welfare)http://www.mhlw.go.jp/english/topics/import/index.html

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Hobbies

Musical Instruments

As long as the product do not made from special materials (i.e., such as rosewood and ivory thoseregulated under the Convention on International Trade in Endangered Species of Wild Fauna and Flora:CITES, Washington Convention), no particular restrictions apply to musical instruments.However, electronic musical instruments are subject to the regulations of the Electrical Appliance andMaterial Safety Law.:Pianos (HS9201), Guitars, Violins, and other string instruments (9202), Wind musical instruments (9205),Percussion instruments (9206), Electronic musical instruments (9207)

1. Electrical Appliance and Material Safety Law (Electronic musical instruments only)All persons engaged manufacturing or importing electrical appliances in Japan shall notify the

Ministry of Economy, Trade and Industry (Regional Bureau of Economy, Trade and Industry) of theirbusiness commencement within 30 days from the date of starting business (hereinafter referred to as aNotifying Supplier). The Notifying Suppliers have the obligation to secure the conformity of electricappliances and materials they import and sell to the mandatory technical standards.

The Order for Enforcement of this law groups subject products into the categories of SpecifiedElectrical Appliances and Materials (115 items / Category A) and Other Electrical Appliances andMaterials (339 items / Category B). Category A products must pass the third-party conformityassesment by an inspection agency registered with national government and receive a certificate ofconformity. Self-confirmation of conformity is required for Categories A and B (all regulated ElectricalAppliances and Materials) whose methods are designated by the government. Also this self-inspectionmay be subcontracted to a registered inspection bodies. The Notifying Supplier may sell the productsonly after they satisfy these standards, have been subjected to inspection and other tasks, and have

been labeled with the marking required such as the PSE mark, the company name, rated current, etc.The Notifying Supplier also is required to report any serious accidents after sale of the products.Electronic musical instruments are classified as Category B. However, since wiring devices (such as

power cables, plugs, and AC adapters) are classified as Category A, if the instrument includes suchdevices importers shall either undergo third-party conformity assessment for they import and obtain andkeep the certificate thereof, or official copy ofthe equivqlent of certificate through manufacturers of thespecified electrical appliances concerned and keep the official copy of the equivalent of a certificate.

While so-called vintage electric musical instruments may be sold without the PSE mark, theyr

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