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Our law firm has relocated as of May 10th, 2021 due to an increase in lawyers and staff.

Please find us at:

2F, Kudan Iida Building, 1-7-5,
Kudankita, Chiyodaku, Tokyo 102-0073

Further information can be found on our Access page.

Prohibited Items

There are items that are prohibited from being imported. This article covers stolen cultural property and counterfeit/imitation products which fall under this category.

 

Stolen Cultural Property

 The import of stolen cultural properties is effectively prohibited under the Law on the Prohibition of Illegal Import and Export of Cultural Properties1. In other words, although the Law requires that specified foreign cultural property2 be approved for import under the Foreign Exchange and Foreign Trade Law (Article 4 of the Act on the Prohibition of Illegal Import and Export of Cultural Property, etc.), since the property is stolen, it will not be approved and will be returned to the rightful owner3.

Counterfeit and Imitation Products

 Importation of counterfeit or imitation products such as coins, stamps, and postage stamps are prohibited.

 

Import Restrictions

Terms

Act on Control of Imitation of Revenue Stamps

(i) items that have a confusing appearance of government-issued stamps (imitation stamps)4

(ii) items that have a confusing appearance of tax stamp5 impressions

(iii) devices that may produce impressions that have a confusing appearance of tax stamps

 

Import is prohibited without a permit (Law 1 article). An import permit issued by the Minister of Finance. 

[tax stamp]

Act on Control of Imitation, of Postal Stamps

items that have a confusing appearance as postage stamps or other postage related vouchers.

 

 

Import is prohibited (Article 1 of the Law). Import is exceptionally allowed with the permission of the Minister of Internal Affairs and Communications, but permission is basically not expected.

Criminal law

Counterfeit or altered coins, paper money or banknotes

Import is prohibited (Article 148 of the Law). 

Counterfeit or altered foreign coins, paper money or banknotes

Importation for the purpose of enforcement is prohibited.

1 The official name of the law is the “Law Concerning the Control of Illegal Import and Export of Cultural Properties”.
2 The term “designated foreign cultural property” refers to cultural property designated by the Minister of Education, Culture, Sports, Science and Technology as cultural property when notification is received from a foreign country that cultural property has been stolen in accordance with Article 7 of the Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property. Specified Foreign Cultural Properties are introduced on the website of the Agency for Cultural Affairs.
3 If the importer (or the client) is a bona fide acquirer, the victim is to recover the cultural property after compensation (Article 6 of the Law).
4 Refer to Article 128 of the Basic Circular on the Stamp Tax Law for the criteria for determining whether or not imitation stamps are used.
5 A “tax stamp” is a seal stamped on a certificate or ledger to certify that the tax has been paid when the taxpayer has paid the amount equivalent to the stamp tax in cash instead of affixing a stamp. It is stamped with a tax stamp stamping machine.


Please contact us if you have any questions.

Importing Explosives or Nuclear Fuel Material

 Explosives

Any person who intends to import gunpowder shall obtain permission from the prefectural governor (Article 24.1), and shall notify the prefectural governor to that effect without delay after importation (Paragraph 3 of the same article).

In addition, after importation, the company is obliged to conduct stability tests and report the results to the prefectural governor (Article 36).

 

Nuclear Fuel Materials

The import of nuclear fuel materials is regulated as shown in the following table.

Act on the Regulation of Radioactive Isotopes

Radioisotope1

(Exceeding standard2)

・Importation is allowed for (1) licensed radioisotope users, and (2) notified dealers and notified leasing companies.

・At the time of import, a copy of the permit and documents proving the business of sale or lease are required3.

Radioisotope

(Below Standard)

・Imports are allowed by (1) companies notified of the use of radioisotopes, and (2) companies notified of the sale of radioisotopes and companies notified of the lease of radioisotopes.

・At the time of import, a copy of the certificate of use and documents proving the business of sale or lease are required.

Law Concerning the Regulation of Nuclear Source Materials, Nuclear Fuel Materials and Reactors

Nuclear fuel materials

(Plutonium, uranium, thorium, and their compounds,)

・Import approval is required under the Foreign Exchange and Foreign Trade Law.

・For the transportation of nuclear fuel materials or materials contaminated by nuclear fuel materials, necessary measures for safety must be taken in accordance with technical standards in accordance with the Nuclear Regulation Law (Article 59, Section 1 of the Act). In addition, when it is particularly necessary for the prevention of disasters caused by contaminated materials and for the protection of specific nuclear fuel materials, it is necessary to obtain confirmation from the Nuclear Regulation Authority (Paragraph 2 of the same Article, Article 48 of the Order).

・A person entrusted with the storage of nuclear fuel materials is required to take necessary measures for security in accordance with technical standards(Article 60).

Specific nuclear fuel materials

(Plutonium, uranium-233, enriched uranium and its compounds)

・Import approval is required under the Foreign Exchange and Foreign Trade Law.

・When transporting the material, the person responsible for transporting the material must be identified, measures must be taken to ensure that the prescribed arrangements are concluded, and confirmation must be obtained from the Nuclear Regulatory Commission (Article 59.2).

 

1 The term “radioisotopes” refers to “radiation-emitting isotopes, their compounds, and their contents (including those installed in equipment). The term “radioisotopes” refers to “radiation-emitting isotopes and their compounds and their contents (including those installed in equipment). However, it does not include “nuclear fuel materials” and “nuclear source materials” in the Atomic Energy Basic Law (see Article 1 of the Enforcement Order).
2 The quantity of radiation-emitting isotopes is specified in the “Law Concerning the Determination of the Quantity, etc. of Radiation-Emitting Isotopes.
3 Input Note 12 No. 177.

Importing Petroleum

The import of petroleum is regulated by the Oil Stockpiling Law and the Law Concerning the Quality Assurance of Petroleum Products, as shown in the following table.

Oil Stockpiling Law

Petroleum (refers to crude oil and designated petroleum products/ gasoline/kerosene/diesel oil/heavy oil1)

・Business of petroleum import must be registered by the Minister of Economy, Trade and Industry (Article 16).

・Upon customs clearance, a copy of the Oil Importer Registration Notice must be submitted2.

・Oil importers are required to notify the volume of imports every month(Article 36).        

※Notification of petroleum refining business is required for petroleum refining (production of gasoline, kerosene, diesel oil, and heavy oil). Notification is required for oil sales above a certain scale. As for the transportation and storage of oil, it is necessary to pay attention to the standards for transportation of hazardous materials under the Fire Service Act.

Petroleum gas (=gas consisting mainly of propane gas and butane gas and their liquefied products)

・Import business3 must notify the Minister of Economy, Trade and Industry in advance(Article 28).

・Importers are required to report monthly on the volume of imports (Article 36).

Law Concerning the Quality Assurance of Gasoline (Quality Assurance Law)

Volatile Oil4

(Gasoline for automobiles)

・importers intending to sell or consume gasoline as fuel for motor vehicles, confirm that it conforms to the volatile oil standards (Article 17-4, Paragraph 1 of the Law).

・importers shall notify without delay when they have imported gasoline for use as fuel for automobiles (Paragraph 4 of the same article).

 

※sales gas stations, etc. require registration as business (Law 3)5

Diesel oil6

(Light oil for diesel vehicles)

・Importers intending to sell or consume diesel oil as fuel for motor vehicles, must confirm that it conforms to the diesel oil standard (Article 17-4, Paragraph 1 and Article 17-8, Paragraph 2).

・Importers shall notify without delay when they have imported diesel oil for use as fuel for automobiles (Article 17-4, Paragraph 4; Article 17-8, Paragraph 2).

Kerosene7

(Kerosene for oil stoves)

・Importers intending to sell or consume kerosene as fuel for indoor combustion, must confirm that it conforms to the kerosene standard (Article 17-4, Paragraph 1 and Article 17-10, Paragraph 2).

・Importers shall submit a notification without delay when they import kerosene as fuel for indoor combustion (Article 17-4, Paragraph 4; Article 17-10, Paragraph 2).

Heavy oil8

(Heavy oil thermal power generation, ships.)

・Importers intending to sell or consume heavy oil as fuel for ships must confirm that it conforms to the heavy oil standard (Article 17-4, Paragraph 1 and Article 17-12, Paragraph 2).

・Importers shall submit a notification without delay (Article 17-4, Paragraph 4 and Article 17-12, Paragraph 2).

1 Gasoline has a boiling point (90% distillation temperature) of up to 180 degrees Celsius, and is used in automobiles. Kerosene has a boiling point of up to 270 degrees Celsius. And is used in oil stoves. Kerosene has a boiling point of up to 270 degrees Celsius and is used in oil stoves, etc. Diesel oil has a boiling point of up to 360 degrees Celsius and is used in diesel engines, etc. Heavy oil has a higher boiling point and is used for thermal power generation and ships.
2 The basic tax law is listed in Table 1.
3 Excluding Japan Oil, Gas and Metals National Corporation.
4 Volatile oils have a boiling point (distillation temperature) up to 180°C.
Gas stations must also comply with the Law Concerning Reporting, etc. of Releases to the Environment of Specific Chemical Substances and Promoting Improvements in Their Management (PRTR Law) and ordinances (Tokyo Metropolitan Ordinance on Environmental Preservation, etc.).
6 Diesel oil has a boiling point of up to 360 degrees Celsius.
7 Kerosene has a boiling point of up to 270 degrees Celsius.
8 Heavy oil has a boiling point even higher than 360 degrees.

Importing Gas

This article briefly explains laws and regulations concerning the import of gas into Japan.

1: General Information

The import and sale of gas is regulated by the Gas Business Law, the Law Concerning the Maintenance of Storage and Proper Trade of Liquefied Petroleum Gas (“Liquefied Petroleum Gas Law”), and the High Pressure Gas Safety Law. 

In general, when people talk about gas in their homes, the two most commonly used gases are city gas, which is made from natural liquefied gas (LNG), and propane gas (LP gas).  The former is provided through underground conduits, while the latter is essentially provided through gas cylinders.

The pipeline type is regulated by the Gas Business Law, while the gas cylinder type is regulated by the Liquefied Petroleum Gas Law (and the High Pressure Gas Safety Law) in most cases.

 

Natural gas

Propane gas (LP gas)

Main Use

City gas for household use

Thermal power generation

Natural gas station (truck)

Residential and commercial use

Industrial use

LP gas stations (cabs)

Ingredients

Methane is the main component, and natural gas (such as LNG) is the main raw material.

Mainly composed of propane and butane. Raw materials are imported mainly from the Middle East and produced domestically.

Characteristics

Lighter than air.

Becomes liquid when cooled to -162°C.

Heavier than air.

Becomes liquid when cooled to -42°C.

Supply method

Mainly through gas pipes

※Mostly in urban areas where gas pipes can be connected.

Mainly through gas cylinders

In addition, the High Pressure Gas Safety Act regulates oxygen gas, nitrogen gas, and other high-pressure gases for industrial use. Also, when storing or handling more than 300 kilograms of propane gas, a notification based on the Fire Service Act is required1.

2: Gas Business Law

1 About the Gas Business Law

The Gas Business Law regulates the gas retail business, gas pipeline business, gas manufacturing business, and gas supply sales and import business. 

The term “gas retail business” here refers to the business of supplying gas through “pipelines,” which basically means the “city gas” business. On the other hand, “propane gas” is mainly supplied through gas cylinders, and unless there are special circumstances in which it is provided through “pipelines,” it does not fall under the category of “gas retail business” here.  

In accordance with the Gas Business Law, registration is required for those operating a “gas retail business (Article 3 of the same law). In addition, those who operate a “gas pipeline business” are required to obtain a license (Article 35 of the same law) for a general gas pipeline business or a notification (Article 72 of the same law) for a specific gas pipeline business.

And for those who operate gas production business, notification is required (Article 86 of the same law). However, the “gas production business” refers to liquefied gas storage facilities with a total capacity of 200,000 kiloliters or more that are connected to “pipelines” used for the gas business (Article 2, Paragraph 9 of the Law, Article 5 of the Regulations), so it is understood that businesses that merely produce propane gas and fill cylinders do not fall under this category.

2 Import of Gas Equipment

Gas appliances regulated by the Gas Business Law refer to items (1) through (5) below. In each case, items for propane gas are not included.

 

Item

explanation

1

Gas instant-boiler

Limited to those with a gas consumption of 70 kilowatts or less.

2

Gas Heater

Limited to gas consumptions of 19 kilowatts or less.

3

Bath tub with gas burner

Limited to those with a gas consumption of 21 kilowatts (91 kilowatts for those with a dedicated hot water supply unit) or less.

4

Gas Burner for Bath tub

Limited to gas consumptions of 21 kilowatts or less.

5

Gas Stove

Limited to those with a total gas consumption of 14 kilowatts or less and a gas consumption of 5.8 kilowatts or less per stove burner (21 kilowatts in the case of those with gas ovens).

 

A person engaged in the business of manufacturing, importing or selling gas appliances shall not sell or display (Article 138 of the same law) 2 for sale gas appliances unless they bear the PSTG Mark3.

Therefore, manufacturers or importers of Gas Equipment are required to submit a notification (Article 140 of the same law), inspect the Gas Equipment they intend to handle to ensure that it complies with the standards for Gas Equipment (Appendix 3 of the Ministerial Ordinance on Technical Standards for Gas Equipment), and affix the PSTG Mark.

 

Product Type

Inspection

 

Specific gas supplies

l   Semi-closed combustion gas instant water heater

l   Semi-hermetic gas stove

l   Semi-hermetic combustion

l   bath tub with gas burner

l   gas burner for hot tub

It is necessary to pass a conformity inspection by a registered inspection body. Self-inspection is insufficient.

 

Registered inspection organization

Japan Gas Appliance Inspection Association

 

 

 

 

Others

l   Open-burning, closed-burning, or outdoor gas instantaneous water heaters

l   Open-burning, closed-burning, or open-air gas stoves

l   Closed-burning or open-air stoves with gas burners

l   Gas stoves

It is necessary to pass a conformity inspection, but voluntary inspection is also acceptable.

 

Prepared with reference to the Ministry of Economy, Trade and Industry website.

3: Law Concerning Maintenance of Storage and Proper Trade of Liquefied Petroleum Gas

1 General Information

The “Act on Securing the Storage of and Proper Trade in Liquefied Petroleum Gas” regulates the business of selling liquefied petroleum gas, or LP gas (Liquified Petroleum Gas).

The scope of the “liquefied petroleum gas sales business” excludes the “gas retail business” and “general gas pipeline business” regulated by the Gas Business Law, so businesses “other than pipeline type” are assumed here. In short, “gas cylinder type” businesses are assumed here.

2 Obligations of Liquefied Petroleum Distributors

The law requires registration (Article 3) of “liquefied petroleum gas distributors,” and stipulates that these distributors are obligated to deliver documents at the time of contract (Article 14), have a chief engineer, comply with standards for storage facilities (Article 16), and provide safety services (Article 27).

In addition, the Law prohibits the sale of liquefied petroleum gas that does not conform to the standards set by the Ministry of Economy, Trade and Industry, which must be observed (Article 13 of the Law, Article 12 of the Regulations).

And the distributor is required to obtain a license for each storage facility or specified supply facility (Article 36 of the Law).

In addition to the above, the security equipment to be installed (gas detectors, automatic transmission equipment for gas shutdown, and gas supply shutdown equipment) must basically use equipment that has been certified (Article 35-6).

For more information, the High Pressure Gas Safety Institute of Japan’s “LP Gas Sales Business Guide” is easy to understand.

3 Manufacturers and importers of liquefied petroleum gas appliances

Liquefied petroleum gas appliances” cannot be sold in Japan without the PSLPG mark4.

Therefore, if a manufacturer or importer of liquefied petroleum gas appliances intends to sell liquefied petroleum gas appliances in Japan, it is necessary to notify the Ministry of Economy, Trade and Industry to that effect and have the appliances inspected for compliance with the standards (Appendix 3 of the “Ministerial Ordinance Concerning Technical Standards for Liquefied Petroleum Gas Appliances”) before affixing the PSLPG mark (Article 41, Article 46 of the same law).  In particular, in the case of “specified liquefied petroleum gas appliances” (see the following table)”, it is not sufficient to conduct a voluntary inspection, but must first undergo an inspection by a registered inspection agency (Article 47 of the Law).

 

 

Product Type

Inspection

Indication

Specific liquefied petroleum gas appliances

l   Semi-hermetic instantaneous water heater

l   Semi-hermetic stoves

l   Semi-hermetic stove with burner

l   Burner for bath tub

l   Cartridge gas stove

l   Bath tub with burner

Inspection by a registered inspection agency is required. Self-inspection is insufficient.

 

Registered Inspection Body

Japan Gas Appliance Inspection Association

 

Gas tap

Registered Inspection Body: Japan Gas Appliance Inspection Association

Japan Gas Appliance Inspection Association

Japan LPG Appliance Inspection Association

 

Other Petroleum appliances

Open, sealed, and outdoor instantaneous water heaters, open, sealed, and outdoor stoves, sealed and outdoor stoves with burners, general gas stoves

Inspection is required, but voluntary inspection is also acceptable.

 

Inspection organization:

Japan Gas Appliance Inspection Association, or in-house inspection is also acceptable.

 

Regulator, high pressure hose, low pressure hose, automatic gas shutoff against earthquake

Inspection organization:

Japan LPG Appliance Inspection Association or inhouse inspections

 

 

Gas leak sensor

Inspection organization:

High Pressure Gas Safety Institute of Japan, or in-house inspection

Prepared with reference to the website of the Kanto Bureau of Economy, Trade and Industry, Ministry of Economy, Trade and Industry.

4: High Pressure Gas Safety Act

1 About the High-Pressure Gas Safety Act

Because of the potential for explosions, the High-Pressure Gas Safety Act regulates the manufacture, storage, sale, import, transfer, consumption, and disposal of high pressure gas.

2 Definition of high-pressure gas

The definition of “high pressure gas” is as follows: 1) compressed gas with a pressure of 1.0 MPa or higher5, and 2) liquefied gas with a pressure of 0.2 MPa or higher.

Even though helium and other gases in ordinary spray cans and balloons have a slightly higher pressure, they do not fall under the category of “high-pressure gas. Medical gases (oxygen) and industrial gases (acetylene, LP gas6) that are compressed under higher pressure fall under the category of high-pressure gases.

3 Manufacturing

A person who intends to manufacture high pressure gas using facilities where the volume of gas that can be manufactured (processed) is equal to or greater than the following standard values shall obtain a license as a Class 1 manufacturer (Article 3 of the same law).

Class 1 gases (helium/neon/argon/krypton/xenon/radon/ nitrogen/carbon dioxide/fluorocarbon/air)

300 sq. meters per day

Others

100 sq. meters per day

 All other manufacturers are required to submit a Class II manufacturer’s notification (Article 5, Paragraph 2 of the same law).

4 Importation of High-Pressure Gas

A person who has imported high pressure gas and its container shall not move it unless it has undergone an import inspection conducted by the prefectural governor and has been found to comply with the technical standards for import inspection (Article 22 of the same law).  However, there are certain exceptions7, such as when the product has passed an inspection by the High Pressure Gas Safety Institute of Japan or a designated import inspection organization and a notification has been submitted.

The technical standards for import inspection are to pass the content verification test and the safety level test for containers (Article 45-3 of the General High Pressure Gas Safety Regulations, Article 45-3 of the Liquefied Petroleum Gas Safety Regulations, Article 31-3 of the Refrigeration Safety Regulations).

For detailed information, please refer to the website of the Ministry of Economy, Trade and Industry and the website of the High Pressure Gas Safety Institute of Japan (Guide to High Pressure Gas Import Inspection, etc.).

5 Importation of Containers for High Pressure Gas

A person who has manufactured or imported a container for filling with high pressure gas shall not transfer or deliver the container unless it has undergone the prescribed inspection of the container by the Minister of Economy, Trade and Industry, the High Pressure Gas Association of Japan, or a person designated by the Minister of Economy, Trade and Industry, and has been stamped or marked as having passed the inspection (Article 44, Paragraph 1 of the same law)8.

6 Storage, Sales, and Transfer

A permit or notification is required for the storage of a large quantity of high pressure gas (Article 16 and 17-2), a notification is required for the sale or consumption of a large quantity (Article 20-4 and Article 24-2), and necessary measures for safety shall be taken when moving the gas (Article 23).

1 Article 9-3 of the same law and Article 1-10, Paragraph 1, Item 3 of the Cabinet Order on the Control of Dangerous Goods.
2 PSTG stands for “Product Safety of Town Gas Equipment and Appliances”.
3 However, there are certain exceptions, such as when the approval of the Minister of Economy, Trade and Industry is obtained.
4 PSLPG stands for ”Product Safety of Liquefied Petroleum Gas Equipment and Appliances”.
5 As for acetylene gas, a pressure of 0.2 MPa or higher falls under the category of high-pressure gas.
6 Liquefied petroleum gas (LP gas) is regulated by the High Pressure Gas Safety Act when used primarily for industrial purposes, and by the Liquefied Petroleum Gas Act when used primarily in homes.
7 See the proviso of the same article, Article 46 of the General High Pressure Gas Safety Regulations, and Article 45-4 of the Liquefied Petroleum Gas Safety Regulations.
8 For exceptions, see Article 44(2) of the Act and Article 5 of the Container Regulations.

Importing Consumer Products and Household Goods

Consumer Product Safety Act

1 General Remarks

 In order to ensure the safety of consumer products, the Consumer Product Safety Act establishes safety standards for certain products (“specified products”), requires products that comply with these standards to bear the PSC Mark, and prohibits the sale of products that do not bear the PSC Mark.

In addition, it stipulates certain products that require long-term maintenance (“specified maintenance products”), and it also stipulates reporting obligations in the event of a serious accident and recall obligations in the event of the discovery of a serious defect.

2 Regulations pertaining to the manufacture or import of specified products

 A person who manufactures or imports a product of a specified product may not sell or display the product unless the person has submitted a notification of the business (Article 6 of the same law) and has obtained a “PSC Mark” to indicate that the product conforms to safety standard1 (Article 4, paragraph 1 of the same law).

 With regard to the method of obtaining the PSC mark, in the case of specified products, the importer must personally inspect2 and pass the inspection to ensure that the imported product complies with the technical standards.  In addition, in the case of special specified products, it is not sufficient for importers to conduct their own inspection, but they must also pass a conformity inspection by a registered inspection body (Article 12, paragraph 1 and Article 13).

 

 

Product Category

Products

Inspections

Signs

Specific

Products

Specially Designated Products

 

Infant beds, portable laser application devices, hot water circulators for bathtubs, cigarette lighter

It is necessary to pass a conformity inspection by a registered inspection body. Self-inspection is not acceptable.

 

Others

Pressure cookers for household use, helmets, climbing ropes, oil water heaters, oil bath tubs, oil heaters

Although it is necessary to pass a conformity inspection, but self- inspection is also acceptable. 

 

3 Manufacture and import of specified maintenance products

 The Consumer Product Safety Act designates certain products that are used for a long period of time and are highly likely to cause serious accidents due to age-related deterioration as “specified maintenance products” and imposes various obligations on manufacturers and importers of such products, including safety inspections, to ensure the safety of such products.

Special maintenance products

Indoor gas instantaneous water heaters (for city gas/propane gas), oil water heaters, indoor gas bath tubs (for city gas/propane gas), oil bath tubs, built-in electric dishwashers, FF-type oil hot-air heaters, electric bathroom dryers

 

A business operator that manufactures or imports specified maintenance products shall have the following obligations.

 (1) Obligation to notify the relevant business within 30 days of the start of business (Article 32-2 of the same law).

 (2) Obligation to indicate the legal description of the special maintenance products to be sold (Article 32-3 of the same law).

 (3) Obligation to attach to the product a document (“owner’s slip”) showing the basis for calculation of the design standard specification period and the arrangement of the inspection office (Article 32-4 of the same law).

 (4) An obligation to explain, at the time of delivery of the product to the consumer, (i) that there is a risk of danger in the use of the product due to age-related deterioration, (ii) that maintenance work such as inspections must be carried out to prevent danger, and (iii) an outline of the procedures for maintenance and inspection (Article 32-5 of the same law).

 (5) Obligation to inspect products in accordance with inspection standards3 (Article 32-15 of the same law).

 (6) Obligation to provide advance notice of inspections (Article 32-12 of the same law).

Household Goods Regulation Law

 The “Law Concerning the Regulation of Household Products Containing Harmful Substances” (Household Goods Regulation Law) implements certain regulations to prevent health hazards caused by chemical substances contained in household products.

1Refer to the technical standards in Appendix 1 of the “Ministerial Ordinance on Technical Standards, etc. for Specified Products Relating to the Ministry of Economy, Trade and Industry.
2 The contents of the inspection must be recorded and preserved (Article 13 of the same law).
3 See Article 13 of the “Ministerial Ordinance on Specified Maintenance Products Relating to the Ministry of Economy, Trade and Industry” for inspection standards.

Asbestos and Asbestos-Containing Materials

Asbestos and asbestos-containing materials

The Occupational Safety and Health Law, which sets standards for the safety and health of workers, regulates asbestos and materials containing asbestos because asbestos dust has caused mesothelioma and lung cancer in many workers. In accordance with the Law, importation of asbestos and asbestos-containing materials requires an import permit, and customs requires a copy of the import permit to be submitted.

Importing Electrical Appliances and Materials

This article contains information on the importation of electrical appliances and material. Relevant laws include the Electrical Appliance and Material Safety Law, the Radio Law, the Public Management Law (Pachinko Machines).

General Information

 When importing electrical goods, a number of laws may be relevant, including the Electrical Appliance and Material Safety Law, Consumer Product Safety Law, Household Goods Control Law, Household Goods Quality Labeling Law, Industrial Standardization Law (JIS Law), Home Appliance Recycling Law, Law for Promotion of Effective Utilization of Resources, Energy Conservation Law, Radio Law (wireless communication equipment), Telecommunications Business Law (Devices for communication terminal), Water Supply Law (water supply equipment), and Entertainment Law (pachinko machines).  In addition, the Food Sanitation Law (juicers, coffee makers) and the Pharmaceutical Affairs Law (medical devices such as electric massage machines), which have already been explained, may also be relevant.

Electrical Appliance and Material Safety Law

1 General Information

 The Electrical Appliance and Material Safety Law regulates the manufacture, import, and sale of a wide range of electrical appliances and materials in order to ensure the safety of electrical appliances and materials.

2 Notification of Manufacturers and Importers

A manufacturer or importer of electrical appliances and materials must notify the Minister of Economy, Trade and Industry of its address and the type of electrical appliances and materials it handles within 30 days of the commencement of its business.  In addition, foreign corporations that have not registered a branch office or a representative in Japan are not allowed to submit the notification1.

3 Compliance with Safety Standards and PSE Mark

A manufacturer or importer of electrical appliances and materials shall comply with the technical standards when manufacturing or importing electrical appliances and materials (Article 8, Paragraph 1)2.  The relevant standards are set forth in the “Ministerial Ordinance on the Technical Standards for Electrical Appliances and Materials”.

 In the case of specified electrical appliances and materials (electric pumps, vending machines, electric toys, etc.3), a technical standards conformity inspection must be conducted by a registered inspection body and a certificate of conformity must be issued (Article 9 of the same law). In the case of other electrical appliances (electric kotatsu, electric refrigerator, electric razor, electric stand,), the inspection shall be conducted voluntarily, and the inspection records shall be prepared and stored (Article 8, paragraph 2).

Manufacturers and importers of electrical appliances and materials may display the PSE Mark4 on their electrical products if they have fulfilled the above obligations, while sales of electrical appliances and materials without the PSE Mark are prohibited (Article 27).

 

Products

Inspections

Indication

specified electrical appliance5

l   Electric water heaters

l   Electric heating and electric toys

l   electric pumps,

l   electric massagers,

l   vending machines,

l   DC power supply equipment 

and more than 100 other items

It is necessary to pass a conformity inspection by a registered inspection body. Self-inspection is not sufficient. 

As of the date of publication of this document, the registered inspection bodies include Intertec Japan K.K., TÜV Rheinland Japan K.K., the Research Institute of Electrical Safety and Environment, the Japan Quality Assurance Organization, and the Electric Wire Technical Center. For details, see the METI website.

Other Electrical Appliances

Electric kotatsu/electric kettle/ electric refrigerator/electric toothbrush/electric razor/incandescent lamp/electric stand/television receiver/audio equipment/lithium-ion storage battery

and more than 300 other items

 

It is necessary to pass a conformity inspection, but inhouse inspection is also acceptable.

 

Note that smartphones and notebook computers are basically exempt from PSE as enumerated, but lithium-ion batteries and AC/DC adapters are subject to PSE, so it is easy to make a wrong judgment.

4 Long-term use of product safety indication system

For certain products (fans, air conditioners, electric washing machines and electric dehydrators, CRT televisions, ventilation fans) that often cause accidents due to aging and deterioration, labeling of standard use periods and precautions is mandatory6.

Radio Law

1 About the Radio Law

 Radio waves are used in various technologies such as smartphones, WI-FI (wireless LAN), radios, and drones, and the Radio Law regulates the use of radio waves.

 Radio waves are limited in frequency, and radio waves of the same frequency interfere with each other, making it impossible to listen to the radio if an illegal wave is broadcast.

 Therefore, technical standards and specifications for frequency distribution and management have been formulated, and a licensing system for the establishment of radio stations has been established.

2 What is a license under the Radio Law?

 When establishing a radio station that transmits radio waves, it is necessary to obtain a “radio station” license (Same law 4 this article).

 The term “radio station” may conjure up images of large-scale equipment, but cell phones, wireless microphones, transceivers also emit radio waves and thus fall under the category of radio equipment.

 Therefore, the Radio Law states that if there is no or little risk of interference between radio waves, there is no need to obtain a license7. Specifically, in the cases listed in the following table, no license is required.

1

weak-wave wireless equipment

A license is not required if only equipment that emits extremely weak radio waves8 is used. Exceptions may be made for in-vehicle FM transmitters9, wireless microphones, remote controls, car keyless entry, wireless headphones, radio-controlled devices, anti-shoplifting devices, and RFID devices.

2

Civil Radio Station

No license will be required for civil radio stations using radio equipment (limited to those with a technical compliance mark).

3

Low-power special-purpose radio stations

(Low-power radio station)

 

A license is not required for radio stations using low-power radio equipment for certain applications (limited to those with a technical compliance mark).  A wide variety of applications have been specified, including low-power security systems (home security, fire alarms), low-power data communication systems (wireless LAN, Bluetooth), and cordless phones.

4

Simplified radio station

(Registered station)

For the following types, registration is considered to be sufficient instead of a license10

・PHS radio station base stations (with an aerial power of 1 watt or less) and repeaters

・Premises radio stations (920 MHz band/2.4 GHz band)

・Base stations for radio access systems (5 GHz band)

・Digital simplex radio stations (350 MHz band)

Since the general public uses radio equipment (cell phones) without obtaining a license or registration, it is considered important for manufacturers/importers to make products with the “weak radio mark11” (see (1)) or with the “technical conformity mark” [for low-power radio stations] (see (3)) if they want to make them widely available to the general public.

None of the exceptions in (1) through (4) above can be utilized for cell phones. For cell phones, the base station and the handset (corresponding to a land mobile station) are considered as a pair, and the cell phone operator is supposed to apply for a license for both, so the user does not need to apply for a license under the Radio Law.

3 Standard Certification System under the Radio Law

The Radio Law stipulates the technical standards specified in the Radio Law for a certain range of radio equipment, “Specified Radio Equipment”. to be used for small-scale radio stations, and a system has been established in which a person registered by the Minister of Internal Affairs and Communications (registered certification body) judges whether or not the equipment complies with the relevant standards.

The following table simplifies the licensing procedures for radio stations that use radio equipment bearing the technical conformity mark.

Translation of [Source: Japan Electronics and Information Technology Industries Association (JEITA) website.]

First, for specified low-power radio stations, Wi-Fi, Bluetooth, BLE, Zigbee, etc., no license or registration is required as long as the radio equipment with the technical compliance mark is used (Category 1 above; Article 38-2-2, Paragraph 1, Item 1 of the same law).

Second, in the case of cell phones, 5G, LTE and WCDMA handsets (“specified radio stations”), a comprehensive license can be obtained, eliminating the need for inspections of each individual radio installation (Category 2 above; Article 38-2-2, Paragraph 1, Item 2 of the same law). Taking cell phones as an example, it is not necessary for users to open their own radio stations to use cell phones, since telecommunication carriers, etc. have obtained a comprehensive license in advance on behalf of the actual users.

Third, in the case of base stations other than those mentioned above (radio buoys, on-premises radio), these devices can be used by eliminating the need for inspection when obtaining a license, or by substituting a simpler radio station registration for obtaining a license (Category 3 above; Article 38-2-2, Paragraph 1, Item 3 of the same law).

4 Obtaining the “Technical conformity mark” based on the Radio Law

Under the licensing and registration system mentioned in the previous section, most of the radio equipment in general use bears the mark of Technical Regulations Conformity Certification, the so-called “Technical Conformity Mark”. 

For example, the wireless LAN-compatible router (manufactured by NTT) for my personal use, has a technical compliance mark as shown below.

T Certification Number:××× ×× ×××× ×××

R Certification Number:×××―××××××

 

The R mark is an indication of conformity to the technical standards (“Technical Regulations”) under the Radio Law.  It is often attached to things that generate radio waves such as wireless microphones, transceivers, cell phones, routers.

The T mark is an indication of compliance with technical standards under the Telecommunications Business Law.

It is often attached to terminals that connect to the facilities of a telecommunications carrier such as NTT’s communication facilities, (smartphones/old cell phones, analog phones, fax machines, and routers.

Basically, devices that do not have the technical compliance mark on them cannot be used in Japan. The same applies to imported foreign products, as it will explained in the next section.

The requirements and standards for obtaining the “technical conformity mark” are specified in the “Regulations Concerning Technical Regulations Conformity Certification of Specified Radio Equipment”.

In order to obtain the “technical conformity mark”, a conformity inspection to the technical standards12 by a registered certification body is required. However, there have been certain exceptions such as the special specified radio equipment.  If the contractor verifies the construction design by himself and confirms that it conforms to the technical standards, the contractor can be considered to have obtained the technical standards conformity certification. The “Technical conformity mark” can be obtained by submitting the prescribed notification to the Minister of Internal Affairs and Communications after self-confirmation (Article 38-33 of the same law).

For specific test methods, please refer to the website13 of the Ministry of Internal Affairs and Communications.

5 Regulations on imports

 In relation to imports, the Radio Law provides for exceptions to the importation of radio equipment.  First of all, in order to import “specified radio equipment” from overseas and use it in Japan without a license, it is necessary to obtain a technical standards conformity certification from a registered certification body and attach a technical conformity mark (Article 38-6 of the same law).  Even if a product already has an American FCC mark standard or the European EC mark standard affixed to it, indicating that it has undergone conformity assessment under foreign standards, it must be given a new Japanese technical compliance mark.

However, when importing products from countries that have concluded a Mutual Recognition Agreement (MRA), such as the U.S., Europe, and Singapore, if the product is certified by a certification body in these countries, it will be treated as if it has obtained a Technical Regulations Conformity Certification and can bear the Technical Regulations Conformity Mark12.

 In addition, importers who imports transceivers of foreign standards shall endeavor to avoid importing radio equipment that does not conform to the technical standards specified in the Radio Law (Article 102-11, paragraph 1 of the same law). When a radio station using equipment that does not conform to such standards is likely to interfere with the radios of other radio stations or cause serious adverse effects on their operation, the Ministry of Internal Affairs and Communications may issue recommendations and orders to take the necessary measures (Article 102-11, Paragraph 2 and Paragraph 4 of the same law)14.

 

Public Management Law (Pachinko Machines)

 The Entertainment Establishments Control Law does not specifically regulate the importation of pachinko machines, but prefectural approval is required for the replacement of pachinko machines (Application mutatis mutandis of Article 9, paragraph 1 pursuant to Article 31-23 of the Act), and pachinko machines cannot be used for pachinko business unless they do not meet the standards set by the National Commission (Article 20, Paragraph 1 of the Law).

 As a result, approval for machines to be installed in pachinko parlors cannot be granted unless the Public Safety Commission certifies that the machines in question do not meet the standards set by the National Commission, effectively making it impossible to install them.  Application procedures for certification are described in the “Regulations Concerning Certification and Model Approval of Amusement Machines”.  If the type has already been verified, this approval procedure will be simplified.

 Therefore, as an importer, it is useful to apply for certification for pachinko machines (Article 20, Paragraph 4 of the Law) and obtain approval for the model of the machine to be imported before importing the machine.

1 See Product Safety Division, Ministry of Economy, Trade and Industry, “Questions Concerning the Electrical Appliance and Material Safety Law” (regarding the possibility of notification by overseas businesses).
2 With the approval of the Minister of Economy, Trade and Industry, except in the case of experimental manufacture and import (proviso of paragraph 1 of the same Article).
3 For details, see Appendix 1 of the Enforcement Order.
4 PSE stands for “Product Safety” and “Electronic Appliance and Materials”.
5 The specific scope of “specified electrical appliances” and “other electrical appliances and materials” in relation to the Electrical Appliance and Material Safety Law is described in the upper and lower columns of Appendix 1 and 2, respectively, of the Enforcement Order of the Law.
6 Article 8, paragraph 1 of the same law, and Article 20 of the Ministerial Ordinance on the Technical Standards for Electrical Appliances and Materials.
7 See the proviso of Article 4 of the Act and the items of the same Article. For more details, see the Ministry of Internal Affairs and Communications’ website on “Radio Utilization HP – Radio Stations Not Requiring License or Registration.
8The standard for “extremely weak” differs for each frequency, but the electric field strength at a distance of 3 meters from the radio station is (1) 500 microvolts per meter or less for frequencies of 322 Mhz or less, (2) 35 microvolts per meter or less for frequencies of 322 Mhz to 10 GHz, and (3) 150 microvolts per meter or less for frequencies of 10 GHz to 150 GHz. is … etc. (Article 6, Paragraph 1, Item 1 of the Regulations). The standard for radio-controlled oscillators and radio microphones is a field strength of 200 μV/m or less at a distance of 500 meters from the radio equipment. The details are specified in the Ministry of Internal Affairs and Communications public notice (“Uses and Radio Types and Frequencies of Radio Stations Not Requiring a License under Article 6, Paragraph 1, Item 2 of the Ordinance for Enforcement of the Radio Law”). The details are specified in the Notification of the Ministry of Internal Affairs and Communications (“Uses, Types and Frequencies of Radio Stations Not Requiring a License under Article 6, Paragraph 1, Item 2 of the Enforcement Regulations of the Radio Law”).
9 An FM transmitter is a device used to listen to music from a device connected to the car’s cigarette lighter socket through the FM radio equipment in the car.
10 See Article 4, Item 4 of the Law and Article 16 of the Regulations.
11 The Japan Automobile Manufacturers Association (JAAMA) and the Electro-Magnetic Compatibility Council (EMCC) are voluntarily attaching the “weak radio conformity mark” (ELP mark) to weak radio equipment that has been fairly tested and conforms to the technical standards for weak radio equipment. Although it is not obligatory to affix the ELP mark, it enables users to confirm that the equipment is weak radio equipment at the time of purchase.
12 See “Regulations Concerning Technical Regulations Conformity Certification, etc., of Specified Radio Equipment”.
13 Ministry of Internal Affairs and Communications, “Radio Utilization Homepage – List of Specified Radio Equipment and Special Specified Radio Equipment”.
14 Article 33 of the “Law Concerning the Implementation of Mutual Recognition between Japan and Foreign States of the Results of Conformity Assessment Procedures for Specified Equipment

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Importing Firearms, Swords, or other Weapons

This article details the importation of weapons such as firearms and sword, which is regulated by the Act for Control of Possession of Firearms or Swords and Other Such Weapons.

Act for Control of Possession of Firearms or Swords and Other Such Weapons

The Firearms Control Law regulates the possession of swords1, guns, rifles, machine guns or artillery, gun cartridges, and gun parts (Article 3 to Article 3-6 of the Law). Exceptions are (i) when a permit to possess is obtained (Sections 4 and 6 of the Act), and (ii) when a “firearms and swords registration certificate” is obtained for old-style firearms and swords of artistic value.

When importing unregistered old-style firearms or swords of artistic value from overseas, it is necessary to obtain a “certificate of registrability” upon importation in order to obtain registration.

When importing, it is assumed that the product can be legally possessed after importation, so customs will check the possession permit/firearms and swords registration certificate/certificate of registrability or a copy of these in accordance with the Customs Law.

In addition, in relation to the Foreign Exchange and Foreign Trade Law, the import of swords, guns, gun cartridges, and gun parts requires import approval from the Minister of Economy, Trade and Industry, so it is necessary to pay attention to its procedure2.

1 “Swords” means swords with a blade length of 15 cm or more, javelins and naginatas, swords with a blade length of 5.5 cm or more, daggers, and flying knives with a device that automatically opens the blade at 45 degrees or more (Article 2, Paragraph 2 of the Firearms Act).
2 See “93-02” to “93-05” in the first part of item 2-2 of the import announcement.


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Importing Chemicals

This article details regulations covering the import of chemicals such as the Chemical Substances Control Law, the Pollutant Release and Transfer Register Law (PRTR Law), and the Poisonous and Deleterious Substances Control Law.

 

The Chemical Substances Control Law

The import of chemical substances is regulated by “Chemical Substance Control Law”, as shown in the following table.

New chemical substances

・In the case of imports, notification is basically required (Law 3). Upon receiving the notification, a safety assessment is conducted and the results are notified to the notifier (Law 4).

・Foreign manufacturers may also submit notifications of new chemical substances (Law 7).

General chemical substances

・Importers must submit a notification of the amount imported for each general chemical substance every fiscal year (Law 8).

Priority Assessment Chemical Substances8

・Importers must submit a notification of the import quantity for each priority assessment chemical substance every fiscal year (Law 9).

Monitored chemical substances

・Importers must submit a notification of the import quantity for each monitored chemical substance every fiscal year (Law 13).

 

Class 1 chemical substances

・Any person who intends to import shall obtain a permit.

However, this shall not apply in the case of import for the purpose of testing and research (Same as the proviso).

Products using Class 1 chemical substances

Import is Prohibited (Law 24).

Class 2 chemical substances

・Notification is required. In case of importing more than the notified quantity, notification of change is required.

Products using Class 2 chemical substances

・Same as above.

Substances to be reported (Priority Assessment, Monitoring, Class II and General Chemical Substances)

・The importer shall report the results of the hazard investigation when it has been conducted and the hazard has been confirmed (Law 41).

If you would like to know more, please refer to the Ministry of Economy, Trade and Industry’s “What is the Chemical Substances Control Law?”

 

The Pollutant Release and Transfer Register Law (PRTR Law)        

In accordance with the Law Concerning Reporting of Releases to the Environment of Specific Chemical Substances and Promoting Improvements in Their Management, certain businesses are required to report the amount of Class I Designated Chemical Substances released into the environment and the amount transferred as waste (Article 5).

In addition, when a business operator provides a Class I Designated Chemical Substance, a Class II Designated Chemical Substance, and certain products containing these substances to another business operator, it is required to provide the other party with information on the chemical substance (Article 14). A Security Data Sheet (SDS) will be provided to provide this information.

Targeted businesses are defined according to the type of business, number of employees, and annual handling volume of target chemical substances. It should be noted that importers may also fall under the category of covered entities.

If you want to know more, you can refer to the Ministry of the Environment’s “PRTR Information Plaza” website.

 

The Poisonous and Deleterious Substances Control Law

1 Definition of Poisonous and Deleterious Substances

Among chemical substances, those with high toxicity are called poisons and those with low toxicity are called deleterious substances, and the scope of each is specified in Appended Table 1 and Appended Table 2 of the Poisonous and Deleterious Substances Control Law9.  the product is a drug or quasi-drug, it is not subject to the Poisonous and Deleterious Substances Control Law, but is regulated by the Pharmaceutical Affairs Law.

 

2 Importation of Poisonous and Deleterious Substances

(1) General Information

According to the Poisonous and Deleterious Substances Control Law, only companies registered as importers of poisonous10 and deleterious substances11 may import poisonous and deleterious substances for the purpose of selling or giving them away (Article 3.2). This means that anyone who imports poisonous or deleterious substances for the purpose of transferring ownership to a third party, whether for a fee or free of charge, is required to register as an importer. 

 Those who are not registered as importers are in violation of the above regulations unless they are importing for their own use or purpose.

 

(2) Import of poisonous or deleterious substances for the purpose of sale or award by a registered importer

 For importation by a registered importer, a copy of the registration certificate for the importation of poisonous and deleterious substances is required.

 When a person intends to import a poisonous or deleterious substance of an item other than a pre-registered item, he/she must obtain a change in the registration of the poisonous or deleterious substance (Article 9).

 

(3) Importation for purposes other than selling or giving away

(a) Import of ordinary poisonous and deleterious substances

In the case of importation for purposes other than sale or award, the issuance of an import confirmation certificate may be permitted in the following cases: ① for testing and research, ② for internal samples, ③ for personal use, ④ for personal use by medical personnel12, ⑤ for re-imported or returned goods, and ⑥ for personal consumption13.

 

(b) Import of specified deleterious substances

With regard to specific poisons14, only researchers of specific poisons are allowed to import specific poisons.

 

(4) Sales and distribution

After importation, those who sell or give away deleterious or poisonous substances are required, in principle, to register as a distributor for each business office or store(Article 3.3)15. This means that importers have to wholesale to registered [distributors].

 

(5) Main duties of importers and distributors

Sellers and importers of poisonous and deleterious substances are required to appoint a person in charge16 of handling each business office or store where they are directly handled, and take charge of the prevention of harm(Article 7). A person in charge of handling poisonous and deleterious materials shall be appointed from among those who meet the qualification requirements of a pharmacist and a person who has passed the examination for handling poisonous and deleterious materials (Article 8).

In addition, sellers and importers are obligated to (1) take measures to prevent theft and loss of poisonous and deleterious substances (Article 11, Paragraph 1), (2) take measures to prevent dispersal and leakage (Article 11, Paragraph 2), (3) properly store poisonous and deleterious substances during transportation (Article 11, Paragraph 3 and Article 16), and (4) label poisonous and deleterious substances on containers and packaging (Article 12).

 

(6) Relationship with import approval under the Foreign Exchange and Foreign Trade Law

For poisons and deleterious substances, import approval is basically required.  The items that require import approval are explained in another section, but the phrase “poisonous and deleterious substances” does not appear there, so it is difficult to understand that import approval is required, but depending on the type of poisonous and deleterious substances, they fall under the substances specified in the Chemical Substances Control Law (Approval of No. 2 and No. 2-2), the substances specified in the Montreal Protocol (Approval No. 2 and No. 3), and the substances specified in the Agricultural Chemicals Control Law (Approval No. 3). In the case of approval No. 3, import confirmation is sufficient, but an application for a certificate of confirmation of import of poisonous or deleterious substances is required, and the procedures related to the application are carried out in accordance with the Guidelines for Confirmation of Import of Poisonous and Deleterious Substances.

1See “Ministerial Ordinance Determining Cases Not Requiring Registration under Article 3, Paragraph (1) of the Agricultural Chemicals Control Act“.
2 See Ministry of Agriculture, Forestry and Fisheries, “Handling at the time of import customs clearance of agricultural chemicals based on the Agricultural Chemicals Control Law,” 4(3).
3 The Minister of Agriculture, Forestry and Fisheries and the Minister of the Environment designate as specified pesticides those that do not pose a risk of harm to humans, livestock, or crops in light of their raw materials, and exclude them from registration. Currently, five types of pesticides are designated: baking soda, vinegar, natural enemies that live in the area, ethylene, and hypochlorite water (limited to that obtained by electrolysis of hydrochloric acid or potassium chloride solution).
4 It appears that the submission of documents for import verification is not required (see 4(3) of the Ministry of Agriculture, Forestry and Fisheries’ “Handling of Import Customs Clearance of Agricultural Chemicals under the Agricultural Chemicals Control Law”).
5 Import and Export of Agricultural Chemicals” (Notification of the Director-General of the Production Bureau, Ministry of Agriculture, Forestry and Fisheries, No. 14 Production No. 9525, dated February 28, 2003)
6 Import and Export of Agricultural Chemicals” (Notification of the Director-General of the Production Bureau, Ministry of Agriculture, Forestry and Fisheries, No. 14 Production No. 9525, dated February 28, 2003)
7 Import and Export of Agricultural Chemicals” (Notification of the Director-General of the Production Bureau, Ministry of Agriculture, Forestry and Fisheries, No. 14 Production No. 9525, dated February 28, 2003)
8 Excluding Class 2 Specified Chemical Substances.
9 Be sure to pay attention to the extension of the scope of poisonous and deleterious substances in accordance with the revision of the Cabinet Order on June 24, 2020.
10 The term “poison” refers to substances listed in Appended Table 1 of the Poisonous and Deleterious Substances Control Law, other than pharmaceuticals, quasi-pharmaceuticals, and in vitro diagnostic pharmaceuticals. For example, yellow phosphorus, sodium cyanide, mercury, arsenic, etc.
11 The term “deleterious substances” means substances listed in Appended Table 2 of the Poisonous and Deleterious Substances Control Law, other than drugs, quasi-drugs, and in vitro diagnostic drugs. For example, ammonia, hydrogen chloride, carbon tetrachloride, sulfuric acid, etc.
12 This refers to cases where there is an urgent need for treatment, no alternative products are available in Japan, and the medical personnel who imported the product intend to use it for the diagnosis or treatment of their own patients under their own responsibility. Cases in which veterinarians import products for the purpose of diagnosing or treating their own animals under their own responsibility are also treated in the same way.
13 This refers to cases where the product is used as a raw material for the company’s own products, or for the manufacture of the company’s own drugs, etc. for which approval, etc. has been obtained.
14The term “specified deleterious substances” refers to the deleterious substances listed in Appended Table 3 of the Poisonous and Deleterious Substances Control Law (and Article 3 of the Poisonous and Deleterious Substances Control Order). Octamethyl Pyrophosphoramide (also known as Schlardin), tetraalkyl lead, monofluoroacetic acid, etc.
15 However, if a registered importer or a registered manufacturer sells only to a registered manufacturer, a registered importer, or a registered distributor, registration as a distributor is not required.
16 Sellers who do not directly handle poisonous or deleterious substances, but only receive orders and make shipping arrangements (=ordered sellers), do not need to appoint a person in charge of handling poisonous or deleterious substances.