Importing Specified Products

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 standard 1 (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 of the same law).

 

 

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).

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.


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Importing Rice, Wheat, Sugar, Starch

There are also laws concerning certain sections of food. Below is information pertaining to importing rice and wheat and sugar and starch into Japan.

1. Rice and Wheat

Since there is a large price difference between domestic and foreign prices, the Japanese government buys rice and wheat from importers at a lower price, sells them back to the importers at a higher price, and pays the difference to the government which is used to support domestic farmers.

In relation to rice, the following items are subject to tax payment: (1) rice grains (= rice husks, brown rice, polished rice, crushed rice), (2) rice flour, (3) ground rice grains and meal, (4) rice cakes, dumplings, and other similar food preparations of rice grains (= rice snacks, sake, sweet sake)1, (5) Granular rice grains that have been cooked or otherwise prepared by heating in advance (= rice balls/ rice burgers/ red rice/ rice balls/ boiled rice/  fried rice/ lunchboxes including rice/ frozen food/ retort food/ packaged rice/ germinated brown rice)2.

In relation to wheat, these include (1) wheat, (2) wheat flour, barley flour, unpolished wheat flour and (3) ground wheat meal, barley meal3

When importing rice and wheat which are subject to these payments, the payment must be made after submitting a payment request form, receiving a delivery notice, and submitting a receipt for the delivery notice and its copy to customs.

However, in cases where the goods are exempted from customs duties, such as portable goods for personal use by the entrant, unaccompanied shipments (100 kg or less per year in the case of rice), relief goods, and sample goods, payment of adjustment fee is not required.

In this case, the person who intends to import these grains, shall notify the Minister of Agriculture, Forestry and Fisheries.

 

2. Sugar and Starch

There is a significant difference in prices between sugar imported from overseas and sugar produced in Japan.  For this reason, the “Law Concerning Price Adjustment of Sugar and Starch” collects an adjustment fee from imported sugar, which are inexpensive, and uses it as a financial resource to provide support to domestic sugar cane producers and manufacturers of sugar cane and sugar sweeteners, thereby eliminating the difference between the prices and maintaining a stable supply of sugar in Japan.

Under the Law, importers of sugar and other products are required to sign a written sale and repurchase agreement between Agricultural and Livestock Industries Corporation (ALIC) and the importer before declaring the import to customs, and pay the difference between the sale and repurchase to ALIC as an adjustment payment.  However, there are some exemptions related to duty exemption4.

A “Letter of Acceptance for Purchase and Repurchase” or a copy thereof issued by ALIC is required at the time of customs clearance.   

The products subjected to this is designated sugars5, isomerized sugars, mixed isomerized sugars, imported sweetened preparations, starch, and imported agricultural products used as ingredients for starch.

1 Excluding those for infants or for dietary use, or those containing less than 30 percent of the total weight of rice grains.
2 Except for those containing less than 30 percent of the total weight of rice grains.
3 See “Handling of Rice and Wheat at the Time of Import Customs Clearance under the Law Concerning Stabilization of Supply, Demand and Prices of Major Foodstuffs.
4 See “Handling of Designated Sugars, Isomerized Sugars, etc., Imported Sugar Prepared Products, and Designated Starch, etc. at Import Customs Clearance under the Law Concerning Price Adjustment of Sugar and Starch.
5 Raw sugar, high-sugar raw sugar, refined sugar, sugar in ice, sugar cubes, special sugar, and sugar mixed with glucose or other sugar other than sugar, other than those to which flavoring agents are added or those that are colored.


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Regulations related to Importing Animals

Section 1 General Information

When importing animals into Japan, quarantine may be required in accordance with laws and regulations.

Rabies Prevention Law

Dogs, cats, raccoons, foxes, skunks

Communicable Diseases and Medical Care Law

Monkeys

Act on Domestic Animal Infectious Diseases Control

Even-toed ungulates, horses, poultry, dogs, rabbits, bees

Law for the Protection of Fishery Resources

Salmon, carp, goldfish, shrimp

In addition, a certificate of legal capture may be required for the import of birds under the Bird and Beast Protection Law, and certain procedures may be required for the import of butter under the Livestock Management Stabilization Law. As for endangered species, the import of plants and animals designated by the Convention on International Trade in Endangered Species is prohibited or requires import approval, and import permits are required under the Species Survival Law. The importation of specified foreign species, which may cause a collapse of the ecosystem, may be greatly restricted under the Invasive Alien Species Act. 

 

Section 2 Rabies Prevention Law (Dogs, Cats)

Dogs, cats, raccoons, foxes, and skunks must be quarantined for importation to prevent rabies.  An import quarantine certificate or a copy thereof is required at the time of import.

 

Section 3 Infectious Diseases Control Law

1 Prohibition of Importation of Designated Animals

The Act on Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases prohibits the importation of “designated animals” specified by government ordinance in order to prevent the spread of infectious diseases that can be transmitted to humans.

Designated animals to be targeted

Weasel badgers, bats, monkeys, raccoon dogs, civets, prairie dogs, and house mice (English name: Mastomys)

However, monkeys are exceptionally allowed to be imported from a specified region (the U.S.) if the import is necessary for a certain purpose (such as testing and research at a research institution).

 

2 Regulations pertaining to the import of animals other than designated animals

There are also restrictions on the import of animals other than “designated animals”. When importing (1) animals other than “designated animals” that are likely to transmit infectious diseases to humans or (2) dead animals that are likely to transmit infectious diseases to humans, a notification must be submitted to the Minister of Health, Labor and Welfare with a certificate from the government agency of the exporting country attached.

In addition, permits and notifications are required for the importation of Class I pathogens, Class II pathogens, and Class III pathogens.

 

3 Details

A more detailed explanation of the regulations pertaining to importation based on the Infectious Disease Control Law is given in the following table.

Subject to import restrictions

Types of regulations pertaining to imports

Weasel badgers, bats, raccoons, civets, prairie dogs, and shrew rats (English name: Mastomys)

All imports are prohibited. 

Monkeys

Import for testing, research, and exhibition as part of the work of a testing and research institution or a designated zoo

○Import from the United States, Indonesia, Guyana, Cambodia, Suriname, People’s Republic of China, the Philippines or Vietnam is allowed.

○Prior to import, the product must be quarantined in the exporting country and a certificate issued by the government agency of the exporting country stating that there is no risk of Ebola or Marburg disease must be attached.

○Prior notification of importation is required.  The notification must be made between 70 days and 40 days prior to arrival in Japan.

○Imports are limited to Narita International Airport and Kansai International Airport, and must undergo a minimum of 30 days mooring inspection for quarantine upon arrival in Japan.

○Customs will check the “Import Quarantine Certificate” or a copy thereof. 

Imports not listed above

○Imports from all over the world are prohibited.

○In cases falling under this category, the importation of monkeys, including the carrying importation of pet monkeys taken abroad, will not be permitted.

Notifiable animals

(1) The following animals

-Mammalian animals (terrestrial)

-Birds

Parrots/sparrows/pigeons/ hawks/owls

(2) Dead bodies of the following animals:

-Carcasses of rodents

-Carcasses of rabbits

A person who intends to import shall submit a notification of import, and shall attach a sanitation certificate or a copy thereof to the notification.

Class I pathogens

Ebola hemorrhagic fever/ Lassa fever/South American hemorrhagic fever/pox/ Crimean-Congo hemorrhagic fever/ Marburg disease

○Import is prohibited.

○However, this shall not apply when a possessor of a Specified Class I Pathogen imports a Specified Class I Pathogen that is designated by the Minister of Health, Labor and Welfare as one that needs to be procured from a foreign country.  Customs will require a certificate of designation of import of the specified type of pathogen, or a copy thereof.

Class II Pathogens

SARS corona/plague/ botulism/tularemia/anthrax

A person who intends to import must obtain a permit from the Minister of Health, Labor and Welfare. Customs will require a permit for importation or a copy thereof.

Class III Pathogens

Tuberculosis/typhoid fever/ rabies

Import notification must be submitted within 7 days of the date of import.

 

Section 4 Livestock Infectious Disease Control Law

In order to prevent the outbreak of infectious diseases in livestock (cattle disease, foot-and-mouth disease), the Livestock Infectious Disease Control Law establishes the following import restrictions in general.

・Prohibit the import of prohibited items.

・Notification of importation of certain pathogens (known pathogens and not pathogens that cause surveillance epidemics)

・Attachment of Inspection Certificate for Importation of Designated Quarantine Items

・Notification to the Animal Quarantine Station regarding the import of animals (designated by the Minister of Agriculture, Forestry and Fisheries) among designated quarantine items.

 

 A more detailed explanation is given in the following table.

Import Prohibited Items

(i) Objects set forth in each item of Article 37, paragraph 1 of the Act that have been shipped from or through regions designated by the Minister of Agriculture, Forestry and Fisheries.

(ii) Pathogens of communicable diseases of livestock under surveillance

(iii) Pathogens of infectious diseases of unknown livestock

Import is prohibited. However, in the case of special circumstances such as testing and research, importation is permitted with permission. If a permit is granted, an import permit certificate must be shipped with the prohibited goods.

Pathogens of infectious diseases pertaining to livestock other than (ii) and (iii) above

Any person who intends to import shall notify the Minister of Agriculture, Forestry and Fisheries.

Designated quarantine items designated by the Minister of Agriculture, Forestry and Fisheries as requiring quarantine, and specifically refers to the following

(1) Animals (even-toed ungulates, horses, domestic animals, dogs, rabbits, bees) or their carcasses

(2) Eggs of domestic animals

(3) Any part of the animal in (1) above

(4) Milk products, semen, fertilized eggs, unfertilized eggs, and manure of the animal in (1)

(5) Bone meal, meat meal, meat and bone meal, blood meal, skin meal, feather meal, hoof horn meal and organ meal of animals in (1)

(6) Sausage, ham and bacon made from (3) above

(7) Grain straw and hay for animal feed

(8) Articles to be imported with permission under the proviso of Article 36, paragraph 1 of the Act.

・No importation shall be permitted unless it is accompanied by an inspection certificate issued by the government agency of the exporting country and stating that it is confirmed or believed that there is no risk of spreading the pathogens of the monitored infectious disease as a result of the quarantine, or a copy thereof (Article 37 Section 1).

・Imports of designated quarantine item shall notify the Animal Quarantine Station of such fact and undergo an inspection without delay after the arrival of the cargo in Japan. Specifically, an application form for import inspection is to be submitted to the Animal Quarantine Service with the inspection certificate of the exporting country attached.

・The animal quarantine officer may also conduct the importation of the designated quarantine items to be imported prior to the importation on board the vessel or aircraft. If there are no problems based on these inspections, an import quarantine certificate will be issued, and the designated quarantine item will be marked with a clear seal, inlay or other mark. 

Animals that are designated as quarantine items by the Minister of Agriculture, Forestry and Fisheries.

(1) Even-toed ungulates and horses

(2) Poultry

(3) Dogs

 A person who intends to import shall notify the animal quarantine station of the species and quantity of such animals, the time and place of import and other matters provided for in the Ordinance of the Ministry of Agriculture, Forestry and Fisheries as provided for in the Ordinance of the Ministry of Agriculture, Forestry and Fisheries. However, this shall not apply in the event of importation as portable goods or postal items or as otherwise provided for in the Ordinance of the Ministry of Agriculture, Forestry and Fisheries.

 

Section 5: Bird and animal protection law

In principle, birds and animals (including processed products thereof as specified by the Ordinance of the Ministry of the Environment) or eggs of birds may not be imported unless accompanied by a certificate from a foreign government certifying that they have been legally captured or collected.

In addition, after importation, it is necessary to obtain from the Minister of the Environment a sign indicating that the bird or animal has been imported in compliance with the said regulations, and attach this sign to the bird or animal.

 

Section 6 Livestock Management Stabilization Act

The Law Concerning Stabilization of Livestock Management imposes certain restrictions on the import of designated dairy products (butter, skimmed milk powder, whey, adjusted whey, daily spread, and butter oil).

In other words, the person who declares the import of the designated dairy products (or the owner of the designated dairy products if he or she is not the owner at the time of the import declaration) must sell the designated dairy products related to the import declaration to the Organization upon importation and must also buy them back, which requires a contract with the Organization. Profits will be made on the difference between the sale and repurchase, which will be used to subsidize the domestic firm.  The importer registers the applicant, submits an application for sale or repurchase to the Organization, obtains a letter of acceptance, and then completes import customs clearance procedures with the customs office. However, there are certain exemptions.

 

Section 7: Fishery Resources Protection Act

Under the Law for the Protection of Fishery Resources, import permission from the Minister of Agriculture, Forestry and Fisheries is required for the import of specified aquatic animals and their containers and packaging in order to prevent domestic fishery resources from being damaged by exotic infectious diseases.

 

Fishery products

Living Fishery19

Fish

Salmonids/Carp/Goldfish/big-head carp/Silver Carp/Black Carp/Grass Carp/ Tilapia/ Red sea bream

Crustacean

Shrimps (Tiger Shrimp/Cherry shrimps/Pnaeid shrimps)

Shellfish

Tokobushi abalone/Tokobushi-abalone/ Ezo-abalone/Black-abalone/Siebold’s abalone/Giant abalone/oysters/scallops/Sea pineapple

Un-living Fishery Products

Cultivated fishery mentioned above (excluding fish powder and fish oil)

 

Section 8: Washington Convention

The Convention on International Trade in Endangered Species (CITES) imposes certain restrictions on certain endangered species, such as prohibiting their import and export in principle, in order to prevent their extinction. In response, the Foreign Exchange and Foreign Trade Law requires import approval for the import of plants and animals designated under CITES.

 

Section 9: Act on Preservation of Endangered Species of Wild Fauna and Flora

The Act on the Preservation of Endangered Species of Wild Fauna and Flora prohibits the import of individuals of domestically rare species of wild fauna and flora, their organs, or their processed products for the purpose of preserving rare wild fauna and flora, and allows import only for academic research purposes.  To allow import, approval based on the Foreign Exchange and Foreign Trade Law is required.

 

Section 10: Invasive Alien Species Act

The Invasive Alien Species Act is a law aimed at preventing the destruction of ecosystems.  The Act regulates the import of invasive alien species as shown in the following table.

Specific Invasive Species

Import is prohibited.  However, this shall not apply to the case where a person who has obtained permission for the keeping of the specified alien organism imports the specified alien organism pertaining to the permission.

Undetermined Invasive Species

・A person who intends to import must submit an import notification for the undetermined alien species in advance.

・Upon receipt of the import notification, the Ministry of the Environment will conduct a review, and the results of the review will be notified within six months.

・If, as a result of the examination, the notifier is notified that there is a risk of harm to the ecosystem, importation will be prohibited.

Species for which a type name certificate must be attached

Importation is not allowed without attaching a certificate issued by a foreign government agency or other certificate specified by the Ordinance of the competent ministry (i.e., type name certificate) certifying the type of the organism concerned.

 


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Regulations related to Importing Plants

General Information

Quarantine is required for importing plants in accordance with the Plant Protection Law.  

As for endangered species, in the case of plants subject to the Washington Convention, importation may be prohibited or import approval may be required based on the Foreign Exchange and Foreign Trade Act, and importation of individuals of domestically rare wild animal and plant species or their organs or their processed products may be prohibited based on the Law for Preservation of Species.

Plant Protection Law

1 General Remarks

The Plant Protection Law is a law aimed at protecting plants from insect pests.  The law imposes certain restrictions on the importation of plants (Article 6 to 10).

2 Prohibited Imports

Plants and their containers and packages to be imported shall not be imported unless accompanied by an inspection certificate issued by a government agency of the exporting country and stating that it confirms or believes that no quarantine pests are attached as a result of the inspection, or a copy thereof (Article 6, Paragraph 1)1.

In addition, with respect to plants shipped from areas provided (Article 5-4 of the Enforcement Regulations of the Law, Appendix 1-2) for in the Ordinance of the Ministry of Agriculture, Forestry and Fisheries, it is necessary to conduct an inspection at the place of cultivation in order to properly conduct an inspection pursuant to the provision of Article 8, paragraph 1 of the said Law, the results of the inspection conducted at the place of cultivation by the governmental organization of the exporting country, in addition to the provision of the preceding paragraph, shall not be imported. Importation shall not be permitted unless an inspection certificate or a copy thereof is attached, stating that it is confirmed or believed that no quarantine pests provided (Paragraph 2). 

In addition, various other regulations, such as prohibition of import of prohibited plants and inspection of imported plants, are generally regulated as shown in the following table.

Import Prohibited Plants

(i) Plants shipped from or through the areas specified in the Ordinance of the Ministry of Agriculture, Forestry and Fisheries [appended table to the Ordinance for Enforcement of the Plant Protection Law] and specified in the Ordinance of the Ministry of Agriculture, Forestry and Fisheries [appended table to the Ordinance]2.

(ii) Quarantine Pests3

(iii) Soil or plants to which soil is attached

(iv) Containers and packages of items listed in (i) to (iii) above.

・Importation of prohibited plants is prohibited.

・However, this shall not apply in the event that permission has been obtained from the Minister of Agriculture, Forestry and Fisheries for the purpose of testing, research and specimen, and in this case, the import shall be accompanied by a permit (Paragraph 2).

 

※The database of import conditions on the website of the Plant Protection Station is useful for determining which products are prohibited for import.

Plants

・ Any person who imports plants shall notify the Plant Protection Station of such fact without delay and receive an inspection(Law 8)4.

・Specifically, in order to prevent pests and diseases from attaching to plants and invading Japan, all plants, regardless of quantity or use, must be subject to import inspection by the Plant Protection Station, accompanied by an inspection certificate5 issued by the government agency of the exporting country.

・However, the attachment of a certificate of inspection is exempted for dried turmeric, as it is less likely to be contaminated by diseases or pests.

1 There are exceptions according to the proviso of the same paragraph and each item of the same paragraph.
2 Fresh fruit, etc.
3 The term “pest” means any injurious animal or injurious plant that is likely to cause damage to useful plants if it spreads. However, it excludes those listed in each item of Article 5-2 of the Ordinance for Enforcement of the Plant Protection Law.
4 In the case of importation by mail, Japan Post Co., Ltd. notifies the Plant Protection Station, which becomes the inspection (Article 8, Paragraph 6 of the Law).
5 In English, this is called a “Phytosanitary Certificate”.


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Regulations related to Importing Food

When importing food into Japan, the following topics often become problematic in relation with Japanese laws:

Food Sanitation Law

1 General Information

The Food Sanitation Law regulates importing food, additives, utensils, containers and packaging, toys for infants, and cleaning detergents.  Therefore, importers of these products need to pay attention to the Food Sanitation Law. For the definition and scope of each term, please refer to the following table.

Food

All food and beverages. However, this does not include pharmaceuticals, quasi-drugs, and products for regenerative medicine. 

Therefore, health foods that do not fall under the category of drugs or quasi-drugs are included as ‘Food’. 

Additives

The term “food additives” means substances that are added to, mixed with, infiltrated into, or otherwise used in food in the process of manufacturing food or for the purpose of processing/preserving food. 

There are four types of additives:

(1) designated additives (= additives designated by the Minister of Health, Labor and Welfare, such as sorbic acid and xylitol),

(2) existing additives (= additives listed in the list of existing additives),

(3) natural flavors (= additives obtained from plants and animals or mixtures of plants and animals which is additives of natural origin that are used for the purpose of flavoring foods)

(4) general food and beverage additives

Utensils

Utensil for eating and drinking, Kitchen utensils, and other utensils used for collecting, manufacturing, processing, cooking, storing, transporting, displaying, or consuming food or additives.  This also includes machine, apparatus, or other object that comes into direct contact with food or additives.  However, this shall not include machines, appliances, and other objects used for the collection of food in agriculture and fisheries.

Eating and drinking utensils

Plates, teacups, cups, bowls

Cooking utensils

Knives, cutting boards, pots, iron plates, iron nets

Others

・Collection equipment (ice saws) ・Manufacturing and processing equipment (hand noodle machines/ice cream freezers/cabbage slicers/Agricultural product washing machine and fish processing machine/factory conveyor belt, pipes and hoses/ovens)・Cooking equipment (rice cookers/steamers/whiskers/ juicers)・Storage equipment (refrigerators/tanks/bottles/water bottles)・Transport equipment (milk tankers/concentrated fruit juice tank containers), display equipment (food baskets/trays/ display shelves), food containers/Styrofoam container boxes), eating utensils (knives/forks/spoons)

 

※Items that do not come into direct contact with food or additives, such as motors, air conditioners, and degassing pumps, are not included.

Containers

And

Packaging

“Containers and packaging” mean articles containing or wrapping food or additives, which are delivered as they are when food or additives are given or received.  Packaging includes bottles, cans, bags, plastic bottles, boxes, and wrapping paper for food and additives.

Infant Toys

Toys for infants under the age of 6.  Specifically, it refers to (1) toys that are essentially intended for infants to come into contact with their mouths, and (2) accessory toys, shadow graph(写し絵), roly-poly toy, mask, origami, rattles, intellectual toys (those that may come into contact with the mouth), building blocks, telephone toys, animal toys, dolls, clay, vehicle toys, balloons, flock toys, Balls, Toys for playing house. 

Cleaning Detergent

This term refers to cleaning agents that are used for cleaning vegetables, fruits, or eating and drinking utensils.

 

2 Import notifications

When a business operator imports (1) food or additives, (2) equipment or packaging containers for these items, or (3) toys for infants and young children to be used for sale or in business, the business operator must submit an import notification and undergo an examination at a quarantine station to determine whether there is any violation of the Food Sanitation Law.  In other words, import notification is required for the importation of food and other products for business and sales purposes.

However, there are exceptions. First, import notification is not required for cleaning detergents.

Second, foods that fall under any of the following categories do not require import notification.  This is regardless of whether or not they are intended for sale or business.

Raw salt / Copra / Animal and Vegetable fat oils used in the manufacture of edible oils and fats/ Brown Sugar / Crude distilled alcohol / Molasses /Malt / Hops

Third, import notification will not be required for imports of (1) food and additives, (2) equipment and packaging containers for these items, and (3) toys for infants and toddlers that are not used for sale and are not used in the course of business.  For example, in the case of (1) food for personal use, display, testing and research, or internal review, (2) food weighing 10g or less, or (3) food of which it is clear that the entire amount imported will be re-exported, if it is clear that the purpose is not to sell or use as food in Japan, import notification is not required.  However, even in the case of importation by an individual, importation for the purpose of sale or for use in a restaurant run by the individual is not recognized as personal use, and import notification is required.

Fourth, import notification is not required for utensils and containers and packaging that do not come into direct contact with food. 

 

3 Application for Import Notification and Notification of Changes

Applications for import notification are accepted at the quarantine office seven days prior to the scheduled arrival of the cargo.  The quarantine station where the procedures are carried out depends on the region where the import is cleared.  Use of the “How To” guide on “How to fill out the import notification form” can be helpful.  The relevant documents to be attached depend on the items to be imported, so it is useful to consult with the quarantine station in advance, but according to the Tokyo Quarantine Office, documents that can confirm “when”, “where”, “what”, and “how” they are made are required.  In addition, documents that can confirm compliance with the Food Sanitation Law may be requested.  Specifically, depending on the item, it may be necessary to attach a “description of its ingredients and production process” (for processed food), a “hygiene certificate” (for meat, meat products, pufferfish), or a “test report” (for items with individual standards).

In addition, when there is a change in the date of arrival of the cargo, the name and address of the manufacturer, exporter or packager, the name and flight number of the ship or aircraft carrying the cargo, the name of the warehouse where the cargo is stored, and the date of delivery as stated in the import notification, notification of the change is required.

There is also a system to simplify the items to be entered and the documents to be attached at the time of import, by registering in advance the item’s ingredients, additives, production methods, and test reports. 

 

4 Notification of imports based on the planned import system

The planned import system is a system that allows importation of the same food without import notification for a certain period of time after the submission of the import notification, by submitting an import notification stating the import plan at the time of initial importation.  The following table shows items that are subject to the planned import system.  As a general rule, identity is judged based on whether the place of manufacture, raw materials, and manufacturing method are the same, but for grains (rice, barley, wheat, soybeans, and hollyhocks), identity is judged based on whether they are produced in the same country, and there are exceptions as well.

 

Machinery for food production, aluminum utensils/ containers and packaging, stainless steel utensils/ containers and packaging/ colorless glass utensils/ containers and packaging

3 years

 

Alphanized rice/ ethyl alcohol/ barley/ canned and bottled foods (excluding meat products and fruit wine)/ Alcoholic beverages (except fruit wine)/  Sorghum bicolor (こうりゃん)/ sesame/ wheat/ rice/ safflower seeds/ spirits/ food (excluding meat products)  which have been put into airtight containers and packages, sealed, and then pressured and heat-sterilized (excluding canned and bottled foods)/ Vegetable protein/ buckwheat/ soybeans, starch (excluding tapioca starch), animal fats and oils (excluding fish and marine mammal fats and oils)/ rapeseeds/ sunflower seeds/ corn/ rye/ containers and packaging other than those made of aluminum, stainless steel, colorless glass or synthetic resin,

1 year

The following food, additives, or containers and packaging, which have been imported continuously since before the submission of the import notification stating the import plan prescribed in Article 32, paragraph 4, and the same food, has not fallen under any of the items of the same paragraph [i.e., food whose import is prohibited] for three years prior to the date of submission.

 

Bean jam/temporarily stored fruits and rinds/ ground coffee beans/ boiled locusts/ fish roe (limited to dried ones)/ boiled fish/ fats and oils of fish and sea mammals,/ oatmeal/ seaweeds/cacao beans (excluding grounded ones)/ Ingredients for fruit wine/ frozen food for consumption after heating (meaning frozen food that has been manufactured or processed and requires heating when served for eating or drinking)/ Gymnema tea/ ingredients for fruit juice

 

Grain/ bean or potato powder/ cocoa products (excluding powdered soft drinks)/ Coffee extracts/ coffee beans (excluding those that are infused), corn flakes, konjac jelly(こんにゃく)/ salt/ plant-based creamer powder/ vegetable fats and oils/ shortening/ sake/ tea/ chocolate/ sugar/ eucommia tea/ boiled beans/ boiled beehives/ honey with beehives/ breads/ bread mix/ beer/ margarine/ yerba mate/ sweet sake/ noodles/ boiled vegetables/ vegetable puree and paste/ Frozen fruits (excluding manufactured or processed frozen fruits)/ Frozen vegetables (excluding manufactured or processed frozen vegetables), Additives other than those listed in Appended Table 1 of the Food Sanitation Act Regulations/ Food containers and packaging made of synthetic resin

1 year

 

Reports on actual imports during the planned import period must be submitted on an annual basis.  In the event that an accident occurs during planned importation, it is necessary to promptly submit an “Accident Occurrence Report” to the food monitoring counter of the quarantine station in charge of the place where the cargo is to be cleared.

 

5 Examination of import notification based on the Food Sanitation Law

In the examination of import notifications, documentation is first examined, and if it is determined that an inspection is necessary, then an inspection is conducted.

If the inspection reveals that the product is in violation of the Food Sanitation Law, it will be rejected and no import license will be issued, and the quarantine office will instruct the customer to dispose of the product or return it to the warehouse.  On the other hand, if no violation of the Food Sanitation Law is found, the product will pass the test and a notarized seal will be affixed to the import notification based on the Food Sanitation Law.

 

6 Document Screening

In the document screening, the following points will be checked to ensure that the necessary application documents and attached documents are not missing. Also, whether an inspection is necessary or not will be examined as well.

①Meat, milk and organs of animals (cattle, horses, pigs, sheep and goats)

②Poultry meat and organs (chickens, ducks, turkeys)

③ Products containing ① and ② (meat products, milk, dairy products)

Items to be used for sales may not be imported without a sanitary certificate or a copy thereof from the government agency of the exporting country.

In United States, Australia, and New Zealand, hygiene certificates issued electronically are also accepted.

①Meat and organs of animals and livestock (cattle, horses, pigs, sheep and goats)

②Meat and organs of poultry (chicken, duck, turkey)

Products for sale may not be imported unless they are manufactured or processed in “a country designated by the Minister of Health, Labor and Welfare”.

The scope of “countries specified by the Minister of Health, Labor and Welfare” is defined in “countries, regions, or facilities specified by the Minister of Health, Labor and Welfare pursuant to the provisions of Article 11, paragraph 1 of the Food Sanitation Act.

Raw Oysters

A sanitary certificate from the government agency of the exporting country is required.

In addition, since the examination will be conducted based on the “Handling of Imported Edible Oysters,” it is useful to check that as well.

Puffer Fish

A sanitary certificate from the government agency of the exporting country is required. The inspection will be conducted in accordance with the “Handling of Imported Pufferfish” and the “Guidelines for the Inspection of Imported Pufferfish.” There are restrictions on the types of pufferfish that can be imported and the waters where they can be fished, and these will also be checked during the document review.

 

Tar-based pigment

It is prohibited to sell, display for sale, or use in business any product that has not been inspected by a registered inspection agency and has not been labeled as having passed the inspection. Therefore, the food inspection report may be checked by document examination.

 

7 Types of inspections based on the Food Sanitation Law

There are four types of inspections based on the Food Sanitation Law:

 

Inspection

Expense’s burden by

Remarks

Ordered Inspection

Registered Inspection Agency

Importers

Ordered inspections are inspections conducted based on an order issued by the Minister of Health, Labor and Welfare when there is a high possibility of violating the Food Sanitation Law.

Violation of the inspection order is subject to criminal penalties. The results of the inspection will be sent directly to the quarantine station. In order to understand the types of cases in which inspection notices are issued, the notices of implementation of inspection orders published on the website of the Ministry of Health, Labor and Welfare can be used as a reference.

Guided Inspection

Registered Inspection Agency

Importers

Guided inspections refer to inspections conducted based on where the government provides guidance to business operators.  As part of the importer’s voluntary sanitation management, the government provides guidance to the importer on the implementation of periodic inspections (Including the first import)

Administrative Inspection

Quarantine Station

Administrator

This is an inspection conducted when the administration finds it necessary to determine whether there is a violation of the Food Sanitation Law. The inspection is conducted by the food sanitation inspector of the quarantine station, such as when the product is first imported, when a violation of the law is found, or when an accident occurs during transportation.

Monitoring Inspection

Quarantine Station

Administrator

This is an inspection conducted by the government based on an annual plan for monitoring, regardless of whether or not there is a suspected violation of the Food Sanitation Law. Unlike other inspections, the operation is such that a notified certificate is issued even before the results of the inspection are available, but if a violation of the law is found, the importer is required to promptly take measures such as recalling the product.

 

8 Items to be confirmed by inspections based on the Food Sanitation Law

During the inspection, the following points will be checked and guidance will be given as necessary:

・Check if the food or additive is unhygienic

・Check if it contains any additives other than designated additives, existing additives, natural flavors, and general food and beverage additives

・Check if the food, additive, apparatus, container or packaging, or infant toy in conformity within the “standard criteria”.  In addition, “Standards for Foods and Additives”, “Standards for the Production of Foods and Additives Using Recombinant DNA Technology”, and “Ministerial Ordinance on the Standards for the Ingredients of Milk and Milk Products” have been established as “Standards for Foods and Additives”.

・Check if food items contains residues of agricultural chemicals (agricultural chemicals, feed additives, veterinary drugs) above the standard value.

・Check if apparatus, containers and packaging contains or adheres toxic/hazardous substances that are likely to damage human health by

・Check for utensils, containers, or packaging that may harm human health by coming into contact with food or additives and give harmful effect human health. 

・Check if the imported food is prohibited by the Food Sanitation Law or not.

 In addition, when importing food containing cyanide compounds, the “Handling of Food Containing Cyanide Minerals” seems to apply. 

 

9 Quarantine based on the Food Sanitation Law and quarantine based on other laws and regulations

In addition to inspections (quarantine) based on the Food Sanitation Law, quarantine based on other laws, such as the Plant Protection Law and the Livestock Infectious Disease Prevention Law, may be required depending on the goods to be imported, but these quarantines are based on different laws and must be considered separately.

10 Customs Clearance

A notification of importation of food, with a notarized seal affixed (“notarized certificate”) or a copy thereof is required at customs clearance, .

In cases where import notification is not required, but import verification is required by customs, an application for verification shall be submitted to the quarantine station.

11 Self-Management for Food Imports

Importers of processed food are subject to the “Guidelines for the Voluntary Control of Imported Processed Food (Guidelines)”.

12 Sale of Food Products

In some cases, a business license or business notification based on the Food Sanitation Law or ordinances (such as the Tokyo Metropolitan Government’s “Food Manufacturing Control Ordinance” or Hokkaido’s “Sanitation Ordinance for Food Manufacturing and Sales”) may be required for sales in Japan.  In addition, revision of the Food Sanitation Law, which will come into effect on June 1, 2021, has significantly changed the framework for business licenses. 

Food Labeling Law

Food for sale (including food for free to unspecified persons) is subject to food labeling standards under the Food Labeling Law. Selling food that is not labeled in accordance with these standards and giving food away for free to an unspecified number of people is also prohibited.

In addition, when recalling food that is not labeled with allergens in accordance with the Food Labeling Standards, a notification to that effect must be submitted.


Please contact us if you have any questions.

Regulations related to Importing Alcohol

When importing alcohol into Japan, the Alcohol Business Act, the Liquor Tax Act, the Pharmaceutical Affairs Act, and the Fire Service Act can be problematic.

1 Liquor Tax Act

The Liquor Tax Act defines alcoholic beverages as those with an alcohol content of one degree or more. Items that are not for drinking, such as alcohol disinfectant solutions (pharmaceuticals), do not fall under the category of alcoholic beverages.  On the other hand, medicinal nourishment wine and other products are often classified as alcoholic beverages even when they fall under the category of pharmaceuticals.

Alcohol with alcohol content of 90 percent or more corresponds to the Alcohol Business Law and not to the Liquor Tax Act; however, if the alcohol is used in the manufacture of liquor, it exceptionally corresponds to the Liquor Tax Act.

2 Alcohol Business Law

The Alcohol Business Law regulates the sale, use, and import of alcohol.  The Alcohol Business Act regulates alcohol above 90 degrees, which is usually too strong to drink, so no liquor tax is charged at the time of importation. 

It is believed that it is inappropriate to impose a liquor tax on alcohol not intended for drinking, such as alcohol for disinfection in medical facilities.

However, since the ingredients are the same as the main ingredients of alcoholic beverages, they can be diluted and used in alcoholic beverages.  If alcohol imported in a form that is not subject to liquor tax is used for bootlegging and consumed, the government will lose revenue from the liquor tax. Therefore, the Alcohol Business Act establishes regulations on the manufacture, sale, import, and use of alcohol over 90 degrees.

Manufacture

Permission is required to operate as a business (Article 3).

Import

A permit is required. However, imports may be made with the approval of the Minister of Economy, Trade and Industry only for the purpose of use in testing, research and analysis (Article 17).

Sale

A license is required for sales as a business. Non-professional sales require the approval of the Minister of Economy, Trade and Industry (Article 22, Paragraph 1). In addition, in principle, alcohol cannot be transferred to anyone other than those who have obtained permission or approval for its use (Article 22, Paragraph 2).

Utilization

Permission is required for industrial use, and other uses are permitted only when approved by the Minister of Economy, Trade and Industry for use in testing, research and analysis (Article 27).

Dilution

Manufacturers, importers, distributors, and approved users shall not dilute alcohol to less than 90 percent alcohol by dilution, except when the approved user dilutes the alcohol in the process of use or as otherwise permitted by law (Article 35).

If the manufacturer or importer transfers the alcohol as “specified alcohol,” the restrictions on the sale, use, and dilution of alcohol listed in the table above will not apply, but the manufacturer or importer will be required to pay a fee to the government (Article 31).

3 Pharmaceutical Affairs Law

When a product falls under the category of pharmaceutical products, such as alcohol disinfectant solutions, it is necessary to comply with the provisions of the Pharmaceutical Affairs Law.

4 Fire Service Act

In most cases, alcohol above 60 degrees falls under the category of hazardous materials. Therefore, it is necessary to pay attention to the regulations pertaining to the handling of hazardous materials.

 


Please contact us if you have any questions.

Regulations related to Importing Drugs

Importing drugs is regulated by the Pharmaceutical Affairs Law which covers “manufacture and sale,” “production,” “marketing,” and “advertising” of pharmaceuticals, quasi-drugs, medical devices, and cosmetics. 

Pharmaceuticals and Quasi-drugs

1 Importation as a Business

 In the case of importing pharmaceuticals and quasi-drugs as a business and selling them in Japan:

  1. The business operator conducting the importation is required to obtain a manufacturing and sales license.
  2. Those who intend to manufacture pharmaceuticals and quasi-drugs imported into Japan from foreign countries need to be certified as foreign manufacturers for each manufacturing site.
  3. If there is a business operator who manufactures label replacement for Japanese text labeling in Japan, a manufacturing license is required for the business operator who replaces the label.
  4. It is necessary to obtain approval for the drug or quasi-drug itself.  However, drugs and quasi-drugs that are designated by the Minister of Health, Labor and Welfare based on established standards do not require approval, but instead require notification of manufacture and sale.
  5. Manufacturers and sellers are required to submit notifications and publicize the information contained in the attached documents.

2 Imports other than for Business Purposes

In cases such as (1) importation for personal use, (2) personal importation by a physician or dentist for treatment, and (3) importation for use in clinical trials conducted primarily by a physician or dentist, importation of drugs is possible without approval. In such cases, import verification is required.

However, importation for personal use of: ①(i) topical medicines in quantities of 24 or less; (ii) poisonous, deleterious, or prescription medicines in quantities of 1 month; and (iii) other medicines in quantities of 2 months and ②(i) quasi-drugs in topical form not exceeding 24 units, and (ii) quasi-drugs not exceeding 2 months’ supply, does not require Import verification as well. 

3 Prohibition of Importation

The importation of defective drugs and quasi-drugs is prohibited, whether as a business or personal import. 

4 Prohibition of Advertising

It is illegal for foreign distributors to advertise unapproved/unauthenticated drugs on drug sales websites, even to those in Japan.  In many cases, advertising by import agents is also illegal.

Please contact us if you have any questions.