Guide to Safety Assurance
for Products Imported
to Japan

Manufactured Imports and Investment Promotion Organization (MIPRO)

Introduction
It is essential to remember that importers are responsible for the safety of the
products they handle.
The Basic Consumer Act specifies that business operators are responsible for
ensuring the safety of the products they supply, and for providing necessary consumer
information in a clear and easy-to-understand manner. This means that importers
are required to comply with laws and regulations, confirm product safety, provide
information on the quality and safety of products through appropriate labeling, and takeprompt measures for problems.
MIPRO provides information on laws, regulations, and procedures for import andsales through seminars and the publications. This new guidebook highlights safety andsummarizes points for importers to remember about products that are often handled in
the small-lot import business.
It is our hope that this guidebook will help everyone involved in the import businessto consider the safety of imported products.

November 2013
Manufactured Imports and Investment Promotion Organization (MIPRO)[Notes]● This guidebook is an English translation of a revised version of the Guide to Safety Assurance for
Products Imported to Japan (in Japanese only) published in March 2012.
● Regulations described in this guidebook are mainly related to product safety. The content in thisguidebook does not cover all regulations regarding the products described herein. For more detailed
information on related regulations, please see other reference materials published by MIPRO andwebsites of the relevant government ministries and agencies.
● Content described in this guidebook is valid as of September 2013. Please continue to check for further
revisions.

Contents
1. For the Safety of Import Goods

・Import Goods and Japanese Acts and Regulations… ……………………………………………………… 2・JIS and JAS… …………………………………………………………………………………………………… 3
・Voluntary Industrial Standards and Qualification Systems… ……………………………………………… 3・Product Safety Measures to be Taken by Importers… ……………………………………………………… 4・Response to Product-Related Accidents……………………………………………………………………… 5[Topics] Four Acts related to Product Safety… ……………………………………………………………… 6

2. The Import and Sale of Food

・Points to Remember for Safety………………………………………………………………………………… 8・Major Import and Sales Regulations…………………………………………………………………………… 8
・Procedures Specified by the Food Sanitation Act… ………………………………………………………… 8
・Import Quarantine… ………………………………………………………………………………………… 10
・Food Labeling… ……………………………………………………………………………………………… 11[Topics] Safety Assurance for Health Foods… …………………………………………………………… 11

3. The Import and Sale of Cosmetics and Quasi-Drugs

・Points to Remember for Safety……………………………………………………………………………… 12
・Major Import and Sales Regulations………………………………………………………………………… 12
・Cosmetics……………………………………………………………………………………………………… 12・Quasi-Drugs…………………………………………………………………………………………………… 13
・Other Points to Remember…………………………………………………………………………………… 14

4. The Import and Sale of Home Appliances

・Points to Remember for Safety……………………………………………………………………………… 15
・Major Import and Sales Regulations … …………………………………………………………………… 15
・Procedures Specified by the Electrical Appliance and Material Safety Act… ………………………… 15・Labeling based on the Household Goods Quality Labeling Act… ……………………………………… 17
・Voluntary Safety Mark………………………………………………………………………………………… 17
・Other Points to Remember…………………………………………………………………………………… 17

5. The Import and Sale of Gas-Fired and Oil-Burning Appliances

・Points to Remember for Safety……………………………………………………………………………… 18
・Major Import and Sales Regulations………………………………………………………………………… 18
・Procedures Specified by the Gas Business Act and Liquefied Petroleum Gas Act… ………………… 18
・Procedures Specified by the Consumer Product Safety Act……………………………………………… 19[Topics] Prevention of Product Accidents…………………………………………………………………… 20

6. The Import and Sale of Products for Children

・Points to Remember for Safety……………………………………………………………………………… 21
・Major Import and Sales Regulations………………………………………………………………………… 21
・Safety Regulations for Toys… ……………………………………………………………………………… 21
・Safety Regulations for Clothes… …………………………………………………………………………… 22
・Voluntary Safety Marks… …………………………………………………………………………………… 23
・Regulations for Other Items… ……………………………………………………………………………… 23

7. Import and Sales of Other Household Products

・Points to Remember for Safety……………………………………………………………………………… 24
・Major Import and Sales Regulations………………………………………………………………………… 24
・Procedures Specified by the Food Sanitation Act… ……………………………………………………… 24
・Procedures Specified by the Consumer Product Safety Act……………………………………………… 25
・Regulations for Harmful Substances… …………………………………………………………………… 25・Labeling based on the Household Goods Quality Labeling Act… ……………………………………… 26
・Voluntary Safety and Warning Marks… …………………………………………………………………… 26
・Regulations for Other Items… ……………………………………………………………………………… 27

8. References… ……………………………………………………………………………………………… 28

1. For the Safety of Import Goods
Import Goods and Japanese Acts and Regulations
Products imported into and sold in Japan are subject to regulation. First of all, let’s take a look at therelationship between import goods and domestic acts and regulations.
    Some import regulations are designed to achieve major regulatory purposes such as the protectionof domestic industry, the assurance of product quality and safety, and the protection of the natural andsocial environment. These regulations are categorized as Import Acts and Regulations and stipulate theinspection and screening of imports by Customs authorities during clearing procedures for the required
permission or approval (see (1) below).
Other regulations control the sale or use of import goods rather than the actual import of said goods.
Such regulations apply to products without regard to whether they are imported or manufactured
domestically. These regulations hold importers responsible for the products they import just as domestic
manufacturers are held responsible for the products they manufacture. The major content of such
regulations relates to applications and permission to import and sell, inspections, compliance withspecifications and standards, and the labeling of import goods (see (2) below).
Importers are required to comply with regulations for import products and assure the safety of the
products they import.

Flow of Cargo

Arrival of Cargo

Transport to Bonded Area

Customs Clearance
Import declaration
Customs screening/ inspection
Payment of tariffs/ consumption tax
Import permit

Receipt of Cargo from the Bonded Area

Sales

Domestic Acts and Regulations(1) When importing (until import declaration/
Screening or inspecting by Customs)<Acts and Regulations on Imports>
Foreign Exchange and Foreign Trade Act(Import Trade Control Order), Firearm andSwords Control Act, Pharmaceutical Affairs Act,
Fertilizer Regulation Act, Act on the Protectionof Fishery Resources, Explosive Control Act,Act on the Examination of Regulation of
Manufacture of Chemical Substances, Food
Sanitation Act, Plant Protection Act, Act on
Domestic Animal Infectious Disease Control,
Rabies Prevention Act, High Pressure Gas
Safety Act, etc.

(2) When distributing and selling insideJapan
Pharmaceutical Affairs Act, Food Sanitation
Act, Act for Standardization and Proper
Labeling of Agricultural and Forestry Products(JAS Act), Electrical Appliances and Materials
Safety Act, Gas Business Act, Act on the
Securing of Safety and the Optimization ofTransaction of Liquefied Petroleum Gas(Liquefied Petroleum Gas Act), Consumer
Product Safety Act, Household Goods Quality
Labeling Act, Act on Control of Household
Products Containing Harmful Substances, Fire
Service Act, Road Traffic Act, Act against
Unjustifiable Premiums and Misleading
Representations, etc.

(Some act names are abbreviated.)

2

JIS and JAS
Japanese Industrial Standards (JIS) and Japan Agricultural Standards (JAS) were established asnational standards. These standards are voluntary and applied as appropriate according to the intention ofbusiness operators.

JIS

JIS were established as national standards based on
the Industrial Standardization Act, whose purpose is topromote industrial standardization. When applying JIS
as reference values for technical standards specified bydomestic acts and regulations, JIS are enforced.

JIS labeling system

The JIS labeling system allows business operators who
are approved by an accredited certification body to use
the JIS label on products approved by said certification
body.

JAS

JAS were established as national standards basedon the Act for Standardization and Proper Labeling ofAgricultural and Forestry Products (JAS Act) whose
purpose is to improve the quality of agricultural andforest products. Targets are food and forestry products.

JAS qualification system

The JAS qualification system allows business operators
to use the JAS label on products satisfying JAS standards.

JIS

JAS

(Certified Organization)

Voluntary Industrial Standards and Qualification Systems
Each industry also places effort into ensuring the quality and safety of products and winning theconfidence of the consumer public by establishing voluntary standards and qualification systems. Individual
standards and qualification systems allow products that meet their standards to be labeled to show
consumers that the quality and safety of the products have been confirmed. For example, the SG mark is
for consumer products, the ST mark is for toys, the SF mark is for toy fireworks, and the S mark is forelectric products.
In addition, regardless of the application of voluntary industrial standards or qualification systems, it
is important for importers to have a system for the voluntary examination of the capability, strength andendurance of products (or the outsourcing of testing and attachment of the test results) to assure safety.

Private Imports
Imports for private use are relatively free of import acts and regulations based on the assumption that
responsibility for product safety is borne by the private importer.
This limits the importer to private use, prohibits sale or distribution to a third person, including free
distribution to the general public, regardless of whether the importer is an individual or a company. The numberof products that can be imported is also limited to the amount appropriate for private use.
Items on the embargo list such as illegal drugs, firearms, explosives, and counterfeit currency are prohibitedeven for private importers, and quarantine is also required to prevent the import of harmful animals, plants,
and diseases.

3

Product Safety Measures to be Taken by Importers
The safety of imported goods is monitored and guided by the government based on safety regulations
specified by domestic acts and regulations according to the items imported, such as the Food Sanitation
Act for food products and Pharmaceutical Affairs Act for cosmetics. Importers are required to take safetymeasures appropriate to the individual regulations and the characteristics of the item or items imported.

■ Voluntary Principles for Product Safety (Guidelines for the Establishment of
Voluntary Principles on Product Safety)
To ensure the safety of imported consumer products*, the Ministry of Economy, Trade and Industry (METI)
established Voluntary Principles for Product Safety, which specifies that importers ensure product safety
centering on the items listed below.
*Note: Consumer products are defined as those used by general consumers for daily life, except those for whichsafety measures are covered separately by other acts and regulations, including the Food Sanitation Act andPharmaceutical Affairs Act.

Voluntary Principles for Importers(1) Importers should not merely seek high-performance or low-cost products, but they should also recognize
their social responsibility to provide safe products to consumers and establish a safe and secure society
by placing a priority on consumers and product safety assurance in the basic policies of their business,and disseminate the specific policies to employees.
(2) A department responsible for the handling of product safety should be installed in the company and given
the authority to give directions to other departments in a cross-sectoral manner.
(3) In the case that any department obtains information on a product accident, said department should
immediately report such to top management.
(4) Any information on a product-related accident should be disclosed immediately and appropriately toconcerned individuals outside the company, such as distributors and those involved in installation andrepair.
(5) Even when the seriousness of a product-related accident does not require a report to the government, it
still must be reported to the National Institute of Technology and Evaluation (NITE).
(6) In the case that there is risk of insufficient funds for emergencies such as a product recall, a system mustbe established to secure funding for the purchase of insurance, etc.
*There are other items that major companies are responsible for.

■ Product Liability
The Product Liability Act (PL Act) specifies that the manufacturer, etc. shall be liable for damages arisingfrom the infringement of life, body or property of others which is caused by the defect in the delivered
product which was manufactured, processed, imported, or provided with the representation of name, etc.
In the case of imported goods, importers bear the same responsibility as manufacturers.
In order to improve and ensure safety, importers are expected to place a priority on manufacturing
process management, pre-shipment inspections, provide proper labeling, manuals, and aftercare toprevent the occurrence or expansion of damage after the sale of imported goods.
In order to promote compliance with the PL Act, the PL Insurance System is available to small andmedium-sized enterprises through each local Chamber of Commerce and Industry. Sole proprietors are
eligible to join the insurance system after becoming members of the local Chamber of Commerce andIndustry.

4

Response to Product-Related Accidents■ Requirement to report serious product-related accidents to theConsumer Affairs Agency
The Consumer Product Safety Act specifies that any person engaging in the manufacture or import ofconsumer products who comes to know that a serious product-related accident has originated with theconsumer products manufactured or imported thereby shall report such to the Consumer Affairs Agency
within 10 days from the day on which said person comes to know the fact (System for the reporting andpublication of product-related accident information).
The range of product-related accidents includes death, serious injury or sickness (requiring 30 ormore days for treatment), residual disability, carbon monoxide intoxication, and fire (confirmed by the fire
department). Unless it is shown that any such accident was not caused by a product-related defect, it
will be deemed a product-related accident. In other words, even when improper use of a product by the
consumer causes the accident, if factors exist that may have led to improper use (for example, a lack of
caution marks, etc.), the accident is deemed a product-related accident and must be reported.
Information contained in accident reports is immediately disclosed to general consumers. In addition, inorder to prevent the recurrence of accidents, importers are required to investigate the cause of productrelated accidents and take measures such as the voluntarily recall of products when necessary.

■ Non-serious product-related accidents must be reported to the
National Institute of Technology and Evaluation (NITE).
Information on product-related accidents that are not subject to the System for the reporting andpublication of product-related accident information is collected through the NITE accident informationcollection system. The NITE investigates product-related accidents based on the information collected,
identifies cause, and publicizes information on a periodic basis to business operators. Such information
includes the cause of accidents and measures designed to prevent recurrence.
<Accessing accident information>
Search the NITE Consumer Product Safety Field.
⇒ http://www.jiko.nite.go.jp/php/jiko/search/index.php?lang=en
Accident information from FY1996 can be searched through the NITE website.

Search the accident information databank.
⇒ http://www.jikojoho.go.jp/ (Japanese only)This system unifies information on consumer accidents possessed by the Consumer Affairs Agency, nationwide
consumer affairs centers, and other governmental ministries and agencies. This data system is freely accessible byanyone who wishes to search for information on product-related accidents (approx. 95,000 entries as of September2013).

5

Overseas Safety Marks

Reference

Conformity to overseas specifications and standards may be a guide to product safety; however, marksthat indicate conformity to overseas specifications and standards do not indicate conformity to Japanese
specifications and standards. Therefore, conformity to Japanese specifications and standards must be
verified separately.

CE mark in Europe

CCC mark in China

The CE mark indicates product conformity to

China Compulsory Certificate (CCC) mark is

the Essential Safety Requirements (ESRs)

affixed to products approved by China. Without

specified by EU Directives. Without the CE

the CCC mark, products cannot be exported

mark, products cannot be distributed or soldto or sold inside China. This mark is affixed toinside the EU.

products meeting safety and electromagnetic
compatibility (EMC) standards.

Topics Four Acts related to Product Safety
Let’s take a look at the major Japanese acts and regulations designed to ensure product safety.
Four acts have been established to promote product safety. These acts are the Consumer Product
Safety Act, the Electrical Appliance and Materials Safety Act, the Gas Business Act, and the Liquefied
Petroleum Gas Act.
These four acts were established to ensure the safety of general products. The national
government designates products subject to each act and indicates technical standards that must be
met to prevent harm. Importers of products designated by the acts are responsible for confirming that
products conform to the required technical standards and that the products to be sold are labeled as
specified by the relevant act. Furthermore, special specified products which have a high potential forharm are required to undergo conformity assessment by registered assessment bodies recognized by
the national government.

Reference

6

Product Safety (PS) marks based on the four acts related to product safety

Product Safety System
Ministry of Economy, Trade and Industry
Domestically registeredconformity assessment
body
Overseas registeredconformity assessment
body

Application for Registration as an
Assessment Body
(Registered assessment bodies arelisted in the registry.)

Designation of Items

Non-designated Items

Judgment by Technical Standards* Defects and accidents
caused by the productsthat are not specified by
the Consumer Product
Safety Act, Liquefied
Petroleum Gas Act, Gas
Business Act, Electrical
Appliance and Material
Safety Act, and other acts
and regulations shall be
subject to the Consumer
Product Safety Act.

Notification of Business as a
Manufacturer/ an Importer

Self-Inspection
Conformity Assessment
Subject Products·Special specified products(Consumer Product Safety Act)·Specified liquefied petroleum
gas equipment and appliances(Liquefied Petroleum Gas Act)·Specified gas equipment(Gas Business Act)·Specified electrical appliances(Electrical Appliances andMaterial Safety Act)

Special Specified
Products

Issue ofCertificate

Creation/ Retention ofInspection Record
Retention of Certificate(Effective period is
specified by eachgovernment ordinance.)

Specified products
other than special
specified products

Labeling of marks bymanufacturers/ importers

Before Product Distribution

Sales

Sales

After Product Distribution

Sales of non-labeled products
Sales of products that do notconform to technical standards

Occurrence of emergent
crises/ accidents

Collection of Reports/ On-Site Inspection/
Submission of Consumer Products

Order of Improvement
Prohibition of Labeling

Hazard Prevention Order
Order of Disaster Prevention
Order of Prevention ofHazards, etc.

Hazard Prevention Order

Penalty
Source: Ministry of Economy, Trade and Industry website

7

2. The Import and Sale of Food
Points to Remember for Safety● The Food Sanitation Act is designed to ensure the safety of imported food, and all food sold or used inbusiness must conform to the specifications and standards contained therein. In order to import food, an
import declaration must be submitted to the Quarantine Information Office, Ministry of Health, Labour andWelfare (MHLW).
● In order to prevent the invasion of pests and disease from abroad, fresh vegetables, fruit, meat and meatproducts must undergo the relevant plant or animal quarantine. Some products from specific regions areprohibited or subject to restrictions.

Major Import and Sales Regulations

At the time of import

Submission of declaration in accordance with plant and animal quarantine and the
Food Sanitation Act
Allocation/ approval of imports in accordance with the Foreign Exchange and Foreign
Trade Control Act (targeting a segment of fishery products)/ Liquor sales license/
Specified salt retailer, etc.

At the time of sale

Labeling in accordance with the Food Sanitation Act and JAS Act
Labeling based on the Measurement Act, Health Promotion Act, and Act against Unjustifiable Premiums and Misleading Representations/ Registration or submission systems for business permission, and license systems for specific products and business
forms

Procedures Specified by the Food Sanitation Act
Procedures stipulated in the Food Sanitation Act must be followed to import products for sale or use in Japan.

■ Submission of documents for importing food
Following the arrival of cargo, food import and related documents (depending on the item or
items being imported, such documents may include ingredient charts, manufacturing process charts,
certificates of sanitation issued by the government of the exporting country, etc.) must be submitted to
the MHLW Quarantine Station. The Quarantine Office screens documents, and conducts inspections of
the actual products if such is deemed necessary. If the results of the screening and inspections meet therequirements, a certificate of completed declaration is issued. Products cannot be sold or used in businesswithout first completing this procedure.

Important Points in Screening● Food products conform to manufacturing standards specified by the Food Sanitation Act.
● Food additives conform to the relevant standards.
● Food products are free of harmful substances.
● Food products from the relevant manufacturer imported in the past have not had any problems involving hygiene.

Inspections are required when …
● it is suspected that the imported food violates the Food Sanitation or other act● the imported food product is subject to monitoring inspection by the national government as stipulated
in its annual plan.
● the food product is being imported into Japan for the first time.
● it is determined that sanitation problems may have occurred due to accident during transportation.
● it is determined that safety needs to be assured through inspection due to other reasons.
*The Quarantine Office gives guidance for voluntary inspection of food imported for the first time.

8■ Specifications and Standards for Food, Food Additives, etc.
The Food Sanitation Act specifies standards for the production, processing, use, preparation, andpreservation of food and food additives, and specifications for ingredients. For example, General
Compositional Standards for Food specify that foods shall not contain antibiotics or antibacterial
substances and that genetically modified foods shall be screened for safety, and it provides a Positive Listof Agricultural Chemical Residues in Food.
In addition, some items such as soft drinks and frozen food products are subject to separate
specifications and standards. Due to the fact that milk and milk products require strict sanitation andmanagement, the Ministerial Ordinance on Milk and Milk Products concerning Compositional Standards,
etc. specify separate specifications and standards.

Caution!
● List of foods with separate specifications and standards

The foods listed below have separate specifications and standards. It is necessary to exercise caution
to ensure conformity to each of the relevant specifications and standards. For mineral water (in the softdrink category) in particular, there are many specifications and standards that are applied according to theproperties of the product, which complicates conformity.
● Soft drinks● Powdered beverages● Crushed ice● Flavored ice

the exception of meat and frozen whale meat for raw consumption)● Meats and whale meat (with● Beef for raw consumption (except

organs) ● Poultry eggs ● Blood, blood corpuscles and blood plasma ● Meat products ● Whale meatproducts● Fish-paste products● Salmon roe or cod roe● Boiled octopus● Boiled crab

● Freshfish and shellfish for raw consumption ● Oysters for raw consumption ● Agar-agar ● Grains, beans andvegetables ● Bean jam for further processing ● Soybean curd (tofu) ● Instant noodles ● Frozen food
● Food packed in containers and sterilized by pressurization and heating● Confirmation of use of food additives

Food additives that can be manufactured, imported, used, and sold are limited to those designatedby the Ministry of Health, Labour and Welfare, excluding existing additives, natural flavoring agents, andgeneral drinks being used as additives. In regard to the use of food additives, ingredient standards thatspecify purity and form, and use standards that indicate maximum amounts allowed for each food productare provided.
● Agricultural chemical residues in food and pharmaceuticals for animals

Residue standards for agrichemicals in food, feed additives, and drugs for animal use (used for disease
prevention and the treatment of livestock and poultry) have been established. Food cannot be imported orsold if residues exceed the allowable limits. In the absence of basic agrichemical standards either in Japanor in the country of origin, the unified standard is set at 0.01ppm.
● Sterilization by irradiation

In principle, food irradiation is prohibited in Japan except for the inhibition of potato sprouts. However,some countries allow irradiation for the sterilization of spices and mushrooms. The Japanese government
recommends voluntary inspection to determine whether spices imported from such countries have been
irradiated or not.

9

● Cyanide compounds

It is recommended that foods containing natural cyanide compounds, such as flax, apricot, plum,and bitter almond, and products processed from these foods undergo voluntary inspection for cyanide
compounds at the time of import. Cyanide levels may not exceed 10 ppm.
*What is voluntary inspection?
The national government provides guidance on regularly scheduled voluntary inspections (including the initialtime of import) to facilitate voluntary sanitation management by importers. The guidance focuses on the use ofagrochemicals and food additives, and violations of the standards and regulations.
*Take advantage of preliminary consultation!
Quarantine Offices handling large amounts of imported products have Food Import Consultation Stations thatprovide advice on individual cases (appointment required). When importing health foods, when importing products
for the first time, or if there have been past violations involving the import of the same product or products, it isrecommended that importers seek detailed advice through consultation with the specialists at the Quarantine Office.

Import Quarantine
Quarantine is required for imported products regardless of the amount or purpose, such as individual or
business use.

■ Plant Quarantine
Plant quarantine applies to all imported plants in accordance with the Plant Protection Act.
Imported products are classified into three categories: imported products to be inspected; imported
products not requiring inspection; and import-prohibited products. For the import of plants, including
vegetables, fruit, and tea, it is necessary to check the individual classification. Products other than importprohibited products and those not requiring inspections are subject to import inspection.
Import products to beinspected

Fruit (fresh, frozen, dried), vegetables (fresh, frozen, dried), nuts, grains, pulses,
coffee beans (raw), spices, rapeseed, sesame seeds, etc.
*Mushrooms are classified as fungi rather than plants; therefore, they are notsubject to plant quarantine.

Import products not
requiring inspections

Salted, crystallized, and vinegared agricultural products, tea, roasted nuts,
designated dried fruits, dried spices in sealed small containers such as bottles andcans.

Import-prohibited products

Products with soil
Plants that may cause damage to agricultural products and those that are
produced in areas where pests and diseases that are difficult to identify throughimport inspection exist, such as fresh fruit produced in specific areas.

■ Animal Quarantine
Animal quarantine applies to animals and animal products specified for inspection in accordance with
the Act on Domestic Animal Infectious Diseases Control. Animals subject to inspection are cloven-hoofed
animals, such as cattle and pigs, and poultry, such as chickens. In addition, meat and meat products are
subject to inspection. An inspection certificate issued by the relevant government agency of the exporting
country is required for the import of such products.

Animal products requiring inspection● Meat, bones, fat, organs, and milk from cloven-hoofed animals (cattle, pigs, sheep, goats, deer), horses,
dogs, and rabbits.
● Meat and eggs from poultry (chicken, quail, pheasant, ostrich, guinea fowl, turkeys, ducks, and geese).
● Sausages, hams, and bacons produced from meat of designated products to be inspected.

10The import of animals suspected of being affected by foot-and-mouth disease, rinderpest, and Africanswine fever, and meat, organs, hams, and sausage from such animals is prohibited on a region-by-regionbasis (excluding products that have undergone heat processing at a certain temperature). In response to
the onset of bird flu, Japan has temporarily prohibited poultry imports from some countries.
*Fisheries Quarantine
Some live fishery products require quarantine. In accordance with the Act on the Protection of Fisheries Resources,
permission from the Ministry of Agriculture, Forestry and Fisheries is required for the import of juvenile carp, salmon, andKuruma prawns.

Food LabelingLabeling is an important source of information about food content that helps consumers in selecting andunderstanding how to preserve and use it when purchasing.
Food labeling is specified by municipal ordinances and several acts and regulations, such as the
Measurement Act, the Health Promotion Act, and the Act against Unjustifiable Premiums and Misleading
Representations, centering on the Food Sanitation Act and Act for Standardization and Proper Quality
Labeling of Agricultural and Forestry Products (JAS Act).

<Major points>● Processed foods (packaged or wrapped) require lump-sum labeling in accordance with the labelingstandards specified by the Food Sanitation Act and Quality Labeling Standards for Processed Foods
specified by JAS Act, and labeling in accordance with the Measurement Act.
● Fresh foods require labeling in accordance with the Quality Labeling Standards for Fresh Foods

specified by JAS Act. Depending on the property of products, some labeling content must comply withboth the Food Sanitation Act and JAS Act.
● Attention must also be paid to other label content such as expiration date, country-of-origin, organic

ingredients, allergenic ingredients, genetically-modified ingredients, and nutritional information.

Topics Safety Assurance for Health Foods
Health food products are included in category of foods. Therefore, it is necessary for such products
to conform to the standards and specifications for foods and the appropriate use of additives.
While there are no specifications or standards applied specifically to health food products,
measures for safety assurance are in place. Such measures focus on the physical form of suchproducts and whether or not there is experience with them. Newly developed products (those that are
not generally known, or that are consumed in ways different for customary food products, for example,
tablets and capsules) are prohibited if their safety is in question. Guidelines are provided for products
whose ingredients are concentrated in tablet and capsule form to promote the homogenization of
product ingredients and safety assurance for raw ingredients.
Furthermore, it is important to distinguish health food products from pharmaceutical products.
Health food products cannot contain ingredients that fall under the category of pharmaceuticalproducts, emphasize pharmaceutical effect or efficacy, or come in a form, such as ampoules, that
may cause consumers to mistake them for pharmaceutical products. The import and sale of products
categorized as pharmaceutical products without permission or approval in accordance with thePharmaceutical Affairs Act is a violation of the Pharmaceutical Affairs Act.

11

3. The Import and Sale of Cosmetics and Quasi-Drugs
Points to Remember for Safety● In addition to drugs and medical devices, cosmetics and quasi-drugs are subject to the Pharmaceutical
Affairs Act for the assurance of safety.
● The Pharmaceutical Affairs Act only allows marketing authorization holders and approved manufacturers
to import and sell subject items. In addition to the need for products to meet the requirements specified
by the acts and regulations, importers must meet the requirements for business approval (the hiring of apharmacist or other qualified responsible personnel) before they are allowed to import and sell cosmetics
and quasi-drugs.
● Even when cosmetics and quasi-drugs are sold as general merchandise, items containing pharmaceuticalingredients or products are subject to the Pharmaceutical Affairs Act.

Major Import and Sales Regulations
At the time of import

Procedures specified by the Pharmaceutical Affairs Act (Approval for business,
Notification of Manufacture, Marketing Authorization Holder, Import, etc.)

At the time of sales

Labeling in accordance with the Pharmaceutical Affairs Act
Standards for the Adequate Advertisement of Pharmaceutical Products

What are cosmetics?
Cosmetics are defined as products that exert mild action on the human body, which are intended to be
applied to the human body through rubbing, sprinkling or other means for the purpose of cleaning, beautifying
or increasing attractiveness, altering the appearance of or keeping skin or hair in good condition. (e.g. soap,
shampoo, conditioner, skincare and makeup products)

What are quasi-drugs?
Quasi-drugs are defined as treatments, excluding devices, that are milder in effect than regular drugs andused for the purpose of (1) reducing the feeling of nausea or other discomfort, breath and body odor, heatrash, hair loss prevention, and hair growth,; or (2) repelling flies and mosquitoes for human and animal health.
(e.g. antiperspirant, hair growers, hair color, bath agents, cosmeceutical products, disinfectants, vitamins, andmosquito mats)Cosmetics■ Procedures Specified by the Pharmaceutical Affairs Act
To import and distribute cosmetics, the importer must obtain a License for the Manufacture andDistribution of Cosmetics, or License for the Manufacture of Cosmetics1. Furthermore, the manufacturer
is required to submit a Notification of the Manufacture and Distribution of Cosmetics for each product inadvance and an Application for Accreditation of Foreign Manufacturers and Notification of Import 2.
Ingredients in cosmetics are specified by the Standards for Cosmetics.
Importers are also required to list specified matters directly on the container or package. Such matters
include the name of the product, the manufacturer, and ingredients. The range of effect or efficacy thatimporters are allowed to claim on products is specified by MHLW notification.
Note 1: License for the Manufacture and Distribution of Cosmetics is a permit to deliver products to market, not tomanufacture. Because the Pharmaceutical Affairs Act deems packaging, labeling, and storing to be part ofmanufacturing, it is necessary to obtain a license for the manufacture of cosmetics, even for the storage of imported
cosmetics only. The application should be submitted to the government of the prefecture in which said importer’s
office is located via the Pharmaceutical Affairs Division of the local government.

12Note 2: Place of submission:· Application for the License for the Manufacture and Distribution of Cosmetics ➡ Pharmaceutical Affairs Division of
the local government· Application for Accreditation of Foreign Manufacturers ➡ Pharmaceuticals and Medical Devices Agency· Notification of Import ➡ Kanto-Shinetsu Regional Bureau of Health and Welfare or Kinki Regional Bureau of Healthand Welfare

Caution!
● Ingredients contained in cosmetics

Cosmetics ingredients must comply with the Standards for Cosmetics. The Standards for Cosmetics
specify the prohibition and restriction of ingredients other than preservatives, UV absorbers and tar colors,
and the restriction of preservatives, UV absorbers and tar colors. Ingredients are allowed in cosmetics
after the safety thereof has been sufficiently confirmed, and such confirmation is the responsibility of thecompany. All ingredients must be included in the product label.
● The range of effect or efficacy of cosmetics

Fifty-six claims such as “cleans scalp and hair” or “makes skin firm,” are specified in the range of effector efficacy of cosmetics. Manufacturers and distributors are allowed to label makeup effects and feeling of
use within the range of these 56 claims. “Reduction/ prevention of wrinkles,” “face-shrinking,” and “reductionof melanin production” exceed the range of effect or efficacy and cannot be used.

Quasi-Drugs■ Procedures Specified by the Pharmaceutical Affairs Act
Importers must obtain a License for the Manufacture and Distribution of Quasi-Drugs, or a License for
the Manufacture of Quasi-Drugs to import and sell quasi-drugs. Overseas manufacturing sites are required
to obtain Accreditation of Foreign Manufacturers. Furthermore, the manufacturer is required to obtain an
Approval for Manufacture and Distribution for each quasi-drug, and submit a Notification of Import 3.
Importers are also required to list specified matters directly on the container or package. Quasi-drugs
must be labeled as “Quasi-drugs.” The label should be one of three classifications according to its purposeof use: Pest control quasi-drugs; Designated quasi-drugs; and Quasi-drugs.
Note 3: Place of submission:· Application for the License for the Manufacture and Distribution of Quasi-Drugs, License for the Manufacture of
Quai-Drugs ➡ Pharmaceutical Affairs Division of each local government· Approval for Manufacture and Distribution of Quasi-Drugs ➡ Pharmaceuticals and Medical Devices Agency/
Pharmaceutical Affairs Division of each local government· Application for Accreditation of Foreign Manufacturers ➡ Pharmaceuticals and Medical Devices Agency· Notification of Import ➡ Kanto-Shinetsu Regional Bureau of Health and Welfare or Kinki Regional Bureau of Healthand Welfare

13Caution!
Comparison of specifications between quasi-drugs and cosmetics
Cosmetics

Quasi-Drugs

Usable ingredients

Specified by theStandards for
Cosmetics.

Approved on a product-by-product basis. Some ingredients
have upper limits.

Ingredient labeling

All ingredients should belabeled.

Specified ingredients (those that may cause skin problems
such as allergy) must be indicated. The active ingredientsof quasi-drugs used for specified quasi-drugs must be
indicated.

56 claims are specified.

Pharmacological expression is acceptable within the rangeof effect or efficacy approved. (e.g. “Reducing melanin
production helps to prevent spots and freckles caused byexposure to sunlight.”)

Range of claims for
effect or efficacy● Cosmeceuticals

So-called “cosmeceuticals” fall into the category of quasi-drugs and require an Approval for
Manufacture and Distribution. Attention must be paid to ingredients for which composition standards
are designated. Please refer to the List of Active Ingredients in so-called Quasi-Drugs (MHLW)” for thecomposition of the active ingredients.
The labeling of all ingredients in quasi-drugs is not required; however, all ingredients are indicated on
the label based on voluntary industry standards regarding cosmetics.

Other Points to Remember● Aerosol products

Aerosol products in spray cans, such as hair mousse and antiperspirant, passing through Customs
are required to have a Certificate of Analysis to show exemption from classification as high-pressure gas
products in accordance with the High-Pressure Gas Safety Act. The High-Pressure Gas Safety Act andFire Service Act require that aerosol products clearly indicate a warning or caution mark such as “Avoid
exposure to high temperatures and open flame.”● The range of private imports

In principle, import for private use requires that importers submit documents for certification to a
Local Bureau of Health and Welfare. As a preferential measure, however, products can be imported upon
confirmation by Customs within the range listed below.
[Cosmetics]
Within 24 units of 1 item in a standard size (e.g. 24 units of lipstick, regardless of brand or color)[Quasi-drugs]
External preparations: 24 units of 1 item in a standard size
Other: A 2-month supply as determined by dosage and administration

14

4. The Import and Sale of Home Appliances
Points to Remember for Safety● The Electrical Appliance and Material Safety Act is established for the purpose of assuring the safety ofhome appliances. For the import of electrical appliances, importers are required to ensure the complianceof electrical appliances with the mandatory technical requirements, and to attach PSE marks prior to sale.
● Caution for long-term use must be indicated on five items: electric fans, ventilation fans, air-conditioners,
CRT-based televisions, and washing machines (excluding dryers).
● Home appliances fall into the category of consumer products, and importers are required to report any
serious product accidents to the Consumer Affairs Agency within 10 days from the day said importers
come to know about the accidents. In addition, importers are required to investigate the cause of accidents
and take appropriate measures when necessary, such as the voluntarily recall of the products.

Major Import and Sales Regulations
At the time of import

Notification of Import in accordance with the Food Sanitation Act (targeting equipmentthat has direct contact with food)Procedures specified by the Pharmaceutical Affairs Act (targeting massage machines,etc.)

At the time of sales

Procedures specified by the Electrical Appliance and Material Safety Act (targeting
electrical appliances)
Labeling in accordance with the Household Goods Quality Labeling Act (targeting 17
electrical appliances)
Reporting serious product accidents
Procedures specified by the Radio Act, Water Supply Act

Procedures Specified by the Electrical Appliance and Material Safety Act
First of all, it is necessary to check whether the home appliance or appliances to be imported fall into
the category of electrical appliances. Most electrical products that connect directly to home outlets (457
items) are designated as electrical appliances and subject to the Electrical Appliance and Material Safety
Act.

■ Importer’s Obligations
Electrical appliance importers are required to notify the Ministry of Economy, Trade and Industry of thecommencement of business within 30 days from the commencement thereof, comply with the TechnicalStandards, conduct self-inspections of the finished products, and label them with PSE marks in theprescribed manner. In addition to self-inspections, specified electrical appliances (116 items) are required
to undergo conformity assessment by registered assessment bodies.
Specified Electrical Appliances

Non-Specified Electrical Appliances[116 items]
Electric water heaters
Electric motor-operated products for children (toys)
Electric pumps
Electric massagers
AC/DC power supply (AC adapter)
Portable power generators, etc.

[341 items]
Electric room heaters
Electric irons
Pedestal lighting fixtures
Television receivers
Other audio equipment
Secondary lithium ion batteries

15

Items that do not fall into the category of Electrical Appliances and Materials● Main unit of electrical appliances and materials used with a removable AC adapter(However, the AC adapter is included under “AC/DC power supply” and falls into the category of specified
electrical appliances and materials.)● Electrical appliances and materials used with power supply via amplifiers● A segment of information and telecommunication devices (personal computers, fax machines, , etc.)● Battery-powered equipment

Reference
Revision of the acts and regulations on the designation of electrical appliances has been discussed
by the national government with the intention of making the range easier to understand, and of promptly
corresponding to composite and new products applying advanced technology.

■ Compliance with the Technical Standards
Current Technical Standards include detailed specifications regarding the size and form of individual
items. However, from January 2014, Specific Safety Guidelines will come into force to clarify the safety
performance requirements for each electrical appliance, such as protection for electrocution andmaintenance of isolation performance. Current Technical Standards (specifications) will be used as
examples for satisfaction of technical requirements.
Importers are responsible for compliance with the Technical Standards. This includes responsibility for
self-inspections, asking the foreign manufacturer to carry out inspections and obtaining and verifying thecontent of inspection records, and the outsourcing of inspections to external organizations.
*When the approval of the Ministry of Economy, Trade and Industry has been obtained for the manufacture or import ofElectrical Appliances and Materials to be used for specific applications, such as models for travelers from abroad, when
the import is for experimental purposes, or when the import is exclusively for export, the obligation of compliance is
exempted.
*Overseas safety standard markings such as the CE and UL marks are based on different Technical Standards due tothe difference in power distribution systems; therefore, the compliance of products with these marks with the TechnicalStandards under the Japanese Electrical Appliance and Material Safety Act must be verified.

Caution!
● Power cord sets and parts for electrical appliances

Dedicated power cord sets included as parts in packages with electrical appliances do not need to bereported or labeled. However, it is necessary that they comply with the Technical Standards as parts or
power cord sets.
● Secondary lithium-ion batteries

In response to the increase of smoke and fire accidents, secondary lithium-ion batteries used for laptop computers and mobile phones became subject to the Electrical Appliance and Material Safety Act from
November 2008*. Since July 2012, the range of batteries subject to the Electrical Appliance and Material
Safety Act has expanded to include rechargeable batteries with special structures.
*Note: Subject to the act are batteries whose volumetric energy density per battery is 400wh/L or more, excluding batteries
for bicycles, motorcycles, medical equipment and devices, and industrial equipment and devices.

● LED lamps

Some lighting equipment using LED lamps, such as pedestal and decorative lighting fixtures, werealready subject to the Electrical Appliance and Material Safety Act; however, from July 2012, LED lamps (inthe shape of light bulbs) and LED lighting fixtures were added.
16

■ Long-Term Use Consumer Product Safety Labeling System
Labels for electric fans, air conditioners, ventilation fans, washing machines, excluding dryers, andCRT televisions, excluding those for industrial use, must include the design standard use period and callattention to age deterioration. The Technical Standards include more details.

Labeling based on the Household Goods Quality Labeling Act
Seventeen electrical appliances subject to the Household Goods Quality Labeling Act must be labeledin accordance with the Quality Labeling Standards for Electrical Appliances.

Electrical Appliances (17 items)
Washing machines/ Electric rice cookers/ Electric blankets/ Electric vacuum cleaners/ Electric refrigerators/
Ventilation fans/ Air conditioners/ Television receivers/ Electric juice squeezers and blenders/ Electric panel
heaters/ Electric kettles/ Electric roasters/ Electric shavers/ Microwave ovens/ Fluorescent desk lamp stands/
Electric cooking heating plates/ Electric coffee makers

Voluntary Safety Mark■ S Mark
The Steering Council of Safety Certification for Electrical and Electronic Appliances and Parts of Japan(SCEA) established the S Mark System as a private certification system for electrical appliances andmaterials. Distinct from safety checks conducted by importers, the S Mark is authorized for products whose
safety has been certified by the SCEA, and this allows importers to indicate to consumers and distributors
that they have achieved standards.

(Labeling combining the S Mark and a certification body logo)

Other Points to Remember● Toys that infants may place in their mouth and cooking tools that have direct contact with food, such as

coffee makers and mixers, are subject to the Food Sanitation Act.
● Furthermore, there are some items that may be subject to the Radio Act and Water Supply Act, etc.
● Built-in type electric dishwashers, electric dryers for bathrooms, and Electric forced-flue oil-burning air

heaters are subject to Long-Term Use Consumer Product Safety Inspection in accordance with theConsumer Product Safety Act.

17

5. The Import and Sale of Gas-Fired and Oil-Burning Appliances
Points to Remember for Safety● Among gas-fired and oil-burning equipment for general consumers, designated products are subject to theGas Business Act, Liquefied Petroleum Gas Act, and Consumer Product Safety Act. To sell these products
in Japan, importers must ensure compliance with the Technical Standards, and PSTG, PSLPG, or PSC
marks should be affixed to the approved products. Without these marks, products may not be sold inJapan.
● Importers are required to establish an inspection system for products, such as instantaneous gas-fired
water heaters and oil-burning air heaters, which carry a high risk of serious product accidents due to agerelated deterioration.
● Gas-fired and oil-burning equipment fall into the category of consumer products and importers are required
to report any serious product accidents to the Consumer Affairs Agency within 10 days from the day
when said importers come to know about the accidents. In addition, importers are required to investigate
the cause of accidents and take appropriate measures when necessary, such as the voluntary recall of
products.

Major Import and Sales Regulations
At the time of importNone

At the time of sale

Procedures specified by the Gas Business Act (targeting gas equipment)
Procedures specified by the Liquefied Petroleum Gas Act (targeting liquefied petroleum gas equipment)
Procedures specified by the Consumer Product Safety Act (targeting 3 oil-burning appliances)
Reporting serious product accidents

Procedures Specified by the Gas Business Act and Liquefied Petroleum Gas Act■ Importer’s Obligations
Five items of city gas equipment are subject to the Gas Business Act. Thirteen liquefied petroleum gas(LP gas) equipments are subject to the Liquefied Petroleum Gas Act.
Importers of gas and liquefied petroleum gas equipment are required to notify the Ministry of Economy,
Trade and Industry of the commencement of business. Importers are also responsible for confirming thatgas and liquefied petroleum gas equipment comply with the required Technical Standards and that the
products to be sold are self-inspected and labeled with PSTG or PSLPG marks in the prescribed manner.
Specified gas and liquefied petroleum gas equipment is required to undergo self-inspections by importers
and conformity assessment by registered assessment bodies.

18

Specified Gas Equipment

Non-Specified Gas Equipment[4 items]
Instantaneous Gas-fired water heaters (semi- sealed
types)
Gas-fired heaters (semi-sealed types)
Bath furnaces with gas burners (semi-sealed types)
Bathtub gas burners[4 items]
Gas cooking stoves
Instantaneous Gas-fired water heaters (open, sealed,
and outdoor types)
Gas-fired heaters (open, sealed, and outdoor types)
Bath furnaces with gas burners (sealed, outdoor
types)

Specified Liquefied Petroleum Gas Equipment.

Non-Specified Liquefied Petroleum Gas Equipment[7 items]
Cartridge type LP gas cooking stoves
Instantaneous LP gas water heaters (semi-sealed)
Bath furnaces with LP gas burners (semi-sealed)
Bath furnaces
Bathtub burners for LP gas
LP gas heaters (semi-sealed)
LP gas fixtures[9 items]
Regulators
LP gas cooking stoves
Instantaneous LP gas water heaters (open, sealed,
outdoor types)
High-pressure hoses with couplings for LP gas
Bath furnaces with LP gas burners (sealed, outdoor
types)
LP gas heaters (open, sealed, outdoor types)
LP gas leak alarms
Low-pressure hoses with couplings for LP gas
Antiseismic automatic LP gas breakers

Caution!
● Gas-fired combination water and air heating systems

In July 2011, the Act was revised to include gas-fired combination water and air heating systems in the
category of Instantaneous Gas Water Heaters, which is subject to the Gas Business Act and Liquefied
Petroleum Gas Act. Systems placed inside also fall into the category of Long-Term Use Consumer Product
Safety Inspection System (indoor type instantaneous gas water heaters).
● Gas cooking stoves

Home-use gas cooking stoves are subject to the Gas Business Act and Liquefied Petroleum Gas Act.
Technical Standards require all burners to have a safety device to prevent oil from overheating and an
automatic burner safety shutoff device to prevent fires caused by gas cooking stoves.
So-called Portable Gas Cooking Stoves/ Cartridge-Type Gas Cooking Stoves are designated as
specified LP gas equipment.

Reference
Fuel containers such as gas cartridges used for Portable Gas Cooking Stoves must be labeled with
“Caution: Flammable and High Temperature!” as a requirement for exemption from the High Pressure Gas
Safety Act.

Procedures Specified by the Consumer Product Safety Act
Obligations of Importers of Specified Products
Three items of oil-burning equipment (oil water heaters, bath furnaces withoil burners, and oil-burning air heaters, including oil fan heaters) are products
specified by the Consumer Product Safety Act.
Importers of specified products are required to submit a notification ofcommencement of business. Importers are also responsible for confirmingthat specified products comply with the required Technical Standards and thatSpecified Products other thanSpecial Specified Products

19the products to be sold are self-inspected and labeled with PSC marks in the prescribed manner.
In order to prevent serious product accidents, the Technical Standards specify the obligation to installa safety device for heating when a low amount of water is present, compliance with standard values forcarbon monoxide concentration, and installation of a safety device for incomplete combustion.

■ Long-Term Use Consumer Product Safety Inspection System
The Consumer Product Safety Act requires importers to develop an inspection system for specified
maintenance products, which pose a high risk of serious product accidents due to difficulty of maintenanceby consumers and age-related deterioration. The Act requires importers to submit a notification of business,label products, and manage owners’ information in addition to the requirement to conduct inspections.

Specified Maintenance Products
Indoor instantaneous gas water heaters (for city gas and LP gas)/ Bath furnaces with indoor gas burners (forcity gas and LP gas)/ Oil water heaters/ Oil bath furnaces/ Forced-flue type oil-burning air heaters/ Built-in
type electric dishwashers/ Electric dryers for bathrooms

Topics Prevention of Product Accidents
According to a METI report*, nearly 80% of the 1,141 serious product accidents that occurredin FY2010 were caused by electrical and combustion appliances. According to the information on
accidents collected by the NITE (including non-serious product accidents), for the four years from2007 to 2010, home appliances always ranked first followed by combustion appliances, and both
home and combustion appliances accounted for approximately 73% of accidents. Manufacturers
and importers of these products are required to establish measures to prevent the occurrence andrecurrence of serious product accidents.
Reports cite the importance of companies assuming a wide range of use in risk assessment fromthe design stage and developing safe products to supply to markets, which will lead to the further
enhancement of measures for the prevention of accidents.
*Note: Current Status of Product Safety Measures by the Product Safety Division, Commerce and Distribution PolicyGroup, Ministry of Economy, Trade and Industry (May 31, 2011)

FY2010 Serious Product Accidents
Home Appliances (564 cases)

Top 5 items by category
Combustion Appliances(339 cases)

Other products (238 cases)

Item

NumberItemof Cases

NumberItemof Cases

Numberof Cases1

Air conditioners82

Gas cooking stoves98

Bicycles32

2Electric heaters

42

Oil-burning air heaters

48

Stepladders, stepstools,
ladders19

3

Microwave ovens

35

Oil water heaters

48

Chairs16

4Electric refrigerators

31

Gas water heaters

31

Shoes

14

5

Lighting fixtures

22

Gas bath furnaces

23Child seats for bicycles

13

Based on data provided by the METI

20

6. The Import and Sale of Products for Children
Points to Remember for Safety● In order to ensure the safety of products for children, it is necessary to consider child behavior and potential
risks.
● There is a risk that infants or children may put toys designed for children under 6 years of age into theirmouths. Therefore, such toys are subject to the Food Sanitation Act.
● The use of harmful substances such as formaldehyde in clothes for children is regulated.

Major Import and Sales Regulations
At the time of import

Notification of Import specified by the Food Sanitation Act (targeting toys for intants,
dishes, feeding bottles)
Procedures specified by the Explosive Control Act (targeting toy fireworks)

At the time of sales

Regulations for the use of formaldehyde (targeting clothes and bedding material for
infants)
Labeling based on the Household Goods Quality Labeling Act (targeting clothes, dishes, and feeding bottles)
Procedures specified by the Consumer Product Safety Act (targeting baby beds, toys
generating laser light)
Safety Standards for child seats, etc.

Safety Regulations for Toys
■ Procedures Specified by the Food Sanitation Act
Considering the risk of harm to infants and children, toys targeting infants and children under 6 years of age areregulated by the Food Sanitation Act. Such products must undergo inspection and importers are required to submit
a Notification of Import.

Products subject to the Food Sanitation Act (designated toys)● Products that will or may come into direct contact with infants’ or children’s mouths● Accessories/ Transfer pictures/ Weighted toy tumblers/ Masks/ Origami/ Rattles/ Educational toys (that may
be chewed by infants)/ Building blocks/ Toy phones/ Toy animals/ Dolls/ Clay/ Toy vehicles/ Balloons/ Blocks/
Balls/ Toys for play houses● Products used in combination with the above-listed toys
“Chapter 4 Toys” in the Specifications and Standards for Food, Food Additives, etc. under the Food Sanitation
Act specifies standards for toys and the raw ingredients, and manufacturing standards for toys. Specified toys are
required to comply with these specifications and standards prior to sale.
● Prevention of accidental ingestion of accessories containing leadIn response to the detection of cadmium in Chinese-made metal accessories for children in the U.S., theConsumer Affairs Agency conducted an investigation. As a result, it was found that some products in Japan also
contained levels of lead exceeding the standard values specified by the Food Sanitation Act.
The Consumer Affairs Agency asked the industry to gather information on lead contained in products, reduce
the amount used in products, and indicate caution marks.

21

■ ST MarkThe Japan Toy Association specifies Safe Toy Standards for the industry and promotes
the use of ST marks on products targeting children up to 14 years of age that meet safety
requirements for form, strength, and material safety. The association also established adamage compensation system for accidents caused by products with ST marks.

■ Safety of Toy Fireworks
Toy fireworks are subject to the Explosives Control Act*, Before import, it is necessary
to submit an Application for Import Permission and Notification of Import to the prefecturein which the port of importation is located.
The Japan Pyrotechnics Association carries out standard inspections for compliance with the Explosive Control
Act, and safety inspections for toy fireworks. Products that meet all the requirements are authorized to display the
SF mark. The SF mark is a voluntary industry standard; however, almost all toy fireworks in Japan have SF marks.
Products that are authorized to display the SF mark are covered by the compensation system.
*Note : In accordance with the Explosives Control Act, the content of regulations differs according to the classification of
products (general explosives, pyrotechnics, toy fireworks, etc.). It is also necessary to check whether or not theimported fireworks fall under the category of toy fireworks. There are regulations for the storage and transportationof explosives (need to store in magazines, need to submit notification of transport, etc.); however, the storage of
25kg or less of gunpowder and explosives contained in toy fireworks, and the transportation of 2 tons or less of
gunpowder and explosives are not subject to the regulations.

Safety Regulations for Clothes■ Regulations for Formaldehyde
Attention must be paid to formaldehyde content in clothing for children. Formaldehyde is often used to prevent
shrinkage and wrinkles in clothing. Because of the risk of dermal irritation, however, the Act on Control ofHousehold Products Containing Harmful Substances specifies the allowable amounts. Products that exceed theallowable amount of formaldehyde cannot be sold.
The amount of formaldehyde allowed in clothing for infants aged 24 months or younger is especially strict.
Regardless of age, the amount of formaldehyde used for underwear, sleepwear, gloves and socks is also regulated.

Regulatory Standards for FormaldehydeHousehold Products

Textile ProductsStandards(Infants at 24 month old or younger)
Diapers/ Diaper covers/ Bibs/ Underwear/ Sleepwear/ Gloves/ Socks/
Intermediate garments/ Outer garments/ Caps and hats/ Bedding material
Underwear/ Sleepwear/ Gloves/ Socks/ Tabi socks

Adhesives

Hairpieces/ False eyelashes/ False beards/ Adhesives for socks

Upper limit or lower(16ppm or lower)

75ppm or lower

ReferenceWith guidance from the Ministry of Economy, Trade and Industry, voluntary industry regulations specify
1,000ppm or lower for outer garments and 300ppm or lower for intermediate garments for children aged 3
years and older and adults.

22*Caution for migration of formaldehyde!
It is easy for formaldehyde to adhere to or be absorbed by other materials through air and moisture. Therefore, while theamount of formaldehyde contained in products may be under the allowable values at the time of production, formaldehyde
may migrate from display shelving material where products are placed or stored, or from other non-regulated textile
products. Except for samples, therefore, clothing for infants and children should be kept in packages.
*In addition to formaldehyde, the amounts of dieldrin and DTTB, which are used as mothproofing agents for wool products,
contained in clothing are also regulated.

■ Children’s Clothing DesignChildren’s clothing must be carefully designed to prevent accidents (entanglement in strings or hoods,
accidental ingestion of buttons, etc.). In Europe and the U.S., information on accidents caused by children’s
clothing is gathered and analyzed to create safety standards for design for the purpose of reducing
accidents. In Japan, the Japan Women’s and Children’s Wear Manufacturers’ Association took the lead inestablishing Safety Guidelines for the Design of Children’s Clothing as voluntary standards for the apparelindustry.

Voluntary Safety Marks
In addition to above-mentioned ST and SF marks, the SG mark is also used toindicate the safety of products for children.

■ SG MarkThe Consumer Product Safety Association specifies Safe Goods Standards required for the assuranceof safety of consumer products that may pose a risk because of structure or material, and authorizes
products that meet SG Standards to display the SG mark. While manufacturers and importers are notrequired to obtain SG marks, 21 items of infant and children’s clothing are currently certified, and themark has become a guide for consumers in selecting safe products. The SG mark is covered by thecompensation system for physical injury due to defects in products authorized to display SG marks.

Items covered by the SG Mark (Products for Infants and Children)
Strollers/ Walkers/ Swings/ Slides/ High bars for children/ Tricycles for children/ Pedal cars/ Beds for infants
and children/ Slings/ Extendable poles for carp-streamers/ Metal-frame nursery items/ Child safety barriers/
One-person swings/ Baby chairs/ Baby high-chairs/ Playpans/ Portable infant seats for tables/ Baby carriers/
High and low chairs for children/ Child bed guards/ Baby cradles

Regulations for Other Items■ Safety Regulations for Baby Beds
Beds for infants (up to 24 months of age) are designated as special specified products by the Consumer
Product Safety Act. Importers are responsible for submitting a Notification of Commencement of Business,
conforming that the products comply with the required Technical Standards, and that the products tobe sold are self-inspected, labeled with PSC marks, and undergo conformity assessment by registeredassessment bodies.

■ Safety Standards for Child Car Seats
Safety Standards for child car seats are specified in accordance with the Road Transport Vehicle
Act (Paragraph 5, Article 22, Safety and Maintenance Standards for Road Transport Vehicles), andthe Designation System for Device Models is in place as a method of confirming compliance with thestandards. Child car seats that meet the standards are authorized to display the relevant designation mark.

23

7. Import and Sales of Other Household Products
Points to Remember for Safety● Tools that come into direct contact with foods, such as dishes and cooking equipment, are subject to the
Food Safety Act.
● Household pressure cookers and autoclaves, helmets for motor vehicle users, mountaineering ropes, andlighters are designated as specified products by the Consumer Product Safety Act. These products are
required to meet the Technical Standards and to display the PSC mark prior to sale.
● Use of harmful substances in household detergent fluids, aerosol products, and textile products such as
bedding are regulated.
● Products specified by the Household Goods Quality Labeling Act are required to indicate components,
performance, usage, handling precautions, etc.

Major Import and Sales Regulations

At the time of import

Notification of Import specified by the Food Sanitation Act (targeting equipment thatcomes into direct contact with foods)
Procedures specified by the Pharmaceutical Affairs Act (targeting soaps, toothpaste,hair color, thermometers, manometers, etc.)
Procedures required for plant quarantine/ Procedures specified by the Washington
Convention and the Wildlife Protection and Hunting Act according to productAt the time of sales

Procedures specified by the Consumer Product Safety Act (targeting specified
products)
Labeling based on the Household Goods Quality Labeling Act (targeting textile goods,
plastic manufactured goods, miscellaneous manufactured goods)
Act on the Control of Household Products Containing Harmful Substances (targetinghousehold detergent fluids, household aerosol products, a segment of textile products,
household adhesives, etc.)
Report of serious product accidents
Labeling specified by the Food Sanitation Act and Pharmaceutical Affairs Act according
to product
Procedures specified by the Fire Service Act, Electrical Appliances and Materials
Safety Act, Gas Business Act, Liquefied Petroleum Gas Act, etc. according to product

Procedures Specified by the Food Sanitation Act■ Safety Regulations for Dishes
Dishes fall into the category of “apparatuses” specified by the Food Sanitation Act, for which importers
are required to submit a Notification of Import and undergo inspection. Specifications and standards fordishes are included in Chapter 3. Apparatuses and Containers/ Packages, Specifications and Standards
for Food, Food Additives, etc. Products are required to meet said specifications and standards prior tosale. Products in the form of dishes intended for sale as picture plates or stationary articles for ornamental
purposes may not be subject to the procedures specified by the Food Sanitation Act.
Dishes made of plastic, reinforced glass, heat-resistant glass, or dishes coated with lacquer or cashew
resin must be labeled in accordance with the Household Goods Quality Labeling Act.
*In addition to dishes, pans, flying pans, cooking apparatuses, water purifiers, and kitchen detergent are subject to the Food
Sanitation Act.

24

Procedures Specified by the Consumer Product Safety Act■ Regulations for Specified Products
The Consumer Product Safety Act ensures consumer product safety for products not individually
regulated by other acts such as the Food Sanitation Act and Pharmaceutical Affairs Act. In particular,
products that pose a risk of injury or death are regulated as specified products.
Importers of specified products are required to submit a Notification of Business Commencement1,
comply with the required Technical Standards, conduct self-inspections, and label products with PSC
marks in the prescribed manner. In addition to these requirements, special specified products are required
to undergo self-inspection by importers and conformity assessment by registered assessment bodies.
Note 1: Submission of Notification of Business Commencement requires that importers be covered by Liability Insurance.

Special Specified Products

Specified Products other than the Special Specified
Products[4 items]
Baby beds
Portable laser-applied equipment (laser pointers, laseraligners, toys emitting laser beams)
Hot water circulators for bathtubs (whirlpool bathtubs,
24-hour hot water bathtubs, etc.)
Lighters (disposable and multi-purpose lighters)[6 items]
Helmets (for motorbikes, etc.)
Pressure cookers and autoclaves for home use
Climbing ropes
Oil water heaters
Oil bath furnaces
Oil-burning air heaters● Regulations for Lighters

To prevent accidents resulting from children playing with lighters, disposable and multi-purpose lighters
are designated as special specified products 2. From September 2011, businesses have been prohibitedfrom selling lighters other than those carrying the PSC mark. The Technical Standards specifies heightof flame and heat resistance performance, and requires installation of a function that makes it difficult forchildren to operate (child-resistance function).
Note 2: The term “lighters” here includes home-use equipment that lights articles other than tobacco, and that has a unified
structure with fuel containers made from plastic.

Regulations for Harmful Substances■ Harmful Substances Contained in Household Products
The Act on Control of Household Products Containing Harmful Substances regulates the use ofchemical substances such as mercury compounds in household products. To prevent health hazards, the
MHLW designates harmful substances for each household product and establishes standards for content,elution and emission. The sale of products exceeding the standard values is prohibited.
In addition to textile products, household detergent fluids, aerosol products, adhesives, paints, wax,
shoe polish, wood preservatives, and wood pesticides are also regulated. Attention must be paid to thechemical substances such as wrinkle-resistant and shrink-resistant agents, fungicides, insecticides, flameproofing agents, and solvents used in these products.

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Harmful Substances (20 items)
Hydrogen chloride/ Sulfuric acid/ Vinyl chloride/ DTTB/ Sodium hydroxide/ Potassium hydroxide/
Tetrachloroethylene/ Trichloroethylene/ APO/ TDBPP/ Triphenyl-tin compounds/ Tributyl-tin compounds/
BDBPP/ Dieldrin/ Formaldehyde/ Methanol/ Organomercury compounds/ Dibenzo[a,h]anthracene/ Benzo[a]anthracene/ Benzo[a]pyrene*Household products and harmful substances whose standard values are not specified may not be used freely. If
serious damage to health occurs during the use of said products and substances, they must be recalled. Importers andmanufacturers are required to prevent health hazards caused by chemical substances contained in home-use products.

■ Preventive Measures for Sick Building Syndrome
Chemical substances such as formaldehyde and VOC (toluene, xylene, etc.) that are emitted frombuilding materials used for housing, furniture, and commodities are a cause of sick building syndrome3.
As a preventive measure, the Building Standards Act limits the use of building materials that emit
formaldehyde for the area under the roof and for the interior finishing of rooms. In addition, the use ofbuilding materials containing chlorpyrifos (organic phosphorus insecticide for termite control) in residentialbuildings is prohibited.
Note 3: Sick building syndrome is used to describe situations in which occupants of newly-built or remodeled buildings
experience acute health effects such as irritation of the eyes, dizziness, nausea, and headache.

Labeling based on the Household Goods Quality Labeling Act
The Household Goods Quality Labeling Act designates householdproducts whose quality is extremely difficult for general consumers
to discern at the time of purchase, and with respect to which it isdetermined that there is a particular need to identify quality and ensure
proper labeling. Target items are 35 textile goods, 8 plastic manufactured
goods, 30 miscellaneous manufactured goods, and 17 electricalappliances. In order to sell these products, they must be labeled inaccordance with the individual specifications for quality labeling.

■ Indication of “Danger! Don’t mix!”
In response to a fatality caused by the generation of chlorine gas by simultaneous use of acidic
detergent and chlorine products, the Household Goods Quality Labeling Act now specifies the display of awarning as a matter requiring special care. Subject detergents and bleaches must indicate such a warning.
Matters to be indicated are specified individually for both acidic and chlorine types.

Voluntary Safety and Warning Marks■ SG MarkThe Consumer Product Safety Association specifies Safe Goods Standards for 125 items including
products for infants and children (see page 23), welfare equipment, furniture and household products,
kitchen products, sports and leisure products, home-use fitness products, gardening products, bicycles
and bicycle parts, and other items (14 items are currently excluded.) as targets of the SG mark certification
system.

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■ Graphical Warning Symbols for Consumers
The Japanese Industrial Standards (JIS) specify JIS graphical warning symbols for consumers (JISS 0101) to promote the understanding of warning symbols by consumers. The JIS have no legal force;
however, these symbols are specified by the industry for use as warning.
(Prohibition)(Warning)(Mandatory)(General Prohibition)(General Warning)(General Mandatory)

Regulations for Other Items■ Household Aerosol Products
Although the use of high-pressure gas and containers is regulated by the High Pressure Gas Safety
Act, aerosol products such as aerosol containers, gas cylinders for lighters and simplified gas cooking
stoves, and gas in refrigerant service cans are exempt from the application of the Act. However, it isnecessary to attach inspection results that show compliance with the requirements for exemption from theHigh Pressure Gas Safety Act at Customs.
In addition, importers are required to indicate warnings such as “Avoid exposure to high temperaturesand open flame” in accordance with the High Pressure Gas Safety Act and Fire Service Act.

■ Flame Retardant Goods
Curtains and carpets used in high-rise buildings, underground malls,
and facilities where unspecified numbers of people come and go, such as
theaters, inns, and hospitals, are required by the Fire Service Act to be flame
retardant goods.
To be flame retardant here means the characteristic of not burning easily.
Flame retardant goods cannot be sold without indicating “Flame Retardant.” Individuals labeling flame
retardant goods must be registered by the Commissioner of the Fire and Disaster Management Agency.

■ Safety Regulations for Bicycles
Safety Standards for the size, braking devices, and reflectors of bicycles are specified in accordancewith the Road Traffic Act, and the Model Certification System has also been established.
The Bicycle Association of Japan established Bicycle Safety Standards as voluntary industry standards
to authorize the display of BAA marks on bicycles that meet the standards. Accidents caused by defects
in production are covered by PL Insurance, which manufacturers and importers are required to enroll in.
Bicycles also have JIS, SG, and TS mark systems which are all voluntary.

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8. References
Act, Regulations, Procedures

Websites

Procedures Specified by the Food
Sanitation Act

Ministry of Health, Labour and Welfare“Imported Foods Inspection Services Home Page”
http://www.mhlw.go.jp/english/topics/importedfoods/index.html

Plant Quarantine

Plant Protection Station
http://www.pps.go.jp/english/index.html

Animal Quarantine

Animal Quarantine Service
http://www.maff.go.jp/aqs/english/index.html

Food Labeling Systems

Consumer Affairs Agency, Government Of Japan “Food Labeling”
http://www.caa.go.jp/en/index.html

Procedures Specified by the Electrical Appliances and Material Safety
Act

Ministry of Economy, Trade and Industry“Electrical Appliance and Material Safety Law”
http://www.meti.go.jp/english/policy/economy/consumer/pse/index.html

Procedures Specified by the Consumer Product Safety Act
Procedures Specified by the Gas
Business Act
Procedures Specified by the Liquefied Petroleum Gas Act

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Ministry of Economy, Trade and Industry
Product Safety Guidelines > For Business Operators (in Japanese)
http://www.meti.go.jp/product_safety/producer/index.html

Labeling based on the Household
Goods Quality Labeling Act

Consumer Affairs Agency, Government Of Japan “Household Goods
Quality Labeling Law”
http://www.caa.go.jp/en/index.html

Act on Control of Household Products Containing Harmful Substances

Ministry of Health, Labour and Welfare“Summary of Criteria for Control of Household Products Containing
Harmful Substances”
http://www.nihs.go.jp/mhlw/chemical/katei/PDF/120326_list_eiyaku.pdf

Procedures Specified by the Pharmaceutical Affairs Act

Tokyo Metropolitan Institute of Public Health (in Japanese)“Drugs, Quasi-Drugs, Cosmetics Screening”
http://www.tokyo-eiken.go.jp/k_yakuji/i-sinsa/
Manufacture and Distribution of Medical Devices, Manufacture and Repair of Medical Devices, Specially Controlled Medical Devices”
http://www.tokyo-eiken.go.jp/k_iryou/k-sinsa/kikikyokanituite/

Import Clearance Procedures

Japan Customs
http://www.customs.go.jp/english/index.htm

Issued by

Manufactured Imports and Investment Promotion Organization (MIPRO)
6th floor, World Import Mart Bldg.,
3-1-3, Higashi-ikebukuro, Toshima-ku, Tokyo 170-8630, Japan
Tel:+81-3-3971-6571 Fax:+81-3-3590-7585
URL http://www.mipro.or.jp
Unauthorized copying of the contents of this guidebook is strictly prohibited.

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Manufactured Imports and Investment Promotion Organization (MIPRO)URL http://www.mipro.or.jp
November 2013