Japan

Background

In recent years, with the progress of regulatory reform, an increasing number of voluntary Japanese Industrial Standards (JIS) are being adopted as technical standards in regulations, as more and more regulations incorporate performance-based requirements.

Industrial Standardization Law stipulates that JIS standards should be followed when national governments and local governments set technical standards related to mining and manufacturing, or when they create speciﬁcations for their procurement. At the same time, the WTO/TBT Agreement speciﬁes that both regulations and technical standards should be harmonized with international standards with a view toward not creating unnecessary obstacles to international trade. The WTO/TBT Agreement reads: “Where technical regulations are required and relevant international standards exist or their completion is imminent, members shall use them, or the relevant parts of them, as a basis for their technical regulations.” As a member of the WTO, the Japanese government is working to harmonize JIS standards with corresponding international standards to the greatest degree possible. At the same time, it is encouraging the use of JIS standards as references when technical standards are required in regulations. Of the over 109 000700 JIS standards currently existing, 54 7800 have corresponding international standards, and 54 6500 of these are harmonized with their corresponding international standards.

ISO Member Body

The Japanese Industrial Standards Committee (JISC) is the ISO Member body in Japan.

Referencing of JIS standards to regulations and public policy

Ensuring the safety of industrial products is the most important consideration in the context of protection of consumers and labour. JIS standards are referenced as technical standards for self- declaration and third-party conformity assessment in regulations governing safety. 195 laws apply JIS to technical regulations, 1 300 JIS are cited in laws and regulations and the frequency of citation in the laws and regulations is 6 500. There are about 2 000 JIS standards that are referenced in regulations. The Building Law, Pharmaceutical Affairs Law, and Electrical Appliance and Material Safety Law are examples of regulations referencing JIS standards.

Building Law

The Building Law and its related laws stipulate standards for sites, structures, equipment, and the usage of buildings. According to these laws, the quality of building foundations, principal building parts and materials used for building parts that are important in terms of safety, ﬁre prevention, and sanitation must be approved by the Minister of Land, Infrastructure and Transport. JIS standards are used in this approval testing. Building materials conforming to the JIS standards referenced in these laws, however, are not required to obtain such ministerial approval. Nearly 23040 JIS standards are referenced in these laws, and, of these, about 100 are harmonized with their corresponding international standards.

Pharmaceutical Affairs Law

The Pharmaceutical Affairs Law and its related laws provide regulations required to ensure the quality, efﬁcacy and safety of drugs, quasi-drugs, cosmetics and medical devices. For in vitro diagnostic medical devices designated in these laws, manufacturing distributors are required to obtain certiﬁcation by a third-party certiﬁcation organization designated by the government. About 1540 JIS standards are referenced in these laws as performance standards for medical devices. Of this number, about 40 are harmonized with their corresponding international standards.

Electrical Appliance and Material Safety Law

The Electrical Appliance and Material Safety Law and its related rules laws establish restrictions on the manufacturing, import and sale of designated electrical products in order to prevent accidents caused by electrical products. Manufacturers or importers of electrical products are obligated to:

produce or import electrical products that conform to the technical standards stipulated in the laws;
ship those products with a mark (“PSE” mark) that shows that the electrical products conform to technical standards; and
only sell electrical products with the PSE mark. About 29 060 JIS standards are referenced in these rules laws, and almost all of them are harmonized with their corresponding international standards.

Basic Policy for the Promotion of Procurement of Eco-Friendly Goods and Services

Basic Policy for the Promotion of Procurement of Eco-Friendly Goods and Services was established in order to promote comprehensive and planned procurement of materials, components, products and services with low environmental impact. It is considered that local governments, enterprises, and citizens will also make a commitment to the procurement of eco-friendly goods by taking this basic policy into account. According to this policy, 267 items are defined as eco-friendly goods. As of 2014FY, Total 72 JIS standards are referred to this policy as test and product standard.

Japanese Policy / Regulation	Reference to standard/s
Building Law Quality of Building Materials	Article 37: Such building materials as wood, steel, concrete and other materials speciﬁed by the Minister of Land, Infrastructure and Transport used for the foundations, principal building parts, and other parts of building speciﬁed by Cabinet Order which are important from the viewpoint of safety, ﬁre prevention and sanitation (hereafter in this Article referred to as “designated building materials” shall come under either one of the following items: Those qualities conform to the Japanese Industrial Standards or Japanese Agricultural Standards designated for each designated building materials by the Minister of Land, Infrastructure and Transport.
Enforcement Regulation of Pharmaceutical Affairs Law Designated medical equipment that the Ministry of Health Labour and Welfare speciﬁes standards pursuant to the provisions of Item 1 of Article 23-2 of the Pharmaceutical Law.	Medical equipment Thermometer JIS T1140 Standards Purpose of use, effect or impact Making temperature measurement section contact, measure the body temperature of rectum, armpit, buccal cavity (hypoglossal), keeps the highest temperature and indicates it digitally Designated Medical Equipment that the Ministry of Health, Labour and Welfare speciﬁes standards pursuant to the provisions of Item 1 of Article 23-2 of the Pharmaceutical Affairs Law shall conform to the standards given in the table above.
Electrical Appliance and Material Safety Law Technical requirements pursuant to the provisions of the Ministerial Ordinance Specifying Technical Requirements for Electrical Appliances and Materials.	Technical requirements for electrical applicances and materials: Number: J60068-2-2(H14) Title: Basic environmental testing procedures, Part 2: Tests, Test B: Dry heat Text: JIS C 0021: 1995 Notes: Corresponding to IEC 60068-2-2 (1974) Amd. No. 2 (1994) Number: J60068-2-3 (H14) Title: Basic environmental testing procedures, Part 2: Tests, Test C: Damp heat, steady state Text: JIS C 0022: 1987 Notes: Correponding to IEC 60068-2-3 (1969) The harmonized standards are stipulated in Appendix Table 12 of the Interpretation of the Ministerial Ordinance Specifying Technical Standards for Electrical Appliances and Materials, and the Technical Requirements pertinent to each of the relevant products shall be applied..
Basic Policy for the Promotion of Procurement of Eco-Friendly Goods and Services	Item: Light bulb-shaped lamps Evaluation Criteria: Bulb-shaped LED lamps must meet the following criteria. Average color rendering index Ra of 70 or more. Rated life of at least 40 000 hours. Measuring methods of Average color rendering index Ra is in accordance with light source color and color rendition evaluation method of source of light by JIS C 8152-2(Photometry of white light emitting diode for general lighting-Part 2: LED modules and LED light engines). *Rated life* of bulb-shaped LED lamps in this section refers to the total amount of lighting time until the initial luminous flux to decrease by 70%. The method of measurements is in accordance with JIS C 8152-3 (Photometry of white light emitting diode for general lighting-Part 3: measurement methods for lumen maintenance).

Japanese Policy / Regulation

Reference to standard/s

Building Law Quality of Building Materials

Article 37:

Such building materials as wood, steel, concrete and other materials speciﬁed by the Minister of Land, Infrastructure and Transport used for the foundations, principal building parts, and other parts of building speciﬁed by Cabinet Order which are important from the viewpoint of safety, ﬁre prevention and sanitation (hereafter in this Article referred to as “designated building materials” shall come under either one of the following items:

Those qualities conform to the Japanese Industrial Standards or Japanese Agricultural Standards designated for each designated building materials by the Minister of Land, Infrastructure and Transport.

Enforcement Regulation of Pharmaceutical Affairs Law

Designated medical equipment that the Ministry of Health Labour and Welfare speciﬁes standards pursuant to the provisions of Item 1 of Article 23-2 of the Pharmaceutical Law.

Medical equipment

Thermometer

JIS

T1140

Standards Purpose of use, effect or impact

Making temperature measurement section contact, measure the body temperature of rectum, armpit, buccal cavity (hypoglossal), keeps the highest temperature and indicates it digitally

Designated Medical Equipment that the Ministry of Health, Labour and Welfare speciﬁes standards pursuant to the provisions of Item 1 of Article 23-2 of the Pharmaceutical Affairs Law shall conform to the standards given in the table above.

Electrical Appliance and Material Safety Law

Technical requirements pursuant to the provisions of the Ministerial Ordinance Specifying Technical Requirements for Electrical Appliances and Materials.

Technical requirements for electrical applicances and materials:

Number: J60068-2-2(H14)
Title: Basic environmental testing procedures, Part 2: Tests, Test B: Dry heat
Text: JIS C 0021: 1995
Notes: Corresponding to IEC 60068-2-2 (1974) Amd. No. 2 (1994)

Number: J60068-2-3 (H14)
Title: Basic environmental testing procedures, Part 2: Tests, Test C: Damp heat, steady state
Text: JIS C 0022: 1987
Notes: Correponding to IEC 60068-2-3 (1969)

The harmonized standards are stipulated in Appendix Table 12 of the Interpretation of the Ministerial Ordinance Specifying Technical Standards for Electrical Appliances and Materials, and the Technical Requirements pertinent to each of the relevant products shall be applied..

Basic Policy for the Promotion of Procurement of Eco-Friendly Goods and Services

Item:

Light bulb-shaped lamps

Evaluation Criteria:

Bulb-shaped LED lamps must meet the following criteria.
1. Average color rendering index Ra of 70 or more.
2. Rated life of at least 40 000 hours.

Measuring methods of Average color rendering index Ra is in accordance with light source color and color rendition evaluation method of source of light by JIS C 8152-2(Photometry of white light emitting diode for general lighting-Part 2: LED modules and LED light engines).
Rated life of bulb-shaped LED lamps in this section refers to the total amount of lighting time until the initial luminous flux to decrease by 70%. The method of measurements is in accordance with JIS C 8152-3 (Photometry of white light emitting diode for general lighting-Part 3: measurement methods for lumen maintenance).