Japan Reach Regulation for Various Sectors

In Japan, there are four laws to regulate the industrial chemicals which are :

• Chemical Substance Control Law (CSCL)
• Industrial Safety and Health Law (ISHL)
• Law for PRTR and Promotion of Chemical Management (PRTR Law)
• Poisonous and Deleterious Substances Control Law (PDSCL)

Recent trend on chemical regulations in Japan is Chemical Substance Control Law (CSCL) aiming to prevent environmental pollution from PCBs and other hazardous chemicals.

Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc, also known as Chemical Substance Control Law (CSCL) was established in 1973 under three ministries (METI, MHLW, MoE) in Japan. CSCL aims to establish a system for evaluating the properties of new chemical substances in order to prevent environmental pollution that could harm human health or disrupt the habitation and growth of flora and fauna. After establishment, the act went through some major amendments such as introduction of comprehensive assessment of existing chemicals on May 20, 2009. The full implementation of this amendment started from April 11, 2021, and became the fundamental structure of the current act. The most recent amendment came into force on December 13, 2023.

Japan CSCL entirely covers general industrial chemical products; which include both new and existing chemicals (as listed in the Existing and New Chemical Substances Inventory (ENCS).

New substance

• any chemicals other than those listed in certain regulatory provision

Existing substance

• Existing substances include chemicals that were already on the market in Japan before 1973, and the ones that have been notified after 1973. Within the existing substance, several categories exist as follows.

General existing substance

• any chemicals that do not fall under certain high-risk categories

Specified general substance

• general existing substance that pose significant risk to health or environment

Monitoring substance

• chemicals with high persistency, high bioaccumulation, and unknown long-term toxicity
• monitoring substances have a possibility of being categorised under Class I specified substance after assessment

Priority Assessment Chemicals (PACs)

• chemicals with unclear long-term toxicity
• PACs have a possibility of being categorised under Class II specified substance after assessment

Class I specified substance

• chemicals with high persistency, high bioaccumulation, and high level of long-term toxicity to humans and environment

Class II specified substance

• chemicals that are likely to cause damage to human and environment based on extensive environmental persistency or expected persistency in the future

New chemical substances are substances not listed in the inventory of existing and new chemical substances (Japan ENCS). Manufacturers, importers and foreign company of new chemical substances are required to notify those substances at least three months prior to manufacture/import. For adding a substance in substance inventory will take 5 years of time span. The three ministries are the Ministry of Economy, Trade and Industry (METI), the Ministry of Labour and Welfare (MHLW), and the Ministry of the Environment (MOE).

There are two types of notification:

Standard Notification:

A standard notification has no volume limit, while a low volume notification is only applicable if the total volume of the substance manufactured and imported in Japan is = 10 t/y. A standard notification requires data on bio degradation, bio accumulation, and toxicity and Eco toxicity endpoints.

A low volume notification requires data only on bio degradation and bio accumulation, but this type of notification must be renewed once a year.

• General existing substance
  • General existing substance above 1t needs to be annually reported between April 1 to June 30, including the following information
    • Company information, Name of substance, amounts of manufacture/import
• Specified general substance
  • Companies dealing with specified general existing substances need to provide information stating the fact that it is classified as specified general substance when transferring it.

• PACs above 1t needs to be annually reported between April 1 to June 30, including the following information
  • Company information, name of substance, amounts of manufacture/import, country name where it was manufactured
  • Companies dealing with PACs need to provide information stating the fact that it is classified as PACs when transferring it.

• Monitoring substance above 1t needs to be annually reported between April 1 to June 30, including the following information
  • Company information, name of substance, amounts of manufacture/import, country name where it was manufactured
  • Companies dealing with monitoring substances need to provide information stating the fact that it is classified as a monitoring substance when transferring it.

• Official permission is required before manufacture/import. Without permission manufacturing and importing of Class I specified substances is prohibited. Application should be sent to METI, and the result of permission should be notified to MoE. The following is what should be included in the application
  • Company information, name of substance, the structure and capacity of the manufacturing equipment(manufacture) or quantities of import(import)
  • Intended use of Class I specified substance must comply with cabinet order and must be reported, including the following information
    • Company information, name of substance, intended usage
  • Labelling is required, pursuant to GHS guidelines adopted in Japan
  • Importing of products containing Class I substance, specified in cabinet order, is prohibited

• Class II specified substance needs to be annually reported between April 1 to June 30, including the following information
  • Company information, name of substance, amounts of manufacture/import, country name where it was manufactured
  • Labelling is required, pursuant to GHS guidelines adopted in Japan
  • Companies dealing with class II specified substances must comply with technical guidelines set by regulatory authorities such as handling methods.

ISHL (Industrial Safety Health Law) was enacted in 1972 by MHLW to ensure safety and health in work places. Substances that are not listed in the inventory under ISHL are subject to notification to MHLW when introducing a new substance into a workplace. There are two types of notification under ISHL, based on volume limit.

• Standard notification
  • Required data: Ames study report, manufacturing process, materials used, reaction formula, molecular weight, appearance, boiling and melting points, volume, usage, country of origin
• Small volume notification
  • New substance under 0.1t/y
  • No test data are required

In certain cases, new substances are exempted from notification under ISHL, and the cases are as follows.

• Test and research purpose
• When it is confirmed by MHLW that workers are not likely to be exposed to the substance
• When it is already known as not hazardous (e.g. polymer of low concern)
• It is imported primarily as a product for ordinary use by general consumers

ISHL also manages compliance for harmful substances. Through the cabinet order of the according Act, it specifies names of harmful substances that need to comply with regulations under ISHL, such as permission for manufacturing or labelling. The following is the details of ISHL compliance for harmful substances

• Harmful substance that can cause significant risk to worker’s health, specified by the cabinet order (e.g. benzidine) are prohibited
• Those handling harmful substances specified by the cabinet order need to get permission before manufacturing
• Those handling explosive, pyrophorics, flammables, or any other harmful substance specified by the cabinet order need to do labelling and transfer documents to downsim users including information such:
  • Name of substance, effects on human body, precautions in storage/handling
• Those handling harmful substance specified by the cabinet order need to submit SDS and transfer documents to downsim users including information such:
  • Name of substance, effects on human body, ingredients and their amount, physi-chem properties, precautions in storage/handling, emergency measures when spilled

In 1950, to protect the public health from a hygiene point of view from poisonous and deleterious substances, Poisonous and Deleterious Substances Control Law was implemented. This law imposes a license requirement on manufacturers, importers and sellers of poisonous or deleterious substances. It also requires that persons engaged in relevant businesses meet prescribed standards for manufacturing or storing equipment of poisonous or deleterious substances and comply with specific requirements on storing, labeling or Transferring.

The environment of specific chemical substances and promoting improvement in their management ("Law for PRTR and Promotion of Chemical Management" or "PRTR Law") was came into force in 1999. The purpose of this law is to promote businesses' voluntary improvements in the management of specified chemical substances and to prevent any environmental protection impediments.

Under PRTR law,

• Class I Designated Chemical Substances are subject to both the PRTR system and the SDS system while
• Class II Designated Chemical Substances are subject to SDS system only

Only businesses in the published types of industries are obliged to confirm and notify the release amounts of chemical substances in the environment.

PRTR notification requires two parts of information: amount of release and amount of transfer:

Amount of release: Release into atmosphere, release into public bodies of water, release into soil within the place, and reclamation within the place of business concerned.

Amount of transfer: Transfer to sewage and transfer to outside of place of business concerned as a waste;