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.

The Act on the Chemical Substance Control Law came into force in 1973 to prevent environmental pollution by chemical substances that pose a risk to human health or the environment. But it was later updated and amended on May 20th 2009. Full implementation of amended CSCL started from 1 April 2011.

The three government bodies responsible for the implementation of CSCL are the Ministry of Economy, Trade and Industry (METI), Labor and Welfare (MHLW), and the Ministry of the Environment (MOE).

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).

• For existing substances, manufacturers or importers are required to report their quantity and uses annually if the volume of manufacture (M) or importation (I) exceeds certain
• Food or feed additives, pharmaceuticals, cosmetics, agricultural chemicals and fertilizers are subject to different laws and
• The regulation excluded specific chemicals covered by other regulations, e.g. agrochemicals, pharmaceuticals, food,

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.

Substances imported or manufactured in quantities = 1 t/y in Japan, polymers of low concern, intermediates and export only substances are eligible for an exemption from standard notification. Prior confirmation of this exemption status must be obtained on an annual basis. Naturally occurring substances, impurities < 1% w/w, Substance for R&D purposes and substances regulated by other laws (e.g. pesticides, pharmaceuticals, cosmetics) are completely exempt from CSCL notification requirements.

All substances other than Priority Assessment Chemicals (PACs), Class I/II Specified Substances, Monitoring Substances and Exempt Substances;

Existing chemical substances (Approx. 20,600 substances):

Chemical substances that were already manufactured/imported at the time of the promulgation of the Chemical Substance Control Law Mandatory reporting of amounts manufactured and/or imported (I 1 ton/year, usage, etc.

Substances prioritized for assessment due to their potential risks of long-term toxicity to human health or the environment; Annual report if the volume of M/I is >=1t/y; Manufacturers and importers may be requested to provide more hazard data.

Substances which are suspected long-term toxicity for humans or flora and fauna in the human living environment. Suspected risk Mandatory reporting of actual amounts manufactured and/or imported, detailed usage, etc. Companies handling these substances are obliged to make utmost efforts to disclose information.

are required to report their quantity and uses annually if the volume

of manufacture (M) or importation (I) exceeds certain amount.

Class-I Specified Chemical Substances:

The Regulation excluded specific chemicals covered by other regulations, e.g.

agrochemicals, pharmaceuticals, food, fertilizers.

Persistent, bio accumulative, and hazardous (long-term human toxicity or Eco toxicity to higher predators.

Regulation on Chemicals:

Prior permission required for manufacture and/or import (Note: Permission is prohibited (virtually) Prohibition of use unless authorized in advance. Prohibition of import of products containing them recovery of the products.

Class-II Specified Chemical Substances:

Persistent, hazardous (long-term human toxicity or Eco toxicity to living organisms), with concern for long-term existence in the environment.

Mandatory reporting of planned manufactured and/or imported amounts subject to governmental orders that require the change of planned amounts labeling. Compliance with technical guideline provided by Government of Japan (GOJ) and/or governmental recommendation on a legal basis Compliance with guidance provided by GOJ.

Type-I Monitoring Chemical Substances:

Persistent and bio accumulative, but hazardous properties unknown.

Type-II Monitoring Chemical Substances

Persistent and suspected as hazardous to human health.

Persistent and suspected as hazardous to Living Organism

Regulation on Chemicals:

Mandatory reporting of manufactured and/or imported amount annually (Note: These amounts are announced publicly.) Compliance with guidance provided by Government of Japan (GOJ). The GOJ can instruct manufacturer/importer investigate their long- term toxicity.

Japanese ENCS: List of Existing and New Chemical Substances:

The inventory of existing and new chemical substances (Japan ENCS) consists of two parts:

• Existing chemical substances placed on Japanese market before 16 Oct 1973 (approximately 20,600 substances);
• New chemical substances that must be notified under the CSCL, published on government Gazette (approximately 8,000 substances)

ENCS is available for search or download from Chemical Risk Information PlaVorm (CHRIP) or J-check.

General : Industrial Safety and Health Law (ISHL) was firstly introduced in 1972 and this law ensures the safety and health of workers in workplaces. The substances which are prohibited to manufacture or import,

substances requiring permission and chemical substances requiring safety data sheets and labels are included in ISHL. This law controls new substances and requires manufacturers and importers to notify them to the Ministry of Labour and Welfare (MHLW) prior to production and importation.

• For new substance approval required prior to import or
• Harmful substances to be prohibited from import or
• Prior permission is necessary for manufacturing or importation of harmful
• Labels must be used to indicate that the substances are in harmful Also GHS Compliance SDS is also required for harmful substances.
• For notification of new substances which are not on ISHL list must be notify prior to manufacture or importation. Whereas ISHL consist of two parts:
  • Existing chemical substances under CSCL (in commerce in Japan before 1973) - approximately 20,600 substances;
  • New substances notified under ISHL and published on government Gazette;

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;

GHS Implementation In Japan:

GHS SDSs and labels are mandatory for certain specified substances and mixtures regulated by the following regulatory framework:

• Industrial Safety and Health Law (ISHL);
• PRTR law;
• Poisonous and Deleterious Substances Control Law (PSSCL);

For other hazardous chemicals meeting GHS Classification criteria, industry shall comply with the following two industrial standards on chemical Classification and hazard communication in Japan as JIS 7252 (Latest Version JIS7252-2014) based on GHS rev. 4 and JIS 7253 (Latest Version JIS7253-2012) based on GHS Labeling and Safety Data Sheet.

Exemption: Products with low contents of specified chemical substances (<0.1% for Specific Class I designated substances and <1% for other substances), solid substances, products for general consumer purposes and sealed products are exempt from PRTR due to their low emission levels.

To promote businesses voluntary improvements in the management of specified chemical substances and to prevent any environmental protection impediments.

This law controls new substances and requires manufacturers and importers to notify them to the Ministry of Labour and Welfare (MHLW) prior to production and importation.