Japanese Chemical Substances Control Law (CSCL)
Originally enacted in 1973, Japan’s Chemical Substances Control Law (CSCL) aims to prevent pollution to the environment by harmful chemical substances. The latest amendment to CSCL has been in force since 1 April 2011.
The following categories of substances are regulated under CSCL:
Companies intending to place chemicals on the market in Japan will have different obligations depending on which of these lists their substances are listed on.
New substance notification under CSCL
Manufacturers and importers of new chemical substances are required to notify those substances prior to manufacture/import. New chemical substances are substances not listed in the inventory of existing and new chemical substances (Japan ENCS).
There are two types of notification: standard notification and low volume 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 biodegradation, bioaccumulation, toxicity and ecotoxicity endpoints. A low volume notification requires data only on biodegradation and bioaccumulation, 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.
Industrial Safety and Health Law (ISHL)
The Industrial Safety and Health Law (ISHL) was enacted in 1972 with the aim of ensuring worker health and safety by promoting comprehensive and systematic countermeasures concerning the prevention of industrial accidents. As with the Chemical Substances Control Law (CSCL), companies that manufacture or import a new substance into Japan must notify that substance prior to manufacture or import under the ISHL.
Existing substances under CSCL are also considered existing under ISHL, but ISHL also has its own list of notified substances. In addition to the new substance notification requirements, ISHL designates substances that are prohibited to manufacture or import, substances requiring permission to manufacture or import and chemical substances requiring safety data sheets (SDS) and labels.
Pollutant Release and Transfer Register (PRTR)
The Japanese PRTR (Pollutant Release and Transfer Register) requires companies handling chemical substances which are potentially hazardous to the environment, to estimate the quantities of chemical substances released and transferred in waste, and to report that data to their local governments.
Under PRTR, Class I Designated Chemical Substances are subject to PRTR reporting and SDS requirements. Specified Class I Designated Chemical Substances are substances that have lower thresholds for PRTR reporting due to their carcinogenic properties. Class II Designated Chemical Substances are subject to SDS requirements only. SDS required under PRTR must comply with GHS.
Poisonous and Deleterious Substances Control Law (PDSCL)
There are three types of chemical substances under PDSCL.
Any person who manufactures, imports or engages in the sale of a poisonous or deleterious substance must register with the Minister of Health, Labour and Welfare (MHLW). Specified poisonous substances are more strictly controlled and special permission must be obtained in order to use or possess these substances. Enforcement order Article 40-9 requires any person who manufactures or imports for the purpose of selling or distributing, or any person who engages in the sale of poisonous or deleterious substances, to provide information concerning the properties and handling of the substances. A compliant safety data sheet (SDS) will cover these requirements. The law also specifies labelling requirements for each type of substance.
Yordas Group, working with an established leading partner located in Japan, can help you meet these obligations.