CSCL
The official translation of the name of the Chemical Substances Control Law (CSCL) is “Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.”
As stated in its official name, main function of CSCL is the evaluation of chemical substances, and based on the evaluation results, the government is given the authority to regulate manufacture, import and use of certain chemicals. To enable the government to evaluate chemicals, the government is given the authority to order, ask, request industries to provide information.
At this point of time, CSCL has three main functions. The first one is the new chemical notification. The second is the comprehensive assessment of existing chemicals. And the last is regulation on specified chemicals such as PCB.
What is CSCL
New Chemical Notification
Regulation on new chemicals is one of the key functions of CSCL. Production and import of new chemical are not allowed without approval by the government before marketing. If you want to export new chemicals to Japan, new chemical notification is the most straight forward procedure although the process is rather costly due to test requirements by CSCL. Typical dataset includes biodegradation, bioaccumulation, and screening toxicity for both human being and the environment.
Confirmations
Exemptions from the obligation of new chemical notification are available under certain conditions. The most frequently used exemption is for small amount which does not requires any testing of chemicals. Upper limit of the small amount exemption is 1 ton per company and 1 ton nationwide production and import. Low volume exemption requires biodegradability and bio accumulation. These exemption requires confirmation every year. Other types of exemptions available such as intermediate and PLC. For these exemptions, one time confirmation is effective for years.
Comprehensive Risk Assessment
Under the influence of EU REACH, CSCL was amended in 2009 and introduced comprehensive risk assessment scheme which include annual reporting of general chemicals, screening, designation of priority assessment chemical substances (PACs), ,detailed annual reporting of PACs and risk assessment of PACs. The risk assessment framework consist of several phases from further prioritization (risk assessment (1) tier 1) to definitive risk assessment to detrmine the need to designate the PAC as class 2 specified chemical
Specified Chemicals
The original CSCL is the law to regulate PBT (persistent, bio-accumulative and chronically toxic to human) chemicals such as PCB. This category was expanded to protect eco-system (higher trophic animals). Because of the similarity of regulatory scope, CSCL is one of implementation law of the Stockholm Convention on POPs. This category is called class 1 specified chemicals and substantially banned. Another category is class 2 specified chemicals and this category of chemicals are designated because of risk concern over substantially extensive area in Japan.