JAPAN
Exemption for small/ low volume production substances
As for Small Volume Exemptions (SVE), the Chemical Substance Control Law (CSCL) allows manufacturers and importers to manufacture and import up to 1000 kg/year based on government approval. the Industrial Safety and Health Law (ISHL) allows 100 kg/year for each site. In addition, opportunities are granted for manufacturers and importers to apply for Low Volume Exemption (LVE) under CSCL. Those who want to manufacture or import new chemical substances up to 10 metric ton per year may get approval from government by submitting an application form with the results of biodegradation and bioaccumulation studies.
Under CSCL, the application for SVE can be submitted four times per year, but LVE may be submitted only once per year. ISHL allows application any time of the year.
For any exemptions, notifiers may commence manufacturing and import after obtaining a notice of approval.
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