In Japan, there are two main chemical laws that need to be considered as follows:
JCSCL consists in two parts, the prior assessment of new chemical substances and regulations based on their properties, administered jointly by the Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Environment (MOE).
All substances and polymers considered ‘existing’ in Japan are listed on the Existing and New Chemical Substances (ENCS) inventory. Existing substances and polymers can be freely supplied, subject to any regulatory restriction or labelling requirement. Any substance or polymer not listed on the ENCS inventory is considered a new substance/ polymer and must be notified prior to supply in Japan.
Low Volume Exemption (LVE) allows supply of less than 1 tonne (total volume in Japan, not the volume of a company) per year (from April 1 to March 31 of the next year) of a new chemical to Japan without the need for full notification. The LVE requires no testing, only a literature submission, and is renewable on an annual basis.
ISHL regulates chemicals used in workplace for the purpose of preventing workers from exposure to harmful chemicals. The law is administered by the Ministry of Health, Labour and Welfare (MHLW). This law also is the main scope of implementation of GHS in Japan.
A new substance that is not listed on the ISHL list requires a new substance notification under ISHL. The main required data for new chemical notification under ISHL is an Ames test, although any other company and substance specific information should be provided. The process is much simpler than notification under JSCSL, and there are a number of exemptions available as well as Low Volume Exemptions.
Notification under both schemes are required prior to manufacture or importation of a “new” chemical substance.
CS Regulatory Ltd has numerous Information Sheets available for use by our Clients and Colleagues.