Japan
New Chemical Notification etc.
What should be concerned for new chemicals?
What are the new chemicals in Japan?
Japan has two laws that regulate new chemical substances. Chemical Substance Control Law (hereinafter refer to as CSCL) is the one which is applicable to industrial chemical substances and the Industrial Safety and Health Law (hereinafter refer to as ISHL) is applicable to chemicals in workplace.
Each of the two laws has independent inventory (CSCL inventory and ISHL inventory) and chemicals not listed in these inventories are new and hence shall subject to the regulations for new chemicals under these laws.
Pharmaceutical products, Food additives, Agricultural chemicals and others are subject to the other laws and they are excluded from the CSCL.
What is required for new chemicals?
When a substance is new to the inventories, we need to consider notification for new chemicals.
If a substance is plan to be manufactured (including importation volume) more than 1 metric ton per year, 100kg under the ISHL, then new chemical notifications shall be performed under these laws.
Are there any substances that are exempt from the regulations for new chemicals?
Yes, there are exemptions for the following substances.
1. R&D chemicals, 2. Substances in articles, 3. Impurities, 4. Polymers, 5. Natural products, 5. small/low volume substances, 6. Wastes, 7. Intermediates etc. 8. Salts, 9. Consumer products, etc.
NOTE: Details must be checked for the determination of whether a substance is exempt under these exemption categories.
What is required for new chemical notifications?
Under the CSCL, biodegradation test is required for biodegradable substances. If not biodegradable, then bioaccumulation test or Partition coefficient test is additionally required for the chemicals manufactured less than 10 metric ton per year. If you would like to manufacture chemicals without limitation in volume, then toxicity test and eco-toxicity tests are additionally required.
Under the ISHL, for chemicals manufactured more than 100kg/year, then mutagenicity test is required.
Is there any specific notification scheme for polymers?
Yes, Under the CSCL, there are options you can choose for manufacturing a polymer. You can perform standard notification for a polymer with submitting the result of Polymer Flow Scheme Test. This test is to confirm the stability and safety of the polymer. The other option is the application for the exemption for the Polymer of Low Concern (PLC). This application also requires the result of the same test. There are some differences after you completed these procedures. If you choose application of PLC, then the substance will not be listed in the CSCL inventory where as polymers notified under the standard notification will be listed in the inventory.
Under the ISHL, if a polymer meets polymer check list, then no action is required but is recommended that the record should be kept for future tracerbility.
How long does it take for notification?
Under the CSCL, it will take 4 to 6 months from the submission of notification dossiers for a notification. You will be granted approval notice one month or three months after the submission of notification form, and the date you received the notice will be the commencement of manufacturing. Under the ISHL, you can start manufacturing immediately after notification is accepted.
In addition to the above, you need to concern required test period and preparation of notification formats.
What is required for small volume exemptions?
Under both laws, application for small volume exemption is required. Application schedule is fixed under the CSCL (four times in a year); no schedule has been fixed under the ISHL After one month or so, you will be granted approval notice and then you are permitted manufacturing the applied substances.
Information required for the exemptions is such as chemical name, structural formula, product formulation, annual volume etc.
What is the service of JCR-Link for the above notifications and applications?
1. Determination of inventory status under these Laws
JCR-Link checks the inventory status. Fee for one chemical substance is 15,000 JPY + tax for one inventory. However, fee for the two inventories are 21,000 JPY + tax. |
2. Preparation of formats for the small volume exemptions under these law
JCR-Link will prepare application formats per your requests. Packaged fixed fees are set for the preparation of application formats required under the CSCL and the same for the ISHL. If you would like JCR-Link to prepare all the application formats both for the CSCL and the ISHL, discounted fee is also available. |
3. Assistance in the notifications of two laws
JCR-Link will perform as a coordinator for stakeholders for a notification. e.g. among client, authority and test institute.
When you do not have the results of required tests: JCR-Link will introduce Japanese test institute to you and you can conclude agreement such as NDA with the institute where appropriate. You pay required test fee in advance to the test institute. The test institute will conduct all the necessary tests and prepare test reports and notification formats. Notification could also be done by the test institute over the electronical notification system. JCR-Link will support all the necessary matters needed for the notification. Consideration for JCR-Link assistance shall be paid in hourly rate or in fixed packaged fee.
When you have the result of required tests: JCR-Link also introduce test institute for the institute to check if your test results are able to be used for notifications. When it is notifiable, then other required procedures are the same as the case when you do not have test results described above. |
If you need further information, please contact Misao Shiba (Mr.) Mail Address: [email protected]. Depending on the required information, it may be subject to fee of hourly rate. Thank you!
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