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The 2025 notification schedule for new chemical substances, which applies to chemicals produced or imported in amounts greater than one ton annually, was recently made public by Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MOE). The Chemical Substances Control Law (CSCL) serves as the foundation for this project, which attempts to improve the handling of novel chemicals.
The following are the due dates for submitting materials and notifications for new chemical compounds in 2025, per the timetable (notifications cannot be submitted before preliminary materials have been submitted for pre-screening):
The notification dates are August 1, 2025, and February 7, 2025, for compounds for which preliminary materials are not required. Furthermore, each date has a 3:00 PM deadline; applications made after this time will be automatically moved to the next open date.
The company name and address, the name of the responsible party or notifier, and details about the substance (such as name, structure, physicochemical properties, uses, estimated production or import volumes over the next three years, and pertinent test results) should all be included in the preliminary review materials. Relevant information must be included if the material includes heavy metals or if its chemical makeup suggests that it could have long-term negative effects on human health. Test data should be included if ecological toxicity testing is necessary.
Rules for Notification Day
The legal deadline for filing the notification of manufacture or import of a new chemical substance following the conclusion of the preliminary evaluation but prior to the start of deliberation is known as the “Notification Day.” The notification form, a commitment letter, and a determination notice (which includes the name of the company and the accountable person, among other details) are required documents for notification. Prior to the designated notification date, all documentation must be sent in to the METI.
No review is necessary if someone other than the person who notified the new chemical substance tries to submit a copy of the determination notice (such as test results) for notification for a new chemical substance for which a determination result has already been issued.
Announcement of the Schedule for the Next Year
It is anticipated that the notification timetable for the production and import of new chemicals for 2026 would be made public in September 2025.