The Ministry of Health, Labour and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI), and the Ministry of the Environment (MOE) of Japan recently released the notification schedule for new chemical substances for the year 2025, applicable to chemicals produced or imported in quantities exceeding one ton per year. This initiative is based on the Chemical Substances Control Law (CSCL) and aims to strengthen the management of new chemical substances.

According to the schedule, the deadlines for submitting materials and notifications for new chemical substances in 2025 are as follows (preliminary materials must be submitted for pre-screening before notification can be submitted):

For substances that do not require the submission of preliminary materials, the notification deadlines are February 7, 2025, and August 1, 2025. Additionally, the deadline time on each date is 3:00 PM, and submissions after this time will automatically be postponed to the next available date.

Preliminary review materials should include the company name and address, the name of the responsible person or notifier, and information of the substance (such as name, structure, physicochemical properties, uses, estimated production or import volumes over the next three years, and relevant test results). If the substance contains heavy metals or could cause persistent harm to human health based on its chemical structure, relevant data must be submitted. If ecological toxicity tests are required, corresponding test data should also be provided.

Regulations on Notification Day

Notification Day refers to the date set by law for submitting the notification of manufacture or import of a new chemical substance after the preliminary review is completed and before deliberation begins. Required documents for notification include the notification form, a commitment letter, and a determination notice (including company name, responsible person's name, etc.). All documents must be submitted to the METI before the specified notification date.

For new chemical substances that have already been notified and for which a determination result has been issued, if someone other than the notifier of the new chemical substance attempts to submit a copy of the determination notice (e.g., test results) for notification, no review is required.

Reference

For details on the review materials for new chemical substances, preparation and submission of notification forms, and related notification procedures, please refer to the official guide:

https://www.meti.go.jp/policy/chemical_management/kasinhou/files/information/shinki/todokedemanual.pdf

Announcement of the Next Year's Schedule

The notification schedule for the manufacture and import of new chemical substances for 2026 is expected to be announced around September 2025.

https://www.meti.go.jp/policy/chemical_management/kasinhou/files/information/shinki/sinkikagakutodokedenittei2025.pdf