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News > Environmental protection regulations > Japan's Notification Rules for the Production or Import of the "Same New Chemical Substance"

Japan's Notification Rules for the Production or Import of the "Same New Chemical Substance"

2012-12-25

On May 1, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MOE) revised the rules for notifying new chemical substances, requiring companies that produce or import new chemical substances to submit “notifications of the same chemical substance” within a specified time.

"Same Substance Notification" refers to the sharing of test data by multiple notifiers of a substance. In addition to the original notification of the substance, other notifiers sharing the test data must submit their data before the specified deadline (the right column of the table below) and attach a copy of the original notifier's assessment data.

To comply with standard testing methods, identification criteria, and designated monitored substances for new chemical substances, the Japanese government will assess substances submitted under the "Same Chemical Substance Notification" to determine whether they are classified as Priority Assessment Chemical Substances (PACs). Companies that receive a notification for assessment under the "Same Chemical Substance Notification" for new chemical substances by the end of March must provide information by the deadline (left column of the table below): including the notification acceptance number, company name, and contact person information, to assist in completing the PAC assessment.

Companies submitting "Same Chemical Substance Notifications" are required to prepare new chemical substance notifications and submit their files simultaneously. The deadlines listed on the left of the table below are primarily for "Same Chemical Substance Notifications" requiring screening toxicity testing. Considering the potential increase in workload associated with this notification, these deadlines are approximately two weeks earlier than the normal notification deadline.

Deadline for conducting screening toxicity tests on notifiable substances	Normal reporting deadline
5/25 15:00	6/8 15:00
6/29 15:00	7/13 15:00
—	8/17 15:00
8/17 15:00	8/31 15:00
9/14 15:00	9/28 15:00
10/19 15:00	11/2 15:00
11/26 15:00	12/7 15:00

Sources: METI Announcement from Japan's Ministry of Economy, Trade and Industry (2012-05-01) (Compiled by PIDC)

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