News Details

On 3 August 2026, Japan’s National Institute of Technology and Evaluation (NITE) announced a revision to the manual for preparing and submitting new chemical substance notifications under the Chemical Substances Control Law (CSCL). The revised manual, dated 30 July 2026, updates the method for submitting formal notification documents. More information can be accessed via the NITE Portal. 

Background 

Under Japan’s CSCL, companies must determine whether a chemical substance is existing or new before its manufacture or import. New chemical substances may require prior notification and regulatory review. The guidance applies to standard new chemical notifications, foreign manufacturer/exporter notifications, and low-production-volume applications. 

Previous Update 

The previous version of the manual was issued on 24 April 2026. The latest revision specifically updates the submission procedure for CSCL notification documents. Separately, in May 2026, NITE introduced guidance concerning the Polymer Flow Scheme (PFS) for eligible polymer notifications. 

Key Insights 

The revised manual confirms that formal CSCL notification documents may be submitted in one of the following ways: 

• in paper form; or 

• electronically through the e-Gov Electronic Application System using a G-Biz ID 

The e-Gov filing route should be distinguished from NITE’s Communication System and file-exchange system, which continue to be used for notification registration, preliminary review materials, and technical communication. More information on the Regular New Chemical Notification Procedures can be found here. 

Clarification on optical disc submission: The revised manual does not identify CD/optical disc submission as an option for submitting the updated formal notification. However, certain separate CSCL procedures may continue to provide optical disc submission options according to their specific guidance. 

Obligations for Stakeholders 

Manufacturers, importers, foreign manufacturers, exporters, and regulatory representatives preparing new chemical substance notifications should: 

• verify the CSCL inventory status of the substance; 

• identify the correct notification or exemption route; 

• use the latest notification forms and systems; 

• ensure access to G-Biz ID where electronic filing is planned; and 

• monitor NITE’s annual submission schedule and technical requirements. 

For the 10th review round of 2026, the deadline for registration and submission of preliminary review materials is 9 September 2026 at 15:00 JST.