News Brief
On October 30, 2025, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW), and Ministry of the Environment (MOE) jointly issued the latest notification on hazard reporting obligations under Paragraphs 1 and 2, Article 41 of the Chemical Substances Control Law (CSCL).
This notification aims to further strengthen the risk management of new chemical substances.
What Are the New CSCL Hazard Reporting Requirements?
Notification Details
Under Article 41 of the CSCL, manufacturers or importers are required to submit a report to the Ministers of METI, MHLW, and MOE within 60 days of obtaining information that indicates the chemical substances they handle exhibit persistence, bioaccumulation, or toxicity to humans, animals, or plants.
While Paragraph 1 of Article 41 pertains to existing substances, this notification emphasizes the hazard reporting obligations under Paragraph 2 of Article 41 for the following categories of new chemical substances:
Small Volume Exemption (SVE)
Polymers of Low Concern (PLC)
Low Volume Exemption (LVE)
New chemical substances under review (standard notification)
New chemical substances, due to their pre-market approval and review process, are not subject to the provisions of Paragraph 1, Article 41. However, the approval conditions for these substances mandate that they must not pose harm to human health or the ecological environment. If enterprises discover information indicating hazardous properties, it suggests that the conditions for their manufacture or importation may no longer be met.
This notification explicitly requires enterprises to report any newly discovered hazard information for approved or under-review new chemical substances.
Allocation of Responsibilities
The notification also clarifies the allocation of responsibilities in cases of contract manufacturing or importation:
Both the contracting party (e.g., overseas manufacturers) and the contracted party (e.g., Japanese importers) share joint responsibility for hazard information reporting.
Contracted manufacturing/importing enterprises must maintain effective communication with the contracting party to ensure timely information sharing. The contracted party is responsible for fulfilling the reporting obligations to the Japanese government.
For hazard information that should have been reported but remains unsubmitted as of December 26, 2025 (based on the date of receipt), the relevant contracted manufacturing or importing enterprises may submit supplementary reports to the three ministries by this deadline.
Non-compliance, including failure to report or submission of false information, may result in fines of up to 200,000 yen.
Why Is Hazard Reporting Crucial?
The hazard reporting system plays a pivotal role in the Japanese government’s risk assessment and chemical substance regulation framework. Proactive reporting enables authorities to:
Identify potential risks associated with chemical substances.
Determine whether a substance requires priority assessment or additional regulatory measures.
Key Takeaways for Enterprises
REACH24H advises enterprises to closely monitor updates on METI’s and other relevant authorities’ official websites. Staying informed and compliant with the latest CSCL requirements is essential to avoid penalties and ensure smooth business operations. We will continue to track related information and share updates in a timely manner.
For more information and inquiries, please feel free to contact us at customer@reach24h.com.
