News Details

China’s Ministry of Ecology and Environment (MEE) has published MEE Order No. 40, introducing revised Measures for the Environmental Management Registration of New Chemical Substances. Approved on October 15, 2026, and signed on October 24, 2026, the regulation entered into force upon promulgation, replacing MEE Order No. 12, which had been effective since January 1, 2021.

The revised regulation introduces significant changes to China’s new chemical substance registration requirements, particularly concerning applicant eligibility, registration procedures, and environmental risk management.

New Chemical Substance Registration Requirements

Under MEE Order No. 40, substances not listed in the Inventory of Existing Chemical Substances in China (IECSC) remain subject to registration before manufacturing or import.

The regulation maintains three registration categories:

• Regular Registration: Annual volumes of 10 metric tons or more.

• Simplified Registration: Annual volumes from 1 to less than 10 metric tons.

• Formal Registration: Annual volumes below 1 metric ton and qualifying polymers.

Technical review periods remain 60 days for regular registration and 30 days for simplified registration. Formal registration also requires a technical review of up to 30 days.

Key Changes Under MEE Order No. 40

1. Registration Restricted to Chinese Entities

Article 11 requires applicants to be legally registered entities in China engaged in manufacturing or importing new chemical substances. The previous registration pathway involving foreign applicants and Chinese agents is no longer explicitly included.

2. Formal Registration Replaces Record Filing

The previous record-filing pathway for low-volume substances and qualifying polymers is replaced by formal registration, requiring technical review and regulatory approval before manufacturing or import.

3. Revised Regulatory Scope

Article 2 specifies that the Measures apply to the manufacture and import of new chemical substances in China, with certain exemptions for regulated products.

4. Strengthened New Use Management

Articles 34–35 introduce requirements for substances subject to New Use Management, including certain highly hazardous chemicals. Changes in intended use or industrial applications may require additional registration.

5. Revised Enforcement Framework

Unlike Order No. 12, the new regulation does not contain a separate penalty chapter. However, registration certificates may be refused, amended, or revoked under applicable legal provisions.

Post-Registration Compliance Obligations

Manufacturers and importers must comply with several requirements, including:

• Communicating registration information and environmental risk control measures to downstream users.

• Maintaining records for 10 years for regular and simplified registrations or three years for formal registrations.

• Submitting initial activity reports within 60 days of the relevant first activity.

• Filing annual reports by April 30 where required.

• Reporting newly identified environmental or health hazards.

What Should Companies Do?

Foreign chemical manufacturers and Chinese importers should review existing registration arrangements, assess importer responsibilities, and evaluate data-sharing agreements and confidential business information protection.

Companies should also monitor further MEE guidance concerning existing registrations and transitional arrangements.

How GPC Can Help

Global Product Compliance (GPC) supports companies with IECSC screening, registration gap assessments, dossier preparation, importer-led registration strategies, and post-registration compliance.