China New Chemical Registration

China's environmental management framework for new chemical substances includes regular registration, simplified registration, and transitional registration requirements for cases that were previously eligible for filing. Regulix helps companies determine the applicable pathway, identify data gaps, and prepare applications based on substance identity, annual manufacture or import volume, and substance characteristics.

Effective August 15, 2026, China's Ministry of Ecology and Environment stopped processing environmental management filings for new chemical substances. Substances that previously qualified for filing still require a registration application form, documentation demonstrating the applicable condition, and available environmental and human health hazard and environmental risk information before manufacture or import. Applications are accepted, reviewed, and approved by reference to simplified registration procedures and timelines. Learn about the current registration requirements for cases previously eligible for filing.

The sections below explain regular registration, simplified registration, and transitional requirements for former filing cases. The applicable pathway must be assessed against substance-specific conditions and cannot be determined by tonnage alone.

How to Choose the Right Registration Type?

Correctly determining the registration type is the first step toward compliance and the key to cost savings. Here is a simple decision logic:

• First confirm whether it is a new chemical substance
  Check the "Inventory of Existing Chemical Substances in China" (IECSC); substances not listed are new chemical substances.
• Assess volume and applicable conditions
  Cases that previously qualified for filing, including certain substances below 1 metric ton per year, are subject to the transitional registration requirements effective August 15, 2026. Other cases should generally be evaluated for simplified registration at 1 to less than 10 metric tons per year and regular registration at 10 metric tons per year or above, subject to substance-specific conditions.
• Special substance determination
  For polymers, review the new chemical substance monomer or reactant content, polymer of low concern criteria, and other applicable conditions. Former filing cases must follow the current transitional registration requirements; filing is no longer available.

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