China Revises New Chemical Substance Registration Measures

By Lily Hou, PhD, CHMM, regulatory affairs lead, Software, UL Solutions

On October 24, 2026, China’s Ministry of Ecology and Environment (MEE) issued the revised Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 40). The Measures took effect upon publication, replacing MEE Order No. 12, issued in 2020.

The Measures regulate the manufacture and import of new chemical substances in China. Substances not listed on the Inventory of Existing Chemical Substances in China (IECSC) are considered new. Certain listed substances subject to new-use environmental management are also regulated as new substances when used for industrial purposes outside their permitted uses. Manufacturers and importers must obtain an environmental management registration certificate before manufacturing or importing a new chemical substance.

The revised Measures are intended to implement relevant provisions of China’s newly adopted Ecological and Environmental Code and strengthen the registration framework for new chemical substances. Key changes include:

Scope of the Measures

The Measures specify that pharmaceuticals, veterinary drugs, cosmetics, foods, food additives, feeds, feed additives, and fertilizers are excluded from the scope. However, new chemical substances used for other industrial purposes or as raw materials or intermediates for these products remain subject to the Measures. Radioactive substances are exempt. New chemical substances used in pesticide products are regulated under pesticide laws and regulations, except when used for other industrial purposes or as raw materials or intermediates for pesticide products.

Registration Applicant Eligibility

Foreign manufacturers and exporters can no longer register new chemical substances through an appointed Chinese agent. Only manufacturers or importers that are legal entities registered in China and able to bear legal liability independently may apply.

Registration Categories

The Measures establish three registration categories for new chemical substances:

• Regular registration: applies to manufacture or import in quantities of 10 tonnes or more per year
• Simplified registration: applies to manufacture or import in quantities of 1 tonne or more but less than 10 tonnes per year
• Formality registration: applies in either of the following cases:
  • The annual manufacture or import quantity is below 1 tonne; or
  • The new chemical substance is a polymer containing no more than 2% (w/w) new chemical substance monomers or reactants, or is a polymer of low concern.

Formality registration replaces the former Record filing category. Under Record filing, manufacture or import could begin as soon as the filing was completed. Under Formality registration, applicants must receive approval and obtain a registration certificate before manufacture or import can begin.

Noncompliance Penalties

Penalties for noncompliance have increased significantly under the Ecological and Environmental Code, which provides the statutory enforcement basis for MEE Order No. 40. Violations of registration certificate requirements may result in fines of RMB 200,000 to RMB 1 million (up from RMB 10,000 to RMB 30,000 under MEE Order No. 12), increasing to RMB 1 million to RMB 2 million for failure to correct the violation. In serious cases, the registration certificate may be revoked, or operations may be suspended or shut down.

The Measures should be used in conjunction with the Guidance for the Environmental Management Registration of New Chemical Substances. The current Guidance was issued to implement MEE Order No. 12 and has not yet been revised to reflect MEE Order No. 40. Once the revised Guidance is published, it should be consulted for detailed registration requirements.

References

• MEE Order No. 40: Measures for the Environmental Management Registration of New Chemical Substances (生态环境部 部令第40号: 新化学物质环境管理登记办法)
• Ecological and Environmental Code of the People's Republic of China (中华人民共和国生态环境法典)
• Guidance for the Environmental Management Registration of New Chemical Substances (新化学物质环境管理登记指南)