China New Chemical Substance Registration

Overview of the Regulation 

The Ministry of Ecology and Environment (MEE) issued the "Measures for Registration of Environmental Management of New Chemical Substances" (MEE Order No. 12) in January 2020, aiming at standardizing the environmental management and registration of new chemical substances and scientifically and effectively assessing and controlling the environmental risks of new chemical substances. This regulation (MEE Order No. 12) replaces the decade-old "Measures for Environmental Management of New Chemical Substances" (MEP Order No. 7) and has become the new standard for the management of new chemical substances in China.

The regulations are applicable to a wide range of areas, including the environmental management and registration of the research, production, import, processing, and use of new chemical substances in China. Before an enterprise produces or imports new chemical substances that are not listed in the Inventory of Existing Chemical Substances in China (IECSC), it must register new chemical substances and obtain a registration certificate.

About Us

From confirmation of new chemical substances to submission to the Chinese Authority

Our company provides comprehensive services for China's new chemical substance registration, including consultation on new chemical substance management regulations, identification of new chemical substances, application of documents to authorities, and local agent services.

Registration Types

Business Contents

We provide a one-stop service for China new chemical substance registration, covering prior consulting, services related to registration, maintenance of agents and registration after registration, and other consulting services. Our business contents include, but are not limited to:

• New chemical regulation consulting services
• Communication and consultation with competent authorities/experts
• IECSC enquiry and inventory adding
• Overall registration scheme
• New chemical substance registration services (record, simple registration, general registration)
• Non-testing method assessment report (QSAR, read-across, toxicokinetics assessment report, waiver)
• Data assessment/Exemption analysis/Data gap analysis
• New chemical substance risk assessment report preparation
• Registration agent and registration certificate management  
• Post-registration services (annual report, certificate renewal)
• Translation for registration documents
• Customized training services

Our Advantages

• We have a strong team of senior technical personnel with professional backgrounds in analytical chemistry, chemical engineering, toxicology, pharmacology, biology, environment, etc.
• Our experts have been following and studying China's new chemical substance management regulations for many years and have deep qualifications.
• Our professional team provides internationalized service with the ability to speak Chinese, English, Japanese, German, and other languages.
• We have accumulated extensive experience in global chemical regulation response and technical consulting services for many years and are able to provide multinational clients with efficient services.

If you need help or have a question, please feel free to contact us for more details.