China Registration of New Chemical Substances

Registration of New Chemical Substances in China

We provide a variety of services for Measures for the Environmental Management Registration of New Chemical Substances (MEE order 12).

In China, prior registration is mandated for the manufacture and import of new chemical substances according to the order (Order 12) implemented by the Ministry of Ecology and Environment (MEE).

Business contents

Prior consulting

We suggest application plans depending on the nature of the chemical substances, quantity for manufacture and import, and other factors.
We will judge the exemption of required tests and the exclusion requirements that need to be judged in the polymer Record.

Application work

• Selection and arrangement of agents in China

  Reliable agents with extensive experience in applications will be recommended.

• Total support from the preparation of application documents to the completion of registration

  We provide total technical support as follows. We also support applications for information protection that do not disclose information on the application substance that is a trade secret to the applicant.
  -the close examination and suggestion for necessary information
  -arrangement of safety studies
  -preparation of technical documents such as PBT (Persistent, Bioaccumulative and Toxic) identification, and risk assessment report
  -preparation and submission of application documents to the regulatory authorities
  -suggestions to various authority inquiries

Acquisition of studies required for the application

All safety studies required for the application will be obtained at GLP compliant our company and the partner testing institutions.
Studies that use species endemic to China will be reconsigned to Chinese domestic testing institutions with sufficient experience.
The study schedules and data reliability are monitored and controlled by our company.

Maintenance of agents and registration after registration

Activity record, change in registration details, reapplication, and annual reports after the registration will be supported by us.

Registration Types