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Chemical Substance
Management

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Registration of New Chemical Substances in China

We provide a variety of services for Measures for the Environmental Management of New Chemical Substances (MEP order 7).

In China, prior registration is mandated for the manufacture and import of new chemical substances according to the order (Order 7) implemented by the Ministry of Environmental Protection (MEP).

Business contents

Prior consulting

We provide application plans suitable for business plans, including the quantities of new chemical substances to be manufactured and imported and the purpose of import.

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

    Total technical support will be provided, including the close examination of necessary information, arrangement of research studies, preparation of application documents, preparation of GHS-SDS technical documents and risk assessment reports, and responses to authority requests for modification.

Reconsignment of studies required for the application

We handle all types of research studies required for the application, including reconsignment to Chinese testing institutions.
Studies that use species endemic to China will be reconsigned to Chinese domestic testing institutions with sufficient experience.
(Regular visits and inspection are conducted at Chinese institutions to adopt laboratories that are highly reliable.)
The study schedules and data reliability are monitored and controlled by our company

Operations in the maintenance of agents and registration certificate after registration

Change in registration details, reapplication, and yearly reports after the acquisition of the registration certificate will be handled by us.

Main category of application

Type of notification Annual volume of manufacture/import
Scientific research filing
  • For scientific research, less than 0.1 t
  • To test the eco-toxicological characteristics of new chemical substance in China with test organisms for the import of test sample for the new chemical substances.
Simple Declaration Basic Less than 1 t
Special
  • The production or import of intermediate, less than 1 ton
  • Export production, less than 1 ton
  • Scientific research, annual production or import more than 0.1 ton and less than 1 ton
  • Process and product research & development, annual production or import no more than 10 tons, and no more than two years
  • Polymer with monomer content less than 2% in the new chemical substance
  • Polymer with low attention
General Declaration Level 1 1 t or more and less than 10 t
Level 2 10 t or more and less than 100 t
Level 3 100 t or more and less than 1000 t
Level 4 1000 t or more

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