New Chemical Substance Registration (China REACH)

Under the revised Provisions on Environmental Administration of New Chemical Substances (MEE Order 12) issued in 2020, companies must submit new chemical substance registrations for substances not listed in the Inventory of Existing Chemical Substances in China (IECSC). The registration not only applies to new substances, substances in preparations, or substances contained in articles that are intended to be released, but also applies to new substances used as ingredients or intermediates for a variety of uses including pharmaceuticals, pesticides, veterinary drugs, cosmetics, food additives, feed, and feed supplements.

For existing substances that are listed in IECSC but are subject to new use management, new use registration must also be submitted if the substances are to be used for purposes other than the listed uses.

Inventory of Existing Chemical Substances in China (IECSC)

As of December 20, 2023, IECSC contains 46,971 existing substances.

The IECSC is made up of two parts:

• the public part; and
• classified/confidential part where the substances are presented as category names, neither CAS number nor molecular structure is given.

You could quickly check the public part by using CIRS's ChemRadar.

If it is not listed in the public section, you can submit a formal inquiry to the Solid Waste and Chemicals Management Centre (SCC) in order to check whether a substance is listed in the confidential part of IECSC. The SCC then issues a letter of confirmation (usually within two weeks) and a 3,000 RMB fee will be charged by SCC for the inquiry. CIRS Group can assist by submitting the inquiry to SCC on your behalf.

Who Needs to Register?

• Manufacturers of new substances in China;

• Importers of new substances in China;

• Companies who intend to apply for new use registration or to change the registered uses of the preparations managed by other laws and regulations to other industrial uses; and

• Foreign companies introducing new substances to China.

Companies in China can submit a new substance registration or appoint a local agent to do so. Foreign companies can appoint a local Chinese agent to submit new chemical registrations. The local agent must be knowledgeable and qualified to carry out the registration. The role of the agent is similar to the role of "only representative" under EU REACH.

Registration Types

There are three types of registrations under MEE Order 12:

• regular registration;
• simplified registration; and
• record.

Chemical Risk Assessment Report

According to MEE Oder 12, a chemical risk assessment report must be submitted at the same time for regular registration.

Post-Registration Obligations

After registration is complete, a registration certificate containing the specific management category will be issued. The certificate holder needs to fulfill different post-registration obligations depending on the management category of the substance.

Information Change and Re-registrations

After registering new substances under MEE Order 12, if the applicants change the registration information, they must apply for registration certificate change or re-register their substances by one of the following approaches:

Our Services

• Only Representative (OR);

• IECSC Enquiry and Inventory Adding;

• New Chemical registration (Typical registration, Simplified registration, Record);

• Chemical Safety Report (CSR) Compilation;

• Testing Coordination/Supervision;

• Alternative methods (QSAR, Read-Across, In-vitro, Waiver, Evaluation);

• Post-registration (Annual Report, Certificate Renew)

• China REACH Training Service;