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.

Record	New chemical substances with an annual tonnage of no more than one ton; Monomers of new substances, polymers containing less than 2%w/w new substances; Polymers of low concern;
Simplified Registration	New chemical substances manufactured or imported above the annual volume of one ton, yet no more than ten tons.
Regular Registration	New chemical substances manufactured or imported above the annual volume of ten tons.

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.

Registration Type	Post-registration Obligation
Regular Registration	Communicate relevant information, including registration certificate number, registered applications, hazard characteristics, risk control measures as well as environmental management  requirements; Establish a new chemical substance activity situation record system; Keep documents on file for over ten years; Disclose the implementation situations of the environmental risk control measures and environmental management requirements; Submit first-activity report; Report the situation of the new chemical substances over the last year; Submit updates if new hazards or risks arise and take measures to eliminate or reduce the risks;
Simplified Registration	Communicate relevant information, including registration certificate number, registered applications, hazard characteristics, risk control measures as well as environmental management  requirements; Establish a new chemical substance activity situation record system; Keep documents on file for over ten years; Submit first-activity report; Submit updates if new hazards or risks arise and take measures to eliminate or reduce the risks;
Record	Communicate relevant information, including record receipt, registered applications, hazard characteristics, risk control measures as well as environmental management requirements; Establish a new chemical substance activity situation record system; Keep documents on file for over three years; Submit updates if new hazards or risks arise and take measures to eliminate or reduce the risks;

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:

Registration Information Change		Regular Registration	Simplified   Registration	Record   Filling
Applicant/Agent Name		Apply for registration certificate change	Apply for registration certificate change	Apply for a change via the online registration system, and obtain a new receipt No.
Agent Transfer
Substance Identity Information
Activity Type	Manufacture   ->   Import
	Manufacture   ->   Manufacture & Import
	Import   -> Manufacture	Re-registration
Quantity Increase
Registration Use
Environmental Risk Control Measures
Other circumstances leading to increased environmental risks (including changes in process   conditions, production site, or environmental management requirements.)

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;