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. SCC will charge an inquiry fee of 3000RMB. 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.

Related Links

Experience Sharing: Determining Exclusion Scenarios for Polymer Registration — Cationic Polymers, Degradable or Unstable Polymers

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:

China REACH Compliance: Frequently Asked Questions for Industry

Q1: What is the relationship between the Ecological Environment Code of the People 's Republic of China and MEE Order No. 12?

A: They coexist. The Code is a statutory law, while Order No. 12 is a departmental regulation. The Code grants the highest legal authority to the new chemical substance registration system in the form of statutory law.

Q2: How many chemical substances are listed in the IECSC?

A2: Under the Measures for Environmental Management Registration of New Chemical Substances (Order No. 12), any chemical substance not listed in the IECSC is considered a new chemical substance. The IECSC is the sole criterion for distinguishing existing substances from "new chemical substances" and consists of both a public part and a confidential part. As of the latest update on May 6, 2025, the IECSC contains a total of 47,091 chemical substances, including:

• 37,170 substances with CAS numbers;
• 3,634 substances with confidential identification information;
• 161 chemical substances subject to environmental management for new uses.

New chemical substances (substances not listed in the IECSC) must fulfill registration obligations.

Q3: One substance has completed regular registration under MEE Order No. 12, when will it be listed in the IECSC?

A3: Substances that have completed regular registration under Order No. 12 will be officially announced and listed in the IECSC by the competent authority 5 years from the date of their first registration.

Q4: What are the provisions for the confidentiality period under China REACH (Order No. 12)? When will the information be made public?

A4: If confidentiality was approved during registration, the applicant may submit an application to extend the confidentiality period at least 6 months before the expiration of the current confidentiality period. The maximum extension cannot exceed 5 years. If confidentiality was not requested at the time of registration, or if the request was not approved, the applicant cannot apply for an extension to delay the disclosure of the chemical substance identification information.

Q5: What factors need to be considered regarding the cumulative environmental risks under China REACH?

A5: The following factors may need to be considered when evaluating cumulative environmental risks:

1. The P, B, T (Persistence, Bioaccumulation, Toxicity) characteristics of the substance;
2. The intended use in the application;
3. Whether there is any overlap in the supply chain with other applicants;
4. Whether there are other enterprises manufacturing, processing, or using the same substance within the same region;
5. The total applied volume nationwide;
6. Other relevant information, etc.

Q6: Under China REACH, what kinds of substances are required to submit a First Activity Report and an Annual Report?

A6: First Activity Report: This applies to holders of both Regular Registration and Simplified Registration certificates (or their designated agents). A First Activity Report must be submitted within 60 days following the date of the initial manufacturing activity, or the initial import and subsequent transfer to downstream processors/users. 

Annual Report: This applies only if the environmental management requirements specified on a Regular Registration certificate explicitly mandate it. The certificate holder (or their designated agent) must submit the annual report by April 30 of each year, beginning the calendar year after the registration was granted, pursuant to Paragraph 2, Article 41 of the Measures.

Q7: What are the timelines and costs for each type of registration?

A7: * Costs: The only fixed official fee is 3,000 RMB for the IECSC confidential inventory search. The entire acceptance and review process is completely free of charge. Testing and technical service fees vary depending on the registration types and data gaps.

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;

Further Information

Chemradar Guides - China REACH: New Chemical Substance Registration