Under the revised Provisions on Environmental Administration of New Chemical Substances (MEE Order No. 12) issued in 2020, companies shall submit China New Chemical Substance Registration for substances not listed in Inventory of Existing Chemical Substances in China (IECSC). The registration not only applies to new substances, substances in a preparation or substances contained in articles which are intended to be released, but also applies to new substances used as ingredients or intermediates for pharmaceuticals, pesticides, veterinary drugs, cosmetics, food additives, feed, feed supplements, etc.
 
 
For existing substances which are listed in China New Chemical Substance Registration IECSC but are subject to new use management, new use registration shall also be submitted if the substances are to be used for purposes other than listed uses.
 
 
Inventory of Existing Chemical Substances in China (IECSC)
 
As of August 18, 2021, IECSC contains 46782 existing substances, which is made up of two parts; the public part and classified/confidential part, the substances are presented as category names, neither CAS number nor molecular structure is given.
 
You could quickly check the public portion by using CIRS’s free Asia-Pacific Chemical Inventory Search System (APCISS); if it is not listed in the public portion, you may submit a formal enquiry 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 2 weeks) and a 3,000 RMB fee will be charged by SCC for the enquiry. CIRS can assist by submitting the enquiry to SCC on your behalf.
 
 
Who Shall Register
 
1、Manufacturers of new substances in China;
2、Importers of new substances in China;
3、Companies who intend to apply for new uses registration or to change the registered uses of the preparations managed by other laws and regulations to other industrial uses;
4、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 could appoint a local Chinese agent to submit new chemical registrations. The local agent should 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 China REACH: regular registration, simplified registration and record:
 
 

Record	1.New chemical substances with tonnage no more than 1 ton per year; 2.Monomers of new substances, polymers containing less than 2%w/w new substances; 3.Polymers of low concern;
Simplified Registration	New chemical substances to be manufactured or imported above the annual volume of 1 ton, yet no more than 10 ton.
Regular Registration	New chemical substances to be manufactured or imported above the annual volume of 10 ton.

 
 
 
Chemical Risk Assessment Report
 
According to MEE Oder No. 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 new chemical substance activity situation record system; Keep documents on file for over 10 years; Disclose the implementation situations of the environmental risks control measures and environmental management requirements; Submit first-activity report; Report the situation of the new chemical substances of last year; Submit updates if new hazards or risks arises 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 new chemical substance activity situation record system; Keep documents on file for over 10 years; Submit first-activity report; Submit updates if new hazards or risks arises 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 new chemical substance activity situation record system; Keep documents on file for over 3 years;   Submit updates if new hazards or risks arises and take measures to eliminate or reduce the risks;

 
 
Beijing Boardingcard is a professional China New Chemical Substance Registration  consulting service provider of chemical regulations, providing professional technical consulting and efficient compliance services in the field of chemical safety assessment and environmental protection. We are committed to protecting the environment and human health and safety, helping enterprises improve market competitiveness, achieve product compliance, improve product quality, and create extensive value for customers; In the rapidly changing marketing environment, we provide professional, efficient, economic,safety and green solutions for customers. If you have any questions about the registration of new chemical substances, please contact Beijing Boardingcard for consultation.