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New Chemical Substance Registration (China REACH)

China,REACH,Chemical,Registration,IECSC,Administration

 

 

 

 

Under the revised Provisions on Environmental Administration of New Chemical Substances (MEE Order No. 12) issued in 2020, companies shall submit new chemical substance registrations 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 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

  • Manufacturers of new substances in China;

  • Importers of new substances in China;

  • 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;

  • 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

  1. Communicate relevant information, including registration certificate number, registered applications, hazard characteristics, risk control measures as well as environmental management   requirements;

  2. Establish new chemical substance activity situation record system;

  3. Keep documents on file for over 10 years;

  4. Disclose the implementation situations of the environmental risks control measures and environmental management requirements;

  5. Submit first-activity report;

  6. Report the situation of the new chemical substances of last year;

  7. Submit updates if new hazards or risks arises and take measures to eliminate or reduce the risks;

Simplified Registration

  1. Communicate relevant information, including registration certificate number, registered applications, hazard characteristics, risk control measures as well as environmental management   requirements;

  2. Establish new chemical substance activity situation record system;

  3. Keep documents on file for over 10 years;

  4. Submit first-activity report;

  5. Submit updates if new hazards or risks arises and take measures to eliminate or reduce the risks;

Record

  1. Communicate relevant information, including record receipt, registered applications, hazard characteristics, risk control measures as well as environmental management requirements;

  2. Establish new chemical substance activity situation record system;

  3. Keep documents on file for over 3 years;  

  4. Submit updates if new hazards or risks arises and take measures to eliminate or reduce the risks;

Information Change and Re-registrations

After registering new substances under MEE Order No. 12, if the applicants to  change the registration information, they shall apply for registration certificate change or registrate their substances by adopting approaches as following:

Registration Information Change

Regular Registration

Simplified   Registration

Record   Filling

Applicant/Agent Name

Apply for registration certificate change

Apply for registration certificate change

Apply for change through the online registration system, 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 (changes in process   conditions, production site or environmental management requirements, etc.)

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;