Chinese Chemical Regulation

China REACH (MEE Order 12)

What is MEE Order (China REACH)?

In 2003, Chinese Ministry of Ecology and Environment (MEE) introduced the regulation on the registration of New Chemical Substances (MEP Order No.7). In 2010, this regulation was revised for the first time and the Inventory (IECSC) was introduced under Order No.7.

After 9 years’ implementation of Order No.7, MEE called for the second revision of Measures for the Environmental Management Registration of New Chemical Substances, which was finally approved on February 12, 2020 (MEE Order No.12). This new regulation has come into force on January 1, 2021 and replaced the previous regulation (Order No.7).

Under the provisions of this regulation, companies shall submit registration application if manufactured/imported substance is not listed in the Inventory. All activities including research, production, importation and processing have to comply with the regulation requirements as long as the chemical substances are under the scope of this regulation. Business activities are not allowed until a certificate is granted.

Who should register?

Chinese manufacturers or importers
Chinese processing users
Foreign companies selling New Chemical Substances to China can register via Only Representative (OR)

Chinese domestic companies can submit the application by themselves. Overseas applicants can appoint a Chinese agent (OR) who will share the legal responsibility with them to fulfill the registration and post-registration obligations. The OR should have a legal entity in China.

Registration Type

Registration Document

Inventory

The Inventory of Existing Chemical Substances in China (IECSC) was introduced in 2013. The list has been regularly updated since then. Currently, there are 46,192 listed chemical substances as of the latest updates (Latest reference date 2020-11-17). Substances in the inventory are presented as category names, neither CAS number nor molecular structure is given. Substances that are not listed in the Inventory are considered New Chemical Substance.

The Inventory consists of two parts (public and confidential). Currently, there are 3,270 confidential substances. Companies must submit a formal enquiry in order to check if a substance is listed in the confidential part. China Solid Waste and Chemicals Management Center (SCC), a division of MEE, then will issue a letter of confirmation (usually within 2 weeks) and a 3 000 RMB fee will be charged. GPC can assist the enquiry on the customer’s behalf.

Despite all monomers being listed in the inventory, polymers are still required for registration.

Annual Report

First activity report

Certificate holders or their ORs, regardless of registration types, have to submit the first activity reports within 60 days since the first activity (manufacture and import/transfer to downstream user) of concerning chemical substances.

The report should contain the following information:

Domestic importing or producing company’s information
Time, place, volume of the first activity
Transferred user’s information
Environmental risk control measures
Implementation of environmental management requirements

Annual Report

Regular registration certificate holders or their ORs of those noted with Annual Report obligation on their certificates have to submit Annual Reports before 30 April from the second year of registration.

Annual report should include the following information:

Record of new chemical substance’s activities from last year, including the production or importation volume, transferring history and processing users’ information
Record on information communication
Emission into environment
Environmental risk control measures
Implementation of environmental management requirements

Note: processing users are obliged to assist the certificate holders to fulfil the annual report obligation.