Approval Status of New Chemical Substances Registrations in China under MEE Order 12

The Measures on the Environmental Management Registration of New Chemical Substances (MEE Order 12) were implemented two years ago on January 1, 2021. It has not only optimized and adjusted the registration types and relevant data requirements to lessen the burden on enterprises, but also focused on environmental risk prevention and control for new chemical substances with high environmental risks.

In addition, MEE Order 12 has specified the registration standards and improved the approval requirements for new chemical substances in the review and evaluation, stating the specific circumstances for approval, disapproval, reapplication, change, withdrawal, and revocation of registrations.

Over the past two years, the Ministry of Ecology and Environment (MEE) has published and announced qualified registrations after reviews on materials submitted by enterprises. Up until December 12, 2022, dozens of batches of approvals for regular registration, simplified registration, and filings have been announced.

By making a summary and analysis of the announcements on the approved registrations, we can understand what types of enterprises, substances, and activities have been approved for registrations, as well as relevant management requirements to have a preliminary understanding of the application and approval of new chemical substance registrations in China.

I. Approval status of regular registrations

Up until December 12, 2022, a total of 16 applications of regular registration for new chemical substances in five batches have been approved and published by the MEE under Order 12. Of all new chemicals approved for regular registrations, only three of those in the initial two batches were approved for environmental management for new uses, and the following 13 in the other three batches are not subject to environmental management for new uses which means that these substances are low-hazard chemicals. In addition, only three of 16 were approved to keep the identification information confidential and the remaining 13 were published with their names. Most of the registrations were made by one enterprise to apply for one substance. The majority of substances applying for registrations are organic substances, and others are inorganic substances and polymers. As for the types of activities, manufacturers outnumber importers. Among all the enterprises applying for registrations, most of them are Chinese enterprises, accounting for 81%. As to their main business, chemical and pharmaceutical enterprises are in the majority.

* Different colors represent different batches

*Substances that are persistent and bioaccumulative (PB), persistent and toxic (PT), or bioaccumulative and toxic (BT), and are classified as highly hazardous chemical substances and must be subject to environmental management of new uses after they are listed in the Inventory of Existing Chemical Substances in China.

II. Approval status of simplified registrations

Up until December 12, 2022, the MEE has approved and published a total of 236 applications for simplified registration of new chemical substances in 30 batches, of which 50 applications in 11 batches were approved in 2021, and 186 applications in 19 batches were approved in 2022. Only 14% of applications have been approved with identification information kept confidential in simplified registration for new chemical substances. Most substances have been published and announced with their names. Most of the registrations are made by one enterprise to apply for one substance. Organic substances account for 95% of all substances. In the types of activities, manufacturers outnumber importers. Enterprises in China account for the largest proportion of enterprises applying for registration. Chemical and pharmaceutical enterprises account for the main business types submitting registration applications.

III. Approval status of records

The MEE publishes announcements on records on the environmental management of new chemical substances every six months under MEE Order 12. Up until now, the MEE has published three batches of records and approved 9,414 records applications concerning over 30,000 chemical substances.

* Different colors represent different batches

Judging from the above information, what changes can we see about the environmental management of new chemical substances? What implications can we learn from the registrations of new chemical substances?

1. The management of new chemical substances registration under MEE Order 12 is an important approach to the “Action for the Control of New Pollutants”. According to the statistics, it is especially difficult to obtain approvals of regular registrations when chemicals are PB, PT, or BT and chemicals of high hazards. Therefore, applicants are required to conduct assessments on substance hazards and PBT properties before making applications for new chemical substance registrations.
2. Compared with MEP Order 7, it is much more challenging to obtain approvals to protect confidential business information (CBI) of new chemical substances under MEE Order 12. Less than 15% of applications have been approved for confidentiality in regular registrations and simplified registrations under MEE Order 12. It is strenuous to obtain approvals unless applicants take strict measures to keep confidentiality from being obtained through public channels.

Most chemical substances that have obtained the approval of regular registrations and simplified registrations are innovative organic compounds such as new chemical materials and pharmaceutical intermediates.

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