Interpretation of Announcement on Linkage Matters Concerning Environmental Management Registration of New Chemical Substance

The "Measures for the Environmental Management and Registration of New Chemical Substances" (Order No. 12 of the Ministry of Ecology and Environment, hereinafter referred to as Order No. 12) will come into effect on January 1, 2021. The "New Chemical Substances Environmental Management Measures" issued by the former Ministry of Environmental Protection on January 19, 2010 (Order No. 7 of the Ministry of Environmental Protection, hereinafter referred to as Order No. 7) shall be repealed simultaneously. On the basis of extensive solicitation of opinions, the Ministry of Ecology and Environment issued the "Announcement on Linkage Matters Concerning the Environmental Management Registration of New Chemical Substances" (hereinafter referred to as the Announcement) on October 27, 2020, clarifying the transition policy for new chemical substances that have obtained regular registration certificates and simplified registration certificates under Order No. 7, after Order No. 12 came into effect. Compared with the draft for comments, the provisions are basically the same. The biggest change is the extension of the review transition period for accepted applications, and clarification of the specific circumstances under which the registration certificate can be changed. In order to help enterprises respond better, we have sorted out the convergence issues that enterprises are concerned about, and we will give you a detailed explanation below.

 

1. Extension of the registration deadline for accepted applications

After more than four months of waiting, we finally waited for the major good news. The announcement stipulates that applications for environmental management registration of new chemical substances accepted before the entry into force of Order No. 12 can continue to be processed in accordance with the provisions of Order No. 7 after the entry into force of Order No. 12, and the deadline is extended to June 30, 2021, a full 6 months has been added compared with the period in draft for comments. If the registration cannot be obtained on June 30, 2021, the relevant requirements of Order No. 12 shall be applied.

Due to the time-consuming and high cost of new chemical substance notification and registration, the “one size fits all” approach has not been adopted, and the registration buffer period has been extended to allow companies to better respond to registration and protect their enthusiasm for compliance. If companies have complete registration data, it is recommended to submit the application materials as soon as possible. As long as the application is accepted before the end of December, it is very possible that the registration can be obtained directly and there is no need to prepare again in accordance with the new regulations.

 

2. Key environmental management hazardous new chemical substances management

Annual report: After Order No. 12 takes effect, only key environmental management hazardous new chemical substances need to submit annual reports. General hazardous and simplified registered substances do not need to continue to provide annual reports, and the coverage of annual reports will be greatly reduced.

Environmental management for new uses: Key environmental management hazardous new chemical substances continue to implement environmental management registration for new uses, and allow uses when listed in the "Inventory of Existing Chemical Substances in China". That is, after key environmental management new chemical substances are included in the IECSC, they still need to be registered if the uses need to be changed or added.

 

3. Change of registration certificate

The announcement has made major adjustments to this, clarifying several situations in which the information contained in the registration certificate can be changed. In addition, new chemical substances that have obtained the registration certificate need to be re-registered or recorded in accordance with Order No. 12.

Registration types	Changeable cases
General   case	1. The amount of registration is to be reduced; 2. The type of activity is to be changed from   production to import or increase in import; 3. The identification information such as the Chinese   and English name or Chemical Abstract Service Number (CAS number) of the   registered new chemical substance is to be changed; 4. The name of the applicant or agent is to be changed.
Simplified   case	1. The registered volume after the change is less than   1 ton/year; 2. Where the registration certificate is obtained for   the purpose of process and product research and development, the registered   volume after the change is less than 10 tons, and the registration   certificate is still within the validity period; 3. Polymers with monomer content of no more than 2% of   new chemical substances or polymers of low concern.

Although the special type of application for process and product research and development has been cancelled under Order No. 12, the validity period of the registration certificate is still 2 years after the first activity, and the information recorded in the registration certificate can be changed during the validity period, and the registration certificate will not be unexpired due to information changes.

All the changes in the above regulations are not increased risk. All changes to the registration certificate under Order No. 12 will be accepted and technical review will be organized with reference to the simplified registration procedures and time limits, and the management of registration certificate changes will become more standardized.

 

4. Information transmission report and record keeping

The holder of the regular registration certificate shall continue to perform the obligations of information transmission, data recording and preservation, first activity report and new hazard information reporting. The holder of the simplified registration certificate shall continue to perform the obligations of data recording, preservation and new hazard information reporting.

 

5. Revocation of registration certificate

Holders of regular registration certificates and simplified registration certificates may apply to the competent authority for cancellation of registration certificates in accordance with the provisions of Order No. 12.

 

At present, the new "Guidelines" and technical documents have not been officially released. Our company will follow up and share the progress in time. If you have any questions about new chemical substances registration, please feel free to contact us.