Interpretation of the announcement on the convergence matters related to the environmental management registration of new chemical substances

Release time:

2020-11-09 11:52

The Measures for Registration of Environmental Management of New Chemical Substances (Order No. 12 of the Ministry of Ecology and Environment, hereinafter referred to as Order No. 12) will come into force on January 1, 2021, and the Measures for Environmental Management of New Chemical Substances (Order No. 7 of the Ministry of Environmental Protection, hereinafter referred to as Order No. 7) issued by the former Ministry of Environmental Protection on January 19, 2010 shall be abolished at the same time. On the basis of extensive consultation, the Ministry of Ecology and Environment issued the Announcement on Matters Relating to the Registration of Environmental Management of New Chemical Substances (hereinafter referred to as the Announcement) on October 27, 2020, clarifying the transitional policy for new chemical substances that have obtained regular registration certificates and simple registration certificates under Order 7 after the entry into force of Order 12. Compared with the draft for soliciting opinions, the prescribed matters are basically the same, and the biggest change is to extend the examination and approval transition period for accepted applications and clarify the specific circumstances under which the registration certificate can be changed. In order to enable enterprises to better deal with it, we have sorted out the convergence issues concerned by enterprises, which will be explained in detail below.

1. Extension of the deadline for registration of accepted applications

After more than four months of waiting, we finally waited for major good news. The announcement stipulates that the new chemical substance environmental management registration applications accepted before Order 12 takes effect can continue to be processed in accordance with Order 7 after Order 12 takes effect. The deadline is extended to June 30, 2021, which is a full increase of 6 months compared with the draft for comments. If the registration cannot be obtained on June 30, 2021, the relevant requirements of Decree No. 12 shall be followed.

Due to the long time-consuming and high cost of new substance registration, the "one size fits all" approach has not been adopted, and a certain registration buffer period has been extended, which can enable enterprises to better deal with registration and protect their compliance enthusiasm. If there is a regular declaration with 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 hoped that the registration can be obtained directly without re-preparation in accordance with the new regulations.

2. Management of hazardous new chemical substances in key environmental management

Annual Report: After Decree No. 12 comes into effect, only new chemical substances of key environmental management hazardous categories need to submit annual reports, regular hazardous categories and simple registered substances do not need to continue to provide annual reports, and the coverage of annual reports is greatly reduced.

Environmental management for new uses: The environmental management registration of new hazardous chemicals for key environmental management categories will continue to be implemented, and the permitted uses will be stipulated when they are listed in the List of Existing Chemical Substances in China. That is, after the new chemical substances in the key environmental management category enter the "List", if they need to change their use or increase their use, they still need to be registered.

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 filed in accordance with Order No. 12.

Registration Type

Alterable situation

Regular

1. The registration volume is to be reduced;

2. The type of activity is intended to change from production to import or increase imports;

3. Registration of the Chinese and English name of the new chemical substance or the identification information such as the Chemical Abstracts Service number (CAS number) to be changed;

4. The name of the applicant or agent is to be changed.

Easy

1. The registered amount after the change is less than 1 ton/year;

2. If the registration certificate is obtained for the purpose of process and product research and development, the registration volume after the change is less than 10 tons, and the registration certificate is still within the validity period;

New chemical monomer content of not more than 2% of the polymer or belong to the low concern polymer.

Although the special type of application for process and product research and development has been canceled under Decree 12, the validity period of the registration certificate is still 2 years after the first activity. During the validity period, the information recorded in the registration certificate can be changed, and the unexpired registration certificate will not be invalidated due to the change of information.

All the changes in the above provisions are not an increase in risk. All changes in registration certificates under Decree No. 12 will be accepted with reference to the simple registration procedures and time limits and technical reviews will be organized. The management of changes in registration certificates 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 storage, first activity report and new hazard information report. The holder of the simple registration certificate shall continue to perform the obligations of data recording, preservation and new hazard information reporting.

5. Registration Certificate Revocation

The holder of the regular registration certificate and the summary registration certificate may apply to the competent department for the cancellation of the registration certificate in accordance with the provisions of Decree No. 12.

At present, the "Guide" and technical documents supporting Order 12 have not yet been officially released, and our company will keep an eye on and share the progress in a timely manner. If you have any questions about new chemicals, please feel free to contact us.

Small Science Popularization of Existing Chemical Substances Registration in Taiwan