China New Chemical Registration FAQs - Vol.2

According to the Guidance on Environmental Management Registration of New Chemical  Substances, if log Kow ＜3, the substance in question is exempt from bioaccumulation data requirements, provided that the log Kow data is derived from testing reports.

Yes. According to the Circular on Transitional Arrangements for Environmental Management Registration of New Chemical Substances (Circular No. 46 of MEE in 2020), for substances for which regular notification certificates were obtained under MEP Order No. 7, the certificate holder shall, within 60 days of first-time production activity or within 60 days of first-time import and transport to the processing users, submit a first-time activity report, in accordance with Article 41 of MEE Order No. 12.

According to Article 53 of MEE Order No. 12, in the case of substances for which registration was completed under MEP Order No. 7 or SEPA No. 17, their registration is still effective after the implementation of MEE Order No. 12. For simplified notification certificates obtained under MEP Order No. 7, they shall be handled according to provisions in Circular No. 46 of MEE in 2020.

According to the Guidance on Environmental Management Registration of New Chemical Substances ^[3], for substances for which regular notification certificates were obtained under MEP Order No. 7 and which have not been listed into the IECSC yet, they shall be listed into the IECSC after five years have passed since their first-time activity; if there had been no actual activity for such substances as of January 1, 2021, they will be listed into IECSC five years after MEE Order No. 12 took effect.

Meanwhile, for substances for which regular registration certificates are obtained under MEE Order No. 12, they shall be listed into the IECSC by the MEE five years after the completion of their registration.

The MEE will issue notices announcing the listing of the substances described above into the IECSC, and enterprises do not need to submit any application.

To apply for information change in a regular notification certificate obtained under MEP  Order No. 7, one needs to comply with requirements in Circular No. 46 of MEE in 2020. 

The process goes as follows: 

Visit the official government service website of the MEE (http://zwfw.mee.gov.cn); choose "New Chemicals-related Matters"; click "Matter Notification" in the column of "13002  Matters Related to Approval and Issuance of Environmental Management Registration Certificates of New Chemical Substances"; enter the "Gateway to Matter Notification under  Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12) (New System)"; click "Regular Registration" or "Simplified  Registration"; and then click "Change of Registration Certificate" to fill in relevant information.

To cancel a regular notification certificate obtained under MEP Order No. 7, one needs to comply with requirements in Circular No. 46 of MEE in 2020. 

The process goes as follows:

Visit the official government service website of the MEE (http://zwfw.mee.gov.cn); choose "New Chemicals-related Matters"; click "Matter Notification" in the column of "13002 Matters Related to Approval and Issuance of Environmental Management Registration Certificates of New Chemical Substances"; enter the "Gateway to Matter Notification under Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12) (New System)"; click "Regular Registration" or "Simplified  Registration"; and then click "Cancellation of Registration Certificate" to fill in relevant information. 

You will need to implement post-registration management requirements according to Circular No. 46 of MEE in 2020. For identification information disclosure of chemical substances listed in the IECSC and protection extension applications, they shall be handled in accordance with requirements in MEE Order No. 12.

According to the Guidance, applicants shall submit application materials via the online registration system on the government service platform of the MEE. Therefore, they do not need to mail the paper originals of application materials, except when they wish to renew their registration certificates.

According to the Guidance, the following contents shall be made clear in the representative contract or agreement: 

1) The applicant and its representative agent shall jointly perform the obligations of environmental management registration of new chemical substances and post-registration environmental management, and assume legal liabilities according to the law;

2) Provisions on relevant responsibilities and obligations for replacing the representative agent; 

3) The validity period of the representative relationship. The validity period of the representative contract or agreement shall cover the validity period of the responsibilities and obligations assumed by the registration certificate holder or the applicant of record notification, or it may be extended before the validity period expires.

There is no lower limit for quantity of chemical substances subject to new usage environmental management. If a substance subject to new usage environmental management is used for industrial applications other than the permitted uses, new usage registration will be required.

According to the Guidance, after an applicant submits the full, complete application materials for record notification, the online registration system will send a confirmation receipt to the applicant automatically. Then the applicant can carry out relevant activities in line with contents specified in the record notification. 

The MEE would organize the affiliated agencies for environmental management of chemical substances to conduct random inspection of the compliance of record notification materials. 

(1) Where the random inspection finds that the record notification materials submitted by the  applicant do not meet the requirements, or are insufficient to determine whether it meets the  record notification conditions, the applicant shall supplement and correct relevant materials at  one time as required by the supplementation and correction notice. 

(2) Where the random inspection finds that the substance registered under the record notification does not meet the criteria for record notification and an application for regular or simplified registration shall be submitted instead, the MEE shall cancel the record notification. The applicant shall bear the corresponding legal responsibilities stipulated in MEE Order No. 12, and apply for a regular or simplified registration certificate accordingly.

Where any change takes place in the items or relevant information of a record notification, the applicant shall apply for change in the information notified via the online registration system and obtain a confirmation receipt for the change.

According to the Guidance, the registration certificate holder or a representative it designates shall, in accordance with Paragraph 2, Article 41 of MEE Order No. 12, submit an annual report for new chemical substances before April 30 each year starting from the next year of registration.

No. According to the Guidance, for new chemical substances that meet the lower application requirements, applicants are allowed to apply for the environmental management registration of new chemical substances by following the higher application requirements, and a new registration certificate shall be accordingly issued.

In this case, the applicant will need to submit an annual report on the activities of the new  substance throughout the year, including those before and after the change.

If you have submitted a first-time activity report for your original certificate, you will not  be required to submit another one for the updated certificate; otherwise, you will need to submit a first-time activity report.

No. According to the Guidance, for new chemical substances that meet the lower application requirements, applicants are allowed to apply for the environmental management registration of new chemical substances by following the higher application requirements, and a new registration certificate shall be accordingly issued.

Yes.

If you wish to change the name of applicant or representative of a regular registration certificate, you will need to fill in the new name for "2. Applicant Name" or "3. Representative Name" in the application form. See the example below: 

For substance with an only, definite molecular structure, their SMILES codes must be provided for the purpose of environmental management registration.