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Recently, considering that there are still mounting questions over the practices of complying with MEE Order No. 12 [1], the Solid Waste and Chemicals Management Center of the Ministry of Ecology and Environment (SCC-MEE) released a series of FAQs to further help businesses fulfill their obligations under the newly implemented framework.
ChemLinked has selected some of the FAQs to facilitate your understanding of and compliance with MEE Order No. 12:
1. I have obtained a regular notification certificate (for import) for a substance. If I import the substance for the first time for laboratory use (no sale is involved), do I need to prepare the first-time activity report?
Yes. According to the Circular on Transitional Arrangements for Environmental Management Registration of New Chemical Substances (Circular No. 46 of MEE in 2020) [2], 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.
2. I have obtained a simplified notification certificate under MEP Order No. 7. Shall I re-apply for record notification now?
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.
3. For substances for which regular notification certificates were obtained under MEP Order No. 7, how will they be listed into the Inventory of Existing Chemical Substances (IECSC)? Shall enterprises submit an application so that they can be listed into IECSC under MEE Order No. 12?
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.
4. I have obtained a regular notification certificate under MEP Order No. 7. How shall I implement post-registration management requirements?
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.
5. Under MEE Order No. 12, is it required to mail the paper originals of application materials to the competent authority?
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.
6. What are the requirements for the representative contract or agreement?
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.
7. Is there a lower limit for quantity of chemical substances subject to new usage environmental management?
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.
8. When can I start relevant activities after submitting an application for record notification?
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.
9. Where any change takes place in the items or relevant information of a record notification, how to change the information notified?
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.
10. When is the deadline for submission of annual report?
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.
11. If I have updated my registration certificate, how should I submit the annual report?
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.
12. If I have obtained an updated registration certificate, do I need to submit a first-time activity report for it?
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.
13. If an applicant has obtained a simplified registration certificate for a new chemical substance, and later obtained a regular registration certificate for the same substance. Can the applicant hold the two certificates at the same time?
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.
14. How do I change the registration certificate obtained under MEP Order No.7?
According to Circular No.46 of MEE in 2020, you may apply for change of registration certificate by following the steps below:
1. Log in to the MEE official website (http://zwfw.mee.gov.cn); 2. Click New Chemical Substance (新化学物质类）; 3. Click "Material Declaration" （事项申报） in the column of "New Chemical Substance Environmental Management Registration Certificate Issuance and Approval" （新化学物质环境管理登记证核发和审批事项）; 4. Log in to the MEE Order No.12 Declaration Portal （《新化学物质环境管理登记办法》（12号令）事项申报入口）; 5. Choose "Regular Registration" （常规登记） or Simplified Registation" （简易登记）;6. Choose "Change of Registration Certificate"（登记证变更） and fill in the form
15. How do I revoke registration certificate obtained under MEE Order No.7?
According to Circular No.46 of MEE in 2020, you may apply for revocation of registration certificate by following the steps below:
1. Log in to the MEE official website (http://zwfw.mee.gov.cn); 2. Click New Chemical Substance (新化学物质类）; 3. Click "Material Declaration" （事项申报） in the column of "New Chemical Substance Environmental Management Registration Certificate Issuance and Approval" （新化学物质环境管理登记证核发和审批事项）; 4. Log in to the MEE Order No.12 Declaration Portal （《新化学物质环境管理登记办法》（12号令）事项申报入口）; 5. Choose "Regular Registration" （常规登记） or Simplified Registation" （简易登记）;6. Choose "Revocation of Registration Certificate"（登记证撤销） and fill in the form
16. Does LogKow＜3 suffice the exemption condition for bioaccumulation data?
Yes. According to Guidance on Environmental Management Registration of New Chemical Substances, the n-octanol-water partition coefficient (LogKow) ＜3 meets the exemption condition for fish bioaccumulation data. However, the data shall be derived from the testing reports.
17. If our annual production or import volume of polymers are less than 1 ton, can we apply for the record notification as new chemical substances?
Yes.
18. How do I fill out the application form for change of applicants name or representatives' name in registration certificate?
According to Circular No.51 of MEE in 2020, the changed name of applicants and representative shall be written in red circled area as follows:
19. Is the SMILES code required for new chemical substances registration?
For a chemical substance with an unique and specific molecular structure, its SMILES code must be provided.
20. Do registration or record notification for environmental management of new chemical substances need to be reapplied for or renewed every year?
There is no need once you have completed the procedure. However, should any information regarding the registration certificate or notification changes, the person in charge shall apply for a change.
21. Our company has a chemical product that is not included in the IECSC. Will it be added to the inventory once we filed for a record notification?
No. According to MEE Order No.12, Article 44, New chemical substances that have handled simplified registration and record notification shall not be listed in IECSC.
22. After MEE Order No.12 takes effect, what kind of new chemical substances requires annual report? What are the specific requirement?
According to MEE Order No.12 and Circular No.46 of MEE in 2020, new chemical substances as specified in Article 3 of MEE Order No.7, and those which handled regular registration with annual report specified as environmental management requirement under MEE Order No.12 shall file an annual report.
The applicant shall submit to the competent department the actual production or import circumstances, and circumstances of emission into the environment, as well as the implementation circumstances of risk control measures and environmental management requirements of the new chemical subtances for accredited registration of the previous year, before April 30 annually.
