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On October 27th, 2020, the Chinese Ministry of Ecology and Environment (MEE) published the Notice on Transitional Arrangements for Environmental Management Registration of New Chemical Substances [1], as part of the moves to facilitate the upcoming implementation of MEE Order No. 12 [2] and ensure the orderly continuity of the new chemical registration work during the transition from the old to the new scheme.
The following are transitional arrangements detailed in the Notice:
I. Transitional arrangements for regular notification
From the date when MEE Order No.12 enters into effect, for any new chemical substance for which a regular notification certificate has been obtained under MEP Order No.7, the following requirements apply:
1. The certificate holder and downstream users shall implement environmental control measures as indicated in the certificate. (Implementation of environmental risk control measures)
2. The certificate holder shall, according to Article 38, 39, 41, and 42 of MEE Order No.12, communicate relevant information, record and keep relevant documents, submit the first-time activity report, and inform the authority about the newly identified hazards of the registered substance. If it is classified as a new hazardous substance with priority environmental concern under MEP Order No.7, an annual report shall be submitted according to Article 41 of MEE Order No.12. (Information communication and reporting and record keeping)
3. The certificate holder can apply to the competent department of ecology and environment under the State Council for revocation of the certificate according to Article 33 of MEE Order No.12. (Application for revocation of certificate)
4. The new hazardous substance with priority environmental concern under MEP Order No.7 shall still be subject to new usage environmental management and be assigned allowed uses upon the inclusion into the IECSC. (New usage environmental management)
5. The certificate holder shall re-apply for registration according to the provisions of MEE Order No. 12 and obtain a new registration certificate if any information specified in the original certificate is to be changed. However, the certificate holder can apply for change of certificate under any of the following circumstances according to Article 30 of MEE Order No. 12: (Application for change of certificate)
a) The volume registered is to be lowered;
b) The type of activity is to be changed from manufacture to import, or import is to be added as a type of activity for the substance registered;
c) The Chinese and English name, CAS No., or other identification information of the substance registered is to be changed;
d) The name of the applicant or agent is to be changed.
II. Transitional arrangements for simplified notification
From the date when MEE Order No.12 enters into effect, for any new chemical substance for which a simplified notification certificate has been obtained under MEP Order No.7, the following requirements apply:
1. The certificate holder shall record and keep relevant documents as well as inform the authority about the newly identified hazards of the registered substance according to Article 39 and 42 of MEE Order No.12. (Information reporting and record keeping)
2. The certificate holder can apply to the competent department of ecology and environment under the State Council for revocation of the registration certificate according to Article 33 of MEE Order No.12. (Application for revocation of certificate)
3. The period of validity of the simplified notification certificate for product and process orientated research and development (PPORD) is two years after the first-time activity. (Period of validity of the simplified notification certificate for PPORD)
4. The certificate holder shall apply for record notification, or re-apply for registration and obtain the registration certificate according to relevant provisions of MEE Order No.12 if any information specified in the original certificate is to be changed. However, the certificate holder can apply for change of certificate under any of the following circumstances according to Article 30 of MEE Order No. 12: (Application for change of certificate)
a) The volume registered after the change is below 1t/y;
b) In the case of a simplified notification certificate for PPORD, the volume registered after the change is below 10t/y and the certificate is within its period of validity;
c) The substance notified is a polymer containing less than 2% monomers which are new chemical substances, or a polymer of low concern.
III. For new chemical substances for which the registration certificates have been obtained in accordance with MEP Order No.7, the competent department of ecology and environment under the State Council can revoke any of the certificates in accordance with relevant provisions in the Administrative Licensing Law of the People's Republic of China, under any of the circumstances specified in Article 35 of MEE Order No.12.
IV. For new chemical substance registration applications that are accepted before MEE Order No.12 enters into effect, they will be handled according to MEP Order No. 7 until June 30th, 2021; where a certificate cannot be obtained for such applications before June 30th, 2021, they will be then handled according to MEE Order No.12.
As the effective date of MEE Order No. 12 approaches, the authorities have been gearing up to improve relevant systems and mechanisms to help businesses effectively and compliantly cope with the new scheme. The official Guidance on Environmental Management Registration of New Chemical Substances is expected to come out soon. Please stay tuned.
