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On July 29, 2022, China’s Solid Waste and Chemical Management Center of the Ministry of Ecology and Environment (MEE-SCC) held a virtual forum to provide an overview of the implementation status of the Measures for the Environmental Management Registration of New Chemical Substances (a.k.a. MEE Order No.12) and address the problems enterprises encountered in the compliance work, especially the issues regarding record notification of new polymers.
The officials attending the forum stressed again that enterprises should assume primary responsibilities in regulatory compliance and have a clear knowledge of their obligations as applicants or representatives. Highlights in this forum are as below.
Progress in implementation of MEE Order No.12
One and a half years have passed since the MEE Order No.12 took effect on January 1, 2021. Ms. Liu Hongying, director of the Registration Review Office, MEE-SCC, shared the statistics regarding the three registration types.
Progress in 2021
14 applications for regular registration were submitted to the MEE in 2021 and only one of them was approved.
38 applications for simplified registration were approved and made public in 2021.
20 applications for revocation of regular registration and 964 applications for revocation of simplified registration were approved.
7,010 record notifications were submitted to the MEE by 1,324 enterprises, covering 43,873 substances.
Progress in 2022 (as of July 2022)
4 applications for regular registration and 104 applications for simplified registration were approved.
362 annual reports of 2021 were submitted to the MEE before April 30, 2022 by 227 regular registration certificate holders.
259 applications for the change of registration certificate were approved.
Statistics of new chemical record notification in the first half of 2022 will be published soon.
Record notification under MEE Order No.12
As per the MEE Order No.12, new chemical substances manufactured or imported in quantities below 1 ton per year, polymers containing less than 2% of a new chemical monomer/reactant or PLCs are subject to record notification. Notably, there is no approval for record notification, which means that businesses can start relevant activities immediately after submitting application dossiers and receiving the receipt sent via the online registration system. The MEE will only conduct spot checks of the materials. However, in practice, it doesn’t mean that obligations under record notification are that easy to fulfil.
Mr. Liu Xiaojian, an official from the MEE-SCC, shared that quite a lot of problems have been identified in the spot check of record notifications, most of which were for polymers. He pointed out that many enterprises didn’t submit sufficient explanatory materials to clarify that the polymers in question don’t meet any of the conditions specified in Chapter V (Record notification exclusions for polymers) of the Guidance on Environmental Management Registration of New Chemical Substances (hereinafter referred to as the Guidance).
‘That is, applicants cannot simply state in the application dossiers that the polymers in question are exempted from regular registration or simplified registration and eligible for record notification without providing materials such as relevant test data or literatures illustrating that the polymers do not fall under the five exclusions (illustrated one by one in the form of an attachment)’ said Mr. Liu. If applicants fail in providing required materials within the limited period, the record notification receipts will be revoked, and the corresponding activities will be ordered to cease.
Special rules on record notification of new polymers can be accessed in the previous ChemLinked article ‘New Polymer Registration under China MEE Order No.12’ and the Guidance.
