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New Chemical Registration in China: Follow-up Management after Registration Will Be a Priority, Say MEE Officials

Follow-up management requirements are made more concrete and stringent in MEE Order No. 12 and its draft Guidance. Random checks of compliance for record notifications of polymers will be given particular importance. MEE is gearing up for drafting a supporting regulatory document for MEE Order No. 12, as well as three technical specifications.

On September 3rd and 4th, 2020, the Solid Waste and Chemicals Management Center (SCC) under the Ministry of Ecology and Environment (MEE) held a workshop on environmental management registration of new chemical substances in Beijing. Comprised of 11 sessions, the workshop is aimed at facilitating industry understanding of the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No.12) [1], which is set to take effect on January 1st next year, and soliciting the attendees’ comments on the Guidance on Environmental Management Registration of New Chemical Substances (Draft) [2].

The follow-up management of new chemicals after registration was brought up multiple times during the two-day workshop, as it will play a key role in ensuring the effects of MEE Order No.12. According to Ms. Lu Ling from the SCC, the new Measures emphasizes that enterprises assume primary responsibilities in follow-up management, commits to practice more targeted environmental risk control measures, and optimizes regulatory approaches and priorities, information reporting requirements and the process of inclusion into the Inventory of Existing Chemical Substances (IECSC). These improvements are expected to enable sound management throughout the lifecycle of chemicals.

In cases where record notifications are required, since applicants can carry out activities related to new chemicals immediately after they submit relevant materials, random checks of compliance are an important way to ensure follow-up management in this regard. It was pointed out by MEE officials that checking the compliance of record notifications of polymers will be a key focus in their work. MEE Order No.12 provides that, record notifications are required for polymers containing less than 2% monomers or reactants which are new chemical substances, or polymers of low concern, regardless of their annual volumes. (It should be noted that, simplified registration is required for such polymers under MEP Order No. 7 [3].). Therefore, regulators will pay intensified attention to whether such record notification applications are justified and whether their materials meet relevant conditions or not.

MEE officials also said that they are drafting a supporting regulatory document and three technical specifications, including one on risk characterization, to facilitate the upcoming implementation of MEE Order No. 12.

Though MEE Order No.12 provides simplified document requirements and optimized procedures of registration and notifications, the stronger oversight exercised both during and after the handling of matters will press enterprises to devote more efforts to ensure regulatory compliance. So, in light of the adjustments made in the new Measures and the draft Guidance, Mr. Yang Li from the SCC offered the following recommendations to enterprises:

l  Gain a thorough understanding of MEE Order No.12 and make their responsibilities clear

l  Determine the classification of their substances before manufacturing or importing such substances

l  Apply for registration or record notification based on the actual or expected conditions of activities

l  Perform relevant obligations stipulated in MEE Order No.12 and the draft Guidance after the issuance of registration certificates or completion of record notifications

l  Keep a close eye on regulatory updates concerning the environmental management of new chemicals

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