China May Approve Amendments to New Chemical Management by October 2020

Takehome: MEP (now MEE) Order 7 is under revision and more than 500 comments on the proposed amendments have been received by Aug 16th, 2019. The revision of MEP Order 7 and its overarching Regulation on Environmental Risk Assessment and Control of Chemical Substances were notified to the WTO for comments on Sep 2nd. China’s government is developing an E-certificate system, through which the new chemical registration certificate details will be accessible via a QR Code system.

500 public comments have already been received regarding the draft revision of the Measures for the Environmental Management of New Chemical Substances (MEP Order 7, hereafter referred to as the Measures). During REACH24H’s Chemical Regulatory Annual Conference (CRAC 2019) in Xi’an on Sep 2^nd, Ms. Hongying Liu from China’s Solid Waste and Chemicals Management Center (SCC) under the Ministry of Ecology and Environment (MEE) confirmed that regulators have increased their rate of analysis on all the comments received during the public feedback period. She also mentioned that the guidance and relevant registration forms are on the agenda to be updated to align with the revised Measures.

Ms. Liu introduced the major amendments^[1] of the Measures and outlined the ongoing efforts made by the authority to promote and accelerate the legislative process. The Measures and its overarching Regulation on Environmental Risk Assessment and Control of Chemical Substances (hereafter referred to as the Regulation) were notified to the WTO for a 60-day comments on Sep 2nd. The Regulation (G/TBT/N/CHN/1350^[2]) has been updated to address comments received in February. However, the Measures (G/TBT/N/CHN/1351^[3]) notified are actually the same version issued for public comments on MEE website in July. The only difference is that this WTO version provides a date for the enforcement (Oct 15th of an as yet unspecified year). This sheds some light on the possible time for the release of the Measures, expected by October of 2020.

According to Ms. Liu, the current punishment (a fine up to RMB 30,000 only) for violating the Measures are not effective deterrents. China’s new chemical management system will impose more severe punishment on violators. She also mentioned that the authority plans to develop a list of chemical uses categories, which will facilitate management of new chemicals that are listed in the IECSC 5 years after registration and are used for purposes other than that defined in the chemical registration dossier.

Mrs. Liu explained the government will digitalize the new chemical registration certificate (E-certification system). SCC has provided the certificate templates and in the future the certificate details will be probably accessible via QR code. Currently the registration certificates will be posted to applicants by the MEE, which has often delayed importation and production of new chemicals following approval. The E-certificate system would greatly expedite market access.

As for the IECSC supplementation (CL news^[4]), the deadline is looming and all the submitted evidentiary documentation will be reviewed later. According to Ms. Liu, it is uncertain when experts will finish the review work. Also, it is not certain if enterprises will be allowed to provide additional supporting materials if applications are rejected. She highly recommended stakeholders to submit as much information as they can before Sep 30th, 2019.