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China New Chemical Substance Notification Guidance (China NCSN) is planned to be drafted and submitted to China MEP by the end of this year. The development of the guidance is a sub-project of the national critical projects for chemical pollution control, managed by the Department of Pollution Prevention and Control of the MEP.
According to Ms. Lu Ling, SCC-MEP, the guidance revision working related meetings have all been concluded which just leaves some recently received comments for discussion and thus the issuance of the final NCSN guidance is unlikely to be further delayed.
The SCC-MEP is no longer requires China NCSN on APIs (Active pharmaceutical ingredients) or TCs (pesticide technical materials) as APIs have completed registration and TCs have completed pesticide registration. However, SCC-MEP will still focus on registration of substances if the APIs and TCs are used for other industrial uses (ChemLinked news release on 13 Jun). Additionally, fertilizers will be exempt from China NCSN.
The revised China NCSN guidance will define more specifically the qualification of domestic notifiers, which will remain limited to the domestic manufacturers and importers and will not extend to include downstream users.
As for the notification procedures, SCC-MEP is considering not specifying the tonnage on the certificate if the new chemical substance is a polymer notified through Simplified Notification Special Case, which will reduce the subsequent registration modification workload.
SCC-MEP has been planning to standardize the ecotoxicity testing reports for China NCSN for a long time. For testing reports generated by foreign testing institutes, reports generated using outdated testing methods will no longer be acceptable. For ecotoxicological testing reports generated domestically, only those generated by testing institutes accredited by the MEP within the labs accreditation validity period can be used for China NCSN. (ChemLinked news release on 29 Jul)
For information publication, the authority may expose the hazard information of hazardous new chemical substances (including hazardous new chemical substances of priority environmental concern.
