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New chemical substances eligible for special cases of Simplified Notification (SN), are subject to reduced registration requirements compared to general cases of simplified notification. At present, for a new chemical substance, different types of Special Case of Simplified Notification can be applied for concurrently, although each subsequent notification will increase the pooled total volume accordingly. Taking Case 1 for example, ①Intermediates manufactured/imported < 1 t/y and ②Only for the purpose of exporting from China < 1 t/y are two situations where special cases of Simplified Notification are applicable, the notifier can apply for two notifications and obtain two certificates to guarantee the associated activities.
However, according to Miss. Mengsha Zhang from SCC-MEP, notifiers will lose the current benefits associated with dual notification due to a new amendment to regulations which only allows notifiers to hold just one certificate for one substance. In addition, after a higher level registration certificate is obtained, the lower level certificate will be automatically invalid. Although the “one certificate only” rule will certainly be implemented, practical elements are yet to be finalized. Potential cases are illustrated as below.
| Cases | Current | After revision (potential) |
1 | Notifier A: ①Special case of SN: Intermediates manufactured/imported < 1 t/y ②Special case of SN: Only for the purpose of exporting from China < 1 t/y | Two certificates: Two special cases of Simplified Notification (Intermediates & Manufacture for Export Only) with quantity < 1 t/y respectively | One certificate: Applicable activity types listed on one certificate with total quantity limited to < 1 t/y |
2 | Notifier B: ①Special case of SN: Intermediates manufactured/imported < 1 t/y ②General case of SN: manufactured/imported < 1 t/y | Two certificates: One for special case of Simplified Notification (Intermediates< 1 t/y), another for general case of simplified notification< 1 t/y | One certificate: General case of Simplified Notification with quantity < 1 t/y |
3 | Notifier C: ①General case of SN: manufactured/imported < 1 t/y ②Band 1 Regular Notification: manufactured/imported < 10 t/y | One certificate: Band 1 Regular Registration with quantity < 10 t/y | One certificate: Band 1 Regular Registration with quantity < 10 t/y |
4 | Notifier D: ①General case of SN: manufactured/imported < 1 t/y ②Special case of SN: For the purpose of product research or process technology <10 t/y for less than 2 years | Two certificates: One for special case of Simplified Notification (PPORD< 10 t/y), another for general case of simplified notification< 1 t/y | One certificate for sure; based on the current understanding, the certificate for general case of SN will be valid since it is higher level than special case of SN, however, the special case of SN (PPORD)<10 t/y is expected to also be valid in some other form. It is a very special to be further discussed. |
According to Miss. Zhang, in the future, the special case of simplified notification will not apply to (1) unstable or degradable polymers or (2) water-absorbing polymers with Mn≥10,000. SCC will add definitions of these two kinds of polymers in the Guidance. In addition, testing reports proving that the polymer to be notified meets special case of Simplified Notification criteria will not be required, instead a self-statement is adequate.
According to the current schedule for revision of Guidance, notifiers should still follow the current requirements to prepare the annual report for 2015. Simplified notification and regular notification certificate holders are still required to use the annual report template issued in 2012 to report their 2015 production and import activities by 1 Feb 2016.
