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On 15 Nov 2017, the FAQs on China new chemical substances notification (China NCSN, a.k.a China REACH) were updated. To be in line with the new amendments on data requirements in China’s New Substance Notification Guidance (MEP Announcement No.42 of 2017) which took effect from 15 Oct 2017 (CL news), 14 FAQs previously published on the SCC-MEP website were amended or deleted. The updates are specified as below.
For Q41, Q98, Q179 and Q180:
According to the MEP Announcement No.42 of 2017, the fish prolonged toxicity test (14-day) was deleted from the minimum data requirements for Band 2 regular notification, so the descriptions of this endpoint in the FAQs were deleted accordingly.
For Q45 and Q145:
According to the MEP Announcement No.85 of 2016, the evaluation and approval system for eco-toxicological testing institutes qualified for data generation for China new chemical notification was abolished from 1 Apr 2017. SCC-MEP now only accepts testing data generated by institutes published on the platform for chemical test data quality management (CL news). Thus the previous FAQs concerning exo-toxicological testing institutes were all deleted.
For Q161:
One of the exemption conditions for acute inhalational toxicity concerned the granulometric distribution of the inhalable section of the substance, however, there was no explanation for the “inhalable section”. According to the MEP Announcement No.42 of 2017, “particle size<10μm” has been indicated for the “inhalable section”, so the answer in Q161 was updated.
For Q163:
Q163 was deleted since the original question is invalid.
For Q164, Q165, Q166:
The answers were offered by the authority when there were no explanation in the Guidance. However, in MEP Announcement No.42 of 2017 the answers have been clearly indicated, so the three questions and answers were deleted from the FAQs page. All the notifiers should refer to the MEP Announcement No.42 of 2017 for operation.
For Q167:
The requirements of toxicokinetics were updated according to MEP Announcement No.42 of 2017 that from Band 2 regular notification only a toxicokinetics assessment report is required. Q167 was deleted as the original question is now invalid.
For Q168:
Only minor changes on remark No. referred to. There is no impact on the actual content.
For Q188:
The aquatic organism toxicity tests required for Band 3 and Band 4 regular notification have been specified in MEP Announcement No.42 of 2017. So the answer was updated.
The translation of the updated FAQ document is now available on ChemLinked E-BOOK store. ChemLinked standard or corporate members can download it directly.
