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On 12 Dec 2017, China MEP announced on its website by MEP Announcement No.2017-70 a guidance for on-site inspection of eco-toxicological test data which is generated for China new chemical notification (hereafter referred to as the “inspection guidance”). It came into effect immediately.
According to the inspection guidance, the Solid Waste and Chemicals Management Center (SCC under MEP) will be responsible for the on-site inspection.
It should also be noted that "if doubts are found during inspection and it requires technical identification (such as handwriting identification), the time consumed will not be counted into the review time for the notification of new chemicals." It means that for the regular notification or the general case of simplified notification (these two notification types require eco-toxicological data), it may take a longer time for the authority to complete technical review in consideration of the time consumed for inspections.
In principle the new system is limited to random on-site inspection. However, testing institutes will be subject to priority inspection based on the following criteria:
A large number of test reports are generated in which the information about staff number in key positions and the working area don’t match the corresponding information for designated laboratory
Discrepancies are found in the written examination of the submitted test reports;
Problems have been found in previous random inspections.
The inspections will mainly focus on checking of original records for the eco-toxicological test for China new chemical notification in institutes, e.g. testing equipment type, sample recipients records, feeding records for test organism, records of test process, test personnel signature, etc. In addition, whether the institute is in compliance with GLP is also under inspection.
The inspection guidance is a follow-up of the MEP’s announcement of 28 Dec 2016 for standardizing the management of chemical testing institutes. The announcement has been effective since 1 Apr 2017. In addition the previous evaluation and approval system for eco-toxicological testing institutes qualified for data generation for China new chemical notification was abolished. The MEP now no longer reviews and publishes MEP-approved eco-toxicological testing institutes. As previously mentioned all institutes can now fill in relevant information through the “chemical test data quality management system” and are subsequently listed on the management platform (so far 15 institutes). The institutions shall be responsible for their reports and bear legal responsibility. The authority will review the submitted test report and conduct on-site inspection randomly.
Although the new system will offer greater freedom to industry to choose their own testing institutions and should also help solve the capacity and manpower issues which hampered the previous system (previously only 13 MEP-approved institutes), it is advisable that industry does a due diligence check of each testing institution to carefully assess capacities and qualification prior to signing a contract. The confirmation of test plan and final report is important to ensure the validity of the new chemical test data before submission to the SCC.
