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On 28 Dec 2016, China MEP announced on its website that it will abolish the current evaluation and approval system for eco-toxicological testing institutes qualified for data generation for China new chemical notification (China NCSN) from 1 Apr 2017.
To meet industry requirements for qualified testing data acceptable for China new chemical notification, China MEP according to the Measures for the Administration of Chemical Testing Good Laboratory Practice approved in 2012, 2014 and 2015 three batches of eco-toxicological testing institutes.
So far, there are 13 accredited testing institutions. Each testing institute is only authorized to generate data for testing items within a scope officially approved by the MEP for China NCSN. The whole list is accessible here.
The requirements for certification as a MEP-GLP institute are extremely high. In addition, The MEP-approved testing institutions are subject to surveillance and inspection by the MEP every 3 years.
From 1 Apr 2017, testing institutions that wish to provide testing services to meet industry’s demand for China NCSN eco-toxicological testing will be required to meet the following three criteria
Obtain a China Metrology Accreditation (CMA)
Prepare a self-declaration of GLP conformity according to the Guidelines of Chemical Testing Good Laboratory Practices and make it public on the institute’s website and the Solid Waste and Chemicals Management Center’s website (SCC-MEP).
Publish on institute’s website and SCC-MEP’s website the following information, including the name, address, legal person or principal of the institute, eco-toxicological testing capacities, the area of the institute in specified units, devices related to eco-toxicological testing, qualifications obtained, arrangement of staff (number, job title, education, major) including Study Director (SD), Quality Assurance (QA) staff, etc. The information should be updated within 20 working days if there are any updates.
Test reports not meeting GLP criteria, or containing factual errors or generated using inappropriate test methods won’t be accepted for new chemical substance notifications. The institutions will be legally responsible for their all reports submitted and those found guilty of submitting false data/reports will be subject to prosecution and other punishment.
China NCSN requires some ecotoxicology reports to be completed in China and use Chinese test organisms for both “General Case of Simplified Notification” and “Regular Notification”. Potential notifiers of China new chemicals should in the near future pay attention to the public information regarding the qualifications and capacities of eco-toxicological testing institutes on the SCC-MEP website.
As for the physicochemical and toxicology test facilities, the Announcement doesn’t raise any special requirements. So at present, the physicochemical and toxicology tests under China NCSN won’t be affected.
Currently the Guidance on China New Chemical Notification is under revision, the provisions concerning qualification of testing institutes accredited for data generation will also be deleted. The test items already entrusted to MEP-GLP approved institutes will not be affected. In the future industry will have a greater variety of options with regard to selection of accredited testing institutes used to generate data for China NCSN.
