Quite unlike 2009, the new list of testing institutions came along with their applicable notification type (see the table 1) since the MEP plans to adopt a categorized management system upon the labs. Prior to the qualification application, the testing institutes would have to specify their to-be-qualified testing items and scope under China NCSN. Therefore, the labs with qualification limited to simplified notification might not be considered if the notifiers have their minds on regular notification.

Apart from the six labs from the 2009 list, two additional research and testing oriented companies have been included in the newly released batch, namely Jiangsu Hope Analytest Inc. and Suzhou Xishan Zhongke Drug R&D Co., Ltd, testing data generated from which are applicable for Band 1 Regular Notification.

Table 1. List of MEP-approved Eco-toxicological Testing Institutions [2012 MEP Announcement No.77]

It has been three years since the last qualification inspection conducted by the MEP in 2009. Compared with 2009, the qualification inspection has been upgraded to a large extent. Inspection items have increased from 20 to 160. According to the GLP inspector from the MEP, Mr Liu, Chunxin expressed that the 2004 version of Guidelines of Chemical Testing Good Laboratory Practices (HJ/T 155-2004) is more of a coarse framework, while the 2012 version adopts more OECD principles, indicating the authority’s intention to be integrated with the international track. According to draft version of the Guideline, the applying testing institutions will have to pass the qualification inspection, which is composed of both technical competence evaluation and on-site inspection.

Since the MEP manages the GLP labs in a dynamic way, the approved testing institutions will be subject to surveillance and inspection by the MEP every 3 years, according to Article 19 of the MEP Order No.7. Some companies might pose the scenario that what if the labs commissioned to do the tests failing the qualification inspection. As for the testing institutions failing the GLP inspection, the MEP will review the contracts they have previously signed with the notifying companies and take care of those transitional cases. Nevertheless, the testing projects commissioned after the MEP’s review could not be accepted. Hence, an exhaustive research over the testing institutions’ qualification would be considered smart move before the contract signing. The Institute of Pesticide and Environmental Toxicological under Zhejiang University is crossed out from the 2009 MEP-approved list (see Table 2).

Table 2. List of MEP-approved Eco-toxicological Testing Institutes [2009 MEP Announcement No.14 & 2010 MEP Announcement No.78]

The nine labs previously approved were fully loaded most of the time due to the high demand for the new chemical substance notification under China REACH. One could almost be certain that the overloading problem would not be relieved since there are only ten qualified labs (consiting of the new batch of only eight labs and two labs approved from the 2010 MEP Announcement No.78 (see table 2)). Thus, concerned companies are recommended to make the reservation with the qualified labs as soon as possible.

Furthermore, the Chinese domestic testing institutes approved by the MEP will have to submit annual report to the authority every January and will be subject to several regular, random inspections and targeted supervision over non-compliance items.

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