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3 testing institutions have passed GLP qualification inspection by the MEP and are qualified to produce eco-toxicological test data for China new chemical substances notification (China NCSN, a.k.a China REACH). The names of these institutions were released by MEP Announcement No.5 on 16 Jan 2014. One testing institution (Shanghai Research Institute of Chemical Industry Testing Center) which was in the 2010 list has had its accredited testing abilities extended, whilst for the other two labs it is their first time being accredited by the MEP as GLP-approved labs capable of producing data for China NCSN.
MEP-approved testing institutions are subject to surveillance and inspection by the MEP every 3 years. From the list of institutions which were approved by MEP Announcement No.78 in 2010, only the Shanghai Research Institute of Chemical Industry Testing Center has maintained its accreditation status and now has also upgraded the applicable notification types available (from general case of simplified notification to Band 3 regular notification). Guizhou Research Center for Physical Test and Chemical Analysis has been removed from the newly released list due to its involvement in the secret contract scandal disclosed in Jun. So far, only 11 qualified testing institutions are officially approved (See Table 1).
Table 1. List of MEP-approved Eco-toxicological Testing Institutes
No. | Chinese Name | English Name | Applicable Scope | Approved by MEP Announcement No.14 in 2009 (abolished concurrently when the MEP Announcement No.77 in 2012 issued) | Approved by MEP Announcement No.78 in 2010 (abolished concurrently when the MEP Announcement No.5 in 2014 issued) | Approved by MEP Announcement No.77 in 2012 | Approved by MEP Announcement No.5 in 2014 |
| 1 | 上海市检测中心生物与安全检测实验室 | Shanghai Academy of Public Measurement | Band 4 Regular Notification | Y | Y | ||
| 2 | 沈阳化工研究院安全评价中心 | Shenyang Research Institute of Chemical Industry | Band 4 Regular Notification | Y | Y | ||
| 3 | 南京环境科学研究所国家环境保护农药环境评价与污染控制重点实验室 | MEP-approved Key Laboratory for Environmental Evaluation and Pollution Control under Nanjing Institute of Environmental Science | Band 4 Regular Notification | Y | Y | ||
| 4 | 上海市环境科学研究院环境监测实验室 | Shanghai Academy of Environmental Sciences | Band 3 Regular Notification | Y | Y | ||
| 5 | 广东省微生物分析检测中心生态毒理与环境安全实验室 | Guangdong Detection Center of Microbiology | Band 3 Regular Notification | Y | Y | ||
| 6 | 江苏衡谱分析检测技术有限公司 | Jiangsu Hope Analytest Inc | Band 1 Regular Notification | Y | |||
| 7 | 苏州西山中科药物研究开发有限公司 | Suzhou Xishan Zhongke Drug R&D Co., Ltd | Band 1 Regular Notification | Y | |||
| 8 | 中国环境科学研究院中国环境保护部化学品生态效应与风险评估重点实验室 | MEP-approved Key Laboratory of Ecological Effect and Risk Assessment of Chemicals under Chinese Research Academy of Environmental Sciences | Simplified Notification | Y | Y | ||
| 9 | 上海化工研究院检测中心 | Shanghai Research Institute of Chemical Industry Testing Center | Upgrade from General Case of Simplified Notification to Band 3 Regular Notification | Y | Y | ||
| 10 | 浙江省农业科学院农产品质量标准研究所 | Institute of Quality Standards for Agricultural Products, Zhejiang Academy of Agricultural Sciences | Band 1 Regular Notification | Y | |||
| 11 | 北京协和建昊医药技术开发有限责任公司 | Institute of Materia Medica, Chinese Academy of Medical Science & Pecking Union Medical College (IMM) | Simplified Notification | Y | |||
| 贵州省理化测试分析研究中心 | Guizhou Research Center for Physical Test and Chemical Analysis | General Case of Simplified Notification; Band 1 Regular Notification | Y | ||||
| 浙江大学农药与环境毒理研究所 | Institute of Pesticide and Environmental Toxicology under Zhejiang University | Y |
Chinese NCSN notifiers should pay attention to the list of accredited testing items each testing institute is officially approved by the MEP to perform. Obviously labs with testing capabilities limited to simplified notification should not be considered if the notifiers have their minds on regular notification, and the test report generated by those only qualified to perform Band 1 regular notification cannot be accepted for higher tonnage band notifications.
The qualification of testing institutes approved to provide official data for notification dossiers under China NCSN is major concern for both domestic and overseas notifiers. Currently only eco-toxicological testing institutes are managed by the MEP GLP inspection. The institutes providing physicochemical and toxicological data are accredited by other authorities as specified in the China New Chemical Substances Notification Guidance Document. Testing reports generated by these toxicological and PC labs will be accepted before they are formally added to the list of MEP-approved testing institutes. In 2014 MEP will pilot a GLP inspection program for these toxicological and PC labs.
In July 2013, the MEP adopted a more proactive approach to dealing with industry concerns and issues relating to NCSN. Issues relating to chemical identification and testing, physicochemical properties, ecotoxicology, toxicology and health, chemical safety and environmental protection, risk assessment and control, etc. have elicited about 116 feedbacks from industry and relevant stakeholders. The common testing problems encountered during the expert panel’s evaluation under China NCSN will be summarized and published in the form of FAQ updates on CRC-MEP’s website. The controversy surrounding toxicokinetic testing, mutagenicity, etc. is expected to be resolved when MEP publishes the revised China NCSN guidance document, which is the priority task in 2014.
