Chinese official warns firms to check laboratory accreditation

Authorities to review data generation to check quality

22 September 2017 / China

Companies should be careful to select accredited testing laboratories in China when preparing data for regulatory submissions, a director from the National Registration Centre for Chemicals-State Administration of Work Safety told the CW+ AsiaHub Brussels conference this week.

Li Yuncai, who heads up the department of identification and classification of chemicals hazards, noted that there are:

11 institutions accredited by SAWS to identify physical hazards of chemicals; and
24 laboratories accredited by the Ministry of Health to provide health hazard testing.
Further, facilities testing environmental hazards need to follow provisions laid out in the Standard for Management of Chemical Testing Institutions (No85 Announcement 2016) of the Ministry of Environmental Protection (MEP).

Lisa Zhong, of China's National Chemical Information Center's product registration and compliance department, noted that earlier this year, China removed the Good Laboratory Practice scheme in China (see video). She said one of the biggest challenges facing companies seeking data in China is selecting the right laboratory.



Mr Li said that the MEP plans to review data submitted for registration of new chemical substances, and prepare a code of practice for the process.

The work will include inspections to improve quality and accuracy of data.

He added that the Chinese authorities will be looking closely at submitted test data, to ensure that if it is generated:

outside China, it is based on internationally recognised methods, such as OECD Test Guidelines and GLP; and
by Chinese laboratories, they are qualified and the experiments conform to the relevant regulations and standards.