Announcement on Regulating the Administration of Chemical Testing Institutions

Release time:

2019-09-06 15:35

In order to implement the relevant requirements of the notice of the general office of the State Council on cleaning up and standardizing the intermediary services for administrative examination and approval of the departments of the State Council (No.31 [2015] of the State Council), standardize the intermediary services for chemical testing related to the environmental management and registration of new chemical substances, and strengthen the later supervision, the announcement is as follows:

1. Abolishing the Review and Announcement System of Chemical Testing Institutions

The Ministry of Environmental Protection will no longer review and announce chemical testing institutions.

Domestic testing institutions that provide test data for the purpose of declaration of new chemical substances shall pass qualification (measurement certification) in accordance with the law. Those engaged in the eco-toxicological property testing of new chemical substances shall conduct self-examination in accordance with the relevant national good laboratory practice (GLP) series standards and the relevant standards and specifications of the Ministry of Environmental Protection on chemical testing (Guidelines for Qualified Laboratories for Chemical Testing), and make a self-declaration on whether it conforms to good laboratory practice (GLP). Institutions engaged in testing the physical and chemical properties and toxicological characteristics of new chemical substances shall comply with the regulations on the safety management of hazardous chemicals and other relevant laws and regulations and the requirements of the relevant competent departments of the state.

2. Strengthen Information Disclosure and Establish a Lifelong Responsibility System

The testing institution shall publish a self-declaration of compliance with Good Laboratory Practice (GLP) on its official website and the website of the Technical Center for Solid Waste and Chemical Management of the Ministry of Environmental Protection, and publish the following information: the name and address of the testing institution, the legal representative or the person in charge of the institution, the chemical ecotoxicology testing items that can be undertaken, the area of the laboratory, the acquisition of equipment and qualifications related to ecotoxicology testing, the overall situation (including quantity, professional title, education and specialty) of the personnel in key positions such as the research director (SD) of the testing project and the quality management personnel (QA) are subject to social supervision, it should be updated in a timely manner within 20 working days, and the testing agency is fully responsible for the authenticity and accuracy of the content of the statement.

The Solid Waste and Chemical Management Technical Center of the Ministry of Environmental Protection provides services for testing agencies to issue self-declarations free of charge on the website, and does not assume responsibility for reviewing the contents of the declarations.

All chemical testing institutions shall carry out testing work in strict accordance with the relevant national standards for chemical testing, and shall be responsible for the chemical test reports issued for life and bear legal responsibilities.

3. strengthen the audit of test data and the later supervision and management

The Ministry of Environmental Protection will strengthen the examination of the data submitted by the new chemical substance registration office and formulate a standard for the quality management of the new chemical substance registration data. Focus on testing institutions that provide ecotoxicological test data, supervise and inspect the quality of the data issued by them, the standardization and authenticity of the testing process by means of routine inspection, unannounced inspection, cause inspection and sampling verification, and make public the examination and inspection. Establish a risk supervision mechanism, and focus on reviewing and spot checking the data issued by testing institutions that are suspected of false declaration, the number of tests undertaken does not match the testing capability, and the submitted test reports do not conform to GLP specifications and the testing process or methods are in doubt; Test reports that have serious problems such as untrue data, wrong method selection and wrong results will not be used for registration of new chemical substances. For testing institutions that provide false statements, falsify original records, falsify test results, and issue false reports, the environmental protection department shall record their untrustworthy information in their environmental credit records in accordance with regulations, and suspend until they stop accepting their test data. The compliance of testing institutions is incorporated into the environmental credit information system, and the relevant information is made public.

This announcement shall be implemented as of April 1, 2017. If the documents previously issued are inconsistent with the provisions of this announcement, this announcement shall prevail. Notice of the General Office of the Ministry of Environmental Protection on Printing and Distributing the Measures for the Administration of Qualified Laboratories for Chemical Testing (HB [2012] No. 7), Announcement on Publishing the List of Qualified Laboratories for Chemical Testing (Ministry of Environmental Protection Announcement No. 77 of 2012), Announcement on Publishing the List of Qualified Laboratories for Chemical Testing (Ministry of Environmental Protection Announcement No. 5 of 2014), Announcement on Publishing the List of Qualified Laboratories for Chemical Testing (Environmental ministry of Protection Announcement No. 4 of 2015) shall be abolished at the same time.

Ministry of Environmental Protection

December 28, 2016

Issued by the General Office of the Ministry of Environmental Protection on December 29, 2016

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