On 29 December 2016, the Ministry of Environmental Protection (MEP) announced to annul the name list of testing institutions qualified for chemical tests for new chemical substance notification from 1 April 2017.
Meanwhile, MEP will no longer launch appraisal for chemical testing institutions and announce the qualified institutions at the same time.
Based on the Guidance Document of Chinese New Chemical Substance Registration, all the domestic testing organizations must accept and pass the review from MEP. They shall also fulfill relevant requirements. That is to say, testing institutions providing eco-toxicology tests must be those announced by MEP and testing institutions providing physicochemical and health toxicological tests must gain specific qualifications. Since 2009, MEP has carried out review for laboratories applying for providing eco-toxicological tests for several times. Currently, a total of 13 domestic testing institutions can conduct eco-toxicological tests required by new chemical substance notification.
However, MEP now no longer reviews chemical testing institutions and announces qualified institutions. In accordance with MEP, testing institutions must fulfill the following requirements after the Announcement comes into force:
- Testing institutions shall gain the China Metrology Accreditation (CMA) certifications;
- Testing institutions having the intention to carry out eco-toxicological tests shall make self-declarations on whether they are in compliance with Good Laboratory Practice (GLP);
- Testing institutions carrying out physicochemical and toxicological tests shall be in compliance with the requirements of Regulation on Safe Management of Hazardous Chemicals in China and other regulations.
MEP requires testing institutions to strengthen information disclosure. The self-declaration of the testing institution shall be published in the official website of the testing institution as well as the MEPSCC website. The detailed information of the testing institution shall also be published for social supervision. The testing institutions shall be responsibility for the accuracy and authenticity of the declaration. Besides, all the testing institutions are also responsible for the test reports issued by them and bear the legal responsibility.
MEP will also tighten up its review on the data for new chemical substance notification. MEP will supervise the testing institutions, especially the testing institutions providing eco-toxicological data. Testing reports with severe problems such as false data, mistaken testing methods and false results will not be accepted for new chemical substance notification in China. What is worse, MEP may stop accepting test data provided by testing institutions providing false declaration, forging test results and issuing false test reports. The credit information of the testing institutions will be recorded and made public.
CIRS warmly reminds that enterprises applying for new chemical substance registration should pay attention to the self-declaration made by the testing institutions as well as detailed information of the testing institutions. Additionally, although enterprises can have more choices about the testing institutions, careful considerations must also be given to the selection of testing institutions. To avoid notification failure arising from defective test data, enterprises should better choose qualified testing institutions with good reputations and strictly check the test method, data records, quality control as well as the judgment of results.
CIRS suggests that when choosing testing institutions for physicochemical and health toxicological tests, enterprises should particularly pay attention to qualifications acquired by the testing institution and the examination situation. As the State Administration of Work Safety just announced 11 institutions for the appraisal of physical risks of chemicals, enterprises may choose one of the 11 laboratories for physiochemical tests (detailed information of the 11 laboratories can be found here).
CIRS also learns that the amended Guidance will not include the qualification requirements for testing institutions. As a result, enterprises that have already entrusted qualified testing institutions to carry out physicochemical, eco-toxicological and health toxicological test will not be affected by the Announcement.