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FAQs Vol. 15 | NMPA Further Clarifies the Requirements for Conducting Self-testing on Low-risk General Cosmetics

This January, National Medical Products Administration (NMPA) issued a notice allowing notifiers or entrusted manufacturers of Chinese domestic low-risk general cosmetics to conduct self-testing when applying for notification. On March 30, 2023, NMPA released several FAQs to further clarify the requirements for conducting the self-testing and submitting the testing reports.
1. For cosmetic notifiers or entrusted manufacturers who intend to conduct the self-testing, what prerequisites shall they meet? 

Cosmetic notifiers or entrusted manufacturers carrying out self-testing shall:

  • Have a cosmetic production license in accordance with the law;

  • Possess corresponding testing capabilities, as well as be equipped with testing personnel, equipment, facilities, and site environment that meet testing requirements;

  • Undertake the management of testing samples as required, and incorporate the self-testing work into the cosmetics quality management system;

  • Develop and implement the testing and laboratory management systems, strictly control the testing process, and compile self-testing reports based on the testing results. 

2. How should qualified notifiers or entrusted manufacturers carry out the self-testing?

For cosmetics manufactured independently, cosmetic notifiers shall carry out the self-testing and issue a testing report, while for cosmetics subject to entrusted production, entrusted manufacturers are responsible for conducting the self-testing and compiling the report.

If the self-testing conducted by notifiers or entrusted manufacturers cannot cover all the testing items stipulated in the regulations, the notifiers or entrusted manufacturers are allowed to only carry out the self-testing on part of the items within their capability, and compile the corresponding report. For items that cannot be tested, in accordance with the Working Rules for Cosmetic Registration and Notification Testing (the Working Rules), a qualified testing institution can be entrusted to conduct the testing and issue a report. The samples sent for testing shall meet the requirements for notification testing, and be from the same batch as the self-testing samples. 

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3. How should notifiers or entrusted manufacturers make the statement that proves their testing capabilities?

When applying for notification, cosmetic notifiers or entrusted manufacturers who carry out the self-testing are required to submit a statement that proves the corresponding testing capabilities stipulated in the Working Rules for cosmetics notification testing.

Specifically, notifiers or entrusted manufacturers shall take item-by-item inspections on their self-testing capabilities following relevant requirements on cosmetics production and testing management. A statement can be attached to the self-testing report only after the testing capabilities pass all the inspections. Based on the actual inspections, the statement shall include a summary of the testing capabilities in terms of the testing personnel, equipment, facilities and site environment, as well as the commitment of being responsible for the authenticity and accuracy of the testing report. 

4. What are the requirements for the format and contents of the self-testing report? 

If the notification testing is carried out by self-testing, cosmetic notifiers or the entrusted manufacturers shall conduct the testing in accordance with relevant technical requirements, such as Safety and Technical Standards for Cosmetics (STSC). The self-testing report shall be issued and stamped by the notifiers or entrusted manufacturers that carry out the testing. Regarding the format, the testing report format presented in the Working Rules can be the reference. As for its contents, the report shall contain accurate and traceable results comprehensively, at least including the following: 

Report numberTesting's completion date
Sample nameTesting items
Sample quantity and specificationTesting basis
Sample's manufacturing date or batch number Testing results
Sample's color and formTesting conclusion
Sample's shelf life or expiry date

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