On 10.09.2019, the NMPA (National Medical Products Administration) announced changes to the procedures regarding cosmetics sample tests in China (No. 72-2019), followed by an interpretation of their announcement on 12.09.2019. Laboratories – that perform sample tests for cosmetics NMPA approval – need to re-apply for their qualification as a testing institutions because the relevant qualification will be automatically suspended on 01.11.2019. Until then – during the transitional period – there are two possible methods for managing tests. Cosmetics enterprises can follow the original procedures offline, as well as apply for sample tests online. Starting on 01.11.2019, however, laboratories have to be newly accredited. Furthermore, cosmetics enterprises and their NMPA Legal Agents will only be able to apply for and manage tests, which are related to cosmetics registration/filing, online.
1) The goal is to improve the testing workflow, to standardize the test project requirements, to improve the efficiency of tests, and to provide strong technical support for cosmetics safety supervision.
2) The prerequisite for testing institutions is to submit relevant information and obtain a new certification from the CMA (China Inspection Body and Laboratory Mandatory Approval).
3) New guidelines for testing institutions include that testing must not be subcontracted, quality management system has to be ensured, testing work procedures for cosmetics registration and documentations have to be standardized, the facilities and equipment have to meet requirements.
4) In order to improve work efficiency, an “Inspection Information System” was introduced to optimize the workflow of testing institutions. Via the online system, cosmetics manufacturers select a testing institution, submit relevant product information and apply for testing. The testing institution can then accept the test application and issues the test report online after testing.
5) Changes in managing test samples include:
Firstly, rather than regulatory authorities performing the on-site test sample sealing, the testing insitution seals the test samples. This change only applies to domestic “special” cosmetics.
Secondly, laboratories accept samples produced for the purpose of testing if the product is not sold yet. (Please note, however, that the NMPA requires a product to be already sold in the country of origin.)
6) The test requirements are changed to emphasize the safety of products during evaluation and some test items will be adjusted to better reflect the safety situation of products; for instance, by measuring dioxane.
7) During the transition period – until 31.10.2019:
Firstly, testing institutions should apply for their qualification because on 1 November, the old ones will be terminated.
Secondly, already approved cosmetics, whose tests do not comply with the new specifications anymore, have to undergo supplementary testing a year of the announcement.
Third, cosmetics manufacturers can follow the old (offline) way of applying for and managing tests, as well as the new “online” way.