At the beginning of 2023, China National Medical Products Administration (NMPA) published an Announcement on the Optimization of the Testing for Cosmetics Notification (hereinafter referred to as the Announcement). Some questions are raised after the implementation, so the NMPA released another announcement recently in reply to the Frequently Asked Questions (FAQ). This article is the translation of the official reply to the FAQ.
1. Why is it necessary to optimize cosmetics testings required for the notification of general cosmetics?
With regard to the Measures on the Supervision and Administration of the Production and Distribution of Cosmetics and relevant regulations, cosmetics manufacturers shall establish a management system to carry out production process inspection and product release. At present, many manufacturers have established corresponding laboratories, capable of conducting testings to ensure quality and safety before products are placed on the market. Therefore, the Announcement allows notifier/entrusted manufacturers to conduct partial or all testings, which had to be conducted by third-party testing institutes previously. These testing reports can be submitted for cosmetics notification. This, on the one hand, shortens the time for products to be placed in the market. On the other hand, it drives manufacturers to increase investment in research and development, boosting inspection ability to ensure the quality and safety of cosmetic products.
2. What are the requirements for notifiers/entrusted manufacturers to be qualified to conduct testings?
Cosmetics production is a pivotal part to ensure the quality and safety of products, therefore, the Announcement stipulates that the notifiers/entrusted manufacturers shall obtain Cosmetics Production License. Additionally, they shall be equipped with qualified testing personnel, equipment, environment, and a sample management system. Self-Testings shall be included in its quality management system. Meanwhile, testing and lab management system shall be established to regulate the testing process and provide testing reports.
3. How should the notifiers/entrusted manufacturers conduct self-testing?
In order to standardize self-testing and ensure the accuracy of results, it follows the principle of those who produce products responsible for the inspection. If notifiers produce products, they shall conduct testings and provide reports; if products are entrusted to contract manufacturers, they shall conduct testing and provide reports.
For testings that can be completed by the notifiers/ entrusted manufacturers, they can conduct testings and provide reports; for testings that are beyond the capability of the notifiers/entrusted manufacturers, they can entrust the testings to qualified institutions to obtain reports. The samples for self-testing and for third-party institutions shall from the same batch.
4. What documents are required to prove the qualification to do self-testing?
In the Announcement, a statement to prove the qualification to do self-testing shall be submitted during the notification. Notifier/entrusted manufacturers shall conduct self-inspection for their capability to conduct testings. Those convinced of their qualification to conduct testings shall submit a statement to substantiate their capability. The statement shall summarize their testing capabilities in terms of inspection personnel, equipment, and environment, as well as make a commitment to the authenticity and accuracy of the testing results.
5. What is required to be included in the testing reports?
Notifiers/entrusted manufacturers shall conduct testings under the Technical Standard for Cosmetics Safety. Testing reports shall be complete and the results shall be accurate and traceable. The template can be found in the Specifications on the Testings for the Registration and Notification of Cosmetics. It shall cover: the report number, the name, quantity, production date/batch number, color, shape, shelf-life/expiration date of samples, testing date, testings (the exact names of microbiological and heavy metal testings), testing substantiation (the page number, chapter number of valid technical specifications, etc.), testing results, testing conclusion, etc. Notifier/entrusted manufacturers shall proved testing reports with stamps.
By Yingying
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