On January 7, 2022, the NMPA (National Medical Products Administration) announced (No.1-2022) the measure for quality management of cosmetics production that will come into force on July 1, 2022.
The regulatory measure consists of 9 chapters and 67 articles, including general provisions, organization and personnel, quality assurance and control, plant facility and equipment management, material and product management, production process management, entrusted production management, product sales management, and supplementary provisions.
Cosmetics registrants, filing parties, and entrusted production enterprises shall manage the production of cosmetics in accordance with the following requirements as specified in the new regulatory measure:
- Enterprises that have obtained a cosmetic production license before July 1, 2022, and whose hardware conditions such as plant facilities and equipment need to be upgraded, should complete the upgrade and reconstruction before July 1, 2023.
- Establishment of the production quality management system, the control of the whole process of cosmetic material procurement, production, inspection, storage, sales and recall, as well as the traceability to ensure continuous and stable production of cosmetics that meet quality and safety requirements.
- For quality assurance and control, enterprises are required to establish and implement a traceability management system, and to formulate clear batch number management rules for raw materials, inner packaging materials, semi-finished products, and finished products. All recordkeeping related to the production of each batch of products will be the key to ensure the traceability of all activities such as material procurement, product production, quality control, storage, sales and recall.
- For product sales management, cosmetic registrants and filing parties should establish and implement a product recall management system, and implement recall work in accordance with the law. If a product is found to have quality defects or other problems that may endanger the health of the consumer, production of the product should be stopped immediately, all products in the market should be recalled, businesses with sales operation related to the product should be stopped, and all recalls and communication should be recorded. The recalled products should be clearly marked and stored separately, and measures such as remediation, harmless treatment, and destruction should be taken as appropriate.
- For entrusted production management, the entrusting party should be the registrant or filer of the cosmetics produced. The entrusted production enterprise should be an enterprise holding a valid cosmetic production license, and accept the entrustment within the scope of its production license.
By Jeff Jiang. Contact Cisema if you would like to learn more.