China: 11 regulations to implement the New Cosmetic Regulatory Framework

1. Administrative Measures on Cosmetics Registration and Notification Release date: 2021-01-12 – Implementation date: 2021-05-01 The regulation specifies the basic requirements for the administration of cosmetic and new cosmetic ingredient pre-market approval, such as the registration and notification procedures, the obligations of registrants and notifiers, etc. Basically, special cosmetics shall register with NMPA, while general cosmetics only require quick notification. High-risk new cosmetic ingredients require registration with NMPA and obtain approval, while low-risk new cosmetic ingredients is subject to notification.

2. Provisions for Management of Cosmetic Registration and Notification Dossiers Release date: 2021-03-04 – Implementation date: 2021-05-01 The regulation details the documentation requirements for the application, modification, renewal, and cancellation of cosmetic registration/notification. More importantly, it specifies that imported general cosmetics can be exempted from animal testing from May 1, 2021, under certain conditions.

3. Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers Release date: 2021-03-04 – Implementation date: 2021-05-01 The regulation details the requirements for registration dossiers for high-risk NCI, notification dossiers for low-risk NCI and NCI’s safety status report. In addition, it specifies that data from animal testing alternative method for NCI registration/notification can be conditionally accepted.

4. Cosmetic Classification Rules and Catalogs Release date: 2021-04-09 – Implementation date: 2021-05-01 he regulation introduced a classification coding system to subdivide all cosmetics according to their efficacy claims, application areas, target users, dosage forms, and application methods to facilitate product statistics, supervision, and determination of product subcategories. Companies shall notify or register their products based on the classification codes.

5. Standards for Cosmetic Efficacy Claim Evaluation Release date: 2021-04-09 – Implementation date: 2021-05-01 The standards stipulate that 20 kinds of efficacy claims require efficacy evaluation. The efficacy evaluation basis may include literature documents, research data, or test reports of efficacy evaluation test (including human trial, consumer use test and laboratory test). Cosmetic registrants and notifiers shall complete the efficacy evaluation and disclose the abstract of efficacy evaluation basis on the website specified by the NMPA for public view at the time of registration and notification.

6. Technical Guidelines for Cosmetic Safety Assessment 2021 Release date: 2021-04-09 – Implementation date: 2021-05-01 Starting from January 1, 2022, cosmetic registrants and notifiers are required to conduct safety assessments on their own or entrust professional institutions and submit the product safety assessment documents during registration and notification.

7. Inventory of Existing Cosmetic Ingredients in China 2021 Release date: 2021-04-30 – Implementation date: 2021-05-01 The IECIC 2021 includes a total number of 8972 existing cosmetic ingredients in China. Ingredients excluded from the IECIC are regarded as new cosmetic ingredients.

8. Inventory of Prohibited Ingredients for Cosmetics & Inventory of Prohibited Plant (Animal) Ingredients for Cosmetics Release date: 2021-05-28 – Implementation date: 2021-05-28 The two inventories list the ingredients prohibited for use in cosmetics. Cosmetic registrants and notifiers are not allowed to produce or import products containing prohibited ingredients stipulated in the new inventories.

9. Administrative Measures on Cosmetics Labeling Release date: 2021-06-03 – Implementation date: 2022-05-01 The regulation spells out the requirements for the labeling and prohibited claims of cosmetics under China’s new cosmetic regulations.

10. Supervision and Administration Provisions on Children Cosmetics (Draft for Comments) Release date: 2021-06-18 – Implementation date: Draft The regulation contains stricter requirements for children cosmetics, including the use of ingredient, safety assessment, packaging design, production and operation, registration and notification, and post-market surveillance.

11. Supervision and Administration Measures on Cosmetics Manufacture and Operation Release date: 2021-08-02 – Implementation date: 2022-01-01 The Measures refines the responsibilities of cosmetics registrants, notifiers, and entrusted production enterprises, such as establishing production quality management practices, quality and safety management systems, purchase inspection and recording systems, product sales record systems, etc.