1. China Exempts Animal Testing for Imported General Cosmetics
On Mar. 4, 2021, China National Medical Products Administration (NMPA) released the finalized Provisions for Management of Cosmetic Registration and Notification Dossiers. As per the finalized regulation, imported general cosmetics were exempt from animal testing from May 1, 2021. It should be noted that there are two preconditions and three exceptions for the animal testing exemption. [Read More]
Only by fulfilling both of the following two conditions can companies of general cosmetics apply for the exemption of animal testing:
1. General cosmetic manufacturers have obtained the GMP certificate issued by the government of the country (region) where they are located; (click here to find the countries where the local government can issue a GMP certificate)
2. The safety assessment results can fully prove the safety of products.
As long as one of the following three conditions applies, companies are still required to conduct animal testing:
1. Products for infants/children;
2. Products using new cosmetic ingredient during their 3-year monitoring period;
3. The notifier/RP/manufacturer is listed as a key supervision target according to the results of the quantitative rating system established by NMPA.
2. China Releases the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC 2021)
On April 30, 2021, China NMPA finalized the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC 2021), which came into force on May 1, 2021. IECIC 2021 is a list of ingredients that have already been used in cosmetics manufactured and sold in China. All ingredients excluded from the list are deemed as "new cosmetic ingredients (NCI)" and subject to mandatory pre-market registration or notification with the NMPA.
The key highlights of IECIC 2021 are:
Increasing the total number of existing cosmetic ingredients from the original 8783 to 8972;
Adding cosmetic ingredients’ highest historical use concentration as one of the references for cosmetic safety assessment;
Adding the notes related to ingredient safety reviews. [Read More]
3. China Conditionally Accepts Data Derived from Animal Testing Alternative Method for NCI Registration/Notification
On May 1, 2021, China NMPA implemented the finalized Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers. As per the finalized regulation, data derived from animal testing alternative method can be conditionally accepted for NCI registration/notification. If the animal testing alternative method (not included in the Safety and Technical Standards for Cosmetics but is validated by an international authoritative alternative method validation agency) is used for toxicological tests for NCI, the evidence proving that the method can accurately predict the toxicological endpoint should be submitted. [Read More]
4. China Finalizes the Requirements for Cosmetic Labeling
On Jun. 3, 2021, China NMPA released the finalized Administrative Measures on Cosmetics Labeling, spelling out the requirements and prohibited claims of cosmetics labeling under China’s new cosmetic regulations. The Measures is scheduled to be implemented on May 1, 2022. The most significant change relates to the full ingredient listing. Ingredients with content more than 0.1% (w/w) shall be listed in descending order, while ingredients less than 0.1% (w/w) shall be labeled separately under "other trace ingredients." [Read More]
5. China Implements the Finalized Administrative Measures on Cosmetics Registration and Notification
On May 1, 2021, China implemented the finalized Administrative Measures on Cosmetics Registration and Notification. The Measures clarified the basic requirements for the registration and notification management of cosmetic products and new cosmetic ingredients, including some new concepts, patent protection for the new ingredients, ingredient traceability management, annual report, etc. [Read More]
6. China Implements Amended Cosmetic Prohibited Ingredient Inventories: 24 Newly Prohibited Ingredients Including Cannabidiol (CBD)
On May 28, 2021, China NMPA released and implemented the finalized Inventory of Prohibited Ingredients for Cosmetics and Inventory of Prohibited Plant (Animal) Ingredients for Cosmetics. Starting from May 28, 2021, cosmetic registrants and notifiers are not allowed to produce or import products containing prohibited ingredients stipulated in the new inventories.
The key highlights of the new inventories are:
There are a total of 1,393 prohibited ingredients;
24 new prohibited cosmetic ingredients have been added to the two inventories, including CBD and three Cannabis Sativa derived ingredients;
The product information of some prohibited ingredients has been revised;
Some prohibited drug ingredients have been re-categorized into Anti-infectives, Antihistamines, Hormones, and Adrenergic Agents.
For cosmetics containing newly prohibited ingredients, it is not mandatory to cancel the registration/notification. The original registration or notification number can be retained after the formula is changed, and the prohibited ingredients are replaced or deleted. [Read More]
7. China Details Cosmetic Safety Assessment Requirements
On May 1, 2021, China implemented the finalized Technical Guidelines for Cosmetic Safety Assessment. The finalized Guidelines clarified the detailed requirements for conducting safety assessment, requirements for safety assessors, and necessary content in the assessment report. It also attached corresponding samples and set transitional measures. Starting from Jan. 1, 2022, cosmetic registrants and notifiers shall conduct cosmetic safety assessments in accordance with the Guidelines and submit product safety assessment documents when applying for special cosmetics registration or general cosmetics notification. [Read More]
8. China to Implement the First Children Cosmetics Regulation in 2022
On Oct. 8, 2021, China NMPA promulgated the finalized Supervision and Administration Provisions on Children Cosmetics. The finalized Provisions clarified children cosmetics’ scope, formula design principles, labeling requirements, registrant/notifier’s main responsibilities, post-market supervision requirements, etc. According to the Provisions, children cosmetics are not allowed to use functional ingredients for freckle-removing, whitening, anti-acne, depilating, deodorant, anti-dandruff, anti-hair loss, hair dyeing, and hair perming agents. In addition, children cosmetics should be labeled with the logo designated by NMPA on the upper left corner of one of the easily-observed display panels of the sales package.
Except for labeling requirements, other requirements in the finalized Provisions will come into force on Jan. 1, 2022. [Read More]
Children Cosmetics Logo
9. China Finalizes Standards for Cosmetic Efficacy Claim Evaluation
China NMPA officially released the finalized Standards for Cosmetic Efficacy Claim Evaluationon Apr. 9 and implemented it on May 1, 2021. The standards stipulated that 20 kinds of efficacy claims such as anti-hair loss and sunscreen require efficacy evaluation. The efficacy evaluation basis can be 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 online at the time of registration or notification. [Read More]
Starting from May 1, 2021, China implemented a notification system for low-risk NCI. As long as companies complete the submission of dossiers online, their NCI are considered as “notified” and can be added to cosmetic products. Up to now, the notification information of six NCI have been publicized, four are from Chinese companies, and two are from overseas companies. They are:
β-Alanyl Hydroxyprolyldiaminobutyroyl Benzylamide
Tissue Culture of Saussurea Involucrata
Sodium Lauroyl Methyl Isethionate [Read More]