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China Formally Implements A Brand-new Cosmetic and New Cosmetic Ingredients Pre-market Approval System on May 1

Assorting with the enforcement of Cosmetic Supervision and Administration Regulation, China formally implements a brand-new cosmetic and new cosmetic ingredients pre-market approval system by putting seven crucial regulations into effect on May 1, 2021. Starting from the date, companies shall submit their application dossiers for cosmetic and new cosmetic ingredient registration and notification in accordance with the seven regulations.

Regulations Entering into Force on May 1

No.

Regulations

Brief Introduction

Further Reading

1

Administrative Measures on Cosmetics Registration and Notification

 

The regulation is primarily designed to specify the basic requirements for the administration of cosmetic and new cosmetic ingredient pre-market approval, such as the procedures of registration and notification, the obligations of registrants and notifiers, etc.

2

Provisions for Management of Cosmetic Registration and Notification Dossiers

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

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

The regulation specifies that a coding system will be adopted for the classification of cosmetics. The system has five layers: efficacy claim, application area, target user, dosage form, and application method.

5

Standards for Cosmetic Efficacy Claim Evaluation

The regulation clarifies the efficacy claims, which require efficacy evaluation, and lists requirements for evaluation test methods and report, evaluation institutions and evaluation abstracts.

6

Technical Guidelines for Cosmetic Safety Assessment 2021

The regulation clarifies the detailed requirements for conducting safety assessment, qualification for safety assessor, and content necessary in the assessment report.  Sample assessment report is attached in the appendix.

7

Inventory of Existing Cosmetic Ingredients in China 2021

The IECIC 2021 includes a total number of 8972 existing cosmetic ingredients in China.

Transitional Measures at a Glance

Timing

Obligations

Targets

Measures

After May 1, 2021

New registration or notification

Cosmetics/new cosmetic ingredients to be registered or notified

Applicants shall submit new applications through a new online platform (http://zwfw.nmpa.gov.cn).

Special cosmetics with applications submitted on the previous online platform but without gaining review decision will continue to be reviewed on the previous online platform.

Cosmetic classification code

Cosmetics to be registered or notified

Applicants shall submit the product classification code in accordance with the Cosmetic Classification Rules and Catalogs.

Ingredient submission code

Cosmetics to be registered or notified

Applicants shall submit the source of formula ingredients and the product name information.

For ingredients with quality specifications in the Safety and Technical Standards for Cosmetics 2015, their quality specification certificates or safety-related information shall be submitted.

Animal testing exemption / Safety assessment

General cosmetics to be notified

Applicants can apply for animal testing exemption in accordance with the Provisions for Management of Cosmetic Registration and Notification Dossiers.

For such applications submitted from May 1, 2021 to Dec. 31, 2021, the applicants can submit a simplified version of safety assessment report in accordance with the Technical Guidelines for Cosmetic Safety Assessment 2021.

After Jan. 1, 2022

Ingredient submission code

Cosmetics to be registered or notified

Applicants shall provide safety-related information of preservatives, sunscreens, colorants, hair dyes, freckle removing and whitening ingredients in accordance with the Provisions for Management of Cosmetic Registration and Notification Dossiers.

Annual reporting of general cosmetics

General cosmetics notified on both the new and previous online platforms

Applicants shall submit annual reports of general cosmetics on record over one year through the new online platform from January 1 to March 31 of each year.

Efficacy claim evaluation

Cosmetics to be registered or notified

Applicants shall carry out the efficacy claim evaluation in accordance with the Standards for Cosmetic Efficacy Claim Evaluation, and upload the abstract of the proof materials for product efficacy claim on the website designated by NMPA.

Freckle removing/whitening and anti-hair loss cosmetics to be registered

Applicants shall submit the human trial report in accordance with the Standards for Cosmetic Efficacy Claim Evaluation.

Safety assessment

Cosmetics to be registered or notified

Applicants can submit a simplified version of product safety assessment report in accordance with Technical Guidelines for Cosmetic Safety Assessment 2021.

Before May 1, 2022

Document supplementation

Cosmetics registered and notified on the previous platform

Applicants shall supplement the product executive standards and product label samples, fill in the product formula of domestic general cosmetics, and upload the label picture of the special cosmetics’ packaging through the new online platform in accordance with the Provisions for Management of Cosmetic Registration and Notification Dossiers.

Cosmetic classification code

Cosmetics registered or notified successfully before May 1, 2021

Applicants shall submit the product classification code through the new online platform in accordance with the Cosmetic Classification Rules and Catalogs.

Efficacy claim evaluation

Cosmetics registered or notified successfully from May 1, 2021 to Dec. 31, 2021

Applicants shall carry out the efficacy claim evaluation in accordance with the Standards for Cosmetic Efficacy Claim Evaluation, and upload the abstract of the proof materials for product efficacy claim on the website designated by NMPA.

Freckle removing/whitening and anti-hair loss cosmetics registered successfully from May 1, 2021 to Dec. 31, 2021

Applicants shall supplement the human trial report in accordance with the Standards for Cosmetic Efficacy Claim Evaluation.

After Jan. 1, 2023

Ingredient submission code

Cosmetics to be registered or notified

Applicants shall provide safety-related information of all of ingredients in accordance with the Provisions for Management of Cosmetic Registration and Notification Dossiers.

Before May 1, 2023

Efficacy claim evaluation

Cosmetics registered or notified successfully before May 1, 2021

Applicants shall carry out the efficacy claim evaluation in accordance with the Standards for Cosmetic Efficacy Claim Evaluation, and upload the abstract of the proof materials for product efficacy claim on the website designated by NMPA.

Freckle removing/whitening and anti-hair loss cosmetics registered successfully before May 1, 2021

Applicants shall supplement the human trial report in accordance with the Standards for Cosmetic Efficacy Claim Evaluation.

Ingredient submission code

Cosmetics registered or notified successfully before Jan. 1, 2023

Applicants shall supplement safety-related information of all ingredients in the formula in accordance with the Provisions for Management of Cosmetic Registration and Notification Dossiers.

After May 1, 2024

Safety assessment

Cosmetics to be registered or notified

Applicants shall submit a full version of product safety assessment report in accordance with Technical Guidelines for Cosmetic Safety Assessment 2021.

Before Dec. 31 2025

Manufacture, import and sale

Hair growth products, depilating products, breast beauty products, slimming products and deodorants registered successfully before Jan. 1, 2021

Companies can continue the manufacture, import and sale of these products. Since Jan. 1, 2026, the manufacture, import and sale will be prohibited.

We provide full-scale Chinese cosmetic market entry services (including cosmetic registering & filing, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by cosmetic@chemlinked.com
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