News Details

On 26 June , 2026 China's National Medical Products Administration (NMPA) has officially released the revised Administrative Provisions for Cosmetic New Ingredient Registration, Notification, and Dossier Management, introducing updated requirements aimed at accelerating innovation in cosmetic ingredients while strengthening regulatory oversight and safety management. The new provisions will enter into force on July 15, 2026, replacing the previous 2021 requirements. 

Summary 

The revised regulatory framework issued by the National Medical Products Administration (NMPA) updates the administrative and technical requirements governing cosmetic new ingredient (NI) registration and notification in China. The amendments introduce enhanced obligations related to applicant qualification management, domestic responsible person authorization, technical dossier preparation, safety monitoring, and post-market risk control. 

The new provisions are expected to improve regulatory clarity, facilitate innovation in the cosmetics sector, and strengthen the lifecycle management of cosmetic new ingredients. 

Key Changes to China's Cosmetic New Ingredient Regulatory Framework 

The revised measures establish comprehensive requirements for cosmetic new ingredient registrants, notifiers, and domestic responsible persons. 

Enhanced Applicant Registration and User Management 

Before submitting a cosmetic new ingredient registration or notification, applicants must complete user registration through the cosmetic registration and notification information service platform by providing: 

• Applicant information;  

• An overview of the applicant's safety risk monitoring and evaluation system;  

• Authorization documents for domestic responsible persons where overseas applicants are involved.  

The regulation also allows a single domestic entity holding multiple roles to obtain corresponding user permissions through a consolidated submission process. 

Updated Requirements for Domestic Responsible Persons 

The revised provisions clarify the management responsibilities of domestic responsible persons for overseas applicants. 

Key requirements include: 

• Authorization documents must specify the names of the parties involved, scope of authorization, and authorization period;  

• A single cosmetic new ingredient may only appoint one domestic responsible person;  

• Authorization extensions must be submitted before expiration;  

• Failure to renew authorization in a timely manner may result in suspension of system access rights.  

The regulation further establishes detailed procedures for changes to domestic responsible persons and authorization scope. 

Expanded Technical Dossier Requirements 

Applicants seeking registration or notification of cosmetic new ingredients must submit comprehensive technical documentation, including: 

• Applicant and domestic responsible person information;  

• New ingredient research and development reports;  

• Manufacturing process, stability, and quality control studies;  

• Safety assessment documentation.  

In addition, applicants are required to prepare technical specifications for the cosmetic new ingredient, including: 

• Basic ingredient information;  

• Intended use;  

• Safe use concentration limits;  

• Precautions;  

• Shelf-life requirements.  

Strengthened Requirements for Safety Studies 

The revised provisions reinforce the qualification requirements for institutions conducting safety studies. 

Toxicological and human safety studies must be performed by organizations that meet one or more of the following standards: 

• Accreditation under the China Inspection Body and Laboratory Mandatory Approval (CMA) system;  

• Accreditation by the China National Accreditation Service for Conformity Assessment (CNAS);  

• Compliance with Good Clinical Practice (GCP) requirements;  

• Compliance with Good Laboratory Practice (GLP) standards.  

New Obligations for Sample Retention and Safety Monitoring 

Registrants, notifiers, and domestic responsible persons must retain samples of cosmetic new ingredients for regulatory inspection purposes. 

Sample requirements include: 

• Complete packaging and labelling;  

• Applicant information;  

• Chinese ingredient name;  

• Production date and shelf life;  

• Storage conditions.  

During the safety monitoring period, annual safety monitoring reports must be submitted through the regulatory platform within 30 working days before each annual anniversary of the monitoring period. 

These reports must include information relating to: 

• Cosmetic registrants and manufacturers using the ingredient;  

• Product registration or notification details;  

• Production, import, and sales volumes;  

• Product recalls, inspections, and investigations;  

• Adverse reaction monitoring and risk mitigation measures.  

Strengthened Risk Management and Reporting Obligations 

The revised provisions introduce clearer requirements for reporting safety risks associated with cosmetic new ingredients. 

Where safety concerns or emergency situations arise, registrants, notifiers, or domestic responsible persons must promptly submit a safety risk control report containing: 

• Basic information on the new ingredient;  

• Production, import, sales, and usage data;  

• Root cause analysis of the safety issue;  

• Corrective actions taken;  

• Final handling outcomes.  

Implementation Date 

The Administrative Provisions for Cosmetic New Ingredient Registration, Notification, and Dossier Management will take effect on July 15, 2026. 

At the same time, the previous Administrative Provisions on Cosmetic New Ingredient Registration and Notification Dossier Management issued by the National Medical Products Administration (Announcement No. 31 of 2021) will be officially repealed. 

Key Takeaways 

• Effective date: July 15, 2026;  

• Issuing authority: National Medical Products Administration;  

• Scope: Cosmetic new ingredient registration and notification management;  

• Major updates: Applicant management, domestic responsible person requirements, technical dossier requirements, safety studies, sample retention, annual monitoring, and risk reporting;  

• Objective: Promote cosmetic innovation while enhancing safety oversight and regulatory compliance in China's cosmetics industry.