• Registration/Filing Plan Development;

• Prepare, Organize, and Submit Materials per Filing Regulations;

• Cosmetic Label Review;

• Provide Registration Services for Special Cosmetics;

• Agency Services for Overseas Companies;

• Assist Registrants/Filers with Cosmetic Monitoring and Reporting.

1. Definition and Background

Definition:

Cosmetics are categorized into special cosmetics and general cosmetics. Special cosmetics are subject to registration management, while general cosmetics require filing. Further classified into domestic/imported special cosmetics and domestic/imported general cosmetics.

Background:

Regulatory Drivers:

The 2021 Cosmetics Supervision and Administration Regulation implemented filing for general cosmetics and registration for special cosmetics (e.g., sunscreens, whitening products), enhancing lifecycle oversight.

Quality & Transparency:

Requires full formula disclosure and ingredient safety data to protect consumer rights.

2. Registration/Filing Scope

Applicable Products:

General Cosmetics: Non-functional products (e.g., skincare, makeup, cleansers).

Special Cosmetics: e.g., sunscreens, hair dyes.

3. Basic Requirements

Enterprise Qualifications:

Registrants/filers must be legally established with a QMS and adverse reaction monitoring capability.

Technical Documentation:

Formula: Must comply with the Inventory of Used Cosmetic Ingredients. Restricted/banned ingredients require adherence to the Cosmetic Safety Technical Standards.

Labeling & Packaging: Compliant with the Cosmetic Labeling Management Measures, including product name, full ingredients, net content, shelf life. Medical claims or unsubstantiated efficacy claims are prohibited.

Test Reports: Microbial, physicochemical, toxicology, human safety, and efficacy evaluation reports.

Safety Assessment: Evaluates health risks of ingredients using scientific data.

Production Compliance:

Manufacturers must hold a Cosmetics Production License and pass on-site audits (e.g., facilities, equipment, QMS).

4. Registration Process

1）Apply for access: Obtain user permissions via NMPA.

2）Submit materials: Log in to NMPA’s online system, upload documents, and send samples for testing.

3）Prepare dossier: After testing approval, finalize and submit to NMPA.

4）Review & approval: Certification issued upon compliance.

5. Regulatory Basis

Cosmetics Supervision and Administration Regulation

Cosmetics Registration and Filing Management Measures

Cosmetic Labeling Management Measures

Cosmetic Safety Technical Standards

Cosmetic Efficacy Claim Evaluation Guidelines