Certification and Registration
Registration and Filing of New Cosmetic Ingredients in China
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Registration and Filing of New Cosmetic Ingredients in China
Registration and Filing of New Cosmetic Ingredients in China
In recent years, innovation within China’s cosmetics industry has continued to accelerate, with an increasing number of novel ingredients, technologies, and functional formulations entering the market. However, following the implementation of the Regulations on the Supervision and Administration of Cosmetics and the Regulations on the Management of Cosmetic Registration and Filing Materials, requirements for the registration and filing of new cosmetic ingredients have become significantly more stringent.
For example, when a domestic brand developed an essence product marketed for “sensitive skin soothing,” additional safety evaluations, including skin irritation and skin sensitization tests, were required due to insufficient toxicological data available for the new ingredient. This resulted in a six-month delay before product launch. This case demonstrates that the safety evaluation and regulatory compliance of new cosmetic ingredients have become critical factors influencing cosmetic innovation and product development.
Requirements for the Management of New Cosmetic Ingredients in China
Definition of New Cosmetic Ingredients：New cosmetic ingredients refer to natural or synthetic ingredients that are used for the first time in cosmetic products within the territory of China.If a raw material is already included in the Inventory of Existing Cosmetic Ingredients in China (IECIC) and its intended use remains unchanged, additional registration or filing is generally not required.
The regulatory management system for new cosmetic ingredients mainly includes two pathways:Registration and Filing
Registration:New cosmetic ingredients with functions such as preservation, sun protection, coloring, hair dyeing, or whitening and spot-removing must complete registration with the National Medical Products Administration (NMPA) before use.
Filing:Other new cosmetic ingredients must complete filing with the NMPA before being used in cosmetic products.
Classification of New Cosmetic Ingredients and Types of Submission
|
Scenario |
Detailed Description |
Declaration Type |
|
Scenario 1 |
New cosmetic ingredients used for the first time domestically and internationally, with functions including preservation, sun protection, coloring, hair dyeing, whitening and spot-removing, hair loss prevention, acne treatment, anti-wrinkle (excluding physical anti-wrinkle effects), dandruff control, deodorization, or other new ingredients with high biological activity used for the first time domestically and internationally. |
New Ingredient Registration (for preservative, sunscreen, colorant, hair dye, and whitening/spot-removing functions) |
|
Scenario 2 |
New ingredients used for the first time domestically or internationally without functions including preservation, sun protection, coloring, hair dyeing, whitening and spot-removing, hair loss prevention, acne treatment, anti-wrinkle (excluding physical anti-wrinkle effects), dandruff control, or deodorization. |
New Ingredient Filing (Other Functions) |
|
Scenario 3 |
New ingredients without functions such as preservation, sun protection, coloring, hair dyeing, whitening and spot-removing, hair loss prevention, acne treatment, anti-wrinkle (excluding physical anti-wrinkle effects), dandruff control, or deodorization, with sufficient evidence demonstrating at least three years of safe use history in overseas cosmetic products. |
New Ingredient Filing |
|
Scenario 4 |
New ingredients with functions including preservation, sun protection, coloring, hair dyeing, whitening and spot-removing, hair loss prevention, acne treatment, anti-wrinkle (excluding physical anti-wrinkle effects), dandruff control, or deodorization, with sufficient evidence demonstrating at least three years of safe use history in overseas cosmetic products. |
New Ingredient Registration (preservative, sunscreen, colorant, hair dye, whitening/spot-removing functions) / New Ingredient Filing (other functions) |
|
Scenario 5 |
New cosmetic ingredients with a history of safe food use (the part used in cosmetics must correspond to the edible part). |
New Ingredient Filing |
|
Scenario 6 |
Chemically synthesized polymers consisting of one or more structural units linked by covalent bonds, with an average molecular weight exceeding 1,000 daltons and low molecular weight oligomer content below 10% (relative molecular weight below 1,000 daltons), with stable structures and properties (excluding highly biologically active raw materials). |
New Ingredient Filing |
Requirements for New Cosmetic Ingredient Documentation
|
Data Category |
Specific content item |
|
I. Basic Information |
1. Registration or Filing of Raw Material Information Form |
|
II. Development Report |
4. Raw Material Usage Information |
|
III. Manufacturing Process and Quality Control Standards |
7. Brief Description of the Preparation Process |
|
IV. Safety Assessment |
11. Review of Toxicological Safety Assessment |
|
V. Other Materials |
25. Technical Requirements for New Raw Materials |
Testing Items for Registration and Filing of New Cosmetic Ingredients
The main testing categories include the following:
(1) Physicochemical Parameter Testing
Appearance, odor, pH value, solubility, specific gravity, and refractive index
Stability, thermal stability, heavy metal content, and impurity levels
Microbial Limit Test
(2) Toxicological Safety Testing
Acute Skin Irritation/Corrosion Test
Skin Sensitization Test (Patch Test, LLNA)
Acute Oral Toxicity Test
Phototoxicity and Photoallergy Tests
Genotoxicity Tests (Ames Test, Chromosomal Aberration Test, Micronucleus Test)
Subchronic Toxicity and Dermal Absorption Studies
(3) Efficacy Verification Testing
Sunscreen Ingredients: UV absorption spectrum analysis, SPF/UVA protection efficacy testing
Whitening Ingredients: Tyrosinase inhibition assay, melanin synthesis inhibition assay
Anti-Hair Loss Ingredients: Hair follicle cell viability testing, keratin expression analysis, and other related evaluations
Registration and Filing Procedures for New Cosmetic Ingredients in China
The registration and filing process for new cosmetic ingredients generally consists of six stages:
1. Document Preparation (Approximately 1–2 Months)
Determine the category of the new ingredient and corresponding submission requirements. Prepare documentation related to physicochemical properties, toxicological studies, stability evaluation, and safety assessment.
2. NMPA System Submission
Submit the required documents through the Cosmetic Registration and Filing Information Management Platform.
3. Formal Review (5–10 Working Days)
The submitted documents are reviewed to confirm completeness and compliance with formatting requirements.
4. Technical Review (Approximately 90 Working Days)
Technical experts conduct document evaluation and safety risk assessment.
5. Approval or Filing Completion
Registered ingredients may only be used after approval is granted. Ingredients subject to filing requirements will receive a filing number after successful submission.
6. Post-Market Safety Monitoring (Years 1–3)
Companies are required to submit annual safety-use reports and continuously evaluate raw material safety risks.
SATISFY specializes in cosmetic testing and regulatory compliance services. Our expertise covers major global markets, including the United States, Canada, the European Union, Australia, ASEAN countries, and China. We provide customized efficacy assessments, regulatory consulting, safety evaluations, and testing solutions tailored to the requirements of different countries and regions. For more information, please contact SATISFY customer service for professional guidance and comprehensive testing and certification support.
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