How to Register Whitening and Spot-Removing Cosmetics in China？
Introduction
Whitening and spot-removing cosmetics remain among the most in-demand product categories in the beauty and skincare industry in China and across Asia, where consumers prioritize even skin tone, radiance, and the reduction of dark spots or hyperpigmentation. The approval of the new whitening agent, Isobutylamido Thiazolyl Resorcinol (Trademark™: Thiamidol 630), has drawn significant attention within the industry. This marks an advancement in cosmetic ingredient regulation and provides new options for whitening and spot-removal products.
Under China’s Cosmetics Supervision and Administration Regulation (CSAR), whitening and spot-removing cosmetics are classified as special cosmetics due to their higher associated risks. As such, they must be registered with the National Medical Products Administration (NMPA) before production and sale.
In this article, we break down the key definitions, registration procedures, testing requirements, and expert considerations for whitening cosmetic product approval in China.
Definition of Whitening and Spot-Removing Cosmetics
China currently does not maintain a formal list of approved whitening agents. Instead, a product’s classification depends primarily on its functional claims and actual effects.
According to the Cosmetic Classification Rules and Categories:
- Whitening and spot-removal refers to reducing or inhibiting skin pigmentation to achieve a whitening effect.
- It also includes cosmetic effects like covering skin imperfections to give a whitening appearance.
- This includes products that improve post-inflammatory hyperpigmentation, such as acne marks. Products that reduce post-inflammatory hyperpigmentation(e.g., acne marks) are also included.
However, per the Draft Guidelines on Whitening and Spot-Removing Special Cosmetics, products that enhance skin brightness by hydration, exfoliation, or cleansing are not considered whitening cosmetics. Additionally:
- Sunscreen products without active whitening agents cannot claim a whitening effect.
- They may only claim to reduce UV-induced darkening or pigmentation.
Registration Process and Timeline Considerations
- Prepare quality management system documents and apply for user permissions.
- User permissions activation.
- Online submission via NMPA system, send for inspection.
- 4–6 months → Inspection passed.
- Organize documentation and prepare application materials.
- Submit application materials.
- Approved: Proceed to next step.
- Not approved: Modify/supplement materials and resubmit.
- 5 working days: Formal review.
- Approved: Proceed to next step.
- Not approved: Modify/supplement materials and resubmit.
- 90 working days: Technical review.
- Approved: Proceed to next step.
- Not approved: Modify/supplement materials and resubmit.
- 10 working days: Prepare and obtain electronic approval document.
- Compliance with NMPA regulations:
- Compliant: Proceed to production, market launch, and sales.
- Non-compliant: Provide modification suggestions.
Key Checkpoints:
- If rejected at any stage, revise materials based on feedback and resubmit.
- Final compliance ensures approval for manufacturing and commercialization.
Registration Testing Requirements for Whitening and Spot-Removing Cosmetic Products
1. Skin Patch Tests:
If irritation or ambiguous results occur, a repeat open application test should be conducted.
2. Human Safety Evaluation for Rinse-off Products:
Whitening products intended for rinse-off applications must undergo human use safety evaluations.
3. Preliminary Testing Requirements:
- Before conducting human safety and efficacy evaluations, microbiological, physicochemical, and toxicological tests must be completed.
- If a product fails these tests, it cannot proceed to human trials.
Key Points for Successful Cosmetics Registration in China
1. Listing of Active Ingredients
The formula must clearly contain recognized whitening or spot-removing agents. If a composite ingredient is used, the specific active component must be indicated in the intended use section.
2. Specification of Control Indicators
For non-single-component ingredients, such as Glycyrrhiza Glabra (Licorice) Root Extract, safety documentation should include quantitative indicators that ensure consistent ingredient quality, safety, and efficacy.
3. Choosing Well-Recognized Ingredients
If the formula contains less common whitening agents, companies must provide:
- Mechanism of action for skin whitening.
- Scientific evidence demonstrating whitening efficacy under intended formulation conditions.
Evidence should be obtained using:
- Tests outlined in the Cosmetics Safety Technical Specification (2015).
- If alternative methods are used, they must be scientifically validated against official test methods.
Since China does not yet have an official whitening agent list, using widely accepted ingredients can significantly improve the chances of registration approval.
4. Safety Assessment Considerations
- Simplified safety assessments cannot rely on IECIC-listed ingredient usage limits.
- Full safety evaluations must be based on toxicological and usage history data, rather than previously marketed product information.
Conclusion
Registering a whitening or spot-removing cosmetic product in China is a highly regulated process that requires in-depth knowledge of CSAR guidelines and NMPA procedures. Success hinges on:
- Accurate product classification
- Validated ingredient selection
- Comprehensive safety testing
- Timely preparation and submission of compliance documentation
By staying informed on the latest regulatory updates and ensuring scientific rigor in product development, brands can efficiently navigate the NMPA registration process and launch whitening products in China with confidence.
