In the dynamic landscape of China’s cosmetics industry, understanding and adhering to the guidelines for efficacy claims and evaluation requirements is crucial for global cosmetic companies. This article provides a comprehensive overview of these regulations, helping regulatory professionals navigate the complexities of the Chinese market.

Key Components of the Guidelines

1. Regulatory Framework

The cornerstone of cosmetic regulation in China is the Cosmetic Supervision and Administration Regulation (CSAR), which came into effect on January 1, 2021. This comprehensive framework sets the stage for all aspects of cosmetic product management, including efficacy claims. Additionally, two specific regulations related to cosmetics efficacy claim management are in place: “China Cosmetic classification rules and categories” and “Specification for evaluation of cosmetic efficacy claims,” which specify how to classify claims based on efficacy mechanism and evaluation methods.

Key points:

• CSAR emphasizes the responsibility of registrants and filers for product efficacy claims, and the two efficacy regulations specify detailed management measures on efficacy classification and evaluation.
• The National Medical Products Administration (NMPA), State Administration for Market Regulation (SAMR), and China Customs collectively play crucial roles in enforcing these regulations and monitoring compliance.

2. Understanding Efficacy Claims

Efficacy claims in the Chinese context are a delicate balance between objective product efficiencies and subjective marketing descriptions.

• Objective Efficacy: Determined by the product’s formula, manufacturing process, and selected ingredients
• Subjective Claims: Descriptions provided by companies to highlight product benefits

The same efficacy can evoke vastly different impressions due to the different words used in the description. A well-crafted claim may create a compelling selling point that attracts marketing attention. It’s crucial to ensure that claims accurately reflect the product’s capabilities without misrepresentation or exaggeration. Claims must have a scope and should revolve around the objective efficacy; they cannot misrepresent or exaggerate facts.

3. Types of Efficacy Claims

The Chinese regulatory framework recognizes various categories of efficacy claims:

• Direct Effects: Immediate physical covering, visible results (e.g., make-up, cleansing)
• Non-Direct Effects: Biological reactions on skin surface or less visible benefits (e.g., anti-aging, skin brightening)
• Quantitative Effects: Claims for specific skin types or time-reference conditions (e.g., sensitive skin, tear-free formulas, efficacy of specific raw material or time-reference such as 8-hour moisturize)

Understanding these categories is essential for accurate product positioning and compliance.

4. Evaluation Standards for Efficacy Claims

Different categories of products have different evaluation requirements. For visible effects such as makeup, hair dyes, cleansers, and physical coverings, the summary of the basis for product efficacy claims can be exempted from publication; for non-visible effects, corresponding evaluation requirements are specified based on the characteristics of the effects.

The “Specification for evaluation of cosmetic efficacy claims” and “China Cosmetic classification rules and categories” provide a robust framework for validating product claims. These standards recognize four types of scientific basis:

1. Literature and Research Data: Peer-reviewed scientific publications and authoritative textbooks; Internal studies and data collected during product development
2. Lab Test Results: Outcomes from specific efficacy claim evaluations
3. Consumer use test: Questionnaire designed and collected from consumer volunteers
4. Human efficacy evaluation trials: Clinical trial test conducted on volunteers

Many claims must be substantiated by efficacy claims testing. This includes human efficacy evaluation trials, consumer use tests, and laboratory tests.

5. Product-Specific Requirements

Different product types have varying evaluation requirements:

• Direct Effects: May be exempt from publishing efficacy claim summaries
• Non-Direct Effects: Require more rigorous evaluation and documentation
• Quantitative Effects: Often need specific testing protocols and evidence

For special claims with high requirements for evidence, such as spot removal, whitening, hair loss prevention, and sun protection, human efficacy evaluation tests are required.

6. Raw Material Claims

When making claims based on raw materials:

• Ensure a clear relationship between the raw material’s efficacy and the final product’s performance
• Provide evidence that the raw material is present in sufficient quantities to deliver the claimed benefits
• Conduct literature reviews, research data analysis, or efficacy claim evaluation tests to verify that the raw material has the claimed effects

For example, if a product is named “Collagen Daily Cream”, it should provide evidence that collagen possesses all the claimed benefits of the product.

7. New Efficacy Claims

New efficacy claims are defined as those that do not conform to the approved 26 efficacy classification rules. Examples include anti-blue light, anti-smog, antioxidant, and acid-base balance claims. It’s important to note that new efficacy claims may involve a risk of animal testing. We strongly advise consulting with regulatory experts before venturing into registering products with new, innovative claims.

Compliance Strategies

1. Documentation and Evidence

Maintaining robust records is crucial:

• Keep comprehensive efficacy evaluation records
• Prepare clear, concise summaries for regulatory submission
• Ensure all documentation is readily available for inspection

2. Risk Management

Proactive risk management is key to success in the Chinese market:

• Regularly assess potential compliance issues
• Develop strategies to mitigate regulatory risks
• Stay informed about changing regulatory landscapes

3. Staying Updated

The regulatory environment in China is dynamic. To stay compliant:

• Monitor regulatory changes closely
• Invest in ongoing education and training for your team
• Engage with regulatory experts for the latest insights

Conclusion

Navigating China’s guidelines for cosmetic efficacy claims and evaluation requirements demands expertise, attention to detail, and a commitment to compliance. By understanding these regulations and implementing robust compliance strategies, companies can confidently introduce products that meet both regulatory requirements and consumer expectations.

For personalized guidance on specific products or claims, including assistance with efficacy claims testing and development of testing protocols, it’s advisable to consult with regulatory experts who specialize in the Chinese cosmetics market.