Cosmetic Safety Risk Monitoring Measures: China’s New Regulations Take Effect July 2025

The Cosmetic Safety Risk Monitoring Measures, effective July 1, 2025, will be implemented by the National Medical Products Administration (NMPA) in China. These regulations introduce mandatory lifecycle-wide safety risk monitoring for cosmetics and outline standardized protocols for risk assessment and control. International companies must align with enhanced data reporting requirements and stricter compliance obligations, emphasizing the importance of early preparation and regulatory consultation to ensure uninterrupted market access.

Regulatory Background and Purpose

Background
In recent years, China’s cosmetics market has grown rapidly. However, with the industry’s fast development, cosmetic safety risks have become increasingly prominent. To address this, the NMPA has refined the relevant requirements for safety risk monitoring and evaluation under the “Regulations on the Supervision and Administration of Cosmetics,” issuing the “Measures for the Administration of Cosmetic Safety Risk Monitoring and Evaluation.”

Purpose
The core purpose of these measures is to establish a systematic and standardized mechanism for risk monitoring and evaluation. This aims to promptly identify, assess, and control potential safety risks in cosmetics, ensuring product safety and compliance. Specific objectives include:

• Early Warning: Detect potential risks through monitoring to prevent their escalation.
• Scientific Evaluation: Classify and manage risks based on scientific data.
• Targeted Prevention and Control: Implement differentiated preventive and control measures for different risk levels.
• Information Sharing: Promote transparency of information among regulatory authorities, enterprises, and consumers.

International Perspective

From an international perspective, the European Union, the United States, and other developed markets have long established similar risk monitoring systems. For example, the EU’s Cosmetic Products Notification Portal (CPNP) requires companies to submit product information for regulatory risk assessment. China’s newly released measures align with international practices, reflecting the internationalization trend of China’s cosmetic regulation.

Core Content Analysis

• Comprehensive Coverage: Monitoring covers the entire process of cosmetic ingredients, finished products, and their production, operation, and use.
• Focus on High-Risk Areas: Particular attention is given to:
  • New ingredients and products using new technologies;
  • Special-purpose cosmetics (e.g., sunscreen, whitening, spot removal);
  • Cosmetics sold online;
  • Products with concentrated consumer complaints or high media attention.

Risk Grading and Categorized Management

• Grading Basis: Risks are classified into three levels based on their nature, severity, and impact scope:
  • Level 1 Risks: May lead to serious health hazards or significant social impact (e.g., carcinogenic, teratogenic);
  • Level 2 Risks: May lead to moderate health hazards or localized social impact (e.g., allergic reactions, irritation);
  • Level 3 Risks: May lead to minor health hazards or individual consumer impact (e.g., labeling defects).
• Categorized Management: Differentiated measures for different risk levels:
  • Level 1 Risks: Immediate emergency response, including product recall and production suspension;
  • Level 2 Risks: Rectification within a specified period and enhanced tracking monitoring;
  • Level 3 Risks: Primarily information disclosure and consumer guidance.

Monitoring Process and Technical Requirements

• Monitoring Process:
  1. Information Collection: Gather risk information through multiple channels such as enterprise reports, consumer complaints, and public opinion monitoring;
  2. Risk Assessment: Conduct scientific assessments using expert panels or professional technical institutions;
  3. Risk Management: Implement corresponding preventive and control measures based on assessment results;
  4. Tracking and Feedback: Evaluate the effectiveness of measures to ensure risks are effectively controlled.
• Technical Requirements:
  • Data Integrity: Enterprises must submit complete information, including ingredient sources, production processes, and quality standards;
  • Testing Methods: Use testing methods that comply with national standards to ensure data accuracy and reliability;
  • Information Management: Encourage the use of information technology (e.g., blockchain, big data) to enhance risk management efficiency.

Enterprise Responsibilities and Obligations

• Monitoring Process:
  1. Information Collection: Gather risk information through multiple channels such as enterprise reports, consumer complaints, and public opinion monitoring;
  2. Risk Assessment: Conduct scientific assessments using expert panels or professional technical institutions;
  3. Risk Management: Implement corresponding preventive and control measures based on assessment results;
  4. Tracking and Feedback: Evaluate the effectiveness of measures to ensure risks are effectively controlled.
• Technical Requirements:
  • Data Integrity: Enterprises must submit complete information, including ingredient sources, production processes, and quality standards;
  • Testing Methods: Use testing methods that comply with national standards to ensure data accuracy and reliability;
  • Information Management: Encourage the use of information technology (e.g., blockchain, big data) to enhance risk management efficiency.

Comparison with Existing Regulations and Changes

Connection with the “Regulations on the Supervision and Administration of Cosmetics”
The “Regulations on the Supervision and Administration of Cosmetics” establish the basic framework for China’s cosmetic risk management system. The newly released measures further refine and implement these regulations, particularly in monitoring scope, grading standards, and management processes.

Similarities and Differences with International Standards

• Similarities: The monitoring system shares similarities with those in the EU and the US in terms of monitoring scope, risk grading, and information sharing.
• Differences:
  • Data Requirements: China has higher requirements for data completeness, especially for traceability of ingredient sources and production processes.
  • Risk Management Measures: China has stricter measures for high-risk products, such as immediate recall or production suspension for Level 1 risks.

Evolution of Regulatory Trends

• Refined Regulation: Transitioning from macro-management to micro-detail control, with refined management throughout the product lifecycle.
• Technology Empowerment: Utilizing big data and artificial intelligence to enhance regulatory efficiency.
• Social Co-Governance: Encouraging consumer and media participation in risk monitoring to form a multi-stakeholder governance structure.

Impact on International Companies and Response Strategies

Compliance Challenges

• Data Preparation: International companies must ensure submitted data meets Chinese standards, especially in toxicology and microbiology testing.
• Process Adjustment: Adjust internal risk management processes to ensure timely reporting and risk management.
• Localization Requirements: Some data may need to be stored or processed locally in China, requiring advance planning.

Market Opportunities

• Trust Enhancement: Compliance can increase consumer trust and brand competitiveness.
• Innovation Space: Companies can develop safer and more efficient products through technological innovation within a strict regulatory framework.
• Cooperation Opportunities: Collaborate with local enterprises or institutions to address regulatory challenges and expand market share.

Response Strategies

• Establish Compliance Teams: Set up dedicated teams to track regulatory changes and align internal processes with requirements.
• Internal Training: Improve employee awareness and operational capabilities in risk management.
• Professional Support: Collaborate with consulting firms for updated regulatory interpretations and compliance advice.
• Proactive Communication: Maintain good communication with regulatory authorities and provide timely feedback on issues and suggestions.

Implementation Timeline and Urgency

According to the announcement, the measures will take effect on July 1, 2025. This means companies must complete the following preparations within just one month:

• Internal Process Adjustment: Review existing risk management processes to ensure compliance with the new measures.
• Data Preparation: Collect and organize testing data that meets Chinese standards.
• Personnel Training: Train relevant personnel on regulatory requirements to ensure full awareness and compliance.
• System Upgrades: Upgrade internal management systems to support rapid reporting and handling of risk information.

For international companies planning to enter the Chinese market, it is recommended to initiate the following actions immediately:

• Regulatory Interpretation: Conduct an in-depth study of the specific requirements of the new measures to clarify compliance priorities.
• Market Entry Strategy Adjustment: Adjust market entry plans according to the new measures to ensure smooth entry into the Chinese market.

Further Information

To read the original announcement about the Measures for the Administration of Cosmetic Safety Risk Monitoring and Evaluation (2025) released by China’s National Medical Products Administration (NMPA), please click here.

If you are a cosmetics manufacturer with questions about how to prepare your compliance systems or submit data under China’s updated NMPA measures, please contact Cisema.

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