In this first segment of Part III of our comprehensive series on cosmetic safety assessment in China, we focus on the general principles and self-inspection points for safety assessment reports. These guidelines, developed in accordance with the Cosmetic Supervision and Administration Regulations (CSAR), Administrative Measures, and Technical Guidelines, serve as a crucial reference for cosmetic enterprises and quality and safety managers.
General Principles
Cosmetic safety assessments in China must adhere to the following principles:
- Comprehensive Approach: Assessments should cover all aspects of product safety.
- Accuracy: All information and data must be precise and verifiable.
- Scientific Basis: Assessments should be grounded in current scientific knowledge and methodologies.
- Standardization: Assessments should follow standardized procedures as outlined in the Technical Guidelines.
Safety assessors must consider the specific characteristics and actual use of products when conducting assessments. The outcome of this process should be a detailed cosmetic safety assessment report.
Quality and safety managers are responsible for conducting self-inspections of these reports using the Self-inspection Points provided. They may also delegate the task of drawing safety assessment conclusions to designated safety assessment personnel.
It’s crucial to note that cosmetic registrants and notifiers bear full responsibility for product safety and the authenticity of submitted dossiers.
Self-Inspection Contents for Safety Assessment Report
Brief Product Introduction
Application Method
The product application method should include:
- Application area
- Frequency of use
Application areas can be defined according to the Classification Rules and further refined based on product characteristics.
For example:
- Blush powder: Application area can be specified as “cheeks”
- Oxidized hair dye products: Frequency can be described as “once a month” if the product leaflet indicates an application interval longer than one month
Average Daily Use Amount
When establishing the average daily use amount:
- Use reasonable estimates
- Clearly define the reference basis
- Consider the following sources:
- Latest exposure data from international authoritative institutions
- Publicly available research literature on cosmetic exposure
- Testing and statistical results of actual product use (e.g., consumer tests and research statistics conducted by enterprises)
Product Retention Factor
Selection of an appropriate product retention factor should:
- Be based on product type, characteristics, and application method
- Reference the latest exposure data from authoritative institutions or public research literature
- Consider cross-referencing retention factors for products with similar application methods
By adhering to these general principles and self-inspection points, cosmetic companies can ensure their safety assessment reports meet the high standards set by Chinese regulatory authorities.
In the upcoming segments of Part III, we will delve deeper into specific aspects of the self-inspection process, providing a comprehensive guide for cosmetic safety assessment in China.