This section outlines the comprehensive safety assessment process for cosmetic products in China, including the evaluation of potential risk substances, product stability and microbiological assessment, risk control measures, and the final safety assessment conclusion.
1. Safety Assessment of Potential Risk Substances
1.1 Overview
The identification and assessment of risk substances in cosmetics is an essential part of the product safety assessment report. Risk substances may originate from raw materials, packaging materials, or be introduced during production, transportation, and storage processes.
1.2 General Principles
Personnel engaged in cosmetic safety assessment should meet the requirements specified in the Technical Guidelines for Cosmetic Safety Assessment (2021 Edition). The assessment should be based on the analysis of risk substances introduced by raw materials and those generated or introduced during the product production process.
1.3 Identification and Assessment Process
1.3.1 Harmful Substances Potentially Present in Products
This includes assessment of substances such as mercury, lead, arsenic, cadmium, dioxane, asbestos, free formaldehyde, and methanol.
1.3.2 Risk Substances in Raw Materials with Restrictions
Assess substances like nitrosamines and secondary alkyl amines in certain raw materials.
1.3.3 Risk Substances in Products with Restrictions
Evaluate substances such as acrylamide in products containing certain polymers.
1.3.4 Other Potential Risk Substances
Assess substances like diethylene glycol, phenol, pesticide residues, hydroquinone, and benzene.
1.3.5 Raw Materials Potentially in the Prohibited List
Confirm that certain raw materials are not in the prohibited list of the Technical Standards.
1.3.6 Risk Substances Assessment for Children’s Cosmetics
For children’s cosmetics, additional risk substances should be identified and assessed, including anthraquinone, certain components in cocamidopropyl betaine, sensitizing components in fragrances or essential oils, and diethylene glycol in glycerin.
2. Product Stability and Microbiological Assessment
Cosmetics shall be assessed for microorganisms to determine that the microbiological indicators meet the Safety and Technical Standards for Cosmetics (STSC) requirements. Research should be conducted on:
- Product stability
- Preservative system
- Packaging material compatibility
These assessments should be based on:
- National standards
- Technical specifications
- Industry standards
- International standards
- Technical guidelines
- Self-developed methods of enterprises
Related testing or assessment conclusions shall be included in the safety assessment reports.
3. Risk Control Measures or Recommendations
Based on the product characteristics and the assessment results of cosmetic ingredients and risk substances, develop risk control measures and recommendations for the use of cosmetics. These may include:
- Clarifying product application methods
- Specifying usage frequency
- Identifying appropriate users
- Providing warnings
- Outlining precautions
4. Safety Assessment Conclusion
A clear product safety assessment conclusion shall be drawn based on:
- Safety assessments of ingredients and potential risk substances in cosmetics
- Testing results of microorganisms and hazard substances in cosmetics
- Product stability assessment results
- Risk control measures and recommendations developed
The conclusion should confirm that the products will not cause any hazards to human health under normal, reasonable, and foreseeable use conditions.
By following these comprehensive guidelines, manufacturers can ensure that their cosmetic products meet the stringent safety standards required by Chinese regulations, protecting consumers while allowing for innovation in product development.