China Compliant Cosmetic Ingredients: History of Safe Consumption Guidelines - Draft for Comments

China compliant cosmetic ingredients now have a set of guidelines on how to determine and research their history of safe consumption. China’s National Institutes for Food and Drug Control (NIFDC) has developed guidelines to streamline the evaluation of new cosmetic raw materials by leveraging their history of safe consumption. These guidelines align with existing regulatory frameworks including:

• Cosmetic Supervision and Administration Regulation (CSAR)

• Administrative Measures for the Registration and Filing of Cosmetics

• Provisions for the Registration and Filing of New Cosmetic Ingredients (NCI) (referred to below as NCI Provisions).

Scope and Application

This guidance specifically pertains to Scenario 5 under the "NCI Provisions" which focuses on new cosmetic ingredients that have a documented history of safe consumption. Registrants are expected to comply with relevant regulatory and technical standards and integrate other applicable guidelines as necessary.

Key Requirements for Documentation and Consistency

1. Source of Documentation:

• Documentation must originate from authoritative bodies capable of food safety assessments, including food, agriculture, or health regulatory agencies.
• Sources within China should be at least at the provincial level, while foreign sources should include national-level or recognized international organizations.

2. Consistency of Raw Materials:

• The new China compliant cosmetic ingredient must be consistent with documented food material in source, process, composition, and usage.
• For materials derived from animals or plants, species identification and health certificates are required.
• If the new material is further processed from the documented food material, this consistency must be clearly demonstrated.

3. Edibility and Usage Restrictions:

• Documented evidence must detail consumption methods, purposes, limits, suitable populations, and precautions.
• For ingredients with usage restrictions, safety analyses, and comprehensive toxicity studies are necessary for high-risk ingredients.

Common Sources of Proof

1. China's Regulatory Departments:

• Common Food Ingredients: e.g., "National Livestock and Poultry Genetic Resources Catalogue."
• Ordinary Food Ingredients: e.g., national food safety standards and regulatory announcements.
• Local Specialty Foods: Should have proof of traditional use exceeding 30 years, local food safety standards, and official confirmations.
• New Food Ingredients and Medicinal and Edible Substances: Include approved announcements and detailed ingredient information.

2. Foreign Regulatory Bodies/Institutions:

• Full background information must be provided, including the content of announcements, country of origin, issuing body, publication date, and safety assessment details.
• Ensure all documentation contains specific information about the edible raw materials and any restrictions.

Specific Considerations

• Biological Fermentation Materials: Due to their complexity, the safety of the fermentation product itself should be emphasized, considering how the fermentation process might affect the final composition and safety.
• Food Ingredients with Usage Restrictions: Understand and analyze specific usage requirements and safety risks for restricted ingredients. High-risk ingredients require thorough toxicity studies and safety analyses based on consumption limits and population suitability.

Safety Evaluation

• Even if China compliant cosmetic ingredients have a documented safe food usage history, a comprehensive risk assessment based on their exposure and usage in cosmetics is required.
• Although some toxicological test data (items 2-5) may be exempted, a detailed safety evaluation is still essential. This should consider population epidemiology, habitual consumption patterns, and scenarios of cosmetic exposure.

By adhering to these guidelines, registrants can ensure compliance with regulatory requirements and effectively document the safe consumption history of new China compliant cosmetic ingredients. This approach not only standardizes safety assessments but also supports the development of safe and effective cosmetic products.

Further information

Read the original NIFDC announcement on China New Cosmetics Ingredients Safe Use History Research and Determination Trial Guidelines. For more information about new cosmetic ingredients in China, please refer to these recent blog posts:

• China compliant cosmetic ingredients: history of safe use draft guidelines

• China new cosmetic ingredients research guidelines – draft for comments

• China new cosmetic ingredients communication channel – Trial

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