Table of Contents

NMPA Guidelines for Submission of Cosmetics Safety Assessment, China, Part III.3

In this third segment of Part 3, we focus on the safety assessment of specific types of cosmetic ingredients. These guidelines are crucial for ensuring the safety of cosmetic products in the Chinese market, particularly for ingredients that require special consideration due to their unique properties or potential risks.

1. Flavors and Fragrances

1.1 General Flavor Ingredients

When only a “flavor” ingredient is listed in the “Standard Chinese name” column of the product formula table:

  • Assess according to the principles and requirements of the Technical Guidelines, or
  • Clarify that the flavor meets the International Fragrance Association (IFRA) practice regulation requirements or China’s relevant national standards for flavors.

1.2 Specific Fragrance Components

If both a “flavor” and specific fragrance components are listed:

  • Conduct a safety assessment for each fragrance component individually.

1.3 Children’s Cosmetics

For flavors, plant essential oils, or fragrance components in children’s cosmetics:

  • Identify and assess the sensitizing components contained therein.

2. Nanomaterials

For products containing nanomaterials:

  • Clearly define quality specifications, including:
    • Purity
    • Crystal form
    • Initial particle size distribution
    • Surface coating substances
  • Conduct a safety assessment based on the use amount in the formula.
  • Explain the suitability of the toxicological test method for nanomaterials.

Note: Due to higher inhalation exposure risk, the use of nanomaterials in products with potential inhalation exposure is not encouraged.

3. Components Not Included in Formula

For extremely trace components not listed as formula ingredients (e.g., those added to ensure ingredient quality):

  • Explain each component individually.
  • Conduct a thorough safety assessment to ensure these components do not affect the quality and safety of the ingredients.

4. New Ingredients during Safety Monitoring Period

For new ingredients under safety monitoring:

  • Assess compliance with technical requirements for new ingredients, including:
    • Use purpose
    • Scope of use or applicability
    • Use concentration
    • Use restrictions and requirements

5. Colorants in Hair Dyeing Products

For oxidized hair dyeing products containing organic colorants from the list of permitted colorants (e.g., calcium stearate, CI 73385, CI 45100):

  • Assess safety specifically for use in oxidized hair dyeing products due to potential participation in redox reactions and associated safety risks.

By following these guidelines for specific types of cosmetic ingredients, manufacturers can ensure a comprehensive safety assessment that addresses the unique characteristics and potential risks associated with these ingredients. This approach aligns with China’s stringent regulatory requirements and promotes the overall safety of cosmetic products in the market.

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