This section outlines the specific considerations and procedures for safety assessments of cosmetic products under special circumstances. These guidelines ensure that products with unique formulations, application methods, or target demographics are thoroughly evaluated for safety.

Safety Assessment of Aerosol Cosmetics

When assessing aerosol cosmetics, the following points should be considered:

• Propellants are highly volatile, with only a small amount remaining on the body’s surface after use.
• The exposure of formula ingredients (excluding propellants) is equal to their concentration less the propellants.
• Assessment procedure:
  1. Assess propellants separately from other ingredients.
  2. For other ingredients, assess based on their concentration after deducting propellants (calculated as 100%).
  3. Propellants can be assessed separately or based on their use concentrations in the formula.
  4. Conduct an additional safety assessment of inhalation toxicity for propellants that may pose such risks.

Safety Assessment of Products To Be Used in Conjunction with Two or More Doses

For products requiring the use of multiple doses in conjunction:

• Assess the concentration of mixed ingredients based on the product’s application methods.
• When multiple mixing ratios are possible:
  1. Assess the actual use amount of ingredients separately for each ratio.
  2. Evaluate potential safety risks from chemical and/or biological interactions between ingredients.
  3. Base this evaluation on relevant literature research or product test data.

Safety Assessment of Products To Be Used in Conjunction with Instruments or Tools

For cosmetics used with instruments or tools (excluding simple application aids like hairbrushes, air cushions, hair perming tools, etc.):

• Clearly explain the mechanisms of action of the instruments or tools.
• Assess product safety under conditions of use with these instruments or tools.
• Ensure that the instruments or tools:
  1. Do not have any cosmetic functions.
  2. Do not participate in the reproduction process of cosmetics.
  3. Do not change the ways or mechanisms of action between cosmetics and the skin.
• If instruments affect dermal absorption, adjust the skin absorption rate of ingredients during assessments.
  1. Generally, select a more conservative rate.

Safety Assessment of Children Cosmetics

When assessing children’s cosmetics:

• Clarify the principles of product formula design, which should follow:
  1. Safety priority
  2. Efficacy necessity
  3. Simplest formula principle
• Assess the scientificity and necessity of using ingredients, considering:
  1. Safety
  2. Stability
  3. Function
  4. Compatibility
  5. Physiological characteristics of children
  6. Possible application scenarios
• Pay special attention to:
  1. Flavors and fragrances
  2. Colorants
  3. Preservatives
  4. Sunscreens
  5. Surfactants
• Comply with the requirements of the “Provisions for Supervision and Management of Children Cosmetics and the Technical Guidelines for Children Cosmetics”.

By following these guidelines, manufacturers can ensure that cosmetic products under special circumstances meet the stringent safety standards required by Chinese regulations, protecting consumers while allowing for innovation in product development.