What does the safety assessment of special situation cosmetics include in China?

1. What does the safety assessment of special situation products include when the enterprise conducts self-inspection of the cosmetics safety assessment report?

According to the provisions of Appendix 1 of the "Cosmetic Safety Assessment Material Submission Guidelines" issued by NIFDC, the safety assessment of special situation products includes the safety assessment of aerosol cosmetics, the safety assessment of products that must be used with two or more doses, the safety assessment of products that must be used with instruments or tools, and the safety assessment of children's cosmetics.

2.What are the precautions for safety assessment of aerosol cosmetics?

Since propellants are generally highly volatile, when aerosol products containing propellants are actually used, only a trace amount of propellants remain on the human body surface.

Therefore, the exposure of the formula raw materials other than propellants to the human body is the concentration of the raw materials after removing the propellants. The propellants and other raw materials should be evaluated separately, and the evaluation concentration of other raw materials should be the concentration of each component in the formula (calculated as 100%) after deducting the propellants;

The propellants can be evaluated separately or according to their usage concentration in the formula. In addition, the inhalation toxicity of propellants with inhalation toxicity risks needs to be safety evaluated.

3.What are the precautions for safety assessment of products that must be used in combination with two or more doses?

For products that must be used in combination with two or more doses, the content of the mixed raw materials should be evaluated according to the product's usage method.

When the product may have multiple usage ratios in actual use, the actual usage of the raw materials in each ratio should also be evaluated. At the same time, the potential safety risks caused by chemical and/or biological interactions between the raw materials should be evaluated in combination with relevant literature research materials or product experimental research data.

4.What are the precautions for the safety assessment of products that must be used with instruments or tools?

For cosmetics that must be used with instruments or tools (except brushes, air cushions, perming tools, etc. that only assist in application), the mechanism of the instruments or tools used in conjunction with the cosmetics should be clearly defined, and the product safety under the conditions of the instruments or tools used in conjunction with the cosmetics should be evaluated.

Instruments or tools used in conjunction with the cosmetics should not have cosmetic functions, should not participate in the reproduction process of cosmetics, and should not change the mode and mechanism of action of cosmetics with the skin.

For products used in conjunction with instruments, if the instruments affect transdermal absorption, the skin absorption rate of the raw materials needs to be adjusted during the evaluation, and generally a more conservative transdermal absorption rate should be selected.

5.What are the precautions for safety assessment of children's cosmetics?

When evaluating children's cosmetics, the principles of product formula design should be clarified. Formula design should follow the principles of safety first, efficacy required, and minimal formula. The scientificity and necessity of the raw materials used should be evaluated from the aspects of safety, stability, function, and compatibility of the raw materials, combined with the physiological characteristics of children and possible application scenarios, especially raw materials such as flavors, colorants, preservatives, sunscreens, and surfactants.

The specific evaluation principles should comply with the requirements of the "Children's Cosmetics Supervision and Management Regulations" and the "Children's Cosmetics Technical Guidelines".

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