The following FAQs are all related to cosmetic safety assessments in China. CIRS Group has compiled the information and translated it into English for your reference.
Question 1: What types of safety assessments are required for special-case products when enterprises conduct self-inspection of cosmetic safety assessment reports?
Answer: According to Annex 1: Key Points for Self-Inspection of Cosmetic Safety Assessment Reports in the Guidelines for Submission of Cosmetic Safety Assessment Data issued by the National Institutes for Food and Drug Control (NIFDC), the safety assessment of special-case products includes:
- Safety assessment of aerosol-type cosmetics;
- Safety assessment of products that must be used in combination with one or more other products;
- Safety assessment of products that must be used in combination with specific devices or tools;
- Safety assessment of children's cosmetics.
Question 2: What are the key considerations in the safety assessment of aerosol-type cosmetics?
Answer: Due to the high volatility of propellants, only trace amounts of propellant remain on the human body during actual use of aerosol-type products containing propellants. Therefore, raw materials in the formula, excluding the propellant, should be assessed based on their concentration in the formula after removing the propellant. The propellant and other ingredients should be evaluated separately. The concentration of other ingredients should be calculated based on the formula composition (expressed as 100%) after deducting the propellant content. The propellant can be assessed separately or based on its usage concentration in the formula. In addition, for propellants with potential inhalation toxicity risks, an inhalation toxicity safety assessment is also required.
Question 3: What are the key considerations in the safety assessment of products consisting of two or more components that must be used in combination?
Answer: For products consisting of two or more components that must be used in combination, the safety assessment should be based on the ingredient concentrations after mixing, in accordance with the product’s usage instructions. If the product allows for multiple mixing ratios during actual use, the actual usage amount of each ingredient under each mixing ratio should be evaluated. Additionally, relevant literature or experimental data should be reviewed to assess whether any chemical and/or biological interactions between ingredients may pose potential safety risks.
Question 4: What are the key considerations in the safety assessment of products that must be used in conjunction with devices or tools?
Answer: For cosmetics that must be used in conjunction with devices or tools (excluding tools that merely assist in application, including brushes, puffs, and hair styling tools), the mechanism of action of the accompanying device or tool must be clearly defined, and the product’s safety under the conditions of use with the device or tool should be assessed. The accompanying device or tool must not possess cosmetic functions, must not be involved in the reprocessing of the cosmetic, and must not alter the mode or mechanism of action between the cosmetic and the skin. For products used with devices that may affect transdermal absorption, the skin absorption rate of the ingredients should be adjusted accordingly in the safety assessment, generally adopting a more conservative percutaneous absorption rate.
Question 5: What are the key considerations in the safety assessment of children's cosmetics?
Answer: When evaluating children's cosmetics, the principles of product formulation design should be clearly defined. The formulation should follow the principles of safety first, essential efficacy, and minimal formulation. Raw materials should be assessed for their safety, stability, functionality, and compatibility, taking into account the physiological characteristics of children and possible application scenarios. The scientific rationale and necessity of the selected ingredients should be evaluated, especially for ingredients such as fragrances, colorants, preservatives, sunscreens, and surfactants. The specific assessment principles should comply with the requirements of the Provisions on the Supervision and Administration of Children’s Cosmetics and the Technical Guidelines for Children's Cosmetics.
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Further Information:
https://yjj.beijing.gov.cn/yjj/xxcx/kpxc/hzp36/543530327/index.html
