1. According to the Technical Guidelines for Filling in the Cosmetic Formula (hereinafter referred to as the Technical Guidelines), which ingredients belong to cosmetic formula ingredients?
Cosmetic formula ingredients refer to the ingredients that are purposefully added to the product formula in the production process, and play a certain role in the final product, including preservatives, sunscreens, hair dyes, colorants, moisturizers, pH adjusters, viscosity adjusters, etc.
Ingredients/ingredient components that are not included as part of the formula include: (1) extremely trace amounts of ingredients that are added in order to ensure the quality of cosmetic ingredients in the formula (such as antioxidants, etc.); (2) technically unavoidable trace impurities in the ingredient itself or residues; (3) auxiliaries that are added during the production process but do not react chemically with other ingredients and do not have an effect on the final product and are removed in the subsequent process.
2. What are the requirements for ingredients/ingredient components that are not used as formula ingredients?
Ingredients/ingredient components that are not used as ingredients of the formula, can choose not to fill in the product formula, but it should still be fully analyzed and evaluated in the product safety assessment.
When the type and/or content of ingredients/ingredient components that are not used as the formula ingredients change and do not affect product quality and safety, cosmetic registrants, filing persons, or domestic responsible persons shall update and maintain the information of product formulas and product safety assessment; when the type and/or content increase and may affect the conclusions of product safety assessment, cosmetic registrants, filing persons, or domestic responsible persons shall change the product safety assessment information.
3. If the formula contains propellant in direct contact with the content, how should the formula be filled in and how should the safety assessment be evaluated?
If the formula contains propellant that is directly in contact with the product content, the composition and content of the propellant should be filled in separately. The total propellant content should be 100%, and the filling ratio of the propellant and material body should be indicated.
Propellant-containing spray products for actual use, the human exposure dosage of formula ingredients is the concentration of ingredients that have removed the propellant. Propellant and other ingredients should be evaluated separately, the evaluated concentration of other ingredients should be the concentration of each component in the formula (calculated by 100%, not including propellant).
4. For pH adjusters and viscosity adjusters whose contents may fluctuate with different production batches, how to fill in the formula?
(1) Fill in the typical values of the added amount of such ingredients in the formula table, and then note that "the amount added is the typical value";
(2) Note the range values of the actual added amount at the bottom of the formula table. For example, citric acid is added to the formula for the purpose of pH adjusters, to adjust the pH value during the production process. The range of addition is 0.1%~0.2%, and the water in the formula table is adjusted to 100%.
5. For cosmetics claiming hair dye, hair perm, anti-spot and whitening, sun protection, anti-hair loss, anti-acne, anti-wrinkle, anti-dandruff, deodorant, as well as claiming new function (applicable except for special groups), how to fill in the formula?
The corresponding functional ingredients should be labeled in the purpose of use column of the formula table. If the functional ingredient is not a single component ingredient, its specific efficacy ingredient should be clear in the purpose of use column.
Also, you can follow us on LinkedIn for the latest cosmetic and toothpaste compliance information.