1. What are the restrictions on the use of colorants permitted in cosmetics?
According to the Safety Technical Specifications for Cosmetics, the use of colorants permitted in cosmetics is mainly divided into four categories: various cosmetics, cosmetics other than eye cosmetics, cosmetics specifically for non-contact with mucous membranes, and cosmetics specifically for temporary contact with the skin. For example, CI 10316 and CI 15510 are only allowed to be used in cosmetics other than eye cosmetics.
Recently, the use of permitted colorants beyond the scope of use has been found in cosmetics supervision. The registrant should strictly check it when reviewing the formula.
2. What should be noted when using "iodopropynyl butyl carbamate" in cosmetic formulas?
According to the technical safety specifications for cosmetics, iodopropynol butyl carbamate is used as a preservative, and its scope of use and restrictions are divided into three categories:
(a) Rinse-off products are prohibited from being used in lip products, and the maximum allowable concentration when used in cosmetics is 0.02%;
(b) Leave-on products are prohibited for lip products; body creams and lotions are prohibited (that is, they cannot be used for any dosage form products that are applied to a large area of the body); the maximum allowable concentration when used in cosmetics is 0.01%;
(c) Deodorant products and antiperspirant products are prohibited for use on lips, and the maximum allowable concentration for cosmetics is 0.0075%.
All three categories of products shall not be used in products for children under three years old (except bath products and shampoos in rinse-off products). Only when the product is likely to be used by children under three years old, except for toiletries and shampoos, the label must be marked with the precaution of "not for children under three years old". When using iodopropynyl butylcarbamate, the registrant should check whether it complies with the provisions of the "Technical Specifications for Safety of Cosmetics" in accordance with the above product category requirements.
3. Do powder cosmetics containing ethoxylated structural raw materials need to be tested for dioxane during filing inspection?
The Cosmetics Registration and Filing Inspection Work Specifications require that products containing ethoxylated structural raw materials in their formulas should be tested for dioxane. In March 2024, NMPA issued a notice (No. 12 of 2024) on incorporating 19 formulation and revision items such as the General Rules for Sample Pretreatment of Cosmetic Toxicology Test Methods into the Cosmetic Safety Technical Specifications (2015). In the notice, the scope of application of the test method for dioxane in cosmetics was expanded from the original determination of dioxane content in "liquid water-based, creams and lotions" cosmetics to the determination of dioxane content in "liquid water-based, creams and lotions, gels, powders, and cleansing oils" cosmetics. Therefore, powder cosmetics containing ethoxylated structural raw materials should be tested for dioxane content according to the test method in the notice.
4. How to strengthen the account management of the cosmetics (toothpaste) information service platform?
Cosmetic filers should properly keep the platform user password. All registration and filing-related actions conducted by this user represent the actions of the company. Any losses caused by password loss or leakage will be borne by the company itself. Before submitting the first filing, filing change, or filing cancellation on the platform, the filer should carefully review and confirm, and bear legal responsibility for the submitted content and matters. Some registrants handed over the platform account to other companies for operation and failed to fulfill the responsibility of custody and submission of materials. The consequences are extremely risky and should be taken as a warning.
5. What measures should the cosmetics registrant take when the entrusted production enterprise operates abnormally?
According to the Cosmetics Production Quality Management Specifications, the entrusting party (registrant) shall establish and implement a replacement system for the entrusted production enterprise. If the production conditions and production capacity of the entrusted production enterprise are found to have changed and no longer meet the entrusted production needs, the entrustment shall be stopped in time and the entrusted production enterprise shall be replaced according to production needs.
The entrusting party (registrant) shall supervise the production activities of the entrusted production enterprise. If the entrusted production enterprise is found to operate abnormally, the entrustment shall be stopped in time, the production enterprise shall be replaced as soon as possible and the registration materials shall be changed. The list of abnormal business operations of enterprises can be queried in the National Enterprise Credit Information Publicity System.
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