Q&As on Ordinary Cosmetics Filing in Guangzhou (Vol. 66)

We have collected the latest FAQs on ordinary cosmetics filing from the Guangzhou Administration for Market Regulation and translated them into English for your reference.

1. What usage restrictions should be considered for approved cosmetic colorants?

According to the "Safety and Technical Standards for Cosmetics," the usage of allowed cosmetic colorants is mainly divided into four categories: all types of cosmetics, cosmetics excluding eye products, cosmetics not intended for contact with mucous membranes, and cosmetics intended only for temporary skin contact. For example, CI 10316 and CI 15510 are only allowed for cosmetics other than eye products.

Recently, instances of exceeding the allowed usage scope of colorants have been found in cosmetic regulations. Registrants should strictly adhere to guidelines during formula review.

2. What should be considered when using "Iodopropynyl Butylcarbamate" in cosmetic formulations?

According to the "Safety and Technical Standards for Cosmetics", Iodopropynyl Butylcarbamate, as a preservative, has its usage scope and restrictions divided into three categories:

(a) Rinse-off products: Prohibited in lip products; the maximum allowable concentration in cosmetics is 0.02%.

(b) Leave-on products: Prohibited in lip products, body creams and lotions (i.e., any formulation applied exclusively over the body); maximum allowable concentration in cosmetics is 0.01%.

(c) Deodorant and antiperspirant products: Prohibited in lip products; maximum allowable concentration in cosmetics is 0.0075%.

None of these categories should be used in products intended for children under three years old (except for rinse-off bath products and shampoos). If the product may be used by children under three, excluding bath products and shampoos, the label must include the caution "Not for use in children under three years old." Registrants should ensure compliance with the "Safety and Technical Standards for Cosmetics" when using Iodopropyl Butylcarbamate in accordance with the specified product categories.

3. Is it necessary to test for dioxane in powder cosmetics containing ethoxylated ingredients during registration inspection?

According to the "Inspection Work Standards for the Registration and Filing of Cosmetics," products containing ethoxylated ingredients in their formulation must be tested for dioxane. In March 2024, the National Medical Products Administration issued the "Notice on Including 19 Revision Projects such as the General Rules for Sample Pretreatment Methods in Toxicological Tests of Cosmetics into the Safety and Technical Standards for Cosmetics (2015 Edition)" (2024 No. 12). This notice expanded the application scope of the "Testing Method for Dioxane in Cosmetics" from "liquid water-based, cream and lotion" cosmetics to include "liquid water-based, cream and lotion, gel, powder, and cleansing oil" cosmetics. Therefore, powder cosmetics containing ethoxylated ingredients should undergo dioxane content testing according to the "Testing Method for Dioxane in Cosmetics" specified in the notice.

4. How to strengthen account management on the cosmetic (toothpaste) information service platform?

Cosmetic registrants should securely manage their platform user passwords. Any registration or filing activities conducted through this user account represent the company's actions. The company will bear any losses resulting from password loss or leakage. Before submitting an initial filing, filing changes, or filing cancellations on the platform, registrants must thoroughly review and confirm the information, assuming legal responsibility for the submitted content and matters. Some registrants have delegated platform account operations to other companies without fulfilling responsibilities for password management and document review, which poses significant risks. This should serve as a cautionary example.

5. What measures should cosmetic registrants take when a contracted manufacturer operates abnormally?

According to the "Cosmetic Good Manufacturing Practice," the principal (registrant) should establish and implement a system for replacing contracted manufacturers. If changes in the production conditions or capabilities of the contracted manufacturer are identified that make them unsuitable for production needs, the principal should promptly cease the contract and select a new manufacturer based on production requirements.

The principal (registrant) should supervise the production activities of the contracted manufacturer. If any operational abnormalities are detected, the principal should immediately halt the contract, quickly replace the manufacturer, and update the registration information. The list of enterprises with operational anomalies can be queried on the "National Enterprise Credit Information Publicity System."

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