On June 5th, 2023, the China National Medical Products Administration (NMPA) released new guidance on the registration process for imported cosmetics. To assist cosmetic businesses in navigating this process smoothly, ZMUni has compiled a list of the most frequently asked questions about dossier preparation during registration.
Question 1: What are the requirements for reapplying for registration of special cosmetics that were rejected? Can photocopies be used?
With regard to Article 58 of the Regulations on the Administration of Registration and Notification of Cosmetics, for special products rejected for non-safety reasons and reapplying for registration, photocopies of the original registration materials can be used.
At the same time, reasons of previous rejection and explanations of the rejections not out of safety concern shall be submitted.
Question 2: If multiple imported products are listed on the same Certificate of Free Sale (CFS), do the original certificate need to be submitted for each product? If a photocopy is submitted, does it need to be notarized?
According to Article 27 of the Regulations on the Administration of Registration and Notification of Cosmetics, CFS can list multiple products at the same time.
When applying for registration or notification for these products, one product can use the original certificate, and other products can use photocopies. The name of the product where the original certificate is used and relevant registration certificate number, or notification number should be indicated.
Question 3: Hair dye products contain two formulas, I and II. How should they be registered?
According to Article 35 of the Regulations on the Administration of Registration and Notification of Cosmetics, for cosmetics that contain two or more independent formulas that must be used together or cannot be separated due to packaging, each formula should be filled out separately and registered as one product. Hair dye products with two formulas that must be used together should be registered as one product, with each formula filled out separately.
Question 4: Do all cosmetics need to upload a summary of the product efficacy claims during registration and notification?
According to Article 7 of the Cosmetic Efficacy Claim Evaluation Norms, cosmetics that can be directly identified through sensory organs such as vision and smell (such as cleaning, makeup removal, beauty modification, fragrance, refreshing, hair dyeing, perm, hair color care, hair removal, deodorization, and auxiliary shaving and hair removal, etc.), or those that can produce effects through simple physical covering, adhesion, friction, etc. (such as physical covering for spot whitening, physical exfoliation, and physical blackhead removal, etc.) and clearly marked on the label as having only physical effects, are exempt from publishing a summary of the product efficacy claims.
For other efficacy claims, they should be evaluated in accordance with the Cosmetic Efficacy Claim Evaluation Norms announced by the National Medical Products Administration (Announcement No. 50 of 2021), and a summary of the product efficacy claims should be uploaded during registration or notification.
Question 5: When applying for cosmetic registration, how should safety information for raw materials that have not yet obtained a submission code be submitted?
The following two methods are both acceptable, and the registrant, filer, or domestic responsible person can provide them according to their own situation:
1. Provide the raw material quality specification document or raw material safety-related information (Attachment 14 of the Regulations on the Administration of Registration and Notification of Cosmetics) with the official seal of the raw material manufacturer.
(Note: The registrant or domestic responsible person should also stamp the official seal on each page.)
2. If the raw material manufacturer authorizes the registrant, filer, or domestic responsible person to fill in the raw material safety-related information (Attachment 14), they should provide the raw material safety-related information (Attachment 14) with the official seal of the registrant, filer, or domestic responsible person.
In the "Other Issues to be Explained" section, the following remarks should be added: The registrant, filer, or domestic responsible person (specific enterprise name) is authorized by the raw material manufacturer (specific enterprise name) to fill in the relevant content in Attachment 14, and the content is true, complete, and accurate. This is hereby stated.
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