(1)FAQs on cosmetic registration and notification in China


Q1: Hair dye products contain doseⅠ, doseⅡ with 2 formulas, how to apply for registration?

A1: According to Article 35 of the Rules for Registration and Notification Dossiers of Cosmetics, cosmetics with independent formula containing two or more than two products or whose packaging and container can’t be split up shall separately fill in the formula, and apply for registration as one product. Where two doses of hair dye products are products that must be used together, the formula should be filled in separately, and the products apply for registration as one product.

 

Q2: What are the requirements for the foreign language materials from dossiers of cosmetic registration and notification?

A2: According to Article 4 of the Rules for Registration and Notification Dossiers of Cosmetics, dossiers of cosmetic registration and notification should use the standard Chinese characters published by the state. Except registered trademark, website, patent name, the name and address of overseas enterprise which must use other texts or conventional jargon(such as SPF、PFA、PA、UVA、UVB、VC, etc.), all other texts shall be completely and normatively translated into Chinese, and the original text shall be attached behind the translated text.

 

Q3: What are the requirements for the foreign language materials from dossiers of New Cosmetic Ingredient registration and notification?

A3: According to Article 4 of the Rules for Registration and Notification Dossiers of New Cosmetic Ingredient, dossiers of New Cosmetic Ingredient registration and notification should use the standard Chinese characters published by the state. Except registered trademark, website, patent name, the name and address of overseas enterprise which must use other texts and English abbreviations and acronyms used in our regulatory documents, etc., all dossiers using other texts shall all be completely and normatively translated into Chinese, and the original text shall be attached behind the translated text.

 

Q4: Where Protection Grade of UVA is not shown in the original product registration certificate and the Protection Grade of UVA is needed to be added and labeled, how to apply?

A4: According to Article 44 of the Rules for Registration and Notification Dossiers of Cosmetics, Adding the SPF/PA of the product shall apply for change in accordance with the situation where there is a change in label sample content, and the efficacy test report of the product which is intended to be changed shall be provided.

 

Q5: Can cosmetics of hair growth, depilating, breast beauty, bodybuilding, deodorization apply for change, re-issue, and renewal?

A5: According to relevant NMPA announcements, within the transition period of new cosmetic regulations, cosmetic registrants can apply to NMPA for the cancellation of administrative license approval of hair growth and other 4 types Special Use Cosmetics. Besides, NMPA no longer accepts administrative license application matters such as product change, re-issue and renewal. If there are changes in matters that are not associated with safety and efficacy claims, cosmetic registrants shall promptly notify with NMPA. For matters that can be applied for, the applicant can submit paper materials offline for application.


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ZMUni Chinese Cosmetic Regulation Compliance Centre 中贸合规中心

Contact us: info@zmuni.com

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