Q1: Where imported general cosmetics are notified as set form and marketed, do the single products and set packaging of the set need to be submitted when in notification？
A1: According to Article 32 of the Rules for Registration and Notification Dossiers of Cosmetics, during notification of general cosmetics and prior to special cosmetics going on the market, cosmetic registrant and notifier or Chinese responsible person shall upload the label picture of product sales packaging. Therefore, the picture submitted and uploaded shall be the product notified as set form.
Q2: Which materials are required to be submitted when applying for changing Chinese Responsible Person(Chinese RP)?
A2: According to Article 48 of the Rules for Registration and Notification Dossiers of Cosmetics, product list of Chinese RP which is intended to be changed , Informed Consent of the original Chinese RP or the effective judgement documents which can prove that Chinese RP has changed(rulings, judgments, mediation, etc.), and letter of commitment of Chinese RP which is intended to be changed are required to be submitted when applying for changing Chinese RP.
Q3: After several imported general cosmetics are separately notified and when they are sold in set form, is it necessary to submit the label picture of the set sales packaging?
A3: According to Article 32 of the Rules for Registration and Notification Dossiers of Cosmetics, For registered or notified products sold in combination form of set or gift box, the combination process does not touch the contents of the product, apart from adding the name of the product packaged in combination, other labeled content does not exceed the label content of each product and the label information of the combined packaging covers the label content of each product inside, there is no need to repeatedly upload the label picture when notifying products packaged in combination.
Q4: Are all cosmetic products required to upload the abstract of the product efficacy claim basis on the website designated by NMPA when they are registered or notified?
A4: According to Article 7 of Specifications for Cosmetics Efficacy Claim Evaluation, “Efficacy claims which can be directly identified by sight, smell and other senses (such as cleaning, makeup removing, beauty modifying, aroma, toning, hair dye, perm, hair color care, depilating, deodorant and auxiliary shaving/hair shaving, etc.), or come into effect by simple physical cover, attachment, friction and other means (such as spot whitening by physical cover , physical way to exfoliate and physical way to remove blackheads, etc.) and are clearly identified on the label with only physical effects, can be exempted from publicizing the abstract of the product efficacy claim basis.”
Other efficacy claims shall be evaluated in accordance with NMPA announcement on issuing Specifications for Cosmetics Efficacy Claim Evaluation(NO.50 of 2021). Besides, uploading the abstract of the product efficacy claim basis at the time of applying for cosmetic registration or notification.
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ZMUni regulatory compliance services in China include:
- Registration Service of Special Cosmetic Products
- Filing/Notification Service of General Cosmetic Products
- Infant/Children General Cosmetic Products Filing/Notification Service
- Infant/Children Sunscreen Cosmetic Products Registration Service
- New Cosmetic Ingredients (NCI) Filing/Notification and Registration Service
- Cosmetic Ingredients Code Application Service
- Cosmetic Efficacy Claim Evaluation Service
- Chinese responsible person service
- Apply for CITES permit or certificate of endangered species Service
- Toothpaste Filing/Notification Service
- Mouthwash etc. Dental Care Products regulatory compliance Service
- Custom clearance service
- Disinfection products Filing/Notification Service
- Anti-bacterial products Filing/Notification Service
- QMS (Quality Management System) service
- ACR (Adverse Cosmetic Reaction) Service
- Labelling Reviews
- Regulatory Dossiers
- Compliance Solutions
- Regulatory Support