Q1: For products using carrier materials like patch and film, how to submit them?
A1: Option “whether it is the carrier material” below the formula table should be checked and the material composition of main carrier materials should be noted according to the requirements of the Rules for Registration and Notification Dossiers of Cosmetics. At the same time, the source, preparation process and quality control index and other materials are required to provide.
Q2: If propellant that directly contact product contents is included in the product formula, how to submit the propellant?
A2: According to the Rules for Registration and Notification Dossiers of Cosmetics, relevant information of propellant shall be filled in separately below the formula list and the total propellant content shall be 100%.
Q3: How to fill in and submit phase separation information in manufacturing process in the system of cosmetic application and review?
A3: Phase separation information of the ingredient shall be filled in below the module of “phase separation information” in manufacturing process; There’s no need to fill in the relevant content of phase separation in the column of “Procedure”, “Notes” of manufacturing process.
Q4: Many imported products are listed in the same production and sales certificate, does each product need submitting the original copy of sales certificate? Does it need notarizing if a duplicate was submitted?
A4: According to Article 27 of the Rules for Registration and Notification Dossiers of Cosmetics, many products can be listed meanwhile in the Documents certifying that the imported products have been sold on the market, the Entrustment Document or Documents such as supporting materials belonging to one corporate group. When these product apply for registration or notification, one of them can use the original copy, other products can use the duplicate, and the product name where the original is located and the relevant acceptance NO., registration certificate NO. or notification NO. and other information shall be explained.
Q5: When imported general cosmetics of multiple shade series are sampled to do the toxicological test according to Specification for Registration and Notification Inspection of Cosmetics, can the copy of toxicological test report be used?
A5: Yes, the copy can be used. According to Article 33 of the Rules for Registration and Notification Dossiers of Cosmetics, when general cosmetics of multiple shade series are sampled to do the toxicological test according to Specification for Registration and Notification Inspection of Cosmetics, they can be notified as one group of products, each product shall be attached with the list of series products, basic formula, colorant checklist and list of sampling products.
Q6: Can the copy of the original notification dossiers be used when the imported general cosmetics is re-notified after cancellation?
A6: According to Article 59 of the Rules for Registration and Notification Dossiers of Cosmetics, the explanation shall be submitted when the general cosmetics is re-notified after cancellation. For those which are cancelled due to the non-safety reason, the copy of the original notification dossiers can be used when the product is notified again.
Q7: When the registration of special cosmetics is not approved, what are the requirements for re-application dossiers? Can the copy be used?
A7: According to Article 58 of the Rules for Registration and Notification Dossiers of Cosmetics, for special cosmetics that is re-applied for registration, the registration of which is not approved due to the non-safety reason, the copy of the original registration dossiers can be used, and the illustration of the unapproved registration and not involving safety shall be submitted at the same time including the explanation for the reason of unapproved registration.
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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 agency 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
- Disinfectionproducts 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