1. What is the user information that should be submitted by the domestic filer and the domestic responsible person for the first filing of the toothpaste?
According to Article 10 of the Provisions for Notification Dossiers of Toothpastes (hereinafter referred to as the Provisions), When applying for toothpaste filing for the first time, the domestic filing person and the domestic responsible person shall submit the following user information materials on the filing information service platform:
1). The filer's information form and the resume of the person responsible for quality and safety;
2). Overview of the filer's quality management system;
3). Overview of the filer's adverse reaction monitoring and evaluation system;
4). Overseas filers shall submit the information form of the domestic responsible person;
5). The original authorization letter of the domestic responsible person and its original notarized certificate;
6). If the filer produces on their own or entrusts overseas production enterprises to produce, they shall submit the information form of the production enterprise and the information of the person in charge of quality and safety, and fill in and submit the existing production enterprise information in one go. If the production enterprise is overseas, it shall submit the original production specification information.
Enterprises within the territory of China that only engage in entrusted production shall submit the information form of the production enterprise in item (6) for the purpose of confirming the entrusted production relationship.
For those with multiple identities such as domestic filer, domestic responsible person, production enterprise, etc., or the same domestic responsible person corresponding to multiple overseas filers, they can submit all relevant materials in one go and obtain the corresponding user rights. Users can supplement relevant information and increase user rights according to the situation.
2. What are the filing materials that toothpaste filers should submit for filing?
According to Article 24 of the Provisions, toothpaste should submit the following materials:
1). Name, address, contact information of the filing person;
2). Name, address, contact information of the production enterprise;
3). Product name;
4). Product formula;
5). Product implementation standard;
6). Product label template;
7). Product inspection report;
8). Product safety assessment materials.
3. How to report the product formula for toothpaste using new ingredients?
According to Article 26 (3) of the Provisions, for toothpaste using the new ingredients that are still under safety monitoring, filers or domestic responsible persons shall fill in the registration certificate number or filing number of the new ingredient, and submit an authorization document from the registrant or filer of the new ingredient to allow the use of the new ingredient, confirm the authorized use information of the ingredient.
4. Is it necessary to mark all the ingredients used in the toothpaste production process on the product label?
According to Article 28 (1) of the Provisions, the Toothpaste label shall be marked with the standard Chinese names of all ingredients on the visible surface of the sales package, with "ingredients" as the guiding words. All ingredients shall be arranged in descending order of content in the toothpaste formula. The ingredients that are less than or equal to 0.1% (w/w) in the toothpaste formula shall be labeled separately with "other trace ingredients" as the guide words, whose content may not be arranged in descending order. For formula filling in the form of compound or mixed ingredients, the content of each ingredient in the formula should be used as the basis for arranging and determining whether it is a trace ingredient. The product formula includes auxiliary components such as water and volatile solvents that need to be used in the production process but are removed in subsequent production steps, as well as very small amounts of stabilizers, preservatives, antioxidants, etc. added to the ingredients to ensure the quality of the ingredients, which may not be labeled in the full ingredient list.
5. If multiple production enterprises produce the same toothpaste product, or toothpaste produced with multiple paste-making processes, how to submit product inspection reports?
According to Article 29(1) of the Provisions, if multiple production enterprises produce the same product, only the complete product inspection report of one production enterprise's production sample needs to be submitted, and the microbiological and physicochemical inspection reports of other production enterprises' production samples need to be submitted at the same time. For toothpaste products filed by the same filer, if there are only differences in the fragrance, color, appearance, etc., only the complete product inspection report of one product sample needs to be submitted, and the microbiological and physicochemical inspection reports of other product samples need to be submitted.
6. The product safety assessment report needs to assess the safety of each ingredient in the toothpaste formula. If the safety of the formula ingredients cannot be confirmed through public data, how should they be handled?
According to Article 30 of the Provisions, the product safety assessment report needs to assess the safety of each ingredient in the toothpaste formula. If it is impossible to confirm the safety of the formula ingredients through public data, the product safety assessment materials can also be improved in one of the following ways:
1). For those formula ingredients whose safety cannot be confirmed by public data, provide more than three years of objective proof of safe use history.
2). In accordance with the Technical Guidance for the Safety Evaluation of Cosmetics and other relevant principles and requirements, provide toxicological endpoint assessment data that can support the use of formula ingredients at the formula dosage.
3). Based on the actual situation of the product and with the principle of ensuring product safety, conduct the Acute Oral Toxicity Test, the Mutagenicity Test, the Sensitization Test, and other toxicological tests.
The above evaluation materials should comply with the technical specifications, standards, and technical guidance principles related to toothpaste and cosmetics issued by the National Medical Products Administration.
Toothpaste products for export only should be filed on the registration and filing information service platform, and the production enterprise should submit the following materials:
1). Product name;
2). Intended export country (region);
3). Product label images, including a three-dimensional view of the front of the product's sales package, a plan view of the product's packaging, and the instruction manual (if available)
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