Beijing Medical Products Administration recently issued a general cosmetic filing FAQ Q&A twenty-seven, mainly related to toothpaste filing, details are as follows.

01Q: For the first filing of toothpaste, what user information should be submitted by the domestic filer and the domestic responsible person?

A: According to Article 10 of the Regulations on the Administration of Toothpaste Filing Information

　　For the first time for toothpaste filing, the domestic filer and the domestic responsible person shall submit the following user information related data in the filing information service platform:

　　(i) Filer’s information sheet and resume of the person responsible for quality and safety;

　　(ii) An overview of the filer's quality management system;

　　(iii) An overview of the filer's adverse reaction monitoring and evaluation system;

　　(iv) An offshore filer shall submit an information sheet on the responsible person in the territory;

　　(v) The original authorization of the person responsible in the territory and the original notarized certificate thereof;

　　(vi) the filer has its own production or commissioned the production of overseas production enterprises, should be submitted to the production enterprise information sheet and quality and safety personnel information, a one-time fill in the existing production enterprises and their information. Producers for the overseas, should be submitted to the original production specification information.

　　Enterprises in China that are engaged in commissioned production only shall submit the producer information form in item (f) for the purpose of correlating and confirming the commissioned production relationship.

　　With multiple identities such as domestic filer, domestic responsible person, manufacturer, etc., or the same domestic responsible person corresponds to more than one foreign filer, you can submit all the relevant information at once to obtain the corresponding user rights. Existing users can provide additional information according to the situation and increase user rights.

02 Q: What are the filings that a toothpaste filer should submit when making a filing?

A: According to Article 24 of the Regulations on the Administration of Toothpaste Filing Information

　　The toothpaste filer shall submit the following information when making a filing:

　　(i) The name, address, and contact information of the filer;

　　(ii) The name, address and contact information of the manufacturer;

　　(iii) Product name information;

　　(iv) Product formulation;

　　(v) Standards implemented for the product;

　　(vi) Sample product labels;

　　(vii) Product inspection reports;

　　(viii) Product safety assessment information.

03Q: How do I report a product formulation for toothpaste that uses a new ingredient?

A: According to Article 26 of the Regulations on the Administration of Toothpaste Filing Information

　　(C) the use of new raw materials for toothpaste. The use of new raw materials are still in the safety monitoring of toothpaste, the filer or the responsible person within the territory should fill in the use of new raw materials, registration certificate number or record number, submit the new raw material registrant filer allows the use of new raw materials authorization documents to confirm the authorized use of raw materials information.

04Q: Must all ingredients used in the production of toothpaste be labeled in the product label?

A: According to toothpaste filing information management regulations Article 28 (a) product labeling samples.

　　2. All ingredients labeling. Toothpaste labeling should be visible in the sales package labeling all ingredients of toothpaste standard Chinese name of raw materials, ingredients as a guide to lead, and in accordance with the content of each ingredient in the product formula in descending order of listing. Formulation exists in the content of not more than 0.1% (w / w) of the ingredients, all not more than 0.1% (w / w) of the ingredients should be other trace ingredients as a guide to lead to a separate labeling, can not be listed in accordance with the descending order of the content of the ingredients. Compounding or mixing of raw materials in the form of formulations to fill in, each of which should be the content of the ingredients in the formula as the content of the ingredients of the order and the basis for determining whether the trace ingredients. Product formulations have or need to be used in the production process but in subsequent production steps to remove the water, volatile solvents and other additives, as well as in order to ensure the quality of raw materials in the raw materials added to a very small amount of stabilizers, preservatives, antioxidants and other ingredients can not be labeled in the full composition.

05 Q: A number of manufacturers to produce the same product toothpaste or toothpaste using a variety of manufacturing process, how should be submitted to the product inspection report?

A: According to "toothpaste filing information management regulations" Article 29 (a) the overall requirements of the inspection report.

　　4. A number of manufacturers to produce the same product, only one of the manufacturers need to submit a complete product inspection report of the production samples, while the microbiological and physical and chemical inspection reports submitted to the production of samples of other manufacturers. Using a variety of paste production process of toothpaste, only one of the process needs to be submitted to the production of samples of the complete product inspection report, while submitting other samples of the production process of microbiological and physical and chemical inspection reports. The same filer for the record of toothpaste products only aroma, color, appearance and other different, only one of the product samples need to submit a complete product inspection report, while submitting other product samples of microbiological and physical and chemical inspection reports.

06Q: The product safety assessment report needs to assess the safety of each ingredient in the toothpaste formula, if it is not possible to confirm the safety of the ingredients in the formula through publicly available data and information, how should it be handled?

A: According to the "toothpaste filing information management regulations" Article 30

　　2. The product safety assessment report needs to assess the safety of each ingredient in the toothpaste formula. If the safety of the ingredients in the formula cannot be confirmed by public data, the product safety assessment information can also be improved in one of the following ways:

　　(1) Formulation ingredients whose safety cannot be confirmed by publicly available data and information, provide objective evidence of a history of safe use for more than three years.

　　(2) In accordance with the relevant principles and requirements of the Technical Guidelines for the Safety Assessment of Cosmetics, etc., provide information that can support the assessment of the toxicological endpoints of the formulated ingredients under the formulated use level.

　　(3) According to the actual situation of the products, in order to ensure the safety of the products as a principle, carry out acute oral toxicity test, mutagenicity test, sensitization test and other toxicological tests.

　　The above assessment information should be in line with the relevant technical specification standards and technical guidelines for toothpaste and cosmetics issued by the State Drug Administration.

　　Tips: Toothpaste products for export only should be filed in the registration and filing information service platform, and the following information should be submitted by the manufacturer:

　　1. Product name;

　　2. Countries (regions) to be exported;

　　3. Product labeling pictures, including the front of the product sales package three-dimensional picture, product packaging plan and product instructions (if any).