Chapter I. General provisions

Article I  In order to standardize the management of toothpaste for the record, to ensure that toothpaste for the record of the standardized submission of information, based on the "Supervision and Administration of Cosmetics Regulations," "toothpaste supervision and management measures," and other relevant laws and regulations, the development of the provisions of this regulation.

Article 2  in the People's Republic of China in the territory of the production and operation of toothpaste submitted for the record shall comply with the requirements of these provisions.

Article 3  The toothpaste filer shall be based on scientific research, and be responsible for the completeness, authenticity, reliability and traceability of the filing information submitted, and bear the corresponding legal responsibility. The overseas toothpaste filer shall supervise the filing work of the responsible person in the territory.

Article 4  The filing information of toothpaste shall use the standardized Chinese characters announced by the State. Except for registered trademarks, website addresses, patent names, names and addresses of overseas enterprises, etc., which must use other words, or agreed terminology, all other words shall be translated into Chinese in a complete and standardized manner, and the original text shall be attached to the corresponding translation.

Article 5  toothpaste filing information should be in line with the relevant provisions of the state seal, complete signature, with legal effect. Overseas enterprises and other organizations do not use the official seal, should be signed by the legal representative or the person in charge of the enterprise (other organizations). In addition to user information related information, toothpaste filing information, such as the need for foreign filers to sign the seal, its legal representative or person in charge may authorize the filer or the signatory of the responsible person in the territory to sign. Authorized to delegate the signature should be submitted to the original power of attorney and its original notary certificate, the power of attorney should be written in the authorized signature of the matters and scope.

In addition to the original information issued by the government authorities or relevant organizations, inspection agencies, notary public, etc., the toothpaste filing information should be stamped page by page by the domestic filer or the domestic responsible person.

Article 6  The toothpaste filing information should be used in China's legal units of measurement, the use of other units of measurement, should be converted to China's legal units of measurement; should be accurately cited references, indicating the source, to ensure effective traceability; should standardize the use of punctuation, charts, terminology, etc., to ensure that the content of the information is accurate and standardized.

Article 7 of the toothpaste filing information, the same content should appear before and after the consistency; there are relevant documents, should be consistent with the contents contained in the supporting documents.

Article 8  of the toothpaste filing text information in the main body of the text color should be black, the content is easy to identify, set the appropriate line spacing and page margins to ensure that the text is not lost in the printing or binding information.

Article 9 of toothpaste for the record of paper information should use the international standard A4 type specification paper, the content is complete and clear, and shall not be altered. Toothpaste packaging to expand the picture of the need for larger size paper, you can use other specifications of the paper, to ensure that properly placed within the A4 specification information. The carrier of paper documents and writing materials should meet the requirements of durability.

Chapter II. Information requirements related to user information

Section I. Information items and requirements

Article 10  For the first time for the record of toothpaste, the domestic filer and the domestic responsible person shall submit the following user information related data in the record information service platform:

(i) Recorder'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;

(d) 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;

(F) 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.

Article 11  The resume of the person in charge of quality and safety shall include the educational background, work experience and other contents relevant to his/her requirements.

Article 12  of the quality management system is an overview of the filer's quality management and control capabilities and the process of summarizing the description, should truthfully and objectively reflect the actual situation, including supplier selection, raw material acceptance, production and quality control, product sampling and other management systems. Language should be concise, reflecting the quality control key points set and daily implementation of management requirements.

The filer of both self-production and commissioned production, should be submitted to the appropriate version of the quality management system overview.

Article 13  The overview of the adverse reaction monitoring and evaluation system is a summary description of the capacity and process of adverse reaction monitoring and evaluation of the filer and the responsible person in the territory, and should reflect the actual situation truthfully and objectively. The language should be concise, reflecting the key points of adverse reaction monitoring, the settings of each link and the daily implementation and management requirements.

Article 14  of the responsible person in the territory of the authorization should clearly reflect at least the following content and information: the filer and the responsible person in the territory of the name, authorization and authorized relationship, the scope of authorization, authorization period. The same product shall not authorize more than one responsible person in the territory, the responsible person in the territory should be within the scope of authorization to carry out the filing work.

Article 15  of foreign production enterprises should be submitted to the production enterprise in line with the quality management system or production quality management standards of qualification certificates, documents and other supporting information, supporting information should be located in the country (region), the competent government departments, certification bodies or with the country (region) certification and accreditation qualifications of third parties issued or recognized, set out the name of the producer and the actual production of address information.

If it is not possible to provide the original of the supporting information, a copy notarized by a notary public in China or confirmed by an embassy (consulate) in China shall be provided.

Section II. User information and updates

Article 16  of the user information or related information changes, should be updated in a timely manner to ensure that the record information service platform in the user information and related information is true and accurate.

Updates mainly include self-updating, general audit updates, production site updates and other specific provisions of the audit update. The audit is updated, the drug supervision and management department after the audit, to complete the update of relevant information and data.

Article 17  The information related to user rights that can be updated on its own includes the information of the legal representative, the information of the person in charge of quality and safety, and the contact information.

If the above information changes, the user shall promptly update it by himself/herself.

Article 18  The information related to user rights that can be updated for general auditing includes basic information, overview of the quality management system, overview of the adverse reaction monitoring and evaluation system, and the scope of authorization and duration of authorization for those responsible within the territory.

When the general audit is updated, the General Audit and Update Information Form should be submitted, along with the relevant information that meets the requirements. Among them, the name of the foreign filer changes, should provide the country (region) by the competent government departments or relevant institutions issued by the main body has not changed the original of the relevant documents, can not submit the original, should be provided by the Chinese notary public notarized or by the embassy (consulate) of our country to confirm the copy; overseas production enterprises production site only address text changes, should provide by the country (region) Government authorities or relevant institutions issued by the production site has not changed the original documents, can not submit the original, should be provided by the Chinese notary public notarization or by the embassy (consulate) of China to confirm the copy; the scope of the authorization of the responsible person in the territory to change the scope of the new authorization should include the scope of the original authorization.

Article 19  of the user rights related information, can be updated for the production site for the production enterprise production site information. Specific circumstances include: relocation of production sites, production sites increased, production sites reduced, only production specification documents updated.

Production site update should be submitted to the production site update information form. Among them, the overseas production enterprises of the production site relocation or increase, or production quality management standardization documents for updating, should be required to provide overseas production quality management standardization of relevant information.

Article 20  According to the actual production and operation, such as the need to increase their own production or commissioned overseas production enterprises, can submit the relevant information to increase the production enterprise information, if necessary, also need to supplement the submission of the corresponding quality management system overview.

Article 21  When updating user information, enterprises should first check against all the information under the user name. If more than one piece of information changes at the same time, it should be updated at the same time and submit the relevant information together.

Article 22  After the expiration of the authorization period contained in the authorization letter of the responsible person in the territory, the responsible person shall resubmit an updated authorization letter to extend the authorization period. If the renewed authorization is not resubmitted after the expiration date, the responsible person in the territory will not be able to continue to handle the additional filings for the corresponding foreign filer, and the filings that have been carried out under its name may continue to be completed.

Overseas production of quality management standards to prove the information has a validity period, should be updated in a timely manner to prove the information, the longest shall not exceed 90 days after the expiration of the validity of the deadline; no validity period, should be submitted every five years to the latest version.

Article 23  According to the actual production and operation of the situation, the need to cancel the user rights, should be in the relevant products all complete the cancellation or change, submit the user rights cancellation information form, the user rights cancellation.

Chapter III Toothpaste Filing Information Requirements

Article 24  A 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.

Article 25  The filer shall fill out the toothpaste filing information item by item, and submit relevant information.

(a) product name information. Product name, including the Chinese name and the foreign name of the imported product, the Chinese name of the product should be in line with the "supervision and management of toothpaste," "Cosmetic Labeling Regulations" and other relevant laws and regulations. Product name information should be standardized for the Chinese name of the product trademark name, common name, attribute name, suffix, etc., in the naming basis, respectively, the trademark name, common name, the specific meaning of the suffix, if necessary, to explain the product name as a whole. Trademark name in the Chinese name of the product using letters, hanyu pinyin, numbers, symbols, etc., should provide a trademark registration certificate. Imported products should be on the foreign name and Chinese name respectively, and explain the Chinese name and the corresponding relationship between the foreign name (designed specifically for the Chinese market without foreign names, except).

(b) product categories. The filer should be in accordance with the efficacy of toothpaste and the use of the population to determine the product category.

(c) Production information. Entrusted the production of toothpaste in the territory of the enterprise, the filer or the responsible person in the territory should choose to have opened the user's rights to the production of the enterprise to be associated with the confirmation of the production of the enterprise for the record.

Entrusted foreign enterprises to produce toothpaste, the filer or the responsible person in the territory shall submit the entrusted relationship documents. Entrusted relationship should contain at least the name of the product, the commissioning party, the commissioned producer name, production address, the date of commissioning of the product, the commissioned producer of legal persons or legal persons authorized by the signature. The filer and the commissioned producer belongs to the same group of companies, can be submitted to the same group of companies and the group of companies issued by the product quality assurance documents to confirm the commission relationship.

(d) has been on the market sales certificate. Imported toothpaste should be provided by the toothpaste filer's country or production country (region) government authorities or industry associations and other institutions have been issued by the marketing documents, the domestic filer commissioned the production of overseas manufacturers and product formulations designed specifically for the Chinese market, except. Has been listed on the sales of documents should contain at least the name of the product, the filer or the name of the manufacturer, the name of the organization issuing the document and the date of issuance of the document, and signed by the agency to confirm. Has been listed on the sales certificate has a validity period, for the record should be within the validity period. Combination of packaging products, there are both imported and domestic part of the domestic part, only the imported part of the documents have been marketed and sold to submit.

(e) Multiple products share documents. Imported toothpaste has been listed on the sales of documents, commission relationship documents or documents belonging to a group of companies and other documents can be listed at the same time more than one product. These products for the record, one of the products can use the original, the other products can use a copy, and the name of the product where the original and the relevant record number and other information.

(F) products designed specifically for the Chinese market. Product formulations designed specifically for the Chinese market of imported toothpaste (except commissioned in the territory of foreign production), the record shall be submitted to the Chinese consumer's teeth and surrounding tissue characteristics, consumer demand for the formulation of the design of the information, as well as the selection of Chinese consumers in China to carry out human safety tests or human efficacy test information.

Article 26  The product formulations for the production of feeding formulations, the filer in accordance with the State Drug Administration issued by the toothpaste-related technical specifications standards and technical guidelines, or with reference to the cosmetics-related technical specifications standards and technical guidelines for filling. Product formulations should meet the following requirements:

(a) Formula sheet requirements. Product formulations should include the serial number of raw materials, raw material name, percentage content, purpose of use, notes and other content.

1. Raw material names. Product formulations should provide all the ingredients of the standard Chinese name, such as the name of international cosmetic ingredients (referred to as INCI name) or English name, should also be provided. Formulations containing new ingredients are still in the safety monitoring of toothpaste, should be used to have registered or filed the name of the raw material; the original packaging of imported products labeled ingredients INCI name and the name of the ingredients of the formula is inconsistent, it should be explained.

The use of colorants, should be marked in the product formulation of raw material name column cosmetics safety technical specifications contained in the colorant index number (referred to as CI No.), except without CI No.; the use of colorants for the coloring agent should be marked after the name of the coloring agent "(coloring agent)"; the use of nano raw materials, should be marked after the name of such ingredients "(nanoscale)".

2. Percentage content. Product formulations should provide the content of all raw materials, content in terms of mass percentage, all raw materials should be listed in decreasing order of content; raw materials containing two or more ingredients (except flavors) should be listed in the composition and corresponding content.

3. Purpose of use. Should be based on the raw materials in the product actually play a major role in the labeling of the main purpose of use, and the physical and chemical properties of raw materials, product properties, formulations, etc. in line with the process. If the efficacy of raw materials is not a single component, should be used in the formulation of the purpose of the column to specify the specific efficacy of its ingredients.

4. Remarks column. Fill in the formula sheet of raw materials to further explain the content of the formula should be marked in the remarks column. For example: the use of hydrocarbons derived from petroleum, coal tar (except for a single component), should be marked with the relevant raw material Chemical Abstracts Index number (CAS number for short); the use of categories of raw materials, should indicate the specific name of the raw material; the use of raw materials derived directly from plants, should indicate the specific use of the original plant parts; product formulations formulas fill in the "flavor" raw materials, product labeling to identify the specific flavor components, as well as the formula sheet should be marked in the remarks column. "raw materials, product labeling identification of specific flavor components in the flavor, as well as imported products containing specific flavor components of the original packaging labeling, should be explained in the formulas Remarks column; formulations with the same name of raw materials, but fill in the formulas separately, should be in the formulas Remarks column briefly labeled with the reasons for filling in the formulas, such as the raw materials have different molecular weights, different trade names, etc.; use of colorants for color precipitates, should be described; the use of colorants for color precipitates, should be described in the formulas coloring agent for the color starch, should indicate the type of color starch used.

5. Product formulations only fill in the "flavor" raw materials, without the need to submit the specific flavor components of the type and content; product labeling flavor in the specific flavor components, as well as imported products in the original packaging labeling specific flavor components, should be in the formulations table in the comments column. Product formulations formulated at the same time fill in the "flavor" and flavor of the specific spice components, should be submitted to the manufacturer of raw materials on the flavor of all the spice components contained in the type and content of the information. The use of food flavors and fragrances, should provide the basis for edible information.

6. Contains two or more independent formulations and packaging containers are not detachable toothpaste, should be filled out the formula, according to a product for the record.

(ii) raw material safety-related information. The filer or the responsible person in the territory should fill in the product of raw materials used in the manufacturer's information and submit raw material safety information. Raw material safety information mainly includes raw material quality specifications, safety risk material control, raw material safety risk assessment conclusions and other information related to raw material safety.

(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 allowed to use the new raw material authorization documents, to confirm the authorized use of raw materials information.

Article 27  The standards implemented by the product, including product name, full composition, a brief description of the production process, sensory indicators, microbiological and physical and chemical indicators and their quality control measures, methods of use, safety warnings, storage conditions, use of the term, etc., should be in line with the relevant state laws and regulations, mandatory national standards and technical specifications (see Appendix 1 for compilation instructions, and see Appendix 2 for samples).

(i) Product name. Including the Chinese name and the foreign name of the imported product.

(ii) All ingredients. Including the production of all raw materials used in the product's serial number, the name of the raw material and the purpose of use, all raw materials should be arranged in decreasing order of content.

(iii) A brief description of the production process.

1. Should briefly describe the main steps of the actual production process, including feeding, mixing, filling and so on. Formulation table more than 2 raw materials, such as pre-mixing, filling and other production steps in different production enterprises with the completion of the production process, it should be noted.

2. Should reflect the scope of the main production process parameters, all raw materials should be clearly listed in the production steps, the name or serial number of raw materials used should be the same as those listed in the product formula; if the same raw materials used in different steps of the stage, it should be distinguished. If the production process needs to be used but in subsequent production steps to remove the water, volatile solvents and other additives, should be noted.

3. The simultaneous use of two or more paste production process, should be a brief description of the respective production process.

(d) sensory indicators. Should be described separately in the product contents of the color, nature, smell and other indicators.

1. Color refers to the objective color of the contents of the product. The same product has a variety of distinguishable colors, should be described one by one; difficult to distinguish between colors, can describe the visual presentation of the product or the use of the main color, can also describe the color range.

2. Trait refers to the form of the contents of the product.

3. Odor refers to whether the contents of the product have an odor.

(v) Microbiological and physico-chemical indicators and quality control measures.

1 should be submitted to the actual control of the product microbiological and physical and chemical indicators of control standards, microbiological and physical and chemical indicators should be in line with the "toothpaste for the record microbiological and physical and chemical test project requirements" (see Annex 3, hereinafter referred to as "test project requirements") contained in the relevant project requirements, claiming that anti-caries, plaque inhibition, dentin sensitivity, alleviate the effects of gum problems of the toothpaste, the efficacy of the raw materials should be clear control range, and Submit the corresponding test report.

2. Should be based on the actual control of the product microbiological and physical and chemical indicators submitted to the appropriate quality control measures.

3. The use of testing as a quality control measure, should indicate the frequency of testing, the method used and "test item requirements" contained in the test method is completely consistent, should fill in the "test item requirements" test method name; and "test item requirements" contained in the method is inconsistent with the test method should be filled in the name of the test method, indicating that the method whether the method is with the "test item requirements" contained in the method to carry out the validation of the complete Test methods and method verification information to file for inspection. The filer should set up a reasonable frequency of inspection to ensure the quality and safety of toothpaste products.

4. The use of non-inspection as a quality control measures, should specify the specific implementation of the program, the rationality of quality control measures to ensure that the product meets national standards and technical specifications.

(f) Method of use. When necessary to elaborate the use of toothpaste, the use of the population has special requirements, should be explained.

(vii) safety warning language. Safety warning language should be consistent with laws, administrative regulations, departmental regulations, mandatory national standards, technical specifications. Restricted components of toothpaste, such as the use of components, permitted components of the warning language and safety matters related to labeling requirements; toothpaste for children and other special populations require labeling precautions; the addition of fluoride non-children's toothpaste should be marked "This product is not suitable for children,"; and other should be labeled with the safety warning language, precautions. Safety warning terms should be labeled with "attention" or "warning" as a guide.

(H) storage conditions. Should be based on product packaging and product stability and other characteristics of the product storage conditions.

(ix) Use period. Should be based on the product packaging, the product's own stability or the results of relevant experiments, set the duration of use of the product.

Article 28  The toothpaste should be labeled in Chinese. Chinese labels should use standardized Chinese characters, the use of other words or symbols, should be visible in the product sales package using standardized Chinese characters corresponding to the explanatory notes, Web site, the names and addresses of foreign enterprises and agreed terminology, etc. must be used except for other words. Affixed with Chinese labels, Chinese labels about product safety, efficacy claims should be consistent with the original labeling content corresponds to the original label on the use of crowded attention needs to be adjusted to adapt to the requirements of China's laws and regulations, except. In addition to registered trademarks, Chinese labels on the same visual surface of other text font size should be smaller than or equal to the corresponding standardized Chinese character font size.

The filer shall submit product labeling samples, upload product sales packaging and instructions. Product labeling in the labeling content, labeling and format should be consistent with the "supervision and management of toothpaste," "Cosmetic Labeling Regulations" and other requirements.

(A) product labeling samples. The filer or the person responsible for the territory should fill out the toothpaste product labeling samples, including the filer and producer information, the full composition of the logo, the net content, the use of the term, safety warnings, product name related to the interpretation of the description, according to relevant provisions should be labeled with other content, other text content and so on.

1. The filer and producer information. Toothpaste labeling should be marked with the filer, the person responsible for the territory and the name and address of the manufacturer and other relevant information. Producer name and address should be labeled to complete the last process of contact with the contents of the name of the production company, address. The filer at the same time commissioned a number of production enterprises to complete the last contact with the contents of the process, you can also mark the commissioned producer's name, address, and through the code or other means to specify the product of the specific producer. Production enterprises for the territory, but also in the enterprise name and address should be marked after the production license number.

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.

3. Net content. This should be provided on the basis of the package specification to which the sales package relates.

4. The use of methods, safety warnings, storage conditions, duration of use and other content should be consistent with the implementation of the product standards.

5. Explanation of the product name. The filer should fill in the name of the product needs to be visualized in the sales package to explain and explain the content. Such as the use of combinations of product names may enable consumers to product efficacy of ambiguity, should be explained; product name of the registered trademark in Chinese using letters, hanyu pinyin, numbers, symbols, etc., should be explained to explain its meaning.

6. Other content that should be labeled in accordance with relevant regulations. In accordance with relevant laws and regulations, mandatory national standards, technical specifications and other content should be labeled, as well as the filer to use the innovative terminology of the explanatory notes. Fluoride toothpaste should be added to indicate the amount of fluoride added; claiming anti-caries, plaque inhibition, anti-dentin sensitivity, reduce gum problems efficacy, should be labeled in the labeling of specific efficacy components.

7. Other text content. You can fill in the content of the filer's own choice of labeling.

(ii) Product sales packaging. Toothpaste for the record, the filer or the responsible person in the territory shall upload the product sales package labeling pictures, pictures should meet the following requirements:

1. Pictures include all the visual surface of the packaging plan and can reflect the appearance of the three-dimensional display of the product, the picture should be complete and clear, the plan should be easy to identify all the contents of the label; can not clearly show all the contents of the label, it should also be submitted to the local zoom map or the product packaging design drawings; with a box of the product, it should be uploaded to the direct contact with the contents of the inner packaging plan and three-dimensional display of the map, the inner packaging At least the Chinese name of the product should be labeled and the use of the period.

2. The content of the labels and instructions in the uploaded images must not exceed the content of the product labeling samples.

3. If there are multiple sales packages, the labeling images of all sales packages should be submitted. If one or more of the following circumstances are met, submit one of the sales package labeling pictures, and other sales package labeling pictures can be uploaded without duplication:

(1) Only the net content specifications are different;

(2) Only the uploaded sales package is additionally labeled with information on sales channels, promotions, holiday specials, and giveaways;

(3) Differences in the color of the sales package only;

(4) has been filed products in sets, gift boxes and other forms of combination of sales, the combination process does not touch the contents of the product, in addition to increase the name of the combination of packaging products, other labeling content does not exceed the content of each product label;

(5) Textual description can clearly reflect the difference with the uploaded sales package, and has been noted to explain.

4. Imported toothpaste should be uploaded to the production country (region) products of the original sales package (including instructions), as well as foreign language labels in Chinese translation. Imported toothpaste sales package can be affixed with Chinese labels, can also be designed specifically for the Chinese market sales package. Designed specifically for the Chinese market sales packaging, should be submitted to the product formulation, production process and toothpaste filer's country or production country (region) products consistent with the description of the information.

Article 29  The toothpaste for the record, the filer shall submit product testing reports, including microbiological and physical and chemical test reports, toxicology test reports, efficacy evaluation reports.

(i) General requirements for inspection reports.

1. toothpaste filer can be based on product formulations, categories, etc., commissioned by the cosmetic registration and filing inspection agency, drug non-clinical safety evaluation of research institutions, drug clinical trial organizations and / or medical device clinical trial organizations (with dental purposes of the health care institutions qualified to practice) and other technical institutions to issue a product test report respectively, the selected technical institutions should have the appropriate test or evaluation capabilities, test The management of the organization in accordance with the relevant provisions of the implementation of cosmetics.

2. With reference to the State Drug Administration on the optimization of general cosmetics filing inspection management requirements, in line with the relevant requirements, toothpaste filers can be commissioned by themselves or entrusted to the manufacturer of microbiological and physical and chemical testing requirements (hereinafter referred to as self-inspection). Product filing to submit a self-test report, the filer should be submitted at the same time with the appropriate test capabilities of the statement, to carry out self-test of the corresponding inspectors, equipment, facilities and premises environment and other information, and commitment to the authenticity of the test report, responsible for accuracy.

3. Product inspection report of the inspected samples of relevant product information should be consistent with the product information for the record. Due to name changes and other reasons, resulting in the test report in the product name, company name and other information that does not affect the test or evaluation results are inconsistent with the filing of information, can be explained and submitted to the test report to change the application form and the technical agency issued by the supplemental test report or correction letter.

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 process production samples 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.

(b) Microbiological and physical and chemical tests. Microbiological and physical and chemical testing of the inspected samples should be the same number of products. Microbiological and physical and chemical test items should be consistent with the "test item requirements" requirements, give priority to "Cosmetic Safety Technical Specification" included in the test method.

(c) Toxicology test. In order to further confirm product safety, some toothpaste product inspection reports need to include oral mucosal irritation test items, giving priority to the "Technical Code for Cosmetic Safety" included in the test method, or reference to the relevant oral medical device test methods.

Toothpaste manufacturers have obtained the production quality management system issued by the competent government department in the country (region) of the relevant qualification certification (produced by a number of manufacturers, all manufacturers have obtained the relevant qualification certification), and product safety risk assessment results can fully confirm the product safety, can be exempted from the submission of the product's oral mucous membrane irritation test report, with the exception of the following circumstances:

1. Product claims for children's use;

2. Products claiming to have anti-caries, plaque inhibition, anti-dentin sensitivity, reduce the effectiveness of gum problems;

3. Products using new raw materials that are still under safety monitoring.

(d) Efficacy evaluation. Efficacy evaluation should be carried out as required on the basis of ensuring product safety.

1 toothpaste efficacy claims should have a sound scientific basis, the filer based on the results of efficacy evaluation to prepare and publish a summary of the evaluation of efficacy claims, the summary generally includes, but is not limited to, the following: efficacy evaluation of the name of the project, the evaluation methodology, the evaluation of the organization, the results of the evaluation, and so on. In addition, if you need to claim that the efficacy of raw materials, but also to carry out literature research, research data analysis, evaluation tests, etc., in order to confirm that the raw materials have the claimed efficacy, and the efficacy of raw materials should be claimed to have sufficient correlation with the efficacy of the product claims.

2. Toothpaste product efficacy evaluation methods are generally divided into human evaluation methods and other evaluation methods. When human evaluation is carried out, it shall meet the relevant requirements of laws and regulations in program design, protection of subjects' rights and interests, standardization of operation, data and file management, etc., and the evaluation methods shall meet the technical requirements of relevant standards and specifications. When using methods other than human efficacy evaluation for efficacy evaluation, method selection should ensure that the evaluation results are scientific, accurate and reliable.

3. Toothpaste claiming to have anti-caries, plaque inhibition, dentin sensitivity, reduce gum problems and other efficacy , need to carry out human efficacy evaluation, submit the efficacy evaluation information for the record, and according to the results of the efficacy evaluation compiled and published summary of efficacy claims evaluation. For the addition of fluoride to achieve anti-caries efficacy, and fluoride to achieve the "test item requirements", can be exempted from the anti-caries efficacy evaluation. Toothpaste products filed by the same filer, the use of the same efficacy of raw materials verified to play an efficacy role, and the concentration of the formula is not lower than the filed products, claiming to have the same efficacy of caries prevention, plaque inhibition, dentin sensitivity, gum problems, etc., can be exempted from the evaluation of the efficacy of the human body.

Claims other than clean other effects, the human body is required to conduct efficacy evaluation or other efficacy evaluation, the filer based on the results of efficacy evaluation to prepare and publish a summary of efficacy claims evaluation.

Toothpastes that only claim cleaning efficacy are exempt from efficacy evaluation.

Article 30  The filer shall refer to the "Cosmetic Safety Assessment Technical Guidelines" of the relevant principles and requirements, combined with the actual situation of toothpaste products, scientific and reasonable to carry out product safety assessment, and submit product safety assessment report.

1. The product safety assessment report generally includes, but is not limited to, the following contents: summary, product introduction, product formulation, safety assessment of the components in the formulation, assessment of possible risk substances, risk control measures, conclusions of the safety assessment, curriculum vitae and signature of the safety assessor, relevant references, appendices and so on.

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 the public data and information, 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.

Article 31  The toothpaste products for export only, should be filed in the registration filing information service platform for the record, by the manufacturer to submit the following information:

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).

Article 32  Children's toothpaste means toothpaste claimed to be suitable for children under the age of 12 years (including 12 years). Children's toothpaste can claim that the efficacy of the category is limited to cleaning, caries prevention. Labeling "for the entire population", "the whole family" and other terms or the use of trademarks, patterns, harmonies, letters, hanyu pinyin, numbers, symbols, packaging forms, etc. implying that the use of the product population includes children's products in accordance with the management of children's toothpaste.

Children's toothpaste should be "attention" or "warning" as a guide, in the sales package can be visually labeled "should be used under adult supervision", "should not be consumed", "beware of swallowing" and other relevant warning language; add fluoride children's toothpaste should be labeled single-use limit. Can not be consumed" "Beware of swallowing" and other related warning language; add fluoride children's toothpaste should be labeled single-use limit.

The filer shall design children's toothpaste according to the physiological characteristics of children, follow the principle of safety priority, the principle of efficacy must be, the principle of minimal formulation, submit the formulation design principles in the safety assessment information, and the necessity of using raw materials in the formulation to explain. Children's toothpaste safety assessment, in terms of hazard identification, exposure calculation, etc., should take into account the physiological characteristics of children.

Attachment: 1. Toothpaste products to implement the standardized preparation of instructions

2. Standards implemented for toothpaste products (samples)

3. Toothpaste for the record microbiological and physical and chemical test project requirements

Attachment 1

Toothpaste product implementation of the standardization of the preparation of instructions

(a) The preparation work should be in line with the relevant provisions of national laws, administrative regulations, departmental rules, technical standards and normative documents.

(ii) The design, content and data of the standards implemented for products should be in accordance with recognized scientific principles, accurate and reliable.

(c) product implementation of the standard text, figures, formulas, units, symbols, charts and so on should be in line with the standardization requirements, citing the standard is accurate and effective. Definition of terms should be consistent with the relevant provisions of the State.

1. Standardized Chinese characters should be used. The punctuation marks used should conform to the provisions of GB/T 15834.

2. GB 3101, GB 3102 should be used in accordance with the legal unit of measurement. When expressing the value of a quantity, its unit should be written.

3. The table of contents of the cited standard or document should be accurately listed.

4. The cited standard or document should include the version number or year and the full name of the standard (document).

5. If the cited standard (document) can be obtained on-line through the Internet, details of the path of obtaining and accessing it should be provided. The full URL of the cited standard (document) should be given. In order to ensure traceability, the source URL should be provided.

(iv) The testing methods established in the standards implemented for the products are accurate, precise and methodologically validated.

(e) Product implementation standards have limited requirements, must use clear numerical expression. Should not use only qualitative expressions, such as "appropriate amount" or "appropriate temperature".

(f) product implementation of the standard form should be filled out in accordance with the prescribed style, in addition to the need to correspond to the different formulations, the contents of the form generally can not be split again.

All forms should be sequentially numbered and titled. In the case of multiple recipes, if separate tables are required, they should be named appropriately to reflect the correspondence with the relevant recipes. Where tables are referred to in the text, they should be correctly referenced by table order or title.

(vii) Product implementation of standards may involve intellectual property rights, drug supervision and management departments do not bear the responsibility of identifying the intellectual property rights.

(viii) Standard substances (including standard and control substances) recognized by national statutory departments should be used. If the control substances used are self-developed, the relevant requirements should be submitted in accordance with the relevant identification research information and control substances. Samples for research should be formulated, stabilized and representative of multiple batches of products.

(ix) to carry out research on the implementation of product standards, should be able to meet the standard requirements for the implementation of the product research conditions in the laboratory, and by the appropriate technical staff.

Attachment 2

Standards implemented for toothpaste products (sample)

(Standard No. ** for product implementation)

[Chinese name] (imported automatically by the system)

[Foreign language name] (imported automatically by the system)

[Full ingredients of the formula] (automatically imported by the system, including the serial number of the raw material, the Chinese name of all the raw materials and the purpose of use)

Table 1 Product formulation ingredients and purpose of use

[Brief description of the production process] should be a brief description of the actual production of the product production process, including feeding, mixing, filling, packaging and other major steps, should be submitted to the process parameters mainly refers to the temperature, the temperature range should be set should be considered mainly on product quality, safety, and secondly, also consider the temperature required for different production scales, different production equipment.

An example involving segmented production is shown below:

1. Add phase A raw materials into the water phase pot, heat (70℃-80℃), mix well, stir and put into the main pot.

2. Stir the B-phase ingredients and add them to the main pot after they are well dispersed.

3. Stir the C phase and add it to the main pot after it is well dispersed.

4. ......

5. ......

6. Stir the ingredients in step 6 to disperse them completely and then add them to the main pot.

7. Stirring and cooling (40℃-50℃) to After that, add the ingredients in phase E into the main pot, stirring, cooling (30℃-40℃), and then take the material for testing (semi-finished product 1).

8. After the material body is qualified, defoaming and filtering, discharging the material (semi-finished product 2). Material transfer.

9. Filling (finished product)

Phase A raw materials: parts 1, 4, 5, 10, 17, 23, 29, 32, 33

Phase B raw materials: part 1, 21

Phase C feedstock: part 1, 24

Phase D raw materials: 2, 7, 8, 9, 12, 13, 15, 16, 28

Phase E raw materials: 3, 6, 11, 14, 18, 19, 20, 22, 26, 30, 31

Phase F feedstock: remaining 1,25

G-phase raw materials: 27

The semi-finished product 1 obtained in steps 1-7 is made at the production address 1: No. xxx road xxx, xxx district, xxx country or the production address 2: No. xxx road xxx, xxx district, xxx country.

The semi-finished product 2 obtained in step 8 was made at the production address 3: No. xxx Road xxx, xxx District, xxx State.

The finished product obtained in step 9 was made at the production address 4: No. xxx Road xxx, xxx Province, China.

[Sensory indicators]

Color: e.g. light pink;

Appearance: e.g. paste;

Odor: Please fill in the following three categories according to the actual situation of the product: scented, characteristic odor of raw materials, odorless;

Table 2 Sensory indicators

[Microbiological and physico-chemical indicators and quality control measures]

Table 3 Microbiological and physicochemical indicators and their quality control measures

Remarks: Quality Management Measures* (1) The filer should select more than 1 (including 1) quality management measures for each indicator according to the needs of actual product control, in order to ensure that the final product complies with the "Cosmetic Safety Technical Specification" as well as the requirements of the standard implemented for the product.

(2) Acceptable quality management measures include, but are not limited to: batch-by-batch inspection of products, full inspection, control of raw material-related indexes, and production process control.

Summary statement**

Example (1) production process control and full inspection: the product production process plant air purification level reached ****, and in accordance with the full inspection requirements to carry out the necessary tests; the "gram-negative bacteria qualitative testing" method used, our own development of methods, standardized ISO ***, and with the "Cosmetic Safety Technical Specification" "microbiological test methods" heat-resistant coliforms and Pseudomonas aeruginosa test method for comparison and validation. The "Gram-negative bacteria qualitative test" is a method developed by our company, which is in line with ISO***, and compared with the test methods for heat-resistant coliforms and Pseudomonas aeruginosa in the "Microbiological Test Methods" in the "Technical Specifications for Cosmetics". This method is for qualitative detection of the presence of gram-negative bacteria, heat-resistant coliforms and Pseudomonas aeruginosa are gram-negative bacteria, the test results can be in line with the "Technical Specification for the Safety of Cosmetics" heat-resistant coliforms and Pseudomonas aeruginosa indicator requirements, has been carried out for a number of batches of test data to compare the results.

Example (2) Control of raw material-related indicators and full testing: Require raw material suppliers to issue a certificate of analysis (COA) on the total metal indicators of all raw materials that may bring in heavy metals, stating the residual amount. Attached to the necessary raw materials and products of the full test, the "total heavy metal test" method used for self-developed methods, has been verified with the "Cosmetic Safety Technical Specification" in the mercury, lead, arsenic, cadmium test methods, the total heavy metals in the product to lead, the total content of the test, the total heavy metal residues of no more than 1mg/kg, to ensure compliance with the "Cosmetic Safety Technical Specification". Ensure compliance with the relevant requirements of all heavy metal indicators in the "Technical Code for Cosmetic Safety".

[How to use

[Safety Warning Phrases]

[Storage conditions]

[Term of Use]

Attachment 3

Toothpaste filing microbiological and physical and chemical test project requirements