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Latest Progress and Policy Interpretation of Toothpaste Filing
Release time:
2023-09-27 09:27
On September 25, 2023, the General Department of the State Food and Drug Administration publicly solicited opinions on the ''Regulations on the Management of Toothpaste Filing Materials (Draft for Solicitation of Comments) '', and issued an announcement on the implementation of toothpaste regulatory regulations and simplifying the requirements for the filing materials of listed toothpastes (No. 124 of 2023).
New Anrun consulting for your customers to carry out relevant policy interpretation, for your reference.
1. the implementation of toothpaste regulatory regulations and simplify the requirements for the filing of listed toothpaste.
Type | time node | Content |
Unlisted toothpaste(Formal filing required) | From 1 December 2023 | Domestic toothpaste shall be filed with the provincial drug supervision and administration department where the filer is located before being marketed;Imported toothpaste shall be filed with the State Food and Drug Administration before import. |
Toothpaste already on the market (supplementary information within a limited time after simplified filing) | From 1 October 2023 to 30 November 2023 | Toothpaste filers can submit the following simplified information through the filing platform for filing: (1) Basic information of toothpaste filers. Including the name, address and contact information of the filer. If production is commissioned, the name, address and contact information of the actual production enterprise shall also be submitted at the same time; the basic information of the (II) product shall be submitted. Including product name, product formula, product sales packaging label pictures, etc.; (III) prove that the product has a history of safe use of relevant information. Including but not limited to the production and feeding records, sales invoices, inspection reports and other relevant information since the product was launched, as well as the relevant commitments of the filer to the product safety and the authenticity of the filing information. Note: The content of the label must comply with the requirements of the Regulations, Measures and Cosmetic Label Management Measures (except for the format of the label that needs to be regulated) |
Before 1 July 2024 | If the product label has only format problems, update the product label as required. | |
Before 1 December 2025 | To complete the simplified filing, if the first batch of products are on the market before January 1, 2021, the product filing information can be kept on file by the filer for future reference. | |
If the simplified filing is completed and the first batch of products are sold after January 1, 2021, the filing person shall submit complete filing information through the filing platform. | ||
In addition to those that only claim to have cleaning efficacy, toothpaste products that are simplified for filing need to be uploaded through the filing platform and the summary of the basis for product efficacy claims needs to be published. |
2. announcement on children's toothpaste related instructions
Children's toothpaste refers to toothpaste declared to be suitable for children under the age of 12 years (including 12 years). Children's toothpaste can claim efficacy category is limited to cleaning, caries prevention.
Children's toothpaste shall be marked with children's toothpaste logo on the display surface of the sales package. The pattern of children's toothpaste logo shall meet the requirements of the Announcement of the State Food and Drug Administration on Issuing Children's Cosmetic Logo (No. 143 of 2021), and the text part of the logo shall be replaced by "children's cosmetics" with "children's toothpaste".
Children's toothpaste should also be marked on the visible surface of the sales package with relevant warning terms such as "use under adult supervision", "do not eat" and "beware of swallowing.
Provisions on the Administration of 3. Toothpaste Filing Materials (Draft for Comments)
1. Information items related to user information
Information form of (I) filer and resume of person in charge of quality and safety;
Overview of the quality management system of the (II) filer;
Overview of adverse reaction monitoring and evaluation system for (III) filers;
(IV) overseas filers shall submit the information form of the domestic responsible person;
The original power of attorney and the original notarial certificate of the responsible person within the territory of the (V);
If the (VI) filing person has independent production or entrusts overseas production enterprises to produce, it shall submit the information form of the production enterprise and the information of the person in charge of quality and safety, and fill in the existing production enterprise and its information at one time. If the production enterprise is overseas, it shall submit the original certificate of overseas production specifications.
Enterprises in China that are only engaged in entrusted production shall submit the information form of the production enterprise in item (VI) to confirm the entrusted production relationship.
Those who have multiple identities such as domestic filers, domestic responsible persons, production enterprises, etc., or the same domestic responsible person corresponds to multiple overseas filers, can submit all relevant materials at one time and obtain corresponding user permissions. Existing users can supplement and provide relevant information according to the situation and increase user rights.
2. Requirements for toothpaste filing materials
The name, address and contact information of the (I) filing person;
The name, address and contact information of the (II) production enterprise;
(III) product name information;
(IV) product formula;
Standards implemented by (V) products;
(VI) product labels;
(VII) product inspection report;
(VIII) product safety assessment data.
The product test report includes microbiological and physical and chemical test report, toxicology test report, efficacy evaluation report, etc.
General requirements for (I) inspection report.
1. Toothpaste filers can entrust technical institutions such as cosmetic registration and filing inspection institutions, drug non-clinical safety evaluation research institutions, drug clinical testing institutions and/or medical device clinical testing institutions (with the qualification of medical institutions in stomatology) to issue product inspection reports according to product formula and category, and the selected technical institutions shall have corresponding inspection or evaluation capabilities.
2. With reference to the relevant measures of the national drug regulatory authority on optimizing the filing and inspection management of ordinary cosmetics, if the relevant requirements are met, the toothpaste filing person may conduct relevant microbiological and physical and chemical inspections (hereinafter referred to as self-inspection) by himself or by entrusting the entrusted production enterprise as required. If the self-inspection report is submitted when the product is filed, the filing person shall submit a statement of the corresponding inspection capability at the same time, provide a description of the corresponding inspectors, equipment and facilities, and the environment of the place to carry out the self-inspection, and promise to be responsible for the authenticity and accuracy of the inspection report.
3. The inspected samples in the product inspection report shall be products with the same product name and batch number, and the product information stated therein shall be consistent with the relevant information of the products on record. If the product name, enterprise name and other information in the inspection report that does not affect the inspection or evaluation results are inconsistent with the record information due to reasons such as name change, an explanation may be given, and an application form for change of the inspection report and a supplementary inspection report or correction letter issued by the technical institution shall be submitted.
4. If multiple production enterprises produce the same product, they only need to submit the complete product inspection report of the samples produced by one of the production enterprises, and at the same time submit the microbiological and physical and chemical inspection reports of the samples produced by other production enterprises. If toothpaste is produced by multiple paste processes, only a complete product inspection report for samples produced by one of the processes is required, as well as a microbiological and physical-chemical inspection report for samples produced by other processes. The same series of toothpaste products filed by the same filing person only have different fragrance types, colors, etc., and can be filed as a group of products at the same time. Only a complete product inspection report of one product sample needs to be submitted, and microbiological and physical and chemical inspection reports of other product samples need to be submitted at the same time.
(II) microbiological and physical and chemical examination. Microbiological and physical and chemical inspection items shall meet the requirements of Appendix 3, and the inspection methods included in the Safety Technical Specification for Cosmetics shall be preferred, and the validity of the methods shall be confirmed.
(III) toxicology tests. In order to scientifically evaluate the safety of toothpaste products, the product inspection report shall include the oral mucosa irritation test items, and the test methods included in the "Cosmetic Safety Technical Specification" shall be selected preferentially, or refer to the relevant oral medical device test methods. In addition, if it is necessary to further confirm the safety of the product, the product toxicology test can be carried out according to the actual situation of the product, generally including but not limited to the following items: acute oral toxicity test, mutagenicity test (including at least one gene mutation test and one chromosome aberration test), sensitization test, sub-chronic oral toxicity test, teratogenicity test, chronic toxicity/carcinogenicity combination test, etc.
If the toothpaste manufacturer has obtained the relevant qualification certification of the production quality management system issued by the competent government department of the country (region) where it is located, and the product safety risk assessment results can fully confirm the product safety, the toothpaste that only claims to have cleaning effect can be exempted from submitting the oral mucosa irritation test report of the product, except in the following circumstances:
1. The product claims to be used by children;
2. The product uses new raw materials that are still under safety monitoring;
3. The filing person, the domestic responsible person, or the production enterprise is listed as the key supervision object.
If there are multiple production enterprises, and all production enterprises have obtained the relevant qualification certification of the production quality management system issued by the government department of the country (region) where they are located, they can be exempted from submitting the oral mucosal irritation test report.
(IV) efficacy evaluation. When toothpaste is filed, it shall first complete microbiological and physical and chemical tests, toxicological tests, product safety assessment and issue a report, and carry out efficacy evaluation as required on the basis of ensuring product safety.
1. The efficacy claim of toothpaste should have sufficient scientific basis. The archivist shall prepare and publish the evaluation summary of efficacy claim according to the efficacy evaluation results, which generally includes but is not limited to the following contents: the name of efficacy evaluation project, evaluation method, evaluation institution, evaluation result, etc. In addition, if you need to claim the efficacy of raw materials, you can also carry out literature research, research data analysis, evaluation tests, etc., to confirm that the raw materials have the declared efficacy, and the efficacy of raw materials should be declared with the efficacy of the product claims to have a full correlation.
2. The efficacy evaluation methods of toothpaste products are generally divided into human evaluation methods and other evaluation methods. When conducting human body evaluation, the plan design, protection of subjects' rights and interests, operation standardization, data and file management shall meet the relevant requirements of laws and regulations, and the evaluation method shall meet the technical requirements of relevant standards and specifications. When using methods other than human efficacy evaluation for efficacy evaluation, the selection of methods should ensure that the evaluation results are scientific, accurate and reliable.
3. Toothpaste claims to have anti-caries, anti-plaque, anti-dentin sensitivity, reduce gum problems and other effects, the need for human efficacy evaluation. If the anti-caries effect is achieved by adding fluoride, and the fluorine content meets the relevant requirements of microbiological and physical and chemical test items, the evaluation of the anti-caries effect can be avoided. If toothpaste only claims cleaning efficacy, it may be exempted from efficacy evaluation; if toothpaste claims other than cleaning efficacy, specific efficacy evaluation shall be carried out for specific claims.
Product Safety Assessment Data
The archivist shall refer to the relevant principles and requirements of the "Technical Guidelines for Cosmetic Safety Assessment", combined with the actual situation of toothpaste products, scientifically and reasonably carry out product safety assessment, and submit a product safety assessment report.
1. The product safety assessment report generally includes but is not limited to the following contents: summary, product introduction, product formula, safety assessment of each component in the formula, assessment of possible risk substances, risk control measures, safety assessment conclusions, resumes and signatures of safety assessment personnel, relevant references, appendices, etc.
2. The product safety assessment report requires a safety assessment of the ingredients in the toothpaste formula. If the safety of the ingredients in the formula cannot be confirmed through public data, the product safety assessment data can also be improved through one of the following methods:
(1) Provide objective certification materials for more than three years of safe use history of formula ingredients that cannot be safely evaluated.
(2) In accordance with the relevant principles and requirements of the Technical Guidelines for Cosmetic Safety Assessment, etc., provide toxicological endpoint assessment data that can support the formulation ingredients under the formulation usage.
(3) According to the actual situation of the product, to ensure product safety as the principle, provide product toxicology test report.
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