Provisions for Supervision of Cosmetic Registration and Notification Dossiers
Chapter I General Provisions
Article 1 For the purpose of standardizing the administration of cosmetics registration and notification, ensuring the standardized submission of various documents for cosmetics registration and notification, these Provisions are formulated in accordance with the requirements of “Cosmetic Supervision and Administration Regulations (CSAR)”, “Administrative Measures on Cosmetics Registration and Notification” and other relevant laws and regulations.
Article 2 When applying for cosmetics registration or handling notification within the territory of the People’s Republic of China, documents shall be submitted in accordance with the requirements of these Provisions.
Article 3 The cosmetics registration applicant and notification applicant shall follow the principles of risk administration, based on scientific research, be responsible for the legality, authenticity, accuracy, completeness and traceability of the submitted registration and notification documents, and bear corresponding legal responsibilities. The overseas cosmetics registration applicant and notification applicant shall supervise the registration and notification of domestic responsible persons.
Article 4 The cosmetics registration and notification documents shall use standardized Chinese characters published by the State. Except for registered trademarks, website addresses, patent names, names and addresses of overseas companies, etc., which must use other languages, or conventional terminologies (such as SPF, PFA, PA, UVA, UVB, vitamin C, etc.), all other texts shall be fully and normatively translated into Chinese, and the original text shall be attached following the corresponding translation.
Article 5 The cosmetics registration and notification documents shall comply with the relevant national provisions on the use of seals, be with complete signatures and seals, and have legal effect. If overseas enterprises and other organizations do not use official seals, the documents shall be signed by the legal representative or the person in charge of the enterprise (other organization). In addition to user information related documents, if the overseas cosmetics registration applicant or notification applicant’s signature is required by the product registration and notification documents, the legal representative or person in charge may authorize the signatory of the registration applicant, notification applicant or domestic responsible person to sign. In case of authorized signature, the original authorization letter and the original notarial certificate shall be submitted. The authorization letter shall specify the matters and scope of the authorized signature.
Except for the document originals issued by the competent government departments or relevant institutions, registration and notification testing institutions, notary publics, etc., the cosmetics registration and notification documents shall be stamped with the official seal page by page by the domestic registration applicant, notification applicant or domestic responsible person. The user who uses the official seal with the electronic encryption certificate can directly stamp the electronic official seal on the electronic documents.
Article 6 China’s legal measurement unit shall be used in the cosmetics registration and notification documents. If other measurement units are used, they shall be converted into China’s legal measurement unit; references shall be quoted accurately with the source indicated to ensure valid traceability; the use of punctuation marks, diagrams, terminology, etc. shall be standardized to ensure that the content of the documents is accurate and standardized.
Article 7 The contents of the same item in the cosmetics registration and notification documents shall be consistent; if there are relevant supporting documents, the items shall be accordant with the content included in the supporting documents.
Article 8 The main text in the cosmetics registration and notification documents shall be black, and the contents shall be easy to identify. Appropriate line spacing and page margins shall be set to ensure that no text information is lost during printing or binding.
Article 9 The paper documents for cosmetics registration and notification shall use the international standard A4 size paper with complete and clear contents, which shall not be altered. If larger size paper is needed for the unfolding pictures of cosmetics packaging, other specifications of paper can be used to ensure that it is properly placed in the A4 size documents. The carrier and writing materials of paper documents shall meet the durability requirements.
Chapter II Requirements for User Information Related Documents
Section I Document Items and Requirements
Article 10 When applying for registration of special cosmetics or notification of general cosmetics for the first time, the domestic registration applicant, notification applicant and domestic responsible person shall submit the following user information related documents:
(I) Registration applicant and Notification applicant Information Form (Annex 1) and the resume of the person in charge of quality and safety;
(II) Quality Supervision System Overview of Registration applicants and Notification applicants (Annex 2);
(III) Adverse Reaction Monitoring and Evaluation System Overview Form of Registration applicants and Notification applicants (Annex 3);
(IV) Overseas registration applicants and notification applicants shall submit a Domestic Responsible Person Information Form (Annex 4);
(V) The original of the authorization letter of the domestic responsible person (see Annex 5 for the template) and its original notarial certificate;
(VI) If the registration applicant and notification applicant have self-production or entrust overseas production enterprises to produce, they shall submit the Production Enterprise Information Form (Annex 6) and the information of the person in charge of quality and safety, and fill in the existing production enterprises and their information at one time. If the production enterprise is overseas, the original certification documents of overseas manufacturing practices shall be submitted.
Article 11 Enterprises that only engage in entrusted production in China shall submit the Production Enterprise Information Form in Item (VI) of Article 10 in order to associate and confirm the entrusted production relationship.
Article 12 If the applicant has multiple identities such as domestic registration applicant or notification applicant, domestic responsible person, production enterprise, or if the same domestic responsible person corresponds to multiple overseas registration applicants and notification applicants, he/she may submit all relevant documents at once, and obtain the corresponding user permissions. Existing users can supplement relevant documents according to the situation and increase user permission.
Article 13 The resume of the person in charge of quality and safety shall include the education background, work experience and other contents related to the requirements.
Article 14 The overview of quality supervision system is a summary description of the quality supervision control capabilities and processes of the registration applicant and the notification applicant, which shall reflect the actual situation truthfully and objectively, including supervision systems such as supplier selection, ingredient acceptance, production and quality control, and product sample retention. The words shall be concise and to the point, reflecting the key point setting of quality control and requirements for daily execution and administration.
If the registration applicant and the notification applicant involve both self-production and entrusted production, the corresponding version of the quality supervision system overview shall be submitted respectively.
Article 15 The overview of the adverse reaction monitoring and evaluation system is a summary description of the adverse reaction monitoring and evaluation capabilities as well as processes of the registration applicant/notification applicant and the domestic responsible person, which shall reflect the actual situation truthfully and objectively. The words shall be concise and to the point, reflecting the setting of key points and all links of adverse reaction monitoring, and the requirements for daily execution and administration.
Article 16 The authorization letter of the domestic responsible person shall at least clearly reflect the following contents and information: the names of the registration applicant, the notification applicant and the domestic responsible person, the authorization and the authorized relationship, the authorization scope, and the authorization period. Multiple domestic responsible persons shall not be authorized for the same product, and the domestic responsible person shall carry out registration and notification within its authorization scope.
Article 17 Overseas production enterprises shall submit qualification certificates and documents proving that the production enterprises comply with the quality supervision system or production quality supervision practices. Such certification documents shall be issued or approved by the competent government departments, certification institutions of the country (region) where they are located or third parties that have the certification and accreditation qualifications in the country (region) where they are located, indicating the name of the production enterprise and the actual production address information.
If the original certification documents cannot be submitted, a copy notarized by a Chinese Notary Public or confirmed by a Chinese embassy (consulate) shall be provided.
Section 2 User Information and Document Update
Article 18 When user information or related documents change, it shall be updated in a timely manner to ensure that the user information and related documents in the registration and notification information service platform are true and accurate.
The update methods mainly include self-update, general review update, production site update and other review update under specific specified situations. In the case of review update, the relevant information and documents will be updated after review by the medical products administration department.
Article 19 In the user permission related documents, the content for self-update includes the legal representative information, the information of the person in charge of quality and safety, and the contact information.
When the above information changes, the user shall update it in time.
Article 20 In the user permission related documents, the content for general review update includes basic information, overview of the quality supervision system, overview of the adverse reaction monitoring and evaluation system, the authorization scope and period of the domestic responsible person.
When the general review update is conducted, the General Review Update Information Form (Annex 7) shall be submitted, and relevant documents that meet the requirements shall be submitted at the same time. Among them, if the name of the overseas registration applicant or notification applicant changes, the original copy of relevant certification documents indicating that the entity has not changed, which are issued by the competent government department or the relevant institution of its country (region), shall be provided. If the original cannot be submitted, a copy notarized by a Chinese Notary Public or confirmed by a Chinese embassy (consulate) shall be provided. If the production site of an overseas production enterprise only encounters changes in the address text, the original certification documents issued by the competent governments department or relevant institutions of its country (region) proving that the production site has not been changed shall be provided. If the original cannot be submitted, a copy notarized by a Chinese Notary Public or confirmed by a Chinese embassy (consulate) shall be provided. If the authorization scope of domestic responsible person is changed, the new authorization scope shall cover the original authorization scope.
Article 21 In the user permission related documents, the content for production site update is the production site information of the production enterprise. Specific situations include: the production site is relocated, the production site is increased, the production site is reduced, and only the manufacturing practices certification documents are updated.
When the production site update is conducted, the Production Site Update Information Form (Annex 8) shall be submitted. Among them, if the production site of an overseas production enterprise is relocated or increased, or the certification documents of production quality supervision practices are updated, the certification documents of overseas production quality supervision practices shall be provided as required.
Article 22 According to the actual production and operation situation, if it is necessary to add self-production or entrusted overseas production enterprises, relevant documents can be submitted to add the production enterprise information, and the corresponding quality supervision system overview shall be supplemented and submitted when necessary.
Article 23 When updating user information, the enterprises shall first check all the information under the user name by themselves. If multiple information is changed simultaneously, it shall be updated simultaneously, and relevant documents shall be submitted together.
Article 24 After the authorization period stated in the authorization letter of the domestic responsible person expires, an updated authorization letter shall be resubmitted to extend the authorization period. If the re-submission is not performed within the time limit, the domestic responsible person will not be able to continue to handle the new registration or notification matters for the corresponding overseas registration applicants and notification applicants, while the registrations or notification items that have been carried out under his name can continue to be completed.
If there is a valid period for the certification documents of overseas production quality supervision practices, update shall be made in a timely manner within 90 or less days after the expiration; if there is no valid period, the latest version shall be submitted every five years.
Article 25 According to the actual production and operation situation, if the user permission needs to be canceled, the User Permission Cancellation Information Form (Annex 9) shall be submitted for the user permission cancellation after the relevant products have been completely canceled or changed.
Chapter III Requirements for Registration and Notification Documents
Article 26 When the registration applicant and notification applicant applies for registration or handles notification, the following documents shall be submitted:
(I) “Cosmetics Registration and Notification Information Form” and related documents;
(II) Product name information;
(III) Product formula;
(IV) Product executive standards;
(V) Product label sample manuscript;
(VI) Product testing report;
(VII) Product safety assessment documents.
Article 27 The registration applicant and notification applicant shall fill in the "Cosmetics Registration and Notification Information Form" (Annex 10) item by item and submit relevant documents.
(I) The product name includes the Chinese name and the foreign name of the imported product. The Chinese name of the product shall comply with relevant regulations on cosmetics label supervision.
(II) The registration applicant and notification applicant shall determine the product category and the corresponding product classification code in accordance with the provisions of CSAR and cosmetic classification rules and catalog. Where the special cosmetic efficacy claim is involved, it shall be applied as special cosmetics.
(III) If entrusting a domestic enterprise to produce cosmetics, the registration applicant, notification applicant or domestic responsible person shall select the production enterprise that has opened user permission for association, and submit the registration application or handle the notification after confirmation by the production enterprise.
If entrusting an overseas enterprise to produce cosmetics, the registration applicant, notification applicant or the domestic responsible person shall submit the entrustment relationship documents. The entrustment relationship documents shall at least specify the product name, the entrusting party, the entrusted production enterprise name, the production address, the date when the product is entrusted, and the signature of legal person of the entrusted production enterprise or his authorized person. If the registration applicant, notification applicant and the entrusted production enterprise belong to the same group company, they can submit the certification documents of belonging to the same group company and the product quality assurance documents issued by the enterprise group to confirm the entrustment relationship.
(IV) For imported products, sales certification documents issued by the competent government department or industry association and other institutions of the country where the cosmetics registration applicant or notification applicant is located or the producing country (region) shall be provided, except products that are produced by overseas production enterprises entrusted by domestic registration applicants and notification applicants and whose product formulas are specifically designed for the Chinese market. The sales certification documents shall at least specify the registration applicant name, the notification applicant name or the production enterprise name, the product name, the name of the institution that issues the document, and the date of issuance of the document, and shall be confirmed by the signature and seal of the institution.
1. If there are both imported part and domestic part of the combined packaging product, only the sales certification documents of the imported part shall be submitted.
2. If the sales packaging is designed specifically for the Chinese market, the sales certification documents of the product in the country where the cosmetic registration applicant or notification applicant is located or the producing country (region) shall be submitted, and the explanatory documents that the product formula and production process are consistent with the products of the country where the cosmetic registration applicant or notification applicant is located or the producing country (region) shall be submitted simultaneously.
(V) For imported products whose product formulas are specifically designed for the Chinese market (except the products subject to entrusted overseas production), the following documents shall be submitted:
1. Explanatory documents for formula design according to skin types and consumer demands of Chinese consumers;
2. Documents of consumer testing research or human efficacy test conducted on selected Chinese consumers in China.
(VI) Documents such as sales certification documents, entrustment relationship documents, or certification documents on belonging to the same group company, etc., of imported product can list multiple products simultaneously. When applying for registration or handling notification of these products, one of the products can use the original, and the other products can use the copies, and the product name, relevant acceptance number, hygiene permit number or notification number and other information in the original is shall be specified.
Article 28 The registration applicant and notification applicant shall submit the naming basis of the product name, indicating the trademark name, common name, and attribute name, and explain their specific meanings respectively. The foreign name and Chinese name of the imported product shall be explained separately, and the corresponding relationship between the Chinese name and the foreign name shall be explained (except for those specially designed for the Chinese market and without foreign names).
If the trademark name in the Chinese name of the product uses letters, Pinyin, numbers, symbols, etc., a trademark registration certificate shall be provided.
Article 29 If the product formula is the production feed formula, it shall comply with the following requirements:
(I) Requirements for formula table. The product formula table shall include the serial number, name, percentage content and application purpose of ingredients (Annex 11).
1. Ingredient name. The product formula shall provide the names of all ingredients, which include standard Chinese names, International Nomenclature of Cosmetic Ingredients name (INCI name for short) or English names. The ingredient name of the formula ingredients shall use the standard Chinese name specified in the “Inventory of Existing Cosmetic Ingredients in China (IECIC)”, INCI name or English name; If the formula contains new cosmetic ingredients that are still under safety monitoring, the registered or notified ingredient names shall be used; if the INCI name of the ingredients marked in the original package of imported products is inconsistent with that of the formula ingredients, it shall be explained.
If hydrocarbons (except single components) derived from petroleum and coal tar are used, the chemical abstract service number (referred to as CAS No.) of relevant ingredients shall be indicated in the remarks column of the product formula table; if colorants are used, the colorant index number (referred to as CI No.) specified in the “Safety and Technical Standards for Cosmetics (STSC)” shall be indicated in the ingredient name column of the product formula table, except for those without CI No.; if the colorant used is a color lake, “(Color lake)” shall be marked after the colorant, and the type of the color lake used shall be explained in the remarks column of the formula; if it contains propellant in direct contact with the contents of the product, the type and addition amount of propellant shall be indicated in the remarks column of the formula table; if nano ingredients are used, “(Nanoscale)” shall be marked after the names of such components.
2. Percentage content. The product formula shall provide the contents of all ingredients, which are calculated as mass percentage, and all ingredients shall be arranged in descending order of contents; for ingredients (except flavors) containing two or more components, the composition and corresponding content shall be listed.
3. Application purpose. The main application purpose shall be marked according to the actual role of ingredients in the product; For products applying for freckle-removing and whitening, sunscreen, hair dyeing, hair perming and anti-hair loss products, the corresponding functional ingredients shall be marked in the use purpose column of the formula table. If the functional ingredients are not single component, the specific functional ingredients shall be specified in the use purpose column of the formula table.
4. Remarks column. The following circumstances shall be explained in the remarks column: if denatured ethanol is used, the name and application amount of denaturant shall be stated; where the class ingredients are used, the specific names of ingredients shall be specified; where ingredients directly derived from plants are used, the specific application areas of the original plant shall be explained.
(II) The registration applicant, notification applicant or domestic responsible person shall fill in the manufacturer information of ingredients used in the product and upload the ingredient safety information document issued by the ingredient manufacturer. If the ingredient manufacturer has submitted the information related to ingredient safety (Annex 14) according to the “Guidance on Submitting Cosmetic Ingredients Safety Information” (Annex 12 and Annex 13), the registration applicant, notification applicant or domestic responsible person may fill in the ingredient submission code to associate with the ingredient safety information document.
(III) If the new cosmetic ingredients that are still under safety monitoring are used, the registration applicant, notification applicant or domestic responsible person shall obtain the conformation of the registration applicant and notification applicant of the new ingredients before submitting the registration application or handling notification.
(IV) The flavor of product formula can be filled in in two ways, and the following documents shall be submitted respectively:
1. If only the "flavor" ingredient is filled in the product formula table, there is no need to submit the type and content of specific fragrance components in the flavor; If the specific fragrance components of the flavor are indicated in the product label, and the original packaging label of the imported product contains the specific fragrance components, it shall be stated in the remarks column of the formula table.
2. If “flavor” and specific fragrance components in flavor are filled in the product formula table at the same time, the documents on the types and contents of all fragrance components contained in the flavor issued by the flavor ingredient manufacturer shall be submitted.
(V) If the paster and membrane carrier materials are used, the material composition of the main carrier material shall be indicated in the remarks column, and the documents including its source, preparation process, quality control indicators, etc. shall also be provided.
(VI) If animal organ tissue and blood product extracts are used as ingredients in the product formula, the source, composition and preparation process of the extracts shall be provided, and relevant documents on that the extracts are allowed to be used by the ingredient producing country shall be provided.
Article 30 The product executive standards include full ingredients, brief description of production process, sensory indicators, microbiological and physical and chemical indicators and their quality control measures, application methods, storage conditions, durability and other contents, which shall comply with the requirements of relevant national laws, regulations, mandatory national standards and technical specifications (see Annex 15 for the template and preparation instruction, and Annex 16 for the example).
(I) Product name. Including Chinese names and foreign names of imported products.
(II) Full ingredients. Including the serial number, name and application purpose of all ingredients used in the production of this product, all ingredients shall be arranged in descending order of contents.
(III) Brief description of production process.
1. The main procedures of the actual production process shall be briefly described, including feeding, blending, filling, etc. If the production procedures such as premixing and filling of more than 2 ingredients in the formula table are completed in different production enterprises, it shall be indicated.
2. The range of main production process parameters shall be reflected, all ingredients shall be clearly listed in the production procedures, and the names or serial numbers of the ingredients used shall be consistent with the ingredients listed in the product formula; if the same ingredient is used in different procedures, it shall be distinguished; if additives such as water and volatile solvents need to be used in the production process but removed in the subsequent production steps, they shall be indicated.
(4) Sensory indicators. The color, traits, odor and other indicators of product contents shall be described separately. For product set, the sensory indicators of each part shall be explained respectively, and for products using paster and membrane carrier materials, the color and traits of paster, membrane materials and immersion liquid shall be described respectively.
1. Color refers to the objective color of product contents. The same product has a variety of distinguishable colors and shall be described one by one; if it is difficult to distinguish colors, the main color of the product when it is visually presented or used can be described, the color range can be described as well.
2. Traits refer to the state of product contents.
3. Odor refers to whether the contents of the product have odor.
(V) Microbial and physical and chemical indicators and quality control measures.
1. The actually controlled microbiological and physical and chemical indicators of the products shall be submitted. Microbiological and physical and chemical indicators shall be in line with the requirements of STSC and “Working Rules for Cosmetic Registration and Notification Testing”.
2. The corresponding quality control measures shall be submitted according to the actually controlled microbiological and physical and chemical indicators of the products.
3. If the testing method is used as the quality control measure, the testing frequency shall be indicated. If the method used is completely consistent with that contained in the STSC, the name of the testing method in the STSC shall be filled in; in case of inconsistency with the methods contained in the STSC, the name of the testing method shall be filled in, indicating whether the method has been validated with the methods contained in the STSC, and the complete testing methods and method validation documents shall be kept on filing for future reference.
4. If the non-testing method is adopted as the quality control measure, the specific implementation plan shall be specified and the rationality of the quality control measures shall be explained to ensure that the products meet the requirements of the STSC.
(VI) Application methods. The application methods of cosmetics shall be stated, and if there are special requirements for the users and the application areas, it shall be explained; safety warnings shall comply with the requirements of cosmetic label supervision regulations, STSC, and other relevant regulations.
(VII) Storage conditions. The storage conditions shall be set according to the characteristics of product packaging and product stability.
(VIII) Durability. The durability of the product shall be set according to the product packaging, product stability or relevant experimental results.
Article 31 The registration applicant, notification applicant or the domestic responsible person shall fill out the “Product Label Sample Manuscript” (Annex 17) item by item, and the application method, safety warnings, storage conditions, durability and other contents filled in shall conform to the product executive standards.
For imported cosmetics, the sales packaging (including the leaflet) of the products from the producing country (region) as well as the Chinese translation of foreign labels shall be submitted.
Article 32 During the notification of general cosmetics and before the marketing of special cosmetics, the registration applicant, notification applicant or the domestic responsible person shall upload the label pictures of products sales packaging, which shall meet the following requirements:
(I) The picture includes the plan of all the visible panels of the packaging and stereoscopic display diagram that can reflect the appearance of the product, and the picture shall be complete and clear. The plan shall be easy to distinguish all the marked contents thereof; if it is not possible to clearly display all the marked contents, a partial enlarged drawing or product packaging design drawing shall also be submitted;
(II) If electronic labels are used, the contents of the electronic labels shall be submitted, and the picture code on the sales packaging shall be the preset picture code generated by the registration and notification information service platform;
(III) The contents of the label and the leaflet of the uploaded pictures shall not exceed the contents stated in the product label sample manuscript;
(IV) If there are various sales packaging, the label pictures of all sales packaging shall be submitted. If one or more of the following conditions are met, the label pictures of one of the sales packaging shall be submitted, and the label pictures of other sales packaging can not be uploaded repeatedly:
1. Only the net content specifications are different;
2. Information such as sales channels, promotions, holiday funds, gifts, etc. is only attached to the uploaded sales packaging;
3. Only the colors of sales packaging are different;
4. Registered or notified products are sold in combination in the form of set boxes, gift boxes, etc., the contents of the products are not contacted during the combination process, and the contents marked are not more than the contents of each product label except for adding the name of the combined packaging products;
5. The differences with the uploaded sales packaging can be clearly reflected through the text description, and the explanations have been noted.
Article 33 The product testing report of registered or notified products shall be issued by the cosmetics registration and notification testing institution, which shall comply with the provisions of relevant laws and regulations such as STSC, “Working Rules for Cosmetic Registration and Notification Testing”, etc.
(I) Product testing reports include microbiological and physical and chemical testing, toxicological testing, human safety testing reports and human efficacy testing reports, etc.
1. The tested samples in the product testing report shall be products with the same product name and batch number.
2. The product information stated in the product testing report shall be consistent with the information related to the registered or notified product. Information such as product name, enterprise name and other information in the product testing report that does not affect the testing results are consistent with the registration and notification information due to the name change and other reasons, it shall be explained, and an application form for changing the testing report and a supplementary testing report or correction letter issued by the testing institution shall be submitted.
3. If multiple production enterprises produce the same product, a complete product testing report of samples from one production enterprise shall be provided, and microbiological and physical and chemical testing reports of samples from other production enterprises shall be submitted.
4. Multi-color series general cosmetics sampled for toxicological test according to the “Working Rules for Cosmetic Registration and Notification Testing” can be notified as a group of products, and each product shall be attached with a list of series products, a list of basic formulas and colorants, and a list of sampled products.
5. Cosmetics claiming new efficacy shall be tested in accordance with the “Working Rules for Cosmetic Registration and Notification Testing” and relevant technical regulation documents.
(II) If the production enterprises of general cosmetics have obtained the relevant qualification certification of production quality supervision system issued by the competent government department of the country (region) where it is located, and the product safety risk assessment result can fully confirm the product safety, it may be exempted from submitting toxicological testing report of the product, except for the following circumstances:
1. The product claims to be used by infants and children;
2. The product uses new cosmetic ingredients that are still under safety monitoring;
3. According to the results of quantitative grading, the notification applicant, domestic responsible person and production enterprise are listed as key regulatory objects.
If there are multiple production enterprises, and all production enterprises have obtained the relevant qualification certificates of production quality supervision system issued by the competent government departments of the countries (regions) where they are respectively located, the toxicological test reports may be exempted.
(III) When applying for registration of special cosmetics, a human efficacy testing report that complies with the relevant regulations on cosmetic efficacy claim evaluation shall be submitted.
1. The efficacy testing report of special cosmetic claims shall be issued by the cosmetics registration and notification testing institution.
2. Multi-color series sunscreen cosmetics sampled for human efficacy test according to the “Working Rules for Cosmetic Registration and Notification Testing” can be applied for registration as a group of products at the same time. Each product document shall be accompanied with a list of series products, a list of basic formulas and colorants, and a list of sampled products.
Article 34 The registration applicant and notification applicant shall carry out product safety assessments in accordance with the requirements of relevant technical guidelines for cosmetic safety assessments and form the product safety assessment reports.
Cosmetics that must be used in conjunction with instruments or tools (except brushes, air cushions, hair perming tools, etc. which only assist in rubbing) shall be assessed for their safety under the conditions of use with instruments or tools; in addition, explanatory documents on whether the instrument or tool has cosmetic function, whether it participates in the reproduction process of cosmetics, whether it changes the mechanism of action between products and skin, etc. shall also be provided.
Article 35 Cosmetic containing two or more independent formulas that must be used together or whose packaging containers are inseparable, the formulas shall be filled out separately, and registration or notification shall be applied for as one product.
If one (dosage) or more (dosage) products are special cosmetics, they shall be applied for registration as per special cosmetics; if one (dosage) or several (dosage) products are produced overseas, they shall be applied for registration or notification as per imported cosmetics.
Article 36 The cosmetics registration applicant and notification applicant shall retain samples of each batch of cosmetics produced for future reference, and the quantity of retained samples shall be able to meet the requirements for conducting registration and notification testing. At the same time, for special cosmetics, one sample sealed by the first registration and notification testing institution shall be retained; for imported special cosmetics that submit the trial-produced samples during product registration testing, one trial-produced sample sealed by the testing institution and one unopened marketed product shall be retained at the same time; for general cosmetics, one marketed product shall be retained by the domestic notification applicant or domestic responsible person for future reference; for imported general products with sales packaging specially designed for the Chinese market, one marketed product in the original producing country shall be retained by the domestic responsible person for future reference.
Article 37 Special cosmetics and general cosmetics for export only shall be notified on the registration and notification information service platform, and the production enterprise shall submit the following documents:
1. Product name;
2. The country (region) to be exported;
3. Product label pictures, including the front stereoscopic display diagram of the product sales packaging, the plan of the product packaging and the product leaflet (if any).
Chapter IV Requirements for Changes
Article 38 If the registered matters of a registered product are changed, the corresponding documents shall be submitted before the production or import of the product to be changed, and the production or import can be made only after the corresponding changes are completed.
In case of any change in the notification matters of notified products, the corresponding documents shall be submitted before the products to be changed are marketed or imported, and the products can be marketed or imported only after the corresponding changes are completed.
Products that have been produced, marketed or imported before the change can be sold until the end of the shelf life.
Article 39 If the name and address of the registration applicant, notification applicant, domestic responsible person or production enterprise of registered or notified products are changed (the production site has not been changed), the above-mentioned relevant information of the special cosmetics hygiene permit or general cosmetics notification information and product label sample manuscript shall be subject to one-time change after completing the information update in accordance with the relevant requirements of Section II of Chapter II in these Provisions.
Article 40 If the product name of a registered or notified product is changed, the reason shall be reasonably explained and the following documents shall be submitted:
(I) Special Cosmetics Change Application Form (Annex 18) or General Cosmetics Change Information Form (Annex 19);
(II) The relevant documents of the product name shall be submitted in accordance with the requirements of Article 28 of these Provisions.
Article 41 If the production site is changed or added, the following documents shall be submitted:
(I) Special Cosmetics Change Application Form or General Cosmetics Change Information Form;
(II) The microbiological and physical and chemical testing report of the products produced in the site to be changed;
(III) If the product to be changed for the notification is only evaluated for the product safety through product safety assessment, and the production enterprise to be added cannot provide the production quality supervision system qualification certification documents issued by the competent government department of the country (region) where it is located, the relevant toxicological testing documents of the product shall be submitted;
(IV) If the entrusted production relationship of the product to be changed changes, for domestic products, the changed entrusted production relationship shall be confirmed according to the requirements of Article 27 (III) of these Provisions; for imported products, the entrustment relationship documents or the certification documents belonging to the same group company and the product quality assurance documents issued by the enterprise group shall also be submitted.
Article 42 If the manufacturer of ingredients used in registered or notified products and ingredient quality specifications have been added or changed, and the content of ingredients in the formula and the types and proportions of specific components in the ingredients have not been changed, the information of ingredient manufacturer and ingredient safety shall be updated and maintained through the registration and notification information platform. In case of any change in product safety assessment documents, the product safety assessment documents shall also be changed.
If the manufacturer of ingredients used in the registered or notified products and ingredient quality specifications have been added or changed, the content of ingredients in the formula, the content of main functional components and solvents in ingredients have not changed, while trace stabilizers, antioxidants, preservatives and other components added to ensure the quality of ingredients have changed in types and contents, the following documents shall be submitted:
(I) Special Cosmetics Change Application Form or General Cosmetics Change Information Form;
(II) Product formula;
(III) Description of the change, including the reason of the change and the application purpose of the changed components in the ingredients, etc.
(IV) Product safety assessment document of the product to be changed;
(V) Where the product executive standards change, the executive standards for product to be changed shall be submitted
(VI) If the items to be changed involve changes in the labeling of all ingredients, safety warnings, etc. in the product label sample manuscript, the product label sample manuscript of the product to be changed shall be submitted.
Article 43 In case of any change in the brief description of production process, microbiological and physical and chemical indicators and quality control measures, application methods, safety warnings, storage conditions, and durability in the product executive standards, the following documents shall be submitted:
(I) Special Cosmetics Change Application Form or General Cosmetics Change Information Form;
(II) Executive standards for the product to be changed;
(III) If the brief description of production process is changed, an explanation of the change shall be submitted, and the microbiological and physical and chemical testing report of the product to be changed shall be submitted;
(IV) If the product application method is changed, the product safety assessment documents of the product to be changed shall be submitted;
(V) If the durability of the product is extended, the research documents on the stability of the product to be changed shall be submitted;
(VI) If the content of product safety assessment documents is changed, the product safety assessment documents shall be submitted;
(VII) If the original sales packaging and label of imported product are changed, the original sales packaging (including leaflet) and the Chinese translation of the foreign label of the product to be changed shall be submitted;
(VIII) If the product label sample manuscript is changed, the product label sample manuscript shall also be changed in accordance with the requirements of Article 44.
Article 44 If the content of the product label sample manuscript is changed, the following documents shall be submitted:
(I) Special Cosmetics Change Application Form or General Cosmetics Change Information Form;
(II) The product label sample manuscript to be changed;
(III) If the labeling such as PA, broad spectrum or SPF after bath is added to sunscreen cosmetics, the corresponding efficacy testing reports of the product to be changed shall be submitted;
(IV) If freckle-removing or whitening efficacy claims are added for freckle-removing and whitening cosmetics, the corresponding human efficacy testing report of the product to be changed shall be submitted;
(V) If the original sales packaging and label of imported product are changed, the original sales packaging (including leaflet) and the Chinese translation of the foreign label of the product to be changed shall be submitted.
Article 45 If the content of product safety assessment document is changed, the following documents shall be submitted:
(I) Special Cosmetics Change Application Form or General Cosmetics Change Information Form;
(II) The product safety assessment documents to be changed;
(III) If the cosmetics safety assessment personnel change, the relevant information of the cosmetics safety assessment personnel to be changed shall be submitted.
Article 46 If the product classification changes, the following documents shall be submitted:
(I) Special Cosmetics Change Application Form or General Cosmetics Change Information Form;
(II) Supplementary or updated documents according to the requirements for the product classification to be changed;
(III) Where the registered special cosmetics are intended to add the efficacy of hair dyeing, hair perming, freckle-removing and whitening, sunscreen and anti-hair loss or new efficacy, supplementary documents shall be submitted in accordance with the requirements of Chapter III.
Article 47 In case of the registration applicant changes due to the merger, consolidation, division, etc., of the company, the new domestic registration applicant or the domestic responsible person with the corresponding user permission of the new overseas registration applicant, shall submit the following documents and conduct a one-time change to the special cosmetics hygiene permit:
(I) Statement and related documents on the merger and cancellation of the company, division or the establishment of a wholly-owned subsidiary or operation by different subsidiaries within the same group.
(II) The statement that the interested parties (such as the original registration applicant, new registration applicant and domestic responsible person, etc.) and their legal representatives have no objection to the ownership of the special cosmetics hygiene permit and its original notarized documents.
Article 48 If the domestic responsible person changes, the following documents shall be submitted:
(I) The product list of the domestic responsible person to be changed;
(II) Informed consent of the original domestic responsible person to agree to replace the domestic responsible person, or an effective legal judgment document that can prove that the domestic responsible person has been changed;
(III) Commitment letter of the domestic responsible person to be changed to assume the various responsibilities of the original domestic responsible person of products (including the marketed products before the change).
Article 49 In case of any change in other items, a description of the items to be changed shall be submitted, and relevant documents shall be submitted according to the specific situations.
Article 50 In case of any change in the sales packaging of registered or notified products, according to the principle of Article 32, before the new sales packaging products are marketed, the label pictures of the products sales packaging shall be re-uploaded or remarks on the parts to be changed shall be made.
Article 51 After the change of registered special cosmetics is completed, when requisitioning the paper product hygiene permit after the change, the original product hygiene permit shall be returned.
Chapter V Requirements for Renewal, Cancellation and Other Matters
Article 52 To apply for renewal of the valid period of the special cosmetics hygiene permit, the following documents shall be submitted:
(I) Registration Renewal Application Form (Annex 20);
(II) Description of product self-inspection (see Annex 21 for the template), the main contents include:
1. Production (import) sales certification materials (limited to the previous registration period)
2. Administration sampling inspection, investigation and recall (limited to the previous registration period);
3. Statistical analysis of adverse reactions of this product and measures taken;
4. Other contents to be explained.
(III) According to the adjustment of current regulations and standards, the corresponding product testing report shall be submitted.
Article 53 The annual report of general cosmetics shall include the following contents:
(I) General situation of production and import of products, as well as the suspension of production during the period;
(II) Self-inspection on conformity of products with laws and regulations, mandatory national standards and technical specifications.
Article 54 To apply for re-issuance of the product hygiene permit, the following documents shall be submitted:
(I) Re-issuance Application Form (Annex 22);
(II) If the re-issuance is applied due to damage to the original product hygiene permit, the original product hygiene permit shall be returned when requisitioning the new product hygiene permit;
(III) If the re-issuance is applied due to the loss of the product hygiene permit, the commitment letter shall be submitted.
Article 55 Where a registration applicant applies to withdraw the registration application, a Withdrawal Application Form (Annex 23) shall be submitted.
Article 56 Where a registration applicant applies for cancellation of the registered special product hygiene permit, a Cancellation Application Form (Annex 24) shall be submitted.
Article 57 If the notification administrative department for the notified general products changes due to the address change of the notification applicant or the domestic responsible person, and the notification applicant takes the initiative to cancel the original notification information and then handles re-notification, the original notification documents can be used.
Article 58 When re-applying for registration of special products that are not registered due to non-safety reasons, copies of the original registration documents can be used, and the statement that registration rejection does not involve safety, including the explanation of the registration rejection shall be submitted at the same time.
Article 59 When a general product is notified again after cancellation, a situation description shall be submitted. For cancellation due to non-safety reasons, copies of the original notification documents can be used when re-applying for notification.
Chapter VI Supplementary Provisions
Article 60 These Provisions shall come into effect as of May 1, 2021.
Annexes: 1. Registration applicant and Notification applicant Information Form
2. Quality Supervision System Overview Form
3. Adverse Reaction Monitoring and Evaluation System Overview Form
4. Domestic Responsible Person Information Form
5. Authorization Letter to Domestic Responsible Person for Cosmetics Registration and Notification
6. Production Enterprise Information Form
7. General Review Update Information Form
8. Production Site Update Information Form
9. User Permission Cancellation Information Form
10. Cosmetic Registration and Notification Information Form
11. Formula Table Template
12. Guidance on Submitting Cosmetic Ingredients Safety Information
13. Enterprise Information Form of Ingredient Safety Related Information Notification
14. Ingredient Safety Related Information
15. Product Executive Standard Template
16. Product Executive Standard Example
17. Cosmetic Product Label Sample Manuscript
18. Special Cosmetics Change Application Form
19. General Cosmetic Change Information Form
20. Cosmetic Product Registration Renewal Application Form
21. Example of Cosmetic Registration Renewal Self-Inspection Report
22. Cosmetic Registration Re-issuance Application Form
23. Cosmetic Registration Withdrawal Application Form
24. Cosmetic Registration Cancellation Application Form
