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Are ingredients with content that are equal to 0.1% classified as trace ingredients?According to Article 12 of the Measures for the Administration of Cosmetics Labels, if there are ingredients in cosmetic formulas that are less than or equal to 0.1%(w/w), all these ingredients shall be labeled separately with "other trace ingredients" as the guide words, and may not be listed in descending order. Therefore, ingredients with content that are equal to 0.1% are classified as "other trace ingredients".
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If the product formula contains the propellant that direct contacts with the product contents, how to fill in information related to the propellant?According to the Provisions for the Registration or Filing Dossier of Cosmetics, the information related to the propellant shall be filled separately under the formula table, and the total propellant content shall be 100%.
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Is it possible to apply for a formula change when the formula is filled out and submitted incorrectly due to the enterprise's own reasons?According to the Provisions for the Registration or Filing Dossier of Cosmetics, changes can be applied for only in the following conditions: the raw materials used in the products that have completed the filing, whose manufacturers and quality and specifications have been increased or changed; the content of raw materials in the formula and the content of main functional composition of raw materials and solvent have not changed; the types and content of trace stabilizers, antioxidants, preservatives, and other ingredients have been changed, which are added to raw materials with the purpose of ensuring their quality. If the formula is filled out and submitted incorrectly due to the enterprise's own reasons, the previous filing shall be cancelled, the re-filing shall be adopted.
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How to fill in the content when filling in the product formula?According to Article 29 of the Provisions for the Registration or Filing Dossier of Cosmetics, the product formula shall be the production formula. The product formula shall provide the content of all raw materials, which is calculated by mass percentage, and all raw materials shall be arranged in descending order; for the raw materials that contain two or more ingredients (excluding fragrance), the composition and corresponding content shall be listed.
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How to mark the ingredients with content that are less than or equal to 0.1% in the cosmetic formula?According to the Measures for the Administration of Cosmetics Labels, trace ingredients refer to the ingredients that are less than or equal to 0.1% in the cosmetic formula. When the product formula contains the trace ingredients, they shall be marked separately with "other trace ingredients" as the guide words and may not be listed in descending order of ingredient content. Trace ingredients only need to be marked once, it is no need to be marked repeatedly after the guide words of "ingredients".
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If there are fragrance raw materials in the product formula, how to fill in the product formula and what information should be provided?In accordance with Article 29 (4) of the Rules for Registration and Notification Dossiers of Cosmetics, the fragrance in the product formula can be filled in in two manners, and the following materials should be submitted respectively: 1.Only the "fragrance" raw material is filled in the product formula table: it is not necessary to submit the type and content of the specific flavor components in the fragrance; The product label identifies the specific flavor components, and the original packaging label of the imported product contains specific flavor components: it should be stated in the remarks column of the formula table. 2.The product formula is filled with "fragrance" and the specific flavor components in the fragrance at the same time, the data on the types and contents of all flavor components contained in the fragrance issued by the fragrance raw material manufacturer should be submitted.
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What relevant information should be provided when evaluating the nanomaterials used in the cosmetic formula?When conducting safety assessment of products containing nanomaterials in the product formula, the quality specifications of raw materials issued by the raw material manufacturer should be provided, and the quality specifications based on the raw materials and safety assessment data supporting the dosage of the formula should be provided.
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If the cosmetic formula contains nanomaterials, how should it be marked in the formula table?In accordance with the Rules for Registration and Notification Dossiers of Cosmetics, "纳米级(Nano-level)" should be marked after the name of the nanomaterials.
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When applying for cosmetic registration, how should I submit safety-related information for cosmetic raw materials that have not yet obtained the cosmetic raw material submission code?The registrant, filing person or domestic responsible person can choose either of the following two methods according to their own circumstances: 1. Provide raw material quality specification documents stamped with the official seal of the raw material manufacturer or safety-related information for raw materials (Annex 14 of the Provisions for the Registration or Filing Dossier of Cosmetics). (Note: The registrant or domestic responsible person shall also stamp the official seal page by page at the same time.) 2. If the raw material manufacturer authorizes the registrant, the filing person or the domestic responsible person to fill in the safety-related information for raw materials (Annex 14), it shall be provided with stamping the official seal of the registrant, the filing person, or the domestic responsible person. Meanwhile, the contents that the registrant, the filing person or the domestic responsible person (specific enterprise name) is authorized by the raw material manufacturer (specific enterprise name) to fill in the relevant content which shall be true, complete and accurate in Annex 14, shall be noted in the "other issues to be explained" column.
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What are the precautions for filling out and submitting the ingredient submission code?What are the precautions for filling out and submitting the ingredient submission code? At present, it has been found that some ingredient submission codes on the Information Service Platform for Registration and Filing of Cosmetics are inconsistent with the data on the Cosmetic Ingredient Safety Information Registration Platform. The filing person should verify the following information with the ingredient manufacturer (supplier): (1)Whether the ingredient submission code corresponds to the target ingredient; (2)Whether the specific ingredient in the cosmetic formula, such as the composition and proportion of compound ingredients, are consistent with the information submitted on the Cosmetic Ingredient Safety Information Registration Platform.
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Can I submit more than one ingredient submission code?According to the announcement on the upgrade of the filing management system for general cosmetic on March 14, 2022, the Information Service Platform for Registration and Filing of Cosmetics supports the filling of multiple ingredient submission codes for one ingredient.
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How to fill out and submit the safety-related information of cosmetic ingredients?According to the NMPA notice on the launch of the Cosmetic Ingredient Safety Information Registration Platform, the filing persons of general cosmetics can choose to fill out and submit the safety-related information of cosmetic ingredients in the following ways: (1) Fill in the safety-related information through ingredient information maintenance module of the Information Service Platform for Registration and Filing of Cosmetics; (2) If the ingredient manufacturer or its authorized enterprise has submitted the safety-related information on the Cosmetic Ingredient Safety Information Registration Platform, the filing persons of general cosmetics can fill in the ingredient submission code associated with the safety-related information of cosmetic ingredients.
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How to submit safety-related information of cosmetic ingredients on the Cosmetic Ingredient Safety Information Registration Platform?Domestic users can log in to the Cosmetic Ingredient Safety Information Registration Platform through the NMPA Online Service Hall (https://zwfw.nmpa.gov.cn) to fill out and submit safety-related information of cosmetic ingredients; Overseas users need to open an account on the Cosmetic Ingredient Safety Information Registration Platform (http://ciip.nifdc.org.cn), then fill in and submit safety-related information of cosmetic ingredients.
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What are included in safety-related information of cosmetic ingredients?The safety-related information shall include the trade name of the ingredient, basic information of the ingredient, a brief description of the ingredient production process, necessary quality control requirements, assessment conclusions of international authoritative organizations, and restriction requirements on risk substance, etc.
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How to define a ingredient manufacturer? Can ingredient distributors submit safety-related information of cosmetic ingredients through the Cosmetic Ingredient Safety Information Registration Platform?The ingredient manufacturer refers to an enterprise in charge of the safety of ingredients, which can be the actual production enterprise of ingredients, an affiliated enterprise that belongs to the same group enterprise with the actual production enterprise of ingredients, or an entrusted enterprise in the act of entrusted production of ingredients. Whether the ingredient distributors meet the definition of ingredient manufactures depends on the actual situation. If the ingredient distributor is also the ingredient manufacturer, it can submit the safety-related information by itself; if it is not the ingredient manufacturer, it can be an authorized enterprise and open the rights of submitting safety-related information of cosmetic ingredients after submitting the authorization letter issued by the cosmetic ingredient manufacturer.
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When should the ingredient safety information be submitted?According to the NMPA Announcement on Issues about Implementing the Rules for Registration and Notification Dossiers of Cosmetics (No.35, 2021), from May 1, 2021, registrants and filing persons when applying for cosmetic registration and filing, shall fill in the source and trade name information of ingredients in the formula. For ingredients with quality specifications regulated by the Technical Specification for the Safety of Cosmetics shall submit the quality specification certificate or the safety-related information. From January 1, 2022, registrants and filing persons when applying for registration and filing, shall provide safety information related to cosmetic ingredients with functions of preservative, sunscreen, colorant, hair dye, spot corrector and whitening in accordance with the Rules. From January 1, 2023, registrants and filing persons when applying for registration and filing, shall provide safety information related to all the cosmetic ingredients in accordance with the Rules. For the cosmetic with registration or filing has already completed, registrants and filing persons shall supplement the safety information related to all ingredients in the product formula before May 1, 2023. According to the Rules, if the ingredient manufacturer has submitted safety information related to cosmetic ingredients in accordance with the Guidelines for Reporting Cosmetic Ingredient Safety Information, filing persons and domestic responsible persons can fill in the ingredient submission code to associate with the safety information document.
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If the registrant is merged or a subsidiary company is established by the registrant, can the registrant apply for the change of registrant?According to Article 49 of the Administrative Measures for Cosmetics Regulation and Notification, the cosmetic registration certificate shall not be transferred. If the entity qualification of the original registrant is cancelled due to legal reasons such as enterprise merger or division, and the registrant needs to be changed to a newly established enterprise or organization, an application for registration change shall be applied in accordance with the provisions of the Measures.
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Can the copy version of the original filing materials be used when the imported general cosmetics are re-filed after the original filing is cancelled?According to Article 59 of the Rules for Registration and Notification Dossiers of Cosmetics, when general cosmetics are re-filed after cancellation, an explanation of the situation shall be submitted. For the cancellation for non-safety reasons, the copy version of the original filing materials can be used when applying for the filing again.
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For special cosmetics that are not allowed to be registered, what are the requirements for materials of re-declaration? Can copy versions be used?According to Article 58 of the Rules for Registration and Notification Dossiers of Cosmetics, when applying for the re-registration for special cosmetics that are not allowed to be registered due to the non-safety reasons, the copy versions of original registration materials can be used, and a description that original registration is not allowed without involving safety including an explanation of the reasons for the registration is not allowed shall be submitted at the same time.
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What are the requirements for the enterprise body certificate documents required for overseas users to register on the Cosmetic Ingredient Safety Information Registration Platform?The enterprise body certificate documents shall be notarized by the Chinese notary organ or confirmed by the Chinese embassy (consulate); if the text is in a foreign language, it should be translated into Chinese in a complete and standardized manner, and the original text should be attached to the corresponding translation.
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Can multiple domestic responsible persons be authorized for new cosmetic ingredients?According to Article 11 of the Rules for Registration and Notification Dossiers of Cosmetics, the same new cosmetic ingredients shall not authorize multiple domestic responsible persons.
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How to log in to the Cosmetic Ingredient Safety Information Registration Platform and whether an account needs to be registered?Domestic users do not need to register an account, and can log in to the Cosmetic Ingredient Safety Information Registration Platform through NMPA Online Service Hall (https://zwfw.nmpa.gov.cn); Overseas users need to register on the Cosmetic Ingredient Safety Information Registration Platform (http://ciip.nifdc.org.cn), upload the enterprise body certificate documents notarized by the Chinese notary organ or confirmed by the Chinese embassy (consulate), and log in after approval.
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What should I do if the power of attorney of the domestic responsible person for the new raw materials expires?According to Article 11 of the Rules for Registration and Notification Dossiers of New Cosmetic Ingredients, the power of attorney for extending the authorization period shall be re-submitted or the change of domestic RP shall be handled in accordance with relevant rules within 30 days before the expiration of the authorization period, after the expiration of the authorization period specified in the power of attorney of the domestic RP.
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What should be specified in the power of attorney of the domestic responsible person when applying for the user name of new raw materials?According to Article 11 of the Rules for Registration and Notification Dossiers of New Cosmetic Ingredients, the power of attorney of the domestic responsible person shall at least contain the following contents and information: the name of the registrant, filing person and domestic responsible person of new cosmetic raw materials; authorization and authorized relationship; authorization scope; authorization period.
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What corrective measures can enterprises take if the cosmetic label has defects as specified in Article 20 of the Measures for the Administration of Cosmetics Labels?If the cosmetic label has defects but does not affect the quality and safety and will not mislead consumers, the enterprise should correct them in time. The label can be reprinted, or the defects can be corrected by pasting and covering. Ensure that the corrected labels should be clear, durable, easy to identify and read without situations such as falling off of printing characters, loose pasting, etc.
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Should ingredients such as antioxidants, preservatives, stabilizers and other protective ingredients added to cosmetic raw materials be marked on the product label?The Measures for the Administration of Cosmetics Labels has stipulated that the standard Chinese name of all ingredients of cosmetics shall be marked on the visible surface of the sales package.
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What contents shall be marked on the Chinese label when conducting general cosmetics filing?According to Article 36 of the Cosmetics Supervision and Administration Regulations (CSAR), the Chinese label of cosmetics shall be marked with the following contents: (1) Product name, registration certificate number special cosmetics; (2) Name and address of registrants, filing persons, and entrusted production enterprises; (3) Production license number of the cosmetics; (4) Product implementation standard number; (5) Full ingredients; (6) Net content; (7) Shelf life, instructions, and safety precautions; (8) Other contents that shall be marked as regulated by laws, administrative regulations and mandatory national standards.
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If the production process of filed general cosmetic involves multi-stage production, how to mark the name and address of the production enterprise on the label?According to Article 10, Paragraph 1, Item 3 of the Measures for the Administration of Cosmetics Labels, the name and address of the production enterprise shall be marked with those of the production enterprise that completed the last process of contacting the contents. If registrants or filing persons entrust multiple production enterprises to complete the last process of contacting the contents at the same time, the name and address of each entrusted production enterprise may be marked, and distinguished by code or other means.
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What should we pay attention to when there is a registered trademark with the foreign language on the sales package label?According to Article 6 of the Measures for the Administration of Cosmetics Labels, cosmetics shall have Chinese labels with using standard Chinese characters. If other characters or symbols are used, the corresponding explanation in standard Chinese characters shall be marked on the visible surface of the sales package, except for websites, names and addresses of overseas enterprises, conventional and technical terms, etc. that must use other characters. If multiple visible surfaces of the product label have the same registered trademark with the foreign language, the corresponding explanation in standard Chinese characters may be marked on only one of the visible surfaces.
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What should we pay attention to when submitting the Chinese translation of the label with the foreign language of the sales package for imported products?According to Article 31(2) of the Provisions for the Registration or Filing Dossier of Cosmetics, the registrant, the filing person, or the domestic responsible of imported cosmetics shall submit the sales package (including the instruction) of the product in the country (region) of production, as well as the Chinese translation of the label with the foreign language. The submitted Chinese translation shall faithfully translate the content of the label of the sales package, and shall not conceal it, nor modify the sales package by covering, altering, etc. If there is the same content with the foreign language on the sales package (including the instruction), it can be translated only once without repeated translation.
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How to mark the shelf life of the product on the cosmetic label?According to Article 14 of the Measures for the Administration of Cosmetics Labels, the shelf life shall be marked on the visible surface of the product's sales package with corresponding guide words: (1) Production date and shelf life. The production date shall be marked with Chinese characters or Arabic numerals in the order of a four-digit year, two-digit month and two-digit date (2) Production batch (No.) and expire date. For products with packaging boxes, only the packaging container that directly contacts the contents, in addition to the above two forms, also can use production batch (No.) and period after opening to mark shelf life. When the sales package contains multiple products with their own individual packages, each individual package shall be marked with the expire date, and the expire date on the visible surface of the sales package shall be marked in accordance with the expire date of individual products that expire earliest; the expiry date of each individually packaged product can also be marked separately.
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For imported general cosmetics that are filed and sold in the form of set boxes, do I need to submit each single product in the set box and the packaging of the set box when filing?According to Article 32 of the Provisions for the Registration or Filing Dossier of Cosmetics, when general cosmetics are filed and before special cosmetics are sold in the market, the registrant, the filing person or the domestic responsible person shall upload the label picture of the product sales package, so the submitted and uploaded picture shall be the product that is filed in the form of a set box.
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What services can EnterCo provide?Cosmetic registration and filing in China, new cosmetic ingredient registration and filing in China, cosmetic efficacy evaluation with our own laboratory and so on. Contact us for more info: info@enter-co.com.
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Where is EnterCo located?There are 6 offices in China's main cities (Shanghai, Hangzhou, Guangzhou, Shenzhen, Ningbo, Hainan) and 1 office in Paris. The headquarter is located in Hangzhou, China.
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Team composition of EnterCoEnterCo is composed of senior industry regulatory consultants, certified toxicologists, and Internet technology teams.
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Brief introduction of InnodermInnoderm, a subsidiary of EnterCo, is a professional cosmetic efficacy evaluation laboratory and consumer use test institution.
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