Preface

Filing of domestic ordinary cosmetics is a mandatory procedure for the legal launch of cosmetics on the market, a fundamental task for cosmetics regulation, and also a power newly delegated to provincial drug administration authorities.To better guide the whole city in carrying out the filing of domestic ordinary cosmetics, better assist filers in standardizing the submission of filing materials, and improve the quality and efficiency of filing, the Cosmetics Division of the Municipal Bureau has successively collected the consultation Q&As released by institutions including the National Medical Products Administration, China National Institute of Food and Drug Control, Zhejiang Provincial Medical Products Administration, and Guangdong Provincial Medical Products Administration. Meanwhile, based on cosmetics regulatory regulations, rules, normative documents, technical specifications, relevant standards and practical operations, it has made extended supplements, and sorted them into "500 Examples of Q&As on Filing of Domestic Ordinary Cosmetics", which is divided into 10 major parts including general, filing application form, basis for product name naming, product formula, product formula - new raw materials, product execution standard, product label, product inspection report, product safety assessment materials, and efficacy claims. The Q&A examples are listed and presented one by one in the following order, so as to help the city's filing work of domestic ordinary cosmetics reach a new level in the way of consolidating foundations, grasping standardization and promoting improvement.

1 General Section

1-1. What are the commonly used websites for the filing of general cosmetics?


Answer:(1) Login URL for the Cosmetics Registration and Filing Information Service Platform (Enterprise End): View.
Kind Reminder: Users who have not registered an account for the National Medical Products Administration Online Service Hall shall first register an account as a legal entity or handler for the Online Service Hall; then create an account for the Cosmetics Registration and Filing Information Service Platform; finally click [Account Binding] and select to authorize and bind [Cosmetics Registration and Filing Information Service Platform]. For specific operations, please refer to the *User Manual for Cosmetics Registration and Filing Information Service Platform - Enterprise Information and Data Management (Enterprise Users)* to download.
(2) NMPA Cosmetics Inquiry Platform URL: View.
(3) Website of the Filing Service Platform for Domestic Non-Special Cosmetics (old inquiry platform): View.
(4) Website of the Cosmetic Raw Material Safety Information Registration Platform: View.
(5) Website of the Cosmetics Registration and Filing Testing Information Management System: View.
 

1-2. How to use the Cosmetics Registration and Filing Information Service Platform?


Answer: Unlike the previous old filing information management system where account registration and product filing operations were completed directly on the system, the cosmetics registration and filing platform launched on May 1 this year requires three steps for use:
(1) Log in to the registered corporate account and/or handler account on the Online Service Hall of the National Medical Products Administration;
(2) Access the enterprise information data management system to apply for the role-based permissions of registrants/filers, domestic responsible persons and manufacturing enterprises.
(3) Access the General Cosmetic Filing Management System for new product filing, supplementary recording of existing products, filing modification, filing cancellation, and product annual reporting.
As the cosmetics registration and filing platform has just been put into use recently, there is a large volume of consultations. To collect and record issues more quickly and accurately and improve the efficiency of issue handling, we suggest that you adopt the following methods to solve problems encountered during use:
(1) Conduct troubleshooting on your own by referring to the system operation manual and FAQs. The system will step up its handling of issues reported by enterprises, and for resolved common issues, it will update the relevant content of the operation manual and FAQs in a timely manner to assist enterprises in solving general problems arising during system use. It is recommended that you read them carefully.
(2) It is preferred to use the consultation email for feedback. If your problem is still not solved after referring to the operation manual and FAQ, please send the problem to the corresponding email. Please describe the problem you encountered in as much detail as possible in the email, and attach operation screenshots, contact information and other relevant materials, and the system staff will give priority to handling and replying to you.
(3) Download link for the operation manual of the enterprise information data management system: Download.
(4) Download link for the Operation Manual for General Cosmetics Filing Administration: Download.
(5) FAQ chain: View.
(6) Consultation Email: gcftba@nmpa. gov. cn.
(7) Consultation Tel: 010-88331913.
 

1-3. What points should be noted during the application process for an enterprise account?


Answer:(1) There are mainly two forms for filling in cosmetic account information: filling in and uploading.
1. When filling in the form: The registrant, filing entity and domestic responsible person shall fill in or tick the content in accordance with the template on the information service platform.
2. During upload: The materials shall meet the requirements of the information service platform regarding version, format, size and other aspects, and ensure that the content is clear and legible (PDF format shall be used unless the information service platform allows materials in other formats).
3. Users who use CA signatures shall affix electronic signatures on electronic documents; users who do not use CA signatures and those who need to submit paper documents shall fill in the complete set of document contents on the information service platform, then print and affix seals thereon; after scanning the complete set of fully sealed paper documents, conduct a postback to the information service platform and submit them.
(2) The application materials shall use standard Chinese characters promulgated by the State, with the main text in black, the content being easily recognizable, and punctuation marks, charts, terms, etc. shall be used in a standardized manner to ensure that the content of the materials is accurate and standardized. Appropriate line spacing and page margins shall be set to ensure that no text information is lost during printing or binding.
(3) The application materials shall be printed on international standard A4 paper, with complete and clear content and no alterations allowed.
(4) Except for cases where other scripts are mandatory such as registered trademarks, website URLs, patent names, and the names and addresses of overseas enterprises, or conventional technical terms (e. g. SPF, PFA, PA, UVA, UVB, Vitamin C, etc.), all other texts shall be fully and standardly translated into Chinese, with the original text attached to the corresponding translation.
(5) The application materials shall comply with the relevant national regulations on the use of seals, be complete in signature and seal, and have legal effect. Where overseas enterprises and other organizations do not use an official seal, they shall be signed by the legal representative or the person in charge of the enterprise (other organization). Except for the original materials issued by government competent departments or relevant institutions, registered and filed inspection institutions, notarial organs, etc. , all cosmetics registration and filing materials shall be affixed with the official seal page by page by the domestic registrant, domestic filer or domestic responsible person. Where an official seal with an electronic encryption certificate is used, the electronic official seal may be directly affixed on the electronic materials.
(6) Where a foreign enterprise authorizes a domestic responsible person, or the product is manufactured by a foreign enterprise, the following points shall be noted:
1. The same product shall not be authorized to multiple domestic responsible persons, and the domestic responsible persons shall carry out registration and filing work within the scope of authorization.
2. Where the certificate of good manufacturing practice for overseas production has a valid period, the certificate shall be updated in a timely manner, and the maximum time limit for such update shall not exceed 90 days after the expiration date of the certificate; where there is no valid period, the latest version shall be submitted every five years.
3. If the original supporting documents cannot be provided, a copy notarized by a Chinese notary organ or confirmed by a Chinese embassy or consulate shall be provided instead.
 

1-4. Recently, many issues have emerged with the new filing system. How can I contact the staff in charge of the filing system?


Reply: For inquiries concerning enterprise information management and general cosmetics filing, please call: 010-88331913; or send an email to: gcftba@nmpa. gov. cn.
Consultation hotline for intelligent cosmetics application and review: 010-883636828; E-mail: hukang@nifdc. org. cn.
 

1.5. In the new system, the legal representative has already granted authorization to the handling agent, yet the system shows that the handling agent has no enterprise information authorization and thus cannot apply for a pre-filing number. How can this issue be resolved?


A: You may consult the system. The system phone number is 010-88331913.
 

1-6. How long does the review process take after the "Enterprise Information" of the new system is submitted?


A: 10 working days.
 

1-7. For the filing of ordinary cosmetics via the new system, should it be done before or after obtaining the pre-filing number?


Answer: The inspection of general cosmetics is not related to the pre-filing number.
 

1-8. How to cancel products of the legacy system?


A: Since the products of the old system will only be migrated to the account of the filing entity (the original entrusting party) of the new system, the cancellation of products shall be handled by the filing entity (the original entrusting party).
(1) If the filing party (formerly the entrusting party) has a new system account, it may apply for voluntary cancellation of the old one;
(2) If the filing party (the original entrusting party) does not have an account for the new system, it may apply for cancellation to the local regulatory authority (district market regulation administration).
 

1-9. What are the key points of the new regulations to be noted in the supplementary recording of cosmetics registration and filing products starting from May 1,2022?


A: In accordance with the requirements of the Announcement of the National Medical Products Administration on Relevant Matters Concerning the Implementation of the Provisions on the Administration of Cosmetic Registration and Filing Dossiers (No. 35 of 2021) and the Announcement of the National Medical Products Administration on the Issuance of the Rules for Cosmetic Classification and Classification Catalogue (No. 49 of 2021), registrants and filers shall, through the new registration and filing platform, submit product classification codes, product implementation standards and product label drafts, fill in the product formulas of domestic ordinary cosmetics, and upload the label images of the sales packaging of special cosmetics before May 1,2022.
It has been postponed to August 31,2022 due to the impact of the COVID-19 pandemic.
 

1-10. What are the key points of the new regulations to be noted for the labeling of cosmetics registered and filed as of May 1,2022?


A: In accordance with the requirements of the Announcement of the National Medical Products Administration on Issuing and Implementing the Measures for the Administration of Cosmetic Labels (No. 77), as of May 1,2022, cosmetics applied for registration or filing must comply with the provisions and requirements of the Measures for the Administration of Cosmetic Labels.
Pursuant to the requirements of the Announcement of the National Medical Products Administration on Promulgating the Provisions on the Supervision and Administration of Cosmetics for Children (No. 123 of 2021), as of May 1,2022, all children's cosmetics applied for registration or filing shall be labelled in accordance with the Provisions on the Supervision and Administration of Cosmetics for Children.
 

1-11. What are the key points of the implementation of the new regulations that need attention in the change of products containing prohibited ingredients in cosmetics registration and filing starting from May 1,2022?


A: In accordance with the requirements of the Announcement on Further Clarifying Matters Concerning the Transitional Period Management of Former Special Cosmetics and Other Relevant Issues (Announcement No. 150 of 2021) issued by the National Medical Products Administration, for products that have obtained registration or completed filing prior to the release of the Announcement on Updating the Catalogue of Prohibited Cosmetic Ingredients, applications for formula changes may be submitted before May 1,2022, and the original registration or filing number shall be retained. Where the cosmetic registrant or filing person fails to apply for changes in accordance with the regulations within the time limit, the relevant products shall not continue to be marketed and sold.
 

1-12. What are the key points of the new regulations to be noted regarding the summary of basis for efficacy claims of products containing prohibited ingredients in cosmetic registration and filing as of May 1,2022?


Answer: In accordance with the requirements of the Announcement of the National Medical Products Administration on Issuing the Specifications for the Evaluation of Cosmetic Efficacy Claims (No. 50 of 2021), for cosmetics that obtained registration or completed filing between May 1,2021 and December 31,2021, the cosmetic registrants and filers shall, before May 1,2022, evaluate the efficacy claims of the cosmetics in accordance with the requirements of the Specifications for the Evaluation of Cosmetic Efficacy Claims, and upload the summary of the basis for the product efficacy claims.
 

1-13. For product supplementary entry, what are the differences between imported products and domestic products?


Answer: For imported products, attention shall be paid to the classification code, implementation standard and label draft. For domestic products, attention shall be paid to the classification code, product formula, implementation standard and label draft.
 

1-14. How long does it take to complete the filing of general cosmetics?


Answer: According to Article 20 of the Regulations on the Supervision and Administration of Cosmetics, the filing of ordinary cosmetics is completed once the filer of ordinary cosmetics submits the filing materials specified in these Regulations through the online government service platform of the drug regulatory department under the State Council. The drug regulatory department of the people's government at or above the provincial level shall publish the information related to registration and filing to the public within 5 working days from the date when the registration of special cosmetics is approved, or from the date when the filer of ordinary cosmetics submits the filing materials.
 

1-15. How should cosmetics manufactured in China upon entrustment by overseas parties be filed for registration, and what are the filing requirements for those exclusively for export?


A: According to Article 23 of the Regulations on the Supervision and Administration of Cosmetics, overseas cosmetics registrants and filing parties shall appoint an enterprise legal person within the territory of China to handle cosmetics registration and filing, and assist in the monitoring of adverse cosmetic reactions and the implementation of product recalls. Where overseas parties entrust the domestic production of ordinary cosmetics, the overseas filing party shall appoint an enterprise legal person within the territory of China as the domestic responsible party, who shall register the role of domestic responsible party in the ordinary cosmetics filing management system and obtain approval before handling the filing of products entrusted for domestic production by overseas parties.
Pursuant to Article 37 of the Provisions on the Administration of Cosmetic Registration and Filing Materials, special cosmetics and ordinary cosmetics for export only shall be filed on the registration and filing information service platform, and the following materials shall be submitted by the manufacturer:
(1) Product name;
(2) Intended country (region) of export;
(3) Product label images, including the front view of the product sales packaging, the product packaging layout drawing, and the product instruction manual (if applicable)
 

1-16. Is it allowed to use copies of the original filing documents when re-filing for imported general cosmetics after their cancellation?


Answer: According to Article 59 of the Provisions on the Administration of Cosmetic Registration and Filing Materials, when filing for the record again after a general cosmetic product is deregistered, a statement of circumstances shall be submitted. For products deregistered for non-safety reasons, copies of the original filing materials may be used when applying for filing again.
 

1-17. What contents should be included in the resume of the person in charge of quality and safety?


A: According to Article 13 of the Provisions on the Administration of Cosmetic Registration and Filing Materials, the resume of the person in charge of quality safety shall include educational background, work experience and other content relevant to the required qualifications. The relevant professional knowledge and quality safety management experience of the person in charge of quality safety shall comply with the requirements of laws and regulations.
Internship experience is part of academic education and shall not be counted as work experience in cosmetic production or quality safety management
All paper attachments such as uploaded resume materials shall be affixed with an official seal.
 

1-18. Can the person in charge of quality safety hold concurrent posts in different cosmetic registrants, filing entities and entrusted manufacturing enterprises?


A: According to the *FAQs on Cosmetic Production and Operation (I)* issued by the National Medical Products Administration, to ensure the quality and safety of cosmetics and guarantee that the person in charge of quality and safety performs their duties of product quality and safety management and product release in accordance with the law, in adherence to the principle of "one license, one person", where an application is filed for two or more (inclusive) cosmetic production licenses, the same natural person shall not serve as the person in charge of quality and safety for the aforementioned enterprises; nor shall the same natural person act as the person in charge of quality and safety for different cosmetic registrants and filing entities.Where a cosmetic registrant/filing entity and a contracted manufacturer belong to the same group company and implement the same quality management system, when the contracted manufacturer accepts the entrustment from the said registrant/filing entity to manufacture cosmetics, the said registrant/filing entity and the contracted manufacturer may appoint the same natural person to serve as the person in charge of quality safety.
 

1-19. If the registrant/filing entity has no production capacity and entrusts another cosmetic manufacturer, can it borrow the person in charge of quality and safety from the entrusted manufacturer?


Answer: No. According to Article 32 of the Regulations on the Supervision and Administration of Cosmetics, cosmetics registrants, filing parties, and entrusted manufacturing enterprises shall appoint a person in charge of quality and safety, who shall undertake corresponding responsibilities for product quality and safety management and product release.
The person in charge of quality and safety shall possess professional knowledge related to cosmetics quality and safety, and have at least 5 years of experience in cosmetics production or quality and safety management.
 

1-20. May the person in charge of quality and safety authorize another person to perform his or her duties on his or her behalf?


A: According to Article 28 of the Measures, the person in charge of quality and safety shall, in accordance with the requirements of the cosmetics quality and safety responsibility system, assist the legal representative or principal person-in-charge of the cosmetics registrant, filing entity, and entrusted manufacturer to undertake corresponding responsibilities for product quality and safety management and product release. In light of the operational needs of the production quality management system of the cosmetics registrant, filing entity, and entrusted manufacturer, the person in charge of quality and safety may authorize another person to perform his or her duties on his or her behalf upon the written consent of the legal representative or principal person-in-charge. The authorized person shall have corresponding qualifications and capacity to perform the duties.The time of authorization by the person in charge of quality and safety, the authorized personnel, the authorized matters and other relevant information shall be truthfully recorded to ensure that the authorization process is traceable. The person in charge of quality and safety shall supervise the performance of duties by the authorized person, and the legal liabilities that the said person in charge should bear shall not be transferred to the authorized person.
 

1-21. Do cosmetics registrants and filers engaged in cosmetics production activities need to additionally activate account permissions in the name of a "manufacturing enterprise"? 


A: According to the Provisions on the Administration of Cosmetic Registration and Filing Materials, where an entity holds multiple identities such as a domestic registrant or filer, domestic responsible person, and manufacturer, or where the same domestic responsible person corresponds to multiple overseas registrants or filers, all relevant materials may be submitted in one go to obtain the corresponding user permissions. Existing users may supplement and provide relevant materials as needed to add user permissions.
Cosmetics enterprises in China that only engage in entrusted production shall activate account permissions in the name of "production enterprise" so as to associate and confirm the entrusted production Relations Of Production.
 

1-22. Is it necessary to affix the official seal page by page on the materials related to cosmetics user information?


Answer: According to Article 5 of the Provisions on the Administration of Cosmetic Registration and Filing Materials, cosmetic registration and filing materials shall comply with the relevant national provisions on the use of seals, be complete in signatures and seals, and have legal effect. Where overseas enterprises and other organizations do not use an official seal, they shall be signed by the legal representative or the person in charge of the enterprise (or other organization). Except for the original materials issued by the competent government departments or relevant institutions, registration and filing inspection institutions, notarial organs, etc. , all cosmetic registration and filing materials shall be affixed with the official seal page by page by the domestic registrant, domestic filer or domestic responsible person.
 

1-23. What might be the cause of the unresponsive page during the record-filing operation of the new system?


A: Every browser has a cache limit. When the filing information volume is excessively large, the speed at which the browser releases cache cannot keep up with the speed of opening the filing information. As memory keeps increasing without being released, the browser will prompt a non-responsive status. It is recommended to use Google Chrome and Mozilla Firefox, which have larger cache capacities.
 

1-24. If the filing entity both manufactures products on its own and acts as a contracted manufacturer for other parties, does it need to activate the role of a manufacturing enterprise?


A: To complete the record-filing for products exclusively for export, the production enterprise role needs to be activated. If the filer does not need to handle the record-filing for products exclusively for export, there is no need to activate the production enterprise role, and the entrusted affiliation can be confirmed under the filer role.
 

1-25. What should be done if the enterprise information in the product filing still shows the pre-change information after the enterprise information is updated?


Answer: If the enterprise information change has been verified and approved:
(1) Check the option "Domestic Independent Production" in the "Production Information" section;
(2) Click "Refresh";
(3) Deselect the selection made in step 1 and temporarily store the data.
 

1-26. How to obtain a test system account for a newly registered account on the new registration and filing platform?


Answer: After a newly registered filer on the registration and filing platform completes and passes the application for the registrant/filer role, log in to the Cosmetics Registration and Filing Testing Information Management System, select "Enterprise Login > Retrieve Password", fill in the 9th to 17th digits of the unified social credit code in the "Account" field, and the "Email" field shall be the corresponding email of the contact person filled in when the enterprise applied for the registrant/filer role. Click "Send Email" and then set the password via the link in the received email.
 

1-27. How to handle the situation where the submitter of the inspection report is inconsistent with the registrant/filing holder of the product due to historical reasons?


Answer: Due to historical reasons, for inspection reports where the submitter of the inspection report is inconsistent with the product registrant/filing entity, when the product registrant/filing entity uploads the inspection report on its own during product registration and filing, it shall additionally upload the scanned original copy of the certification letter for entrusted inspection issued by the product registrant/filing entity.
 

1-28. Why does the system prompt "Filing information form not uploaded" when I click Submit?


Answer: When submitting the filing, the enterprise shall note that in the "Attachment Upload" menu on the "Product Safety Assessment" page, it needs to upload the "Filing Information Form" generated by the system and sealed by the enterprise; otherwise, the system will prompt "Filing Information Form not uploaded".
 

1-29. When submitting the filing materials, why does the system display "Error reason: Please contact the administrator, the system cannot find the approver for the current user!"?


A: The record-filing application form for each product must be edited and submitted via the same account; if multiple handler accounts are involved in the editing process, an error prompt will appear upon submission.
 

1-30. Can changes be made after the product filing materials are submitted but before they are publicly announced?


A: After the product filing materials are submitted, the change operation can only be carried out after the "material sorting" link is completed on the supervision side.
 

1-31. After the entrusting party of the old system completes the post-filing inspection, if the post-filing inspection of the entrusted party is ordered to make rectification, can the entrusting party continue to make changes and modifications in the old system?


A: If the entrusted party of a filed product is ordered to make corrections, the entrusting party cannot apply for changes in the old system; only when the entrusting party itself is ordered to make corrections can changes be made in the old system. It is recommended to make changes on the new registration and filing platform in such cases.
 

1-32. When submitting the product after it has been ordered to make corrections, a prompt appears: "Error reason: Filing application submission failed! The submitter is not the same person as the first filer. " How to handle this?


A: After the product is subject to rectification as required, the submitter shall remain consistent with the original filer. If this prompt appears, the enterprise may delete the record-filing application, re-fill in the information and submit the record-filing application again.
 

1-33. If rectification is ordered, since the packaging part does not involve formula-related issues, how should the rectification be carried out? Should the change be initiated in the old system, or can it only be restarted from the new system?


Answer: Only those who are ordered to make corrections during the post-filing inspection can meet the prerequisite for triggering the change, and normal change operations are not available.
 

1-34. I would like to ask whether the filing of general cosmetics has a validity period? If yes, how long is the validity period?


Answer: For general cosmetics that were filed before December 31,2020, in accordance with the provisions of the *Notice on Adjusting Relevant Matters Concerning the Administration of Cosmetics Registration and Filing*(Notice No. 10 of 2013 of the China Food and Drug Administration): the product filing information shall be reconfirmed every 4 years as of the date of filing; if the product is no longer produced, the enterprise shall voluntarily cancel the original filing information. As of May 1,2021, the filer of general cosmetics shall report annually to the drug regulatory department in charge of filing administration on the production and import status, as well as the compliance with laws and regulations, mandatory national standards and technical specifications.
 

1-35. During the filing process of general cosmetics, the product was initially manufactured through a consignment arrangement between the entrusting party and the entrusted party, with the filing completed in the name of both parties. Later, due to adjustments in client requirements, the ownership of the previously developed product was transferred to the entrusted party, and the filing was converted to the form of self-production. As the stock of packaging materials is marked in the consignment format, the initial consignment-based filing has not been cancelled. In this case, is it compliant and permissible for the product to be sold normally when two filing forms coexist for a single product?


Answer: Please cancel the original product filing information and then re-file the aforementioned products.
 

1-36. Both the filing authority for general cosmetics and the entrusted party have completed the online filing procedures for general cosmetics. When the general cosmetics are submitted for on-site verification, the entrusted party has passed the verification, but the entrusting party fails to conduct the on-site verification in a timely manner or submits incomplete materials, and the drug regulatory system issues a rectification order for reasons unrelated to product quality. In this case, can the products already on the market continue to be sold normally?


Answer: Please implement the rectification requirements as required by the regulatory authorities, and complete the post-filing supervision and inspection in a timely manner.
 

1-37. How to register imported cosmetics claimed to be for use by pregnant women?


Answer: If the product is a general cosmetic, it shall be filed as an imported general cosmetic; if the product is a special cosmetic, an administrative license shall be applied for as an imported special cosmetic. Review experts will verify the relevant technical materials to determine whether it is suitable for pregnant women.
 

1-38. If a compound raw material is purchased and directly filled for sale, how should the product filing be handled?


Answer: File for the record as self-produced goods.
 

1-39. A new system account has been created, but the enterprise has now been deregistered. Should the enterprise account be deregistered via the "Enterprise Information and Data Management" section of the Cosmetics Registration and Filing Platform, or via the Service Hall? If the account is deregistered, will all product information that was originally filed under this account be deregistered along with it?


Answer: You can cancel the account in the enterprise information and material management section of the cosmetics registration and filing platform, and all products of the enterprise will be automatically cancelled after the account cancellation.
 

1-40. How should cosmetics registrants and filing entities retain product samples? How to determine the quantity of retained samples?


Answer: In accordance with the *Measures for the Supervision and Administration of Cosmetic Production and Operation*, the *Provisions on the Administration of Cosmetic Registration and Filing Materials*, and the *Good Manufacturing Practice for Cosmetics*, cosmetic registrants and filers shall retain samples for each batch of products leaving the factory. The purpose of this sample retention system is to ensure the traceability of product quality and safety, and to consolidate the primary responsibility of cosmetic registrants and filers for product quality and safety; meanwhile, when sold products encounter quality and safety issues or are counterfeited, it facilitates the verification of the legality and safety of each batch of products.
In the actual implementation of the sample retention system, in accordance with the provisions of the above-mentioned regulations, and to save the operating costs of enterprises, the Cosmetics Supervision Department of the National Medical Products Administration, taking into account factors such as different product categories, packaging specifications, and finished product status, as well as referring to the actual supervision work and combining with industry research, has sorted out the sample retention quantities of common products sold on the market (see the table below) for the reference of the majority of enterprises in their production and operation practices. For product types not listed in the table below, cosmetics registrants and filing entities shall determine the sample retention quantities by themselves in accordance with regulatory requirements.
Serial No. Product Category Reference Quantity for Retained Samples
1 Hair Dye Products ≥3 packages with a total weight/volume ≥90 g or mL
2 Spot-removing/Whitening Category ≥3 packages with a total volume/weight of ≥50 g or mL
3 Cosmetics ≥3 packages with a total volume/weight ≥60 g or mL
4 Skincare Category ≥3 packages with a total weight/volume ≥80g or mL
5 Sunscreen Products ≥3 packages with a total volume/weight of ≥50 g or mL
6 Acne-removal claim category ≥3 packages with a total weight/volume ≥200 g or mL
7(1) Face Mask (Sheet Type) Individually wrapped single-piece products: ≥7 patches with a total weight/volume of ≥140g or mL
Boxed products: ≥3 boxes (≥7 patches) with a total volume/weight of ≥140g or mL
7(2) Face Masks (Rinse-off Type) ≥3 packages with a total weight/volume ≥80g or mL
8 Shampoo and Hair Care Products ≥3 packages with a total volume/weight of ≥50 g or mL
9 Nail polish (for fingernails and toenails) ≥6 packages with a total volume or weight ≥30g or mL
10 toothpaste ≥3 packages with a total weight/volume ≥80g or mL
Note: For cosmetic products with a net content of less than 1 gram, while retaining finished product samples, sample retention may be conducted on the product in combination with its semi-finished products, and the retained samples shall meet the requirements for product quality inspection.
 

1-41. Where shall the registrants and filing parties of imported cosmetics keep samples of the cosmetics they import into China?


A: In November 2021, the National Medical Products Administration (NMPA) issued the Announcement on Matters Concerning the Implementation of the Measures for the Supervision and Administration of Cosmetic Production and Operation (No. 140 of 2021), which clarifies that as of January 1,2022, overseas cosmetic registrants and filing entities shall retain samples for each batch of products they import into China, and the samples and relevant records shall be kept by their domestic responsible parties. For products of the same production batch that are imported in multiple installments, sample retention shall be conducted at least once upon the first import.
Pursuant to the *Good Manufacturing Practice for Cosmetics*, a cosmetics registrant or filing entity that entrusts production shall retain samples at its domicile or principal place of business, or may alternatively retain samples at another business premise located in the same area as its domicile or principal place of business. The term "location" in the phrase "the location of its domicile or principal place of business" is generally interpreted as referring to the administrative area within the same prefecture-level city or municipality directly under the central government. Where a domestic responsible person retains samples, the selection of its sample retention location shall be implemented with reference to the foregoing provisions. The selected sample retention location shall be capable of meeting the requirements of laws and regulations as well as the product storage requirements indicated on the label.
 

1-42. If the filing of a general cosmetic has been completed and cancelled, can the products with production date before the cancellation be normally sold until the end of their shelf life?


A: Yes.
 

1-43. Is there a validity period for the pre-filing number that has been applied for?


A: According to the prompt of the National Ordinary Cosmetics Filing System: for the pre-filing numbers obtained between January 1 and June 30 each year, the filing shall be completed with such pre-filing numbers before June 30 of the same year; otherwise, the said pre-filing numbers will be cleared. For the pre-filing numbers obtained between July 1 and December 31 each year, the filing shall be completed with such pre-filing numbers before December 31 of the same year; otherwise, the said pre-filing numbers will be cleared.
 

1-44. Should cosmetics operators establish and implement a product sales record system?


A: In accordance with the provisions of the Regulations and the Measures, cosmetics registrants, filing entities, and entrusted manufacturing enterprises shall establish and implement a product sales record system. Cosmetics operators such as shopping malls and supermarkets are not mandated to establish and implement a product sales record system, but shall take effective measures to ensure product traceability. Where the customers of a cosmetics operator are other cosmetics operators, it is encouraged for the operator to establish and implement a product sales record system.
 

1-45. Can beauty salons, barbershops, hotels and other similar establishments formulate and fill cosmetics?


A: Cosmetics used or provided to consumers by beauty salons, hotels and other business entities in the course of their operations shall comply with the obligations of cosmetics operators stipulated in the Regulations and the Measures in accordance with the law, and the cosmetics provided to consumers shall conform to the provisions on labels of the minimum sales unit.
Pursuant to the provisions of the Measures, anyone that engages in the preparation, filling and packaging of cosmetic contents shall obtain a Cosmetics Production License. Beauty salons and hair salons and other such entities shall not prepare cosmetics on their own, nor shall they fill or package cosmetic contents without authorization, except for the scenario where cosmetics are mixed on-site for consumers in accordance with the usage instructions specified on the cosmetic labels or instructions.Cosmetics provided to consumers by establishments such as hotels, bathing centers, wedding photography studios, and maternity care centers shall bear product labels that comply with relevant regulations. The labels shall indicate the product name, the registration number of special cosmetics, the names and addresses of the registrant, filing entity, and entrusted manufacturer, the number of the cosmetics production license, the number of the product implementation standard, the full ingredient list, the net content, the shelf life, the usage method, necessary safety warnings, and other contents that shall be indicated as stipulated by laws, administrative regulations, and mandatory national standards.
 

1-46. If consumers buy cosmetics from a company whose cosmetics production license has been revoked via online shopping, does the online store involved violate relevant regulations?


Answer: If the product was manufactured after the production enterprise had its license revoked, or if the product had previously been subject to a recall notice due to quality or other issues, it is an illegal product.
 

1-47. How to determine whether a cosmetic product contains harmful additives?


Answer: It is impossible to judge whether there is illegal addition only based on an incomplete product name. You can inquire about the ingredient information on the filing platform of the National Medical Products Administration. If no relevant information is found, the product is initially suspected to be illegal, and it is recommended to consult and verify with the regulatory authority.
 

1-48. Can a single cosmetic that has completed the filing of general cosmetics and a disinfection product (antibacterial hand sanitizer) that has completed filing be combined into a set for sale together?


A: Yes, there are no relevant restrictions at present.
 

1-49. According to Item (3) of Article 10 (Requirements for Labeling of Enterprise Information) of the *Measures for the Administration of Cosmetic Labeling (Draft for Comment)*(Drug Administration Cosmetic Letter [2020] No. 105), "the name and address of the manufacturer shall be those of the manufacturer that completes the final process in contact with the contents", the phrase "the final process in contact with the contents" can be interpreted as the filling process.The conditions of our company's production activities comply with the requirements of Article 26 of the Regulations on the Supervision and Administration of Cosmetics (State Council Decree No. 727) and the Work Specifications for Cosmetics Production Licensing (No. 265 of 2015). However, in terms of production equipment, we do not have a production emulsification workshop, only relevant production facilities and equipment for filling. Does this meet the requirements for applying for a cosmetics production license?


A: Article 26 of the Regulations on the Supervision and Administration of Cosmetics clearly stipulates the conditions for engaging in cosmetic production activities. If you meet the relevant conditions, you may submit an application to the regulatory authority. Specific requirements shall be implemented in accordance with the "Appendix 2 Work Specifications for Cosmetic Production Licensing" and the "Key Points for Inspection of Cosmetic Production Licensing" as specified in the Announcement of the China Food and Drug Administration on Relevant Matters Concerning Cosmetic Production Licensing.
 

1-50. If a manufacturing enterprise expands its production facilities based on the existing workshop, and accordingly changes the addresses on its business license and production license simultaneously (the scope of the address after change is larger than that of the original address), can the old-version packaging materials (with the address being the one before the change) be normally used in the transitional production process?


Answer: The use of packaging materials shall comply with statutory requirements, and enterprises shall independently control the printing volume and usage of packaging materials; where laws and regulations clearly specify a transition period, compliance with such provisions shall be required.
 

1-51. The product is manufactured by two contracted manufacturers A and B as entrusted by the filing sponsor, and the filing has been completed normally (with the entrusting party associated with A and B). After the production license of Manufacturer A is cancelled, can the packaging materials (marked with contracted manufacturers A and B) still be used up in the production process at Factory B?


Answer: Yes.
 

1-52. Who are the personnel directly engaged in cosmetic production activities? What are the diseases that may jeopardize the quality and safety of cosmetics as stipulated by the competent health department of the State Council?


A: The scope of "personnel directly engaged in cosmetic production activities" as stipulated in the Regulations shall be determined based on actual conditions, and shall in principle include personnel engaged in cosmetic production, inspection and warehouse-related operations. Such employees shall undergo health checks as required before taking up their posts and during their employment, and may start work only after obtaining a physical examination report issued by a medical institution that covers all required items and contains clear conclusions.
Pursuant to the provisions of the Regulations, the competent health department of the State Council shall stipulate the scope of diseases that jeopardize the quality and safety of cosmetics. Prior to the issuance of relevant provisions by the competent health department of the State Council, the current implementation shall follow the scope of diseases that jeopardize the quality and safety of cosmetics as stipulated in the original regulation *Regulations on the Hygienic Supervision of Cosmetics*, which includes: dysentery, typhoid fever, viral hepatitis, active pulmonary tuberculosis, hand skin diseases (tinea manuum, onychomycosis, hand eczema, psoriasis or scales occurring on the hands) and exudative skin diseases, among others. Personnel suffering from such diseases shall not directly engage in cosmetic production activities.
 
 

2. Filing Application Form

 

2-1. Which products do not fall under the definition scope of cosmetics?


Answer: (1) The intended use does not fall under the definition of cosmetics, for example: 1. Claims such as "help improve dark circles and eye bags", "aid sleep, relax via inhalation, use with a gua sha tool, spray on pajamas and bedding", "lymphatic detox, for and inner thighs"; 2. Promotion of medical effects, such as packaging illustrations showing traditional Chinese medicine consultation; 3. Promotion of antibacterial and bacteriostatic effects, such as claims accompanied by bacteria icons; 4. Promotion of mosquito repellent effects, such as claims of mosquito prevention, insect repellent, sterilization and bacteriostasis, or patterns of mosquitoes and insects. (2) The application site does not fall under the definition of cosmetics, such as for eye washing, nasal moisturizing, or . (3) Usage methods that do not fall under the definition of cosmetics, such as injection, aromatherapy, cosmetic injection, oral collagen, micro plastic surgery, boiling, moxibustion, etc.
 

2-2. How to file for products that claim to be for intimate area cleansing (without claiming bacteriostatic effect)?


Answer: Cosmetics refer to chemical industrial products or fine chemical products that are applied to any part of the human body surface, such as skin, hair, nails, lips and teeth, by smearing, spraying or other similar methods, for the purposes of cleansing, maintaining, beautifying, modifying and altering appearance, or correcting body odors and keeping in good condition. belong to mucous membranes, not the surface of the human body, so they do not fall into the category of cosmetics.
 

2-3. Foot bath solutions are products made from raw materials such as vinegar, milk or plant extracts. They are poured into warm water for foot soaking to achieve the effects of warming the feet and delivering a pleasant fragrance. Are such products classified as cosmetics?


Answer: Cosmetics refer to daily chemical industrial products that are applied to any part of the human body surface (such as skin, hair, nails, lips, etc.) by smearing, spraying or other similar methods for the purposes of cleansing, eliminating unpleasant odors, skin care, beautification and modification. For example, body wash is also applied to any part of the human body surface through washing and lathering. The application method of lathering is not a problem. The key lies in what function it performs.
 

2-4. Products that are directly applied to the human scalp and hair, have one or more of the functions of hair care, cleansing, oil control, hair growth promotion, itch relief and dandruff removal, and also have a bacteriostatic effect — do such products belong to disinfection products, cosmetics, or pharmaceuticals?


A: To determine whether a product falls into the category of cosmetics, please refer to Article 3 of the Regulations on the Supervision and Administration of Cosmetics: "For the purposes of these Regulations, cosmetics refer to daily-use chemical industrial products applied to the surface of the human body such as skin, hair, nails and lips by smearing, spraying or other similar methods for the purposes of cleansing, protection, beautification and modification. "
 

2-5. Is tattoo and permanent makeup pigment classified as a special cosmetic? If an enterprise intends to produce and sell tattoo and permanent makeup pigment, what categories must be included in the licensed items on the production license?


Answer: The semi-permanent pigments described above, which are used by being injected into the skin or applied to damaged skin, do not fall under the category of cosmetics. Cosmetic manufacturers are prohibited from placing such pigments on the market for sale as cosmetics.
 

2-6. Which products shall be declared as special cosmetics?


Answer:(1) Claims of freckle removal and skin whitening effects, such as claims of skin whitening, fair complexion, fading acne marks, "fade scar marks and freckles", "instantly reveal fair porcelain-like beautiful skin", etc. ;
(2) Claims of sun protection efficacy, such as claims of "Sunscreen", sun protection, etc. ;
(3) Claiming hair dyeing or perming effects, for example, claiming that hair care products contain curl-fixing ingredients, pigment stabilizers, etc. ;
(4) Promoting anti-hair loss effects, such as claiming to "improve hair shedding" and the like.
 

2-7. The product is labeled to deodorize and eliminate underarm odor, and it works by spraying to achieve deodorization and underarm odor removal. Is this product a cosmetic or a disinfectant?


Answer: Deodorant cosmetics are a type of special cosmetics. Whether a product falls into the category of cosmetics cannot be determined solely based on the term "deodorant"; instead, a comprehensive review of all information about the product should be conducted to verify if it conforms to the definition of cosmetics.
 

2-8. Could you please advise whether shampoos with the "hair breakage prevention" function can currently be filed as "ordinary cosmetics", or whether such products must be regulated as "special cosmetics"?


A: Article 16 of the Regulations on the Supervision and Administration of Cosmetics clearly stipulates that "Cosmetics for hair dyeing, perming, spot-removing and whitening, sun protection, hair loss prevention, as well as cosmetics claiming new efficacy are special cosmetics. Cosmetics other than special cosmetics are ordinary cosmetics. " Schedule 1 "Classification Catalogue of Efficacy Claims" of the Rules and Classification Catalogue for Cosmetics Classification clearly defines the interpretation of "hair breakage prevention" as "helping to improve or reduce hair breakage and split ends; helping to maintain or enhance hair toughness". Cosmetics that meet the above interpretation are hair breakage prevention cosmetics, which belong to ordinary cosmetics.
 

2-9. A customer intends to produce a mask product consisting of a serum and a powder for combined use, which is packaged in the same aluminum pouch; when in use, the serum in the upper part needs to be squeezed into the of the aluminum pouch where the powder is contained. The serum will be manufactured by our company, while the powder will be produced by another manufacturer. Could you please advise on how to file for the registration of such a product?


Answer: The actual manufacturing enterprise shall be determined based on the enterprise that conducts the final production process involving contact with the contents.
 

2-10. Are free gift samples (non-saleable items) required to be filed for record?


Answer: Non-sale items also require filing, and all sales packages shall be filed.
 

2-11. Is it mandatory to upload the supporting documents for record filing?


Answer: It is acceptable not to upload the relevant materials during the record-filing process, but supporting documents shall be provided during the post-record-filing inspection.
 

2-12. What are the different types of suit forms?


Answer: A set product, as the name suggests, is a product sold as a complete set. According to relevant regulations, there are three types of relevant set forms in China: (1) The set product contains two or more (including two) individually packaged items; (2) Non-detachable combined packaging; (3) Two or more products designed to be used in conjunction with each other.
 

2-13. How to register the first type of kit? (The product contains two or more (including two) individually packaged components)


A: This type of set product refers to a product that is only sold in the form of a gift box at the time of sale, and each individual item in the gift box has its own product name.
When products of this type are subject to filing, each individual item shall be filed separately, and the filing name shall be a standalone "product name" or a combination of "kit name" plus "product name".
This type of gift box mostly consists of cleansing and skincare products.
 

2-14. How to register the second type of kit? (Non-detachable combined packaging)


Answer: Products in this type of combined packaging refer to products where all individual items cannot be separated independently without damaging the product packaging. When filing for such products, it is only necessary to file the set as an "individual item", and the filing name shall be the "name of the set box". However, in the formula of the filed product, the formulas of all individual items need to be reported separately. This form of combined packaging is mostly found in makeup and skincare products.
 

2-15. How to file for the third type of kit? (Products that are used in combination of two or more)


Answer: This type of product has a packaging appearance very similar to the first type, both are set products, and the inside of the set box contains individually packaged items. However, the biggest difference between this type of product and the first type lies in the method of use: it requires two or more products to be used in combination and cannot be used alone. When filing for this type of product, only the set box needs to be filed in the form of a "single item". In the formula of the filed product, all individual product formulas shall be reported separately, and for such products, the "set product" option shall be checked in the "other information" section of the data page of the filing application form. Such set products are mostly hair dye products and skin care products.
 

2-16. For a skin care lotion, the semi-finished product is purchased by domestic Company A from overseas and then filled and packaged by domestic Company B in China. Is this skin care lotion considered an imported commodity? Is Company A, which conducts the packaging, regarded as the actual manufacturer, and does its enterprise information need to be displayed on the product?


A: No, it does not. Any product that is declared as raw materials for customs clearance and then packaged domestically shall be recognized as a domestic product. Company A is the entrusting party, and Company B is the entrusted party (the actual manufacturing enterprise).
 

2-17. Multiple imported products are listed on the same production and sales certificate. Is it necessary to submit the original sales certificate for each product? If a copy is submitted, is notarization still required?


A: According to Article 27 of the Provisions on the Administration of Cosmetic Registration and Filing Materials, documents such as the proof of already-marketed and sold products for imported cosmetics, authorization documents, or certification materials proving affiliation with the same group company may list multiple products simultaneously. When applying for registration or completing filing for these products, one of the products may use the original document, while the rest may use copies, with a statement indicating the name of the product where the original document is located, as well as relevant acceptance number, registration certificate number or filing number and other information.
 

2-18. What is the classification code for cosmetics?


Answer: According to Article 3 of the Classification Rules and Catalogue for Cosmetics, cosmetics registrants and filing holders shall conduct classification coding in accordance with these Rules and the Catalogue based on the efficacy claims, application sites, target user groups, product dosage forms and application methods of cosmetics.
Article 4. For cosmetics, the corresponding serial numbers shall be selected sequentially from the classification catalogue of efficacy claims, action sites, target user groups, product dosage forms and methods of use attached to these Rules and the Catalogue, and the codes of each group of catalogues shall be connected with "-" to form a complete product classification code.
Where the same product has multiple efficacy claims, action sites, target user groups or product dosage forms, multiple corresponding serial numbers may be selected, which shall be arranged in sequence and connected with "/" between each serial number.
 

2-19. What are the classification codes for cosmetic efficacy claims?


Serial No. Function Category Definition Explanation and Claim Guidelines
A New Efficacy that do not comply with the following rules
1 hair dyeing Designed for hair color modification; immediate washing after application will not restore the original hair color
2 Perm Used to change the curl of hair (either to curl or straighten it) and maintain a relatively stable state. Note: Products that restore the original shape of hair immediately after washing do not fall into this category.
3 Spot-fading and Whitening Helps reduce or alleviate skin pigmentation to achieve a skin whitening and brightening effect; achieves a skin whitening and brightening effect through physical masking. Note: This includes products that improve acne marks caused by pigment deposition.
4 Sun Protection Used to protect the skin and lips from damage caused by specific ultraviolet rays. Note: For sunscreen cosmetics for infants and children, the application site is limited to the skin only.
5 hair loss prevention Helps improve or reduce hair loss Note: Products that regulate hormonal effects and products that promote hair growth do not fall under the category of cosmetics
6 Acne removal Helps reduce or slow the occurrence of acne (including blackheads or whiteheads; helps the skin recover after acne develops. Note: Products that regulate hormonal effects, kill (resist, inhibit) bacteria, and reduce inflammation do not fall under the category of cosmetics
7 nourish Helps nourish the application site; Note: Products that achieve nourishing effects indirectly through other functions do not fall into this category.
8 Repair Helps maintain the normal condition of the application area. Note: Products intended for use on injured areas such as scars, scalds, burns, and skin lesions are not classified as cosmetics.
9 Clean It is used to remove dirt and attachments on the surface of the application site
10 Makeup Removal Used to remove makeup and other cosmetics from the application area
11 Moisturizing It is used to supplement or enhance the content of components such as moisture and lipids in the application area, and helps to maintain the moisture content of the application area or reduce moisture loss.
12 Beauty grooming Products that are used to temporarily alter the appearance of the application site for beautifying, modifying and other purposes, and can restore the original state after cleansing and removing makeup. Note: Products such as artificial nails or solid decorations (e. g. false eyelashes, etc.) do not fall into the category of cosmetics.
13 Aroma It contains aromatic ingredients, which helps to modify body odor and enhance fragrance.
14 Deodorization Helps reduce or mask body odor Note: Products that achieve deodorization solely by inhibiting the growth of microorganisms do not fall under the category of cosmetics
15 anti-wrinkle helps reduce the formation of skin wrinkles or make them less noticeable
16 firming Helps maintain skin firmness and elasticity
17 soothing Helps improve conditions such as skin irritation
18 Oil Control It helps slow down the sebum secretion and deposition at the application site, or makes the oiliness at the application site unnoticeable.
19 exfoliation helps promote the shedding of skin keratin or facilitate keratin renewal
20 talcum powder Helps keep skin dry or enhance the cooling sensation of the skin. Note: Products targeting pathological hyperhidrosis do not fall under the category of cosmetics.
21 Hair Care It helps improve the combability of hair and beard, prevents static electricity, and maintains or enhances the luster of hair.
22 Prevents hair breakage Helps improve or reduce hair breakage and split ends; helps maintain or enhance hair toughness
23 Dandruff removal Helps slow down the production of dandruff; helps reduce dandruff adhering to the scalp and hair
24 Hair Color Care Helps maintain stable hair color before and after hair dyeing. Note: Products intended to change hair color do not fall into this category
25 Hair Removal Used to reduce or remove body hair
26 Auxiliary Shaving and Hair Removal Used to soften and expand hair, helping to lubricate the skin during shaving and hair removal. Note: Shaving and hair removal tools are not classified as cosmetics.
 

2-20. What are the classification codes for the application sites of cosmetics?


Answer: According to Article 6 of the Classification Rules and Catalogue for Cosmetics, the application site shall be reasonably selected with the corresponding serial number based on the specific application site indicated on the product label. For cosmetics claiming application sites covering "eye area" or "lip area", the corresponding serial number shall be included in the code, and such cosmetics shall be administered in accordance with the safety and efficacy claim requirements for cosmetics intended for the eye area or lip area.
Serial No. Site of action Description
B New Benefits that does not comply with the following rules
1 hair Note: Hair dye and perm products can only correspond to this application area; sunscreen products cannot correspond to this application area.
2 body hair excluding hair on the head and face
3 Trunk excluding the head, face, hands and feet
4 Head Face not included
5 Face Excluding the lips and eye area; Note: Depilatory products are not applicable to this application site
6 eye area Including the skin around the eyes, eyelashes, and eyebrows;(including the beard area) Note: Depilatory products are not applicable to this application site
7 lips Note: Freckle-removing and whitening products, as well as hair removal products, do not correspond to this application site.
8 Hands and feet Note: Deodorant products do not correspond to this action site
9 whole body skin Excluding the lips and eyes
10 Nails (fingernails and toenails)  
 

2-21. What are the categories in the coding system for the applicable population of cosmetics?


Answer: According to Article 7 of the Classification Rules and Catalogue for Cosmetics, cosmetics whose claimed user groups include "infants" and "children" shall have the corresponding serial numbers in their codes, and shall be administered in accordance with the safety and efficacy claim requirements for cosmetics for "infants" and "children".
Serial No. Target Users Description
C New Efficacy Products that do not meet the following rules; products claimed to be suitable for pregnant women and lactating women
1 Infants and toddlers (0 to 3 years old, inclusive of 3 years old) Efficacy claims are limited to cleansing, moisturizing, hair care, sun protection, soothing, and skin refreshing only
2 Children (aged 3 to 12, inclusive of 12 years old) The efficacy claims are limited only to cleansing, makeup removal, moisturizing, cosmetic modification, fragrance, hair care, sun protection, repair, soothing, and body refreshing (moisturizing, hair styling, oil control, exfoliation, and anti-hair breakage have been removed).
3 general population Not restricted to specific user groups
 
2-22. What are the classifications and codes for cosmetic product dosage forms?

Serial No. Product Dosage Form Description
0 Other Not falling within the following scope
1 Creams, lotions and milks ointments, creams, balms, butters, lotions, emulsions, milks, milk lotions and the like
2 liquid Dew, liquid, water, oil, oil-water separation, etc.
3 gel Jelly, glue and similar products
4 Powder Loose powder, granules, etc.
5 bulk Lumpy powder, large solid blocks, etc.
6 mud Sludge-like solids, etc.
7 Wax-based with wax as the main base material
8 Spray Propellant excluded
9 Aerosol with propellant
10 Lamination, coating, with substrate Patches, films, and those containing substrates intended for use with cosmetics
11 freeze-drying Lyophilized powder, lyophilized tablets, etc.

2-23. What are the application methods used in the classification code of cosmetics?


Answer: 01 Rinse, 02 Retain. These two application methods can be used either individually or in combination.
Pursuant to Article 8 of the Classification Rules and Catalogue for Cosmetics, where the method of use includes both rinse-off and leave-on applications, the cosmetic shall be administered in accordance with the requirements for safety and efficacy claims applicable to leave-on cosmetics.
 

3 Basis for Product Naming

 

3-1. What are the requirements if the common name in a cosmetic name uses a specific raw material name or a term indicating the category of raw materials?


A: According to the Administrative Measures for Cosmetic Labels, where a specific raw material name or a term indicating a raw material category is used, it shall be consistent with the ingredients in the product formula, and the efficacy exerted by the said raw material in the product shall be consistent with the product's efficacy claims. For example, if a product is named "XX Amino Acid Mask" and its efficacy claim is anti-wrinkle, then the product formula shall contain amino acids, and the purpose of using the amino acids shall be related to anti-wrinkle.
Where the name of an animal, plant, mineral or the like is used to describe the fragrance, color or shape of a product, such ingredient may not be included in the formula. When naming the product, the generic name may adopt the format of "name of animal/plant/mineral or the like + fragrance/color/shape", or a suffix may be added after the attribute name for clarification, for example, cucumber-flavored facial cleanser or facial cleanser (cucumber-flavored).
 

3-2. How to standardize the filling of the naming basis for cosmetic filing product names?


Answer: According to Article 28 of the Provisions on the Administration of Cosmetic Registration and Filing Materials: "Registrants and filers shall submit the basis for the product name, which shall specify the trademark name, common name and attribute name, and respectively explain their specific meanings. "
 

3-3. Requirements for the use of registered trademarks in the filing of general cosmetics


Answer: According to the Provisions on the Naming of Cosmetics, the Administrative Measures for Cosmetic Labeling, and the Administrative Provisions on Cosmetic Registration and Filing Materials, where a registered trademark in the Chinese name of a product uses letters, Pinyin, numerals, symbols, etc. , the meaning thereof shall be explained on the visible surface of the product's sales packaging, and the trademark registration certificate shall also be provided.
The use of cosmetic trademark names shall comply with the provisions of the relevant national laws and regulations on cosmetics administration, as well as the provisions of the relevant national laws and regulations on trademark administration. According to the relevant provisions of the Trademark Law and the Regulations for the Implementation of the Trademark Law, using a trademark identical with a registered trademark on the same kind of goods without the license of the trademark registrant constitutes an act of infringing upon the exclusive right to use the registered trademark. A trademark registrant may license another person to use its registered trademark by concluding a trademark licensing contract.
Cosmetic filing holders shall be responsible for the legality, authenticity, completeness, accuracy and consistency of cosmetic labels. Where a product uses a "registered trademark" belonging to another party, the filing holder shall obtain a license from the trademark registrant prior to filing; the licensing contract may be submitted as a required document for filing, provided that the filing holder shall guarantee the legality of the license and keep it on file for inspection.
 

3-4. What requirements shall be met for the use of trademarks on cosmetic labels?


Answer: Article 4 of the Administrative Measures for Cosmetic Labels stipulates that "cosmetic registrants and filing holders shall be responsible for the legality, authenticity, completeness, accuracy and consistency of cosmetic labels", and the first paragraph of Article 8 stipulates that "the use of trademark names shall, in addition to complying with the relevant laws and regulations of the state on trademarks, also comply with the relevant laws and regulations of the state on cosmetic administration". Meanwhile, Article 28 of the Provisions on the Administration of Cosmetic Registration and Filing Materials stipulates that "where letters, Chinese pinyin, numbers, symbols, etc. are used in the trademark name of the Chinese name of a product, a trademark registration certificate shall be provided".
 

3-5. If a product has multiple registered trademarks, how to submit via the newly registered filing platform?


Answer: Article 4 of the Measures for the Administration of Cosmetic Labels stipulates that "cosmetic registrants and filing entities shall be responsible for the legality, authenticity, completeness, accuracy and consistency of cosmetic labels", and the first paragraph of Article 8 stipulates that "the use of trademark names shall, in addition to complying with the relevant national laws and regulations on trademarks, also comply with the relevant national laws and regulations on cosmetic administration". Meanwhile, Article 28 of the Provisions on the Administration of Cosmetic Registration and Filing Materials stipulates that "where letters, Chinese pinyin, numerals, symbols, etc. are used in the trademark name of a product's Chinese name, a trademark registration certificate shall be provided".
 

3-6. The product has two trademarks: one is an English trademark (which has been registered and obtained the registration certificate), and the other is a Chinese trademark which is the transliteration of the English trademark. Now we plan to launch new products, and both trademarks will be marked on the outer packaging (the English trademark actually mainly serves to decorate the color box). Do we need to mark the TM symbol and R symbol respectively when labeling? If a product has multiple registered trademarks, please upload them together in one document.


Answer: When uploading to the filing system, there is no need to enter the ® and ™ symbols for the product trademark name, but they shall be truthfully marked on the product outer packaging images. Generally, only one of the trademarks is used for naming cosmetics.
 

3-7. May I ask whether the following two Chinese trademarks can be used on the same product at the same time?


Answer: A product's outer packaging may bear multiple trademarks, but only one trademark name can be used for the product name in the filing system.
 

3-8. The name of a cosmetic product shall generally consist of a trademark name, a generic name and an attribute name. Could you please clarify whether "essence" can be used as an attribute name? (It has been found that such names exist in the inquiry of domestic special-use cosmetics.)


Answer: Please name it in accordance with the nomenclature terms for cosmetics.
 

3-9. The product is urgently needed to be launched on the market, but currently there is only a TM trademark and no R mark. Is it possible to use this trademark for record-filing?


A: There are no relevant restrictions at present.
 

3-10. After a product has been filed for record, its trademark is changed. For example, the trademark was still under registration acceptance when the product was filed for record, but later the trademark failed to pass the registration process and needs to be changed. What procedures should be followed?


Answer: According to the naming regulations, there is no distinction between registered and unregistered Chinese trademarks, and foreign language trademarks are required to be accompanied by Chinese descriptions.
 

3-11. Is it acceptable for the English text on the trademark certificate to differ in capitalization from the English text on the product label?


Answer: Trademarks are not case-sensitive. It is best to be exactly the same.
 

3-12. If a product name contains foreign letters, and the trademark has been registered abroad but not in China, is it acceptable to provide the foreign registered trademark for record-filing purposes?


Answer: Yes, but a Chinese explanation must be provided.
 

3-13. If a registered trademark contains filed prohibited words, can such a prompt appear during the trademark registration process: According to relevant cosmetics regulations, this trademark contains prohibited words?


Answer: No. Trademarks are administered by the National Intellectual Property Administration, and shall be implemented in accordance with the relevant provisions of the Trademark Law. At present, they have not been integrated with the cosmetics regulatory system.
 

3-14. For each individual product included in the set filing, is it required to add the name of the set as well?


A: Yes. There are two ways to add them: ① Set name + individual product name; ② Individual product name.
 

3-15. The issue of using "stock solution" as the attribute name.


Answer: Products named with "stock solution" shall be "liquid cosmetics" that are composed of a single component or a single category of components plus necessary solvents, antioxidants and preservatives, can be used directly or after being diluted in the specified proportion, and meet the claim requirements for cosmetics.
 

3-16. If the product formula consists solely of plant extracts, can the product be named as "hydrosol"?


Answer: According to the definition of hydrosol, it refers to a 100% saturated distilled stock solution separated during the distillation extraction process when refining essential oil. Plant extract refers to a substance extracted or processed from plants (the whole plant or a certain part thereof) using appropriate solvents or methods. The two have different definitions, and also differ in preparation methods, saturation, as well as the proportion and content of components in the raw materials. Therefore, plant extracts cannot be equated with hydrosols, and **when plant extracts are used as raw materials, they should not be named as hydrosols.
 

3-17. Do the terms "all-effect" in "all-effect laundry detergent" and "highly-effective" in "highly-effective laundry detergent" comply with the national naming requirements?


Answer: Laundry detergent is not classified as cosmetics, so it is not required to comply with the naming requirements for cosmetics. Prohibited terms include but are not limited to: special-effect, full-effect, potent, miraculous, high-efficiency, specific-effect, magic-effect, quick-acting, extreme-effect, super-effect, ultra-strong, comprehensive, all-round, most, first, super-grade, top-grade, crown-grade, supreme.
 

3-18. Can spaces be used in the naming of cosmetics?


Answer: No, invalid characters such as spaces are not allowed in the declared name.
 

3-19. Can "ancient prescription", "Han prescription" and "Miao prescription" be used in cosmetic trademark names?


Answer: Yes, but further explanation is required. When terms such as "ancient prescription", "Han prescription" and "Miao prescription" are used as product trademarks, it is necessary to specify on the label that "this is only a trademark and does not have any medicinal efficacy".
 

3-20. Can "Xinglin" be used in a cosmetic trademark name?


Answer: As a product trademark, "Xinglin" needs to be explained on the label with notes such as "only used as a trademark, not to be interpreted as a medical term".
 

3-21. Can "Yingningkang" be used as a cosmetic trademark name?


Answer: As a product trademark, "Yingningkang" is likely to mislead consumers into thinking it is an infant product, so an explanatory note is required on the label.
 

3-22. What are the points for attention in filling in the product name?


Answer:(1) The product name contains no trademark name or attribute name;
(2) The product name uses innovative or peculiar words that are not easily understood by consumers, without explaining their meaning.
 

3-23. How to file for the record when using non-Chinese registered trademarks in product names?


Answer: A non-Chinese registered trademark is used in the product name, which has not been approved by the trademark authority of China and is not explained on the label. If a non-Chinese registered trademark is used as the product trademark name, with a Ⓡ mark on the label and a corresponding Chinese version, no additional explanation is required; if there is no Ⓡ mark or no corresponding Chinese version, an additional explanation is required; for registered trademark names consisting of letters, patterns or other elements with no specific meaning, the standard annotation shall be "This is only a registered trademark with no specific meaning".
 

3-24. Common Prohibited Expressions – Absolute Terms


Answer: special effect; total effect; potent effect; miraculous effect; high efficiency; quick-acting; magic effect; super-strong; comprehensive; all-round; the most; the first; super grade; top grade; crown grade; ultimate; transcendent; skin rejuvenation; wrinkle removal, etc.
 

3-25. Common Prohibited Expressions – False Semantic Meanings


Answer: For cosmetics that only contain some natural product ingredients but are advertised as "purely natural", such claims fall under false and misleading wording.
 

3-26. Common Prohibited Expressions: Exaggerated Meanings


Answer: For example, the term "professional" is applicable to products such as hair dyes, perms, and nail (toe nail) products that are intended for use in professional stores or by professionally trained personnel, but using this term for other products constitutes exaggerated wording.
 

3-27. Common Prohibited Expressions — Medical-related Terms


A:(1) Medical terms. For example, prescription; herbal prescription; for medicinal use; medicine; medical treatment; cure; treat; stretch marks; names of various skin diseases; names of various diseases, etc.
(2) Words that explicitly or implicitly indicate medical functions and effects, such as antibacterial, bacteriostatic, bacteria-eliminating, sterilizing, bacteria-proof, anti-inflammatory, blood-activating, detoxifying, anti-allergic, allergy-proof, desensitizing, freckle-removing, spot-free, scar-fading, hair-growing, hair regrowth, anti-hair loss, weight loss, lipolysis, liposuction, slimming, face slimming, leg slimming, etc.
(3) Names of famous medical experts, such as Bian Que, Hua Tuo, Zhang Zhongjing, Li Shizhen, etc.
(4) The name of the approved drug, such as Fu Man Ling, etc.
 

3-28. Common Prohibited Expressions: Words or phrases that are unrelated to product features and difficult for consumers to understand.


A: Examples include decoding, digital technology, intelligence, infrared rays, etc.
 

3-29. Common Prohibited Expressions — Vulgar Connotations


Answer: When the character "luo"(literally meaning "naked") is used in the term "luoti"(naked body), it carries a vulgar connotation and is prohibited from use; when it is used in the term "luozhuang"(nude makeup, e. g. for color cosmetics), it is permissible for use.
 

3-30. Common Prohibited Expressions – Meaning of Terms Related to Feudal Superstitions.


Answer: Examples include ghosts, goblins, divination, evil spirits, and souls. Another example: when "shen (god/spirit)" is used in "ling shen (deity)", it carries the connotation of feudal superstition; however, when used in "yi shen (refreshing the spirit)"(such as in aromatic cosmetics), it is acceptable.
 
 

4 Product Formulation

 

4-1. How to make supplementary entry if the standard Chinese name or INCI name of raw materials in the formula of historical cosmetic products is inconsistent with the *Catalog of Used Cosmetic Raw Materials (2021 Edition)*?


Answer: According to Article 36 of the Administrative Measures for the Registration and Filing of Cosmetics, the formula of a filed ordinary cosmetic shall not be altered at will. If the name of a raw material changes due to different versions of the Catalogue of Used Cosmetic Raw Materials, it shall be corrected during the supplementary recording, with a note stated in the remarks column.
On May 26,2021, the National Medical Products Administration issued the Announcement on Updating the Catalogue of Prohibited Cosmetic Ingredients (No. 74 of 2021), which updated the catalogue of prohibited cosmetic ingredients. For products that had completed filing prior to the issuance of this announcement but contain the newly added prohibited ingredients in their formulas, applications for formula modification may be submitted before May 1,2022. By replacing or removing the relevant prohibited ingredients, the original filing number shall be retained, and relevant safety documents such as corresponding test reports and safety assessments shall be submitted in accordance with the data requirements for registration and filing of new products.Where an application for change as required is not filed within the specified time limit, the relevant products shall not be continued to be marketed and sold.
 

4-2. How to correctly fill in the safety information of cosmetic raw materials during the cosmetic registration and filing process?


A: In accordance with the provisions of laws, regulations and technical specifications such as the Regulations on the Supervision and Administration of Cosmetics, the Measures for the Administration of Cosmetic Registration and Filing, and the Technical Specifications for Cosmetic Safety, cosmetic registrants and filers shall conduct safety risk assessment on cosmetic raw materials, and fill in the safety information of raw materials used in the product formula during the registration and filing process. To improve the raw material safety management level of China's cosmetics industry, the National Medical Products Administration has made full use of information-based means to organize and establish a cosmetic raw material safety information submission platform, which facilitates raw material enterprises to uniformly fill in raw material safety information and generate raw material submission codes.Cosmetic registrants and filing holders may only fill in the raw material submission code provided by the raw material manufacturer for platform association, without the need to repeatedly fill in detailed raw material safety information, so as to improve the efficiency of cosmetic registration and filing.
For the purpose of protecting trade secrets, the Raw Material Safety Information Platform is only available for cosmetic raw material enterprises to fill in and use. When providing raw material submission codes to cosmetic registrants and filing holders, raw material enterprises shall also provide necessary safety information of cosmetic raw materials. The absence of a raw material submission code shall not affect the cosmetic registration and filing work, and cosmetic registrants and filing holders may fill in the raw material safety-related information on the Cosmetic Registration and Filing Platform in accordance with the raw material safety information document issued by the raw material manufacturer.
 

4-3. How to log in to the Cosmetic Raw Material Safety Information Registration Platform, and is it necessary to register an account?


A: Domestic users do not need to register an account and can directly log in through the "Cosmetic Ingredient Safety Information Registration Platform" module of the National Medical Products Administration 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 entity certification documents notarized by a Chinese notary organ or confirmed by the Chinese embassy (consulate), and log in after the verification is approved.
 

4-4. After the launch of the Cosmetic Raw Material Safety Information Registration Platform, can raw material information only be associated via the raw material submission code?


A: After the launch of the Cosmetic Ingredient Safety Information Registration Platform, cosmetic registrants, filing parties and domestic responsible persons may still fill in the ingredient safety information documents issued by the ingredient manufacturer via the Cosmetic Registration and Filing Information Service Platform, or associate the ingredient safety information documents with the ingredient submission code generated by the Cosmetic Ingredient Safety Information Registration Platform.
 

4-5. How to fill in the safety-related information of cosmetic ingredients?


Answer: According to the National Medical Products Administration's Launch Notice on the Cosmetic Ingredient Safety Information Registration Platform, filers of general cosmetics may choose the following methods to submit ingredient safety-related information:(1) Submit ingredient safety-related information through the ingredient information maintenance module within the Cosmetic Registration and Filing Information Service Platform;(2) Where the ingredient manufacturer or its authorized enterprise has already submitted cosmetic ingredient safety-related information on the National Medical Products Administration's Cosmetic Ingredient Safety Information Registration Platform, the filer of general cosmetics may fill in the ingredient submission code to associate the ingredient safety information document.
 

4-6. What content does the safety-related information of raw materials include?


A: The safety-related information of raw materials shall include the trade name of the raw material, basic information of the raw material, a brief description of the raw material production process, necessary quality control requirements, evaluation conclusions of international authoritative institutions, restriction requirements for hazardous substances, etc.
 

4-7. How to define a raw material manufacturer?


A: A raw material manufacturer refers to an enterprise that assumes responsibility for raw material safety, which can be the actual production enterprise of the raw material, an affiliated enterprise under the same group company as the actual raw material production enterprise, or the entrusting enterprise in a commissioned raw material production arrangement. Whether a raw material distributor falls under the definition of a raw material manufacturer shall be determined based on the actual circumstances.
 

4-8. Can raw material distributors submit safety-related information of cosmetic raw materials via the Cosmetic Raw Material Safety Information Registration Platform?


Answer: If a raw material distributor is also a raw material manufacturer, it may submit the safety information of cosmetic raw materials on its own; if it is not a raw material manufacturer, it may, as an authorized enterprise, obtain the access right to submit the safety information of cosmetic raw materials after submitting the power of attorney issued by the cosmetic raw material manufacturer.
 

4-9. Is a raw material producer only allowed to authorize one other enterprise to submit safety information?


A: Raw material manufacturers may authorize other domestic enterprises to submit and conduct daily maintenance of information related to the quality and safety of raw materials. When the authorized enterprise applies for user access, it shall simultaneously submit the power of attorney issued by the cosmetic raw material manufacturer. The power of attorney shall clearly specify the authorization relationship and the trade name of the raw material for which the submission of quality and safety-related information is authorized. Only one enterprise may be authorized for the quality and safety-related information of raw materials of the same specification.
 

4-10. How to generate the raw material submission code?


A: After the information related to raw material quality and safety is submitted through the information platform, a raw material submission code will be automatically generated. The raw material submission code consists of a 5-digit manufacturer code, a 6-digit raw material code and a 3-digit raw material specification code, with each group of codes separated by a hyphen "-".
The manufacturer code is automatically assigned by the information platform when applying for record-filing authority, and the same cosmetic raw material manufacturer shall use the same code; the raw material code is compiled by the cosmetic raw material manufacturer itself, and in principle, the same raw material or the compound raw material composed of the same components shall correspond to the same raw material code; the raw material specification code is compiled by the cosmetic raw material manufacturer itself, and coding shall be carried out sequentially according to different raw material specifications under the same raw material code.
 

4-11. Usage of Raw Material Submission Code


A: When cosmetics registrants and filers apply for the registration of special cosmetics or handle cosmetics filing, they shall select the corresponding raw material quality and safety-related information via raw material submission codes in the form of an attachment to the formula table in the product registration and filing materials, and at least one piece of raw material quality and safety-related information shall be selected for each raw material.
 

4-12. Are there any differences between the raw material safety information sheet, raw material submission code, and raw material quality specification?


Answer: They are essentially the same: both aim to verify that the raw materials meet the restriction requirements specified in the *Technical Specification for Cosmetic Safety*.
The raw material safety information form and the raw material submission code refer to two different declaration formats for the same document;
The raw material safety information form/raw material submission code is a new concept, which is the integration of raw material information under the background of the new regulatory system, and its contained content is more extensive than that of the raw material information specification.
 

4-13. How to provide the raw material safety information sheet, raw material submission code, and raw material quality specification?


Answer: First and foremost, the content of the materials shall comply with the restriction requirements specified in the *Technical Specification for Cosmetic Safety*.
All colorants and preservatives shall be accompanied by Material Safety Data Sheets or raw material submission codes.
For other raw materials with specified requirements on specifications, the supporting documents can be a raw material safety information sheet, a raw material submission code, or a raw material quality specification. Examples include triethanolamine, tromethamine, cocoamide DEA, etc.
 

4-14. Which raw materials are subject to the quality specification requirements specified in the *Safety and Technical Standards for Cosmetics*?


Answer: In accordance with the requirements of the Announcement on Relevant Matters Concerning the Implementation of the Provisions on the Administration of Cosmetic Registration and Filing Dossiers (No. 35 of 2021) issued by the National Medical Products Administration, as of May 1,2021, when applicants for registration or filers apply for registration or conduct filing, they shall fill in the information on the source and trade name of raw materials used in the product formula; for raw materials that are subject to quality specification requirements specified in the Technical Specification for Cosmetic Safety, they shall also submit the quality specification certification or safety-related information of such raw materials.
Raw materials subject to quality specification requirements in the *Safety and Technical Standards for Cosmetics* include but are not limited to: polyacrylamides, trialkylamines, trialkanolamines and their salts, dichloromethane, fatty acid dialkylamides and fatty acid dialkanolamides, monoalkylamines, monoalkanolamines and their salts, etc. For the specific specification requirements of the above raw materials, reference can be made to the "Other Restrictions and Requirements" in Table 3 "Restricted Substances in Cosmetics" of the *Safety and Technical Standards for Cosmetics*.
 

4-15. How to submit information related to raw material quality and safety for production water?


Answer: Water used in cosmetic production is not required to submit information related to the quality and safety of raw materials, except for water sourced from specific origins.
 

4-16. What are the points for attention when filling in and submitting the raw material submission code?


A: It has currently been found that the cosmetics filing management system indicates inconsistency between the raw material submission codes filled in for some cosmetics filings and the data on the raw material safety information registration platform. Filing holders shall verify with raw material manufacturers (suppliers):
(1) Whether the raw material submission code corresponds to the target raw material;
(2) Whether the specific raw materials in the cosmetic formula, such as the composition and proportion of compounded raw materials, are consistent with the information submitted on the Raw Material Safety Information Registration Platform.
 

4-17. Can multiple raw material submission codes be submitted?


A: According to the Announcement on the Upgrade of the General Cosmetic Filing Management System issued on March 14,2022 by the General Cosmetic Filing Management System, the system supports the submission of multiple raw material submission codes for a single raw material.
 

4-18. The new system requires the full ingredient list to be submitted in the product formula. If the addition content of individual raw materials in the formula needs to be adjusted due to various factors in production, is it allowed to fill in the content as a value range?


Answer: The component list of the system formula shall reflect the actual values of the added contents.
 

4-19. What are the hydrocarbons derived from petroleum coal tar?


A: It generally includes mineral oil, petrolatum, paraffin wax, microcrystalline wax, ozokerite, ceresin, liquid paraffin, etc.
 

4-20. Compared with the Catalogue of Used Cosmetic Ingredients (2015 Edition), which ingredients in the Catalogue of Used Cosmetic Ingredients (2021 Edition) have had their Chinese names updated?


Answer: In the Catalogue of Used Cosmetic Ingredients (2015 Edition), there were cases where a single ingredient had multiple Chinese names, and the Catalogue of Used Cosmetic Ingredients (2021 Edition) has standardized and unified the names of the same ingredients. Starting from May 1,2021, when filing for cosmetics, the filer shall use the ingredient names standardized in the Catalogue of Used Cosmetic Ingredients (2021 Edition).
 

4-21. Which ingredients in the Catalogue of Names of Used Cosmetic Ingredients (2021 Edition) have been newly included in the management of prohibited substances?


A: According to the Announcement of the National Medical Products Administration on Updating the Catalogue of Prohibited Cosmetic Ingredients (No. 74 of 2021), 17 ingredients listed in the Catalogue of Used Cosmetic Ingredients (2021 Edition) have been newly included in the management of prohibited components as of May 28,2021, including formaldehyde, boric acid, borax, 2-chloro-p-phenylenediamine, 2-chloro-p-phenylenediamine sulfate, nut, seed oil, leaf extract, TAGETES ERECTA flower extract, vinyl acetate, etc.
Prior to the issuance of Announcement No. 74 of 2021, some of the above 17 raw materials were restricted components, some were permitted components, and some were already in-use raw materials. All manufacturing enterprises shall strictly comply with the requirements of the announcement and shall no longer produce or import cosmetics whose product formulas contain the above prohibited raw materials.
 

4-22. If a formulation contains nanomaterials, how should it be labeled in the formulation list?


Answer: As required by the Provisions on the Administration of Cosmetic Registration and Filing Dossiers, the phrase "(nano-grade)" shall be indicated after the name of the nano raw material.
 

4-23. If a product formula contains a propellant that comes into direct contact with the product content, how should the propellant be reported?


Answer: In accordance with the requirements of the *Provisions on the Administration of Cosmetic Registration and Filing Materials*, relevant information about the propellant shall be separately filled in below the formula table, and the type and addition amount of the propellant shall be indicated in the formula remark column, with the propellant content being 100%.
 

4-24. If the product formula contains denatured alcohol, how should it be filled in and reported?


A: If denatured ethanol is used, the name and dosage of the denaturant shall be specified in the remarks column.
 

4-25. Is a component with a content of 0.1% classified as a trace component?


A: According to Article 12 of the Administrative Measures for Cosmetic Labels, if there are ingredients with a content not exceeding 0.1%(w/w) in the cosmetic formula, all such ingredients shall be separately listed under the introductory phrase "other trace ingredients" and do not need to be listed in descending order of ingredient content. Therefore, ingredients with a content of 0.1% fall under the category of "other trace ingredients".
 

4-26. How should ingredients with a content not exceeding 0.1%(w/w) in cosmetic formulations be labeled?


Answer: According to the provisions of the Measures, trace components refer to components with a content of no more than 0.1%(w/w) in the cosmetic formula. When a product formula contains trace components, the introductory phrase "other trace components" shall be used to introduce and label them separately, and it is not necessary to list them in descending order of component content. Trace components only need to be labeled once, and shall not be repeatedly labeled after the introductory phrase "ingredients".
 

4-27. Should raw materials with a content of less than 0.1% be arranged in descending order when filling in the formula in the filing system?


Answer: According to Article 29 of the Provisions on the Administration of Cosmetic Registration and Filing Dossiers, all raw materials shall be listed in descending order of their content.
 

4-28. How to sort in descending order when the formula is reported in the form of compounded or mixed raw materials?

Answer: According to Article 29 of the Provisions on the Administration of Cosmetic Registration and Filing Materials, ingredients shall be listed in descending order of the content of the compounded or mixed raw materials, and raw materials containing two or more components (excluding flavors and fragrances) shall clearly state their constituent components and corresponding contents.
 

4-29. How to fill in the colorant information in the cosmetics filing management system?


Answer: For products using colorants, the CI number specified in the *Safety and Technical Standards for Cosmetics* shall be indicated in the "Ingredient Name" column of the "Product Formula" section in the system, except for those without a CI number. For ingredients that can be used both as colorants and for other purposes, such as titanium dioxide, mica, and zinc oxide, when they are used for other purposes, the standard Chinese name shall be used for labeling in the "Ingredient Name" column of the "Product Formula" section in the system.
 

4-30. By what time node should the safety-related information of raw materials be submitted?


Answer: In accordance with the requirements of the Announcement on Relevant Matters Concerning the Implementation of the Provisions on the Administration of Cosmetic Registration and Filing Materials (No. 35 of 2021) issued by the National Medical Products Administration, as of May 1,2021, when applicants for registration or filers apply for registration or conduct filing, they shall fill in and submit the information on the source and trade name of the raw materials used in the product formula; for raw materials that are subject to quality specification requirements as specified in the Technical Specification for Cosmetic Safety, they shall also submit the quality specification certification or safety-related information of such raw materials.
Starting from 1 January 2022, when applicants for registration and filing entities apply for registration or conduct filing, they shall, in accordance with the requirements of the Provisions, provide safety-related information concerning raw materials with preservative, sun protection, coloring, hair dyeing, and spot-removing and skin-whitening functions.
Starting from 1 January 2023, when applicants for registration and filing entities apply for registration or conduct filing, they shall, in accordance with the requirements of the Provisions, provide safety-related information of all raw materials. For cosmetics that have already obtained registration or completed filing prior to that date, the registration applicants and filing entities shall supplement and provide the safety-related information of all raw materials in the product formulation before 1 May 2023.
Pursuant to the requirements of the Provisions on the Administration of Dossiers for Cosmetic Registration and Filing, where a raw material manufacturer has submitted the safety-related information of cosmetic raw materials in accordance with the Guidelines for the Submission of Safety-Related Information of Cosmetic Raw Materials, the filer or the domestic responsible person may fill in the raw material submission code to associate the raw material safety information document.
 

4-31. By what time should the supplementary entry of products from the old system be completed?


Answer: In accordance with the requirements of the Announcement on Relevant Matters Concerning the Implementation of the Provisions on the Administration of Cosmetic Registration and Filing Materials (No. 35 of 2021) issued by the National Medical Products Administration, as well as the Announcement on the Issuance of the Classification Rules and Classification Catalogue for Cosmetics (No. 49) issued by the National Medical Products Administration, the filers of domestic ordinary cosmetics shall complete the supplementary information entry through the new registration and filing platform before May 1,2022. Due to the impact of the COVID-19 pandemic, the deadline for supplementary entry has now been extended to August 31,2022.Where supplementary filing cannot be completed by August 31 due to the impact of the COVID-19 pandemic, a statement of circumstances shall be submitted to the Provincial Center for Drug and Cosmetic Evaluation. The supplementary filing shall be completed in a timely manner after the impact of the pandemic is eliminated, and the submission time shall not exceed December 31 in principle. During this period, the products may be normally manufactured, imported and sold.
 

4-32. What does the supplementary record content include?


A: In accordance with the requirements of the Announcement on Relevant Matters Concerning the Implementation of the Provisions on the Administration of Cosmetic Registration and Filing Materials (No. 35 of 2021) issued by the National Medical Products Administration, as well as the Announcement on the Issuance of the Rules and Catalogue for Cosmetic Classification (No. 49) issued by the National Medical Products Administration, the supplementary recording items include product classification code, applicable standards, draft product labels, and product formula to be filled in.
 

4-33. If a product formula contains flavor raw materials, how should it be filled in when submitting the product formula and what materials need to be provided?


Answer: According to Item (4) of Article 29 of the Provisions on the Administration of Cosmetic Registration and Filing Dossiers, the flavor in the product formula may be filled in in two ways, and the following materials shall be submitted respectively:
(1) Where only "fragrance" is entered as a raw material in the product formulation table, there is no need to submit the types and contents of specific fragrance components in the fragrance; where the specific fragrance components in the fragrance are indicated on the product label, or where the original packaging label of an imported product indicates specific fragrance components, such information shall be specified in the remarks column of the formulation table.
(2) Where both "flavor" and the specific spice components contained in the flavor are filled in the product formula table, the materials concerning the types and contents of all spice components contained in the said flavor issued by the flavor raw material manufacturer shall be submitted.
 

4-34. What are the requirements for filling in the purpose of using raw materials?


A: The main intended use shall be labeled according to the actual function of the raw material in the product; for products applying for the claims of freckle-removing and whitening, sun protection, hair dyeing, hair perming, and anti-hair loss, the corresponding functional ingredients shall be indicated in the "intended use" column of the formula list. If the functional raw material is not a single ingredient, its specific functional ingredients shall be clearly specified in the "intended use" column of the formula list.
 

4-35. What should be noted when applying for products using patch or film-type carrier materials?


Answer: For products using patch or film-type carrier materials, the option "Whether it is a film-based carrier material" shall be checked in the system, in accordance with the provisions of Article 29 (5) of the Provisions on the Administration of Cosmetic Registration and Filing Dossiers:
Where patch or film-type carrier materials are used, the material composition of the main carrier materials shall be specified in the remarks column, and meanwhile documents concerning their source, preparation process, quality control indicators and other relevant information shall be provided.
 

4-36. What is the function of the remarks column in the raw material formula sheet?


Answer: The following circumstances shall be specified in the remarks column:
(1) Where denatured ethanol is used, the name and dosage of the denaturant shall be specified; where categorized raw materials are used, the specific names of the raw materials shall be specified;
(2) For ingredients directly derived from plants, the specific part of the original plant used shall be specified;
(3) For products containing propellants that come into direct contact with the product contents, the type and addition amount of the propellant shall be indicated in the formula remarks column;
(4) Where hydrocarbons derived from petroleum or coal tar (excluding single-component ones) are used, the Chemical Abstracts Service number (CAS number for short) of the relevant raw material shall be indicated in the remarks column of the product formulation list.
 

4-37. When filling in the product formula, how should the content be filled in?


Answer: In accordance with the provisions of Article 29 of the Provisions on the Administration of Cosmetic Registration and Filing Materials:
(1) The product formula refers to the formula used for production feeding;
(2) The product formula shall specify the content of all raw materials in terms of mass percentage, and all raw materials shall be arranged in descending order of content;
(3) For raw materials containing two or more ingredients (excluding flavors and fragrances), their constituent ingredients and corresponding contents shall be clearly specified.
 

4-38. Is it reasonable to fill in the solvent-free form of Kathon compounding in the system?


Answer: Kathon is a common preservative used in cosmetics. It is a mixture of methylchloroisothiazolinone, methylisothiazolinone, magnesium chloride and magnesium nitrate, and the Kathon used in cosmetics is usually in the form of an aqueous solution. According to the requirements of the *Provisions on the Administration of Cosmetic Registration and Filing Materials*: "The product formulation shall provide the names of all raw materials, including the standard Chinese name, the International Nomenclature of Cosmetic Ingredients (INCI name for short) or the English name. " If Kathon contains water or other solvents, such components shall be filled in and reported accordingly in the formulation to ensure that the formulation list covers all raw material information.
 

4-39. When filling in the product formulation for vegetable oils such as "sweet almond oil", is it necessary to specify the specific extraction part?


Answer: Vegetable oils are mainly derived from plant seeds and fruits, and some also come from plant leaves, bark, roots, petals, stamens and other parts. The extraction forms of plants are relatively complex. Since their efficacy and safety are determined by their chemical components, extracts from different plant organs (parts) will vary in efficacy and safety due to differences in the types and contents of their chemical components. For example, sophora flavescens seeds are prohibited for use, while sophora flavescens roots are permissible. To clarify the safety of the source of plant raw materials, it is recommended to indicate the extraction site when filling in the formula.
 

4-40. Can the same raw material be separately declared in the product formulation table of the regular cosmetics filing management system?


A: In principle, the same raw material is not allowed to be repeatedly filled in the formula table of the regular cosmetics filing management system. However, if the same raw material has different quality specifications, it can be filled in separately, with corresponding quality specifications specified in the remarks.
 

4-41. What are the precautions for adding chemical sunscreens to ordinary cosmetics?


Answer: For non-sunscreen products, if chemical sunscreens are used in the submitted formula, the contained chemical sunscreens shall be tested.
For products with a chemical sunscreen content of ≥0.5%(w/w)(excluding rinse-off products, perfumes, and nail polishes), in addition to the specified items, skin phototoxicity test, skin allergic reaction test and SPF value detection shall also be performed;
Depending on the actual product, the intended use of chemical sunscreens can be "stabilizer" or "product protectant", and they shall not be used as "skin conditioner".
 

4-42. For the same raw material manufacturer, should only one entity be reported or is it allowed to report multiple entities?


A: Manufacturers of the same raw material shall fill in and submit the form according to the quality specifications of that raw material. If the raw material quality specifications of multiple manufacturers are consistent, all such manufacturers may be listed in one entry; if the specifications are inconsistent, separate entries shall be submitted for each manufacturer respectively.
 

4-43. For a product of an old system, one of the raw materials in its formulation is a compound raw material, but a single component was filled in the historical filing. Can the enterprise fill in the actual components when supplementing the product record?


Answer: According to Article 42 of the Provisions on the Administration of Cosmetic Registration and Filing Materials, where there is an addition or change to the manufacturer or quality specification of the raw material used for a registered or filed product, provided that the content of the said raw material in the formula and the type and proportion of the specific components in the raw material remain unchanged, the information on the raw material manufacturer and the raw material safety information shall be updated and maintained through the registration and filing information platform. Where the change involves alterations to the product safety assessment materials, such product safety assessment materials shall also be modified accordingly.
Where there is an addition or change to the manufacturer or quality specification of the raw material used for a registered or filed product, provided that the content of the raw material in the formula, the content of the main functional components in the raw material, and the solvent remain unchanged, and that the change only involves the type or content of trace components such as stabilizers, antioxidants, and preservatives added to ensure raw material quality, the corresponding materials shall be submitted.
 

4-44. The ingredient oat (AVENA SATIVA) beta-glucan itself does not have an INCI name, but the system prompts that the field cannot be empty when uploading the formulation table. How should this be handled?


Answer: You can fill in the "INCI Name" field in the formula import template with text first and then import it, and then delete the text in the "INCI Name" field of this ingredient on the system's "Product Formula" interface.
 

4-45. Why is the component content in the raw materials displayed as blank?


A: This is usually caused by entering a value with a "%" sign; you only need to enter the numeric value itself.
 

4-46. Why does garbled text appear in the formula after importing the product formula?


A: When the registrant or filing party uploads the product formula, please confirm that the Excel document does not contain public calculation. If it is confirmed that there is no public calculation in the document, you may provide specific product information and send an email to the system mailbox for further cause analysis. System mailbox: gcftba@nmpa. gov. cn.
 

4-47. Regarding thimerosal and phenylmercury compounds as permitted preservatives: the 2021 edition of the Catalogue of Standard Chinese Names of Cosmetics in Use does not include the INCI names of phenylmercury compounds and thimerosal. When applying for the filing of eye cosmetics, if such raw materials are to be used, how should the filing be conducted? Or are these raw materials already prohibited cosmetic ingredients?


A: The "Notes" in the Catalogue of Used Cosmetic Ingredients (2021 Edition) emphasize that: III. Ingredients included in this catalogue such as sunscreens, preservatives, colorants, hair dyes and restricted substances shall be used in compliance with the requirements of the Technical Specification for Cosmetic Safety. Ingredients such as sunscreens, preservatives, colorants, hair dyes and restricted substances that are not included in this catalogue but are specified in the Technical Specification for Cosmetic Safety shall be administered with reference to used cosmetic ingredients.
 

4-48. 100% pure single essential oil, which is directly extracted from plants and cannot be directly applied to the skin, belongs to which category: cosmetics, or fragrances and flavorings?


Answer: If a product cannot be directly applied to the skin, it does not fall into the category of cosmetics and shall be managed as a raw material.
 

4-49. What are the common non-standard issues in product formula labeling?


Answer:(1) The hydrocarbons derived from petroleum and coal tar in the formula are not labeled with Chemical Abstracts Service (CAS) numbers;
(2) The colorants in the formulation are not labeled with the Color Index Number (CI Number);
(3) The standard Chinese names are not specified in detail in the formula;
(4) The compound raw materials are not reported in the form of a compound formulation;
(5) The intended use of the raw materials in the formulation does not match the actual use;
(6) The specific names of the category raw materials in the formula are not indicated;
(7) The formula is obviously unreasonable, and it is suspected of fabricating a false formula.
 

4-50. Are there documents such as the catalogue of traditional Chinese medicine (TCM) available for shampoo and body wash, as well as the list of commonly added TCM ingredients?


Answer: The use of cosmetic raw materials shall comply with the requirements of the Catalogue of Names of Cosmetic Raw Materials Already in Use (2021 Edition) and the Technical Specification for Cosmetic Safety (2015 Edition).
 

4-51. Issues related to formula submission and reporting.


Answer:(1) Except for compound raw materials such as sodium laureth sulfate and cocamidopropyl betaine that are not classified into the second category of issues in the form of compound reporting, the compound forms of other compound raw materials need to be further clarified before being standardized.
(2) Further standardize and clarify the purpose of raw material use: for example, when off-list preservatives such as caprylyl glycol, ethylhexylglycerin and 1,2-ethylene glycol are compounded with permitted preservatives such as phenoxyethanol, the purpose of use can be as an antioxidant; p-Hydroxyacetophenone can be used as a skin conditioner, etc.
 

4-52. What does it mean that there is an error in the formula submission method?


Answer: The same substance in the formula was reported repeatedly, and no quality specification was provided for it.
 

4-53. For the categorized raw materials in the formula, no specific raw material names are indicated.


Answer: In accordance with the requirements of the Catalogue of Names of Used Cosmetic Ingredients (2021 Edition):
(1) If the name of a raw material is in the form of "extract of a certain plant", it means that the whole plant and its extracts are all already-used raw materials, and the specific part of the plant shall be indicated when the raw material is used. If the name of a raw material is in the form of "extract of flower/leaf/stem of a certain plant" or "extract of flower/leaf/vine of a certain plant", it means that the aerial part of the plant and its extracts are all already-used raw materials, and the specific part shall be indicated when the raw material is used. For example, the specific extraction part shall be indicated for purslane extract and Mediterranean cypress leaf/nut/stem oil extract; the specific taxonomic category shall be indicated for algae extracts.
(2) For raw materials marked with "*" in the "Chinese Name" column, the name indicated refers to a category of raw materials, and the specific name of the raw material used shall be specified during application. For example, for hydrogenated vegetable oil*, the specific type of oil used shall be clearly stated.
(3) For raw materials marked with "**" in the Chinese Name column, whose names are not standardized and whose animal or plant origins are unclear, the standardized specific raw material name and origin shall be indicated when used. For example, Borneol Dipterocarp ** shall be marked with the standardized specific raw material name and origin.
 

4-54. The purpose of using the raw materials in the formula does not match the actual situation.


Answer: If the stated purpose of use is "other", such purpose does not fall under the scope of general-purpose domestic cosmetics: e. g., anti-allergic agents.
 

5-55. The compound raw materials are not declared in the form of a compound formulation, or there are errors in the declaration.

Answer:(1) Compound raw materials such as sodium laureth sulfate and cocamidopropyl betaine were not reported in the form of compound formulation.
(2) Where the Cosmetic Safety Technical Specification (2015 Edition) clearly specifies the reporting format for compound raw materials, the provisions thereof shall be complied with. For example, the compound preservative Kathon is a mixture of methylchloroisothiazolinone, methylisothiazolinone, magnesium chloride and magnesium nitrate, and the formula shall be reported in the compound form.
 

4-56. The colorants in the formulation are not labeled with the Color Index Number (CI number).


Answer:(1) The Colour Index Number (CI Number) of the colorant is not indicated;
(2) Multiple Colour Index numbers (CI numbers) are indicated without any explanation.
 

4-57. Using preservatives or colorants other than the permitted preservatives or permitted colorants.


Answer:(1) Using substances such as p-hydroxyacetophenone, capryloyl hydroxamic acid, ethylhexylglycerin, butylated hydroxytoluene, caprylyl glycol, and decylene glycol, which are not permitted preservatives, as preservatives;
(2) Using colorants other than the authorized colorants.
 

4-58. Common cases of excessive use of restricted substances.


A: The common non-compliant issues include: excessive use of 4-hydroxybenzoic acid and its salts (methylparaben, propylparaben), iodopropynyl butylcarbamate, triethanolamine, polyacrylamide, phenoxyethanol, and triclosan; the mixture of methylchloroisothiazolinone, methylisothiazolinone, magnesium chloride and magnesium nitrate fails to follow the specified 3:1 ratio for the combination of methylchloroisothiazolinone and methylisothiazolinone; the total concentration of the mixture of methylchloroisothiazolinone and methylisothiazolinone exceeds the maximum allowable level.
 

4-59. Common Cases of Off-Scope Use of Restricted Substances


A: Common restricted substances include iodopropynyl butylcarbamate (prohibited in body creams, body lotions and lip products), the mixture of methylchloroisothiazolinone, methylisothiazolinone, magnesium chloride and magnesium nitrate (prohibited in leave-on products), triclosan (excluding shampoo products), and the combined use of 2-bromo-2-nitropropane-1,3-diol and triethanolamine.
 

4-60. Common restricted substances are shown in the table below.


Raw Material Name Corresponding Serial Number
DMDM Hydantoin Permitted Preservatives 22
o-Cymen-5-ol Permitted Preservative 33
Benzyl alcohol Permitted Preservative 8
Phenoxyethanol Permitted Preservatives 37
Zinc Pyrithione Restricted Substances 21, Permitted Preservatives 51
Piroctone Olamine Permitted Preservative No. 39
Dichlorobenzyl alcohol Permitted Preservative 20
Titanium dioxide Approved Sunscreen Agent 26
Methylisothiazolinone Permitted Preservatives 31
Ethylhexyl Methoxycinnamate Approved Sunscreen Agent 14
Polyquaternium-7, Polyacrylamide, Polyquaternium-39 Restricted Component 7: Polyacrylamides
Chlorphenesin Preservables Permitted 15
Citric acid, mandelic acid, lactic acid, sodium lactate, magnesium lactate, potassium lactate, sodium malate, mandelic acid, glycolic acid, calcium gluconate, glycolic acid, tartaric acid Restricted Component 37: α-Hydroxy Acids and Their Salts and Esters (6)
Boric acid Restricted Component 3 (1) Boric acid, borates and tetraborates (excluding ingredients listed in the Prohibited Substances List)
Propylparaben, Methylparaben, Ethylparaben, Butylparaben Permitted Preservatives 35 4-Hydroxybenzoic Acid, its Salts and Esters (3)
Etidronic Acid Restricted Component 18: Hydroxyethanediphosphonic Acid and its Salts
Sodium hydroxide, potassium hydroxide Restricted Substance 32
Triethanolamine, Trometamol Restricted Component 11: Trialkylamines, Trialkanolamines and Their Salts
Potassium sorbate Permitted Preservative 46: Sorbic Acid and Its Salts
Disodium (hydroxymethyl) imidazolidinyl urea Permitted Preservative 18
salicylic acid Restricted component 8: Salicylic acid; Permitted preservative 42: Salicylic acid and its salts
Behentrimonium Chloride, Cetrimonium Chloride, Steartrimonium Chloride, Cetearyltrimonium Chloride, Octyldodecyltrimonium Chloride, Stearyltrimonium Chloride Restricted Substance 1 Alkyl (C12-C22) Trimethylammonium Chloride
Permitted Preservatives: 4-Alkyl (C12-C22) Trimethylammonium Bromide or Chloride
sodium sulfite, potassium sulfite, ammonium sulfite, sodium bisulfite, potassium bisulfite, ammonium bisulfite, sodium metabisulfite, potassium metabisulfite, etc. Restricted Component 25: Inorganic Sulfites and Bisulfites (1) Zinc Oxide, Permitted Sunscreen Agent 27
Cocamide DEA Restricted Substance 43
 

4-61. The category raw materials in the formula are not labeled with specific raw material names.


Answer:(1) The specific name of the raw material "iron oxide class" is not indicated;
(2) For plant extracts, please provide supplementary description on the specific extraction parts of the plant (such as flowers, leaves, stems, whole plant, etc.);
(3) When filling in the product formula, please enter the types and parts of Orchidaceae plant extracts* in the "Other Notes" section at the bottom;
(4) Brown algae extract *: for raw materials marked with "*", the name thereof refers to a category of raw materials, and the specific name of the raw material shall be indicated when it is used;
(5) Where the name of a raw material is in the form of "extract of flower/leaf/stem of a certain plant" or "extract of flower/leaf/vine of a certain plant", it indicates that the aerial parts of said plant and their extracts are all already-used raw materials, and the specific part thereof shall be clearly indicated when in use;
 

4-62. Several scenarios where the intended use of raw materials in a formulation does not match the actual use.


Answer:(1) Propylene glycol is not a preservative and shall not be labeled as a preservative;
(2) When salicylic acid, stearyltrimethylammonium chloride and cetrimonium chloride are not used as preservatives, their purpose of use shall be indicated on the label.
 

4-63. After a product has been filed, if the net content of the product information changes, for example, the net content in the original filing information is 25ml and it is to be changed to 30ml or 30g, what procedures should be followed?


A: The record-filing change procedure.
 

4-64. After a product has been filed, if the percentage of raw materials in subsequently produced products changes (excluding raw materials for restricted substances such as preservatives), is it necessary to conduct re-filing inspection?


Answer: The formula cannot be altered, and a new record-filing is required.
 

4-65. If the common name in a cosmetic name uses a specific raw material name or a term indicating the category of raw materials, what are the relevant requirements?


Answer: According to the Measures, if a specific raw material name or a term indicating a raw material category is used in the product name, it shall be consistent with the ingredients in the product formula, and the efficacy of such raw material in the product shall be consistent with the product's efficacy claim. For example, if a product is named "XX Amino Acid Facial Mask" and its efficacy claim is anti-wrinkle, the product formula shall contain amino acids, and the purpose of using amino acids shall be related to anti-wrinkle.Where the name of an animal, plant, mineral or the like is used to describe the fragrance, color or shape of a product, such ingredient may not be included in the formula. When naming the product, the generic name may adopt the format of "name of animal/plant/mineral or the like + fragrance/color/shape", or a suffix may be added after the attribute name for clarification, for example, cucumber-flavored facial cleanser or facial cleanser (cucumber-flavored).
 

4-66. In the formula list, compound raw materials need to be listed one by one. What should be done if the composition of each raw material is unknown?


Answer: According to regulatory requirements, all original ingredients of the compound raw materials in a product formula must be labeled. If such information cannot be provided, product filing cannot be completed.
 

4-67. If a formulation only contains amino acid surfactants such as sodium cocoyl glycinate, disodium lauroyl glutamate, sodium lauroyl sarcosinate, etc. , can it be labeled as "amino acid"?


Answer: According to the Administrative Measures for Cosmetic Labels, "Where specific ingredient names or terms indicating ingredient categories are used, they shall be consistent with the ingredients in the product formula, and the efficacy exerted by such ingredient in the product shall be consistent with the product's efficacy claims". Claiming "amino acid" is inconsistent with the "amino acid surfactant" ingredient in the formula, and the efficacies of the two are also different.
 

4-68. Should the ingredients added to cosmetic raw materials for protecting the raw materials, such as antioxidants, preservatives, and stabilizers, be labeled on the product label?


A: The Measures stipulate that cosmetic labels shall indicate the standard Chinese names of all cosmetic ingredients on the visible surface of the sales packaging.
 

4-69. Is it permitted to change the cosmetic formula?


Answer: The formula of a registered and filed cosmetic is not allowed to be altered. According to the Measures and the Provisions, for cosmetics that have been registered or filed, minor changes to the product formula that inevitably occur due to reasons such as replacing the supplier of the raw materials used are permitted, but the obligations specified in the Measures and the Provisions shall be fulfilled. However, changes to the product formula other than the aforementioned circumstances essentially constitute a new product, for which a new application for registration and filing shall be submitted.
 

4-70. How to register and file cosmetics that must be used with instruments or tools?


A: For cosmetics that must be used with instruments or tools, except for brushes, puff, perm tools and the like that only serve auxiliary wiping purposes, their characteristics under the conditions of being used with matching instruments or tools shall be assessed during the product evaluation process. In principle, the matching instruments or tools shall not possess cosmetic functions, shall not participate in the reproduction process of cosmetics, and shall not alter the action mode and mechanism of cosmetics on the skin.
 

4-71. How should the product names of essential oil products be written? Are "lavender essential oil" and "kidney care essential oil" acceptable?


A: The naming can be conducted with reference to GB/T 14455.1 *Guidelines for the Naming of Essential Oils*. As it may involve "implying medical effects", it is not recommended to use human organs in the names of essential oils.
 

4-72. Is phenylethyl resorcinol allowed for use in ordinary cosmetics?


Answer: According to the Announcement of the National Food and Drug Administration on Approving the Use of 4-(1-Phenethyl)-1,3-Benzenediol as a Cosmetic Ingredient (Announcement No. 71 of 2012 of the National Food and Drug Administration), the approved use purpose of phenylethyl resorcinol (trade name SymWhite®377) is to whiten the skin and inhibit the formation of melanin by suppressing the activity of tyrosinase. The Administrative Measures for the Registration and Filing of Cosmetics stipulates that: "Where the use purpose, safe dosage, etc. of an already used cosmetic ingredient are to be adjusted, an application for registration and filing shall be submitted in accordance with the requirements for the registration and filing of new cosmetic ingredients. "
If phenylethyl resorcinol is added for other intended purposes in the formulation of ordinary cosmetics, the registration or filing shall be completed in accordance with the requirements for registration and filing of new raw materials.
 

4-73. Can the formula confirmed by the inspection body be changed?


Answer: During the product application phase, the registrant shall submit the product to the cosmetics registration and filing inspection and testing institution, and the product formula confirmed with the seal of the inspection and testing institution generally cannot be altered. If a modification is indeed required due to clerical errors in formula filling, the registrant shall submit explanatory materials for reference and judgment during technical evaluation.
 

4-74. Our company has declared "plankton extract" in the product formula and submitted it to the inspection agency for testing. Later, we were informed that "plankton extract" is a category of raw materials, and the specific raw materials contained therein should be specified. Now our company intends to make modifications through a change application. Is this permissible?


Answer: The "plankton extract" declared in the product formula, as specified in China's Catalogue of Used Cosmetic Ingredients, is a category of ingredients, for which the specific ingredients it covers shall be specified. Compared with the formula confirmed and sealed by the inspection institution, the filer has modified the specific ingredient referred to by "plankton extract", and provided relevant materials on the algae in terms of taxonomy to prove that the specific ingredients referred to before and after the modification only differ in wording, and there is no substantial change to the formula.Upon verification, the provided explanatory documents fail to support the claimant's statement: the two algae referred to before and after the modification have different Latin names and are not the same raw material.
 

4-75. What are the precautions for using oligopeptide-1, an oligopeptide raw material?


Answer: Oligopeptide-1 is easily confused with plant-derived synthetic polypeptides, recombinant peptides, and human oligopeptide-1 (i. e., human epidermal growth factor, hEGF). In the official European Commission database for cosmetic ingredients, Oligopeptide-1 is defined as an oligomer of glycine, histidine, and lysine; the International Cosmetic Ingredient Dictionary describes Oligopeptide-1 as a synthetic peptide composed of glycine, histidine, and lysine.
It was found during the evaluation that the quality specifications of the raw material "oligopeptide-1" show that the "oligopeptide-1" used in the formula is either a plant-synthesized polypeptide composed of 59 amino acids or a recombinant peptide derived from Escherichia coli and composed of 18 amino acids, both of which do not conform to the amino acid composition of oligopeptide-1.
Human oligopeptide-1 is a small-molecule protein widely present in human skin cells, composed of 53 amino acids. It can promote the growth of various cells, including human stem cells; for example, it can facilitate the repair and regeneration of damaged epidermis, and is applied to promote wound healing after dermatological surgeries.
The National Medical Products Administration once stated in a notice that oligopeptide-1 is generally used as a skin conditioning agent. Human oligopeptide-1 is more commonly used in the medical field; due to its large molecular weight, it is difficult to be absorbed under normal skin barrier conditions. Once the skin barrier function is impaired, it may cause other potential safety issues. Based on considerations of efficacy and safety, human oligopeptide-1 shall not be used as a cosmetic ingredient. Therefore, it is indicated that for cosmetic formulas containing oligopeptide-1, the actually used raw material shall be determined according to the raw material quality specification.
 

4-76. The Catalogue of Used Cosmetic Ingredients (2021 Edition) has been implemented. Is it necessary to prepare the supplementary filing formula in accordance with the 2021 Edition for supplementary filing now? If the supplementary filing formula is prepared according to the 2021 Edition catalogue, it will lead to inconsistency between the expression of the filed ingredients and the actual packaging. Is there any problem with this?


A: According to the Announcement on the Catalogue of Used Cosmetic Ingredients (2021 Edition)(No. 62 of 2021) issued by the National Medical Products Administration, the Catalogue of Used Cosmetic Ingredients (2021 Edition) shall come into force as of May 1,2021. If the same ingredient of a product fails to meet the requirements of the Catalogue of Used Cosmetic Ingredients (2021 Edition) due to the name difference between the old and new catalogues, the product shall be modified in a timely manner, and the product label shall be consistent with the formula in the system.
 

4-77. What are the possible adverse reactions caused by the use of AHA (alpha-hydroxy acid)?


Answer: AHA is a type of organic acid with hydroxyl groups attached to the alpha position. In dermatology, AHA has been used as a superficial peeling agent, which can regulate the stratum corneum and improve acne. However, the use of AHA may cause certain adverse reactions, including swelling, burns, itching, etc. , so it should be used with caution.
 

4-78. What is the difference between oligopeptide-1 and epidermal growth factor (EGF)? Can EGF be used as a raw material for cosmetics?


Answer: Oligopeptide-1 is included in China's Catalogue of Used Cosmetic Ingredients (2015 Edition) and is generally used as a skin conditioner. However, Human Oligopeptide-1 is not included in this catalogue, and is mostly used in the medical field, with clinical indications for topical treatment of burns, wounds and surgical wound healing, as well as accelerating the growth of transplanted epidermis. Due to its large molecular weight, EGF is difficult to be absorbed under normal skin barrier conditions; once the skin barrier function is impaired, it may cause other potential safety issues. Based on considerations of efficacy and safety, EGF is prohibited from being used as a cosmetic ingredient.
To sum up, unlike oligopeptide-1, human oligopeptide-1 (EGF) is prohibited from being used as a cosmetic ingredient. Any product that contains it in its formulation or claims to contain human oligopeptide-1 or EGF is an illegal product.
 

4-79. Can Angelica dahurica be added to cosmetics as a formulation ingredient?


Answer: Angelica dahurica is a prohibited plant component and cannot be added.
 

4-80. How are plant components in cosmetics defined?


Answer: The plant kingdom is one of the biological kingdoms. Theoretically, plants include algae, lichens, bryophytes, ferns and seed plants. As can be seen from the Catalogue of Names of Cosmetic Ingredients in Use (2021 Edition), seed plants and algae are the most widely used plants in cosmetics. Among the 8783 cosmetic ingredients in use, there are more than 3000 plant components, of which nearly 97% are seed plants and nearly 3% are algae. Seed plants have six major organs: roots, stems, leaves, flowers, fruits and seeds. However, algae have a simple structure without differentiation of roots, stems and leaves, and most of them are unicellular, colonial or multicellular thalli.
 

4-81. How should plant extracts be named?

A: Plant components are widely used in cosmetics. The plant components applied in cosmetics refer to those directly derived from plants without chemical modification. For example, vegetable oils fall into the category of plant components, while hydrogenated vegetable oils do not. Plant components are used in cosmetics in a variety of forms.
Actually, the nomenclature of different forms of plant components is directly related to their preparation processes; for example, an extract refers to the product obtained through solvent extraction.
It should be noted that the forms of plant extracts are relatively complex. Since their efficacy and safety are determined by the chemical components they contain, extracts derived from different plant organs (parts) will vary in efficacy and safety due to differences in the types and contents of their chemical components. For example, sophora flavescens seeds are prohibited for use, while sophora flavescens roots are usable. Therefore, it is necessary to specify the specific part of origin when naming plant extracts.
In addition, when a certain plant is extracted, the degree of purification treatment varies depending on the target product, which leads to great differences in the physical and chemical properties, efficacy and safety of the obtained product, so there are also differences in the naming methods. Generally, the developers of plant raw materials will give a standard name to the product according to the extraction target and the properties of the obtained product. If the extraction target is to directionally obtain or enrich a certain type of active ingredient group with clear chemical structure, namely "flavonoid components", in this case, it can no longer be named as an extract, but should be named in the form of total components — licorice flavonoids, a type of flavonoid components derived from Glycyrrhiza glabra;If the extraction objective is to obtain the highly purified monomer compound "glabridin"(usually with a purity of ≥80%), the product must not be named after the extract, but should be named after the compound itself, i. e., glabridin.
 

4-82. What documents need to be provided when using extracts from animal organ tissues and blood products as raw materials?


Answer: The source, composition and preparation process thereof shall be provided, together with the relevant documents permitting the use of the raw materials issued by the producing country of the raw materials.
 

4-83. Hydrogenated vegetable oil*, brown algae extract* — what does the asterisk (*) marked here mean?


Answer: For raw materials marked with "*", their names refer to a category of raw materials, and the specific name of the raw material shall be indicated when used.
 

4-84. Can a single ingredient from a compound ingredient blend be used alone?


Answer: Not necessarily. It needs to be analyzed based on the actual situation. If it is listed in the Catalogue of Names of Used Cosmetic Ingredients (2021 Edition), a single component can be used; otherwise, it cannot. For example, Kathon consists of methylchloroisothiazolinone, methylisothiazolinone, magnesium nitrate and magnesium chloride, with the ratio of methylchloroisothiazolinone to methylisothiazolinone being 3:1, and methylchloroisothiazolinone cannot be used alone.
 

4-85. How to declare deionized water used in products?


Answer: According to the Catalogue of Names of Used Cosmetic Ingredients (2021 Edition), deionized water is not included therein, and it is required to be declared as a new ingredient.
 

4-86. How to declare the use of small molecule water in products?


Answer: Water is just water, and there is no distinction between small-molecule water and large-molecule water.
 

4-87. Can personal care and cleaning products such as body wash be formulated without adding surfactants?


A: Surfactants are the core functional ingredients in personal care and cleaning products, so it is obviously unreasonable not to add them.
 

4-88. Nowadays consumers all prefer pure natural products. Why is it mandatory to add preservatives to most products?


Answer: Cosmetics are inevitably subject to microbial contamination during their production, storage and use. The hazards of microbes first manifest as changes in the color, fragrance and taste of the product when used, which leads to quality deterioration and loss of commodity value; more importantly, pathogenic microbes and their metabolites will pose a threat to human health. Therefore, it is necessary to take measures to prevent microbial contamination. In addition to strengthening hygiene management during the production process, preservatives and bactericides must be added to most products to achieve the purposes of antisepsis and mildew prevention.
With the exception of products such as perfumes, nail polishes and nail polish removers, whose raw materials inherently boast extremely high preservative efficacy, the majority of cosmetics have weak preservative capacity and thus require the addition of preservatives.
 

4-89. If "carbomer" as a thickening agent is flagged as problematic, how should the issue be rectified?


Answer: As a thickener, the ingredient "carbomer" should theoretically be used in combination with alkalis or amino acids etc. Please verify the actual formula.
 

4-90. Should a CAS number be reported for hydrocarbons whose origin from petroleum or coal tar is uncertain?


Answer: For such hydrocarbons whose definite origin from petroleum or coal tar is uncertain, marking of the CAS number is not required for the time being.
 

4-91. Where to query the CAS number?


Answer: A CAS Number is a unique numerical identifier assigned to a specific substance (including compounds, polymeric materials, biological sequences, mixtures, and alloys). The Chemical Abstracts Service (CAS), a subordinate organization of the American Chemical Society, is responsible for assigning a CAS Number to every substance documented in published literature. This system was established to eliminate the confusion caused by the multiple names that can refer to a single chemical substance, and to streamline database retrieval. Today, nearly all chemical databases support CAS Number-based search functionality.
The CAS number of the specific substance can be obtained from the raw material supplier or retrieved by yourself.
 

4-92. Where should the type and part of plant extracts be filled in for filing?


A: It should be filled in the remark column corresponding to the raw material on the "Formula" tab of the product formula information page.
 

4-93. How should colorants be filled in when being declared?


Answer: It is required to fill in the corresponding CI number of the colorant in both the standard Chinese name and INCI name fields on the product formulation information page — Formulation section, except for those without a CI number.
 

4-94. For products that integrate multiple formulas into one, such as eyeshadow palettes, how should the product formula be declared? Is it necessary to file for each formula separately?


A: There is no need to file for each powder palette separately; you can file all powder palettes at once. On the product formula information page, you can set up multiple formula pages, use the shade numbers of the available powder palettes as formula names, and fill in the corresponding formula details on the respective formula pages.
 

4-95. What should be done if the INCI name of ingredients marked on the original packaging of imported products is inconsistent with the ingredient name in the formula?


Answer: As such situations may indeed occur for various raw materials, resulting in inconsistency between the INCI names of ingredients labeled on the original packaging of imported products and the names of ingredients in the formula, an explanation shall be provided during the filing process.
 

4-96. What are the key points in product formula design?

Answer:(1) Safety: The safety of cosmetics means that cosmetics should be non-toxic, non-irritating and non-allergenic to the skin (hair) and ocular mucosa, etc. When selecting raw materials for cosmetic formula design, it is necessary to abide by China's cosmetic hygiene regulations, not to select or contain prohibited cosmetic raw materials, and to comply with the dosage regulations when selecting restricted raw materials, and shall not exceed the limit dosage of toxic substances stipulated by China. Safety is the most important quality characteristic of cosmetics.
Stability: Quality problems of cosmetic products during their shelf life mainly manifest in two aspects: one is the hygiene and safety issue caused by microbial contamination; the other is stability problems such as water separation, oil separation, stratification, precipitation, discoloration, off-odor and swelling. The main cause of product instability mostly lies in unreasonable formula design, so product stability is a key priority in cosmetic formula design.
Compatibility: Cosmetics sometimes use as many as over 20 types of raw materials, so the compatibility between various components is a key factor in component selection during cosmetic formula design. If the components in a formula have good compatibility, do not undergo chemical reactions with each other, and also exert synergistic effects, the formula can be regarded as reasonable. Attention shall be paid to the compatibility, contraindications, mutual solubility and applicable pH range among raw materials.
Efficacy: It is built on the basis of safety and stability. Efficacy divorced from safety and stability is just a castle in the air, and relevant efficacy claim evaluation is required for efficacy.
 
 

5 New Raw Materials for Product Formulations

 

5-1. Before applying for the registration and filing of new cosmetic ingredients, user information registration is required. What information is mainly registered?


Answer: Before applying for the registration of a new cosmetic ingredient or conducting the filing of a new cosmetic ingredient, the registrant or filing party of the new cosmetic ingredient shall fill in the following information through the information service platform to complete user information registration:
(1) Information on the registrants and filing holders of new cosmetic raw materials;
(2) Overview of the information security risk detection and evaluation system for registrants and filing entities of new cosmetic raw materials (see Appendix 1 of the Provisions on the Administration of Registration and Filing Materials for New Cosmetic Raw Materials for samples);
(3) Where the registrant or filing sponsor of a new cosmetic ingredient is an overseas entity, the responsible person within the territory shall fill in and submit the relevant information, and meanwhile submit the original of the power of attorney for the domestic responsible person and its notarial certificate.
Where a domestic enterprise concurrently holds multiple identities such as a registrant or filing entity of new cosmetic ingredients, or a domestic responsible person, or acts as the domestic responsible person authorized for multiple overseas registrants and filing entities of new cosmetic ingredients, it may submit all relevant materials at one time to obtain corresponding user authorities. Existing users may supplement and provide relevant materials according to actual conditions to increase user authorities.
 

5-2. When the domestic responsible person registers or records a new cosmetic ingredient, how should the units in foreign language materials such as gallons and pints be declared?


A: The materials for the registration and filing of new cosmetic ingredients shall use the legal measurement units of China; if other measurement units are used, they shall be converted into the legal measurement units of China; the references cited shall be accurate and valid, with the sources clearly indicated to ensure traceability.
 

5-3. Matters concerning the change of information of the registrant, filing holder or domestic responsible person of new cosmetic raw materials.


Answer: Where any of the following information and materials of a cosmetic new ingredient registrant, filing party or domestic responsible person changes, such information and materials shall be updated to ensure that the relevant information and materials on the information service platform are true and accurate:
(1) Where the information such as the legal representative and contact information of the registrant or filing holder of new cosmetic ingredients, or their domestic responsible person changes, the user shall update such information on the information service platform in a timely manner on their own;
(2) Where there is any change in other basic information of the registrant or filing holder of a new cosmetic ingredient or their domestic responsible person, the overview of the safety risk monitoring and evaluation system for the new ingredient, or the scope and term of authorization of the domestic responsible person, the new cosmetic ingredient registrant and filing holder information update form (for the sample, see Appendix 2 to the Provisions on the Administration of Registration and Filing Dossiers for New Cosmetic Ingredients) shall be submitted, and the update of relevant information and materials shall be completed after submitting relevant materials as required.
Where the name or address of an overseas registrant or filing entity changes, the original relevant certification document issued by the competent government department or relevant institution of the country (region) where it is located, certifying that the entity itself has not changed, shall be provided; if the original cannot be submitted, a copy notarized by a Chinese notary organ or confirmed by a Chinese embassy (consulate) shall be provided. Where the name or address of a domestic responsible party changes, the original relevant certification document issued by the competent government department or relevant institution of China, certifying that the entity itself has not changed, shall be provided.
Where the scope of authorization of the domestic responsible person is changed, the new scope of authorization shall include the original scope of authorization; where only the term of authorization is updated, no other content of the power of attorney shall be altered.
Where the domestic responsible person is to be changed, a letter of commitment shall be submitted to the effect that the proposed new domestic responsible person shall assume all relevant liabilities of the original domestic responsible person, and meanwhile a written consent of the original domestic responsible person on the change of the domestic responsible person, or a valid legal judgment document that can prove the change of the domestic responsible person shall be submitted.
 

5-4. What are the requirements for the enterprise entity certification documents required for overseas users to register on the Cosmetic Ingredient Safety Information Registration Platform?


A: The certification documents of the enterprise entity shall be notarized by a Chinese notary organ or confirmed by the Chinese embassy (consulate) abroad; all documents in a foreign language shall be completely and standardly translated into Chinese, with the original text attached to the corresponding translation.
 

5-5. What contents should be specified in the authorization letter of the domestic responsible party when applying for a new raw material user name?


A: According to Article 11 of the Provisions on the Administration of Materials for Registration and Filing of New Cosmetic Ingredients, the power of attorney of the domestic responsible party shall clearly state at least the following contents and information: the names of the registrant, filer of the new cosmetic ingredient and the domestic responsible party; the authorization and authorized relationship; the scope of authorization; and the term of authorization.
 

5-6. Can a new cosmetic raw material be authorized to multiple domestic responsible persons?


Answer: According to Article 11 of the Provisions on the Administration of Registration and Filing Materials for New Cosmetic Ingredients, the same new cosmetic ingredient shall not be authorized to multiple domestic responsible persons.
 

5-7. What should I do if the authorization letter of the domestic responsible person for new raw materials expires?


Answer: According to Article 11 of the Provisions on the Administration of Dossiers for Registration and Filing of New Cosmetic Ingredients, after the expiration of the authorization period specified in the power of attorney of the domestic responsible person, the power of attorney for extending the authorization period shall be resubmitted within 30 days before the expiration of the authorization period, or the change of the domestic responsible person shall be handled as required.
 

5-8. What materials shall be submitted by the registrant or filing applicant of a new cosmetic raw material when applying for the registration of a new cosmetic raw material or handling the filing of a new cosmetic raw material?


Answer:(1) The names, addresses and contact information of the registrant, filing party and domestic responsible person;
(2) Report on the development of new raw materials;
(3) Research materials concerning the preparation process, stability, and quality control standards of the new raw material, etc. ;
(4) Safety assessment materials for new raw materials.
 

5-9. What contents should be included in the development report for new cosmetic ingredients?


Answer:(1) Background of raw material R&D, including R&D background, R&D objectives, R&D process, R&D results, etc. ;
(2) Basic information of raw materials, including raw material name, source, composition, relative molecular mass, molecular formula, chemical structure, physical and chemical properties and other relevant information;
(3) Information on raw material use, including the specification, purpose, applicable or usage scope, safe dosage, shelf life, precautions, warning statements, etc. of the raw material used in cosmetics; the status and approval status of the raw material used in cosmetics overseas;
(4) Function basis materials: The function basis for new cosmetic raw materials refers to relevant materials that can prove the raw materials have functions consistent with the intended use, which generally include scientific literature, regulatory materials, laboratory research data, human efficacy evaluation test materials, etc. ;
(5) Other materials related to the development of new raw materials.
 

5-10. What are the requirements for compiling a brief description of the preparation process for new cosmetic ingredients?


Answer: A brief description of the preparation process for a new cosmetic ingredient shall, in combination with the characteristics of the ingredient's source, briefly describe the main process steps and process parameters for the production of the ingredient, and explain whether safety risk substances may be introduced during the production process as well as the corresponding control measures. The requirements for compiling a brief description of the preparation process for new ingredients from different sources are as follows:
(1) For chemically synthesized raw materials, specific starting materials, reaction conditions, auxiliaries used, intermediates and by-products generated during the reaction process, as well as impurities or auxiliaries remaining in the final product shall be listed;
(2) For natural raw materials, their source, processing technology, extraction method and the like shall be specified, including pre-treatment method, extraction conditions, impurity removal or separation/purification method, solvents used, possible residual impurities or solvents, etc. ;
(3) For raw materials derived from biotechnology, the preparation processes such as cultivation, extraction, separation and purification shall be specified, including impurities that may be generated during the process, impurities that may be present in the raw materials, and potentially harmful microorganisms;
(4) For raw materials from other sources, relevant documents shall be submitted in accordance with the characteristics of the raw materials and the specific preparation process.
 

5-11. What contents should the quality control standard for new cosmetic ingredients include?


A: It shall generally include the following contents:(1) stability test data;(2) quality specification indicators and their test methods;(3) possible safety risk substances and their control standards, etc.
 

5-12. How should the safety assessment data for new cosmetic ingredients be compiled?


Answer: The safety assessment data for new cosmetic raw materials shall generally include toxicological safety assessment data and safety risk assessment data, and shall be prepared in accordance with the following requirements:
(1) The toxicological safety assessment data shall be compiled in accordance with the corresponding requirements for toxicological test item data, after determining the specific category to which the new raw material belongs based on the characteristics of the new raw material subject to application for registration or filing;
(2) Safety risk assessment materials, including assessment materials on the safe dosage of raw materials for use, as well as assessment materials on safety risk substances that may exist in raw materials and their control measures, etc. The assessment of new raw materials and safety risk substances that may coexist shall be conducted in accordance with the relevant requirements such as the principles and procedures for cosmetic safety assessment formulated by the National Medical Products Administration.
 

5-13. Shall the registrant, filing party of new cosmetic ingredients or their domestic responsible person preserve the samples of new cosmetic ingredients?


A: The registrant, filing party or domestic responsible person of a new cosmetic ingredient shall retain samples of the new ingredient for inspection. Where the technical assessment body needs to inspect the samples during the technical assessment process, the registrant, filing party or domestic responsible person shall submit the samples within the specified time limit.
 

5-14. What contents shall be included in the label of the sample of a new cosmetic ingredient?


A: The samples of new cosmetic raw materials shall be provided with complete packaging and labels, which shall contain information including the name of the registrant/filing applicant of the new raw material or the domestic responsible person, the Chinese name of the raw material, the INCI name, the production date and shelf life, and storage conditions.
 

5-15. Can the registration and filing materials of the domestic responsible person for new cosmetic raw materials use foreign language documents?


Answer: According to Article 4 of the Provisions on the Administration of Registration and Filing Materials for New Cosmetic Ingredients, the materials for the registration and filing of new cosmetic ingredients shall use the standard Chinese characters promulgated by the state. Except for other words that must be used such as registered trademarks, website addresses, patent names, and the names and addresses of overseas enterprises, as well as English abbreviations used in Chinese laws and regulatory documents, all materials in other languages shall be completely and standardly translated into Chinese, with the original text attached to the corresponding translation.
 

5-16. What obligations shall the registrant, filing holder or domestic responsible party of a new cosmetic raw material fulfill during the safety monitoring period of the said new cosmetic raw material?


A: The registrant, filing holder or domestic responsible person of a new cosmetic ingredient shall collect and collate the following information and materials in accordance with the relevant requirements for the safety monitoring period of new cosmetic ingredients, and prepare an annual report on the safety monitoring of the new cosmetic ingredient based on the collected and collated information and materials, which shall include the following contents:
(1) Information on cosmetics registrants, filing entities or entrusted manufacturing enterprises that use new raw materials to produce cosmetics;
(2) Information on cosmetics produced with new raw materials, including product name, number of product registration certificate or filing voucher, quantity of product produced, imported or sold, etc. ;
(3) The status of supervision and sampling inspection, investigation and punishment, and recall of cosmetics produced with new raw materials;
(4) The adverse reaction monitoring system for cosmetics produced with new raw materials established by cosmetics manufacturers, the statistical analysis of product adverse reactions, and the measures adopted, etc. ;
(5) The system of the risk monitoring and evaluation management system for cosmetics produced with new raw materials, as well as the measures adopted, etc. , by cosmetics production enterprises.
The registrant, filing party or domestic responsible person of a new cosmetic ingredient shall, within 30 working days before the expiration of each one-year period of safety monitoring for the new cosmetic ingredient, submit the annual report on safety monitoring of the new ingredient through the information service platform.
 

5-17. Is phenylethyl resorcinol allowed to be used in ordinary cosmetics?


Answer: According to the Announcement of the State Food and Drug Administration on Approving the Use of 4-(1-Phenylethyl)-1,3-Benzenediol as a Cosmetic Ingredient (Announcement No. 71 of 2012 of the State Food and Drug Administration), the approved use purpose of phenylethyl resorcinol (trade name SymWhite®377) is to whiten the skin and inhibit the formation of melanin by suppressing the activity of tyrosinase. The Administrative Measures for the Registration and Filing of Cosmetics stipulates that: "Where the use purpose, safe dosage, etc. of an already used cosmetic ingredient are to be adjusted, an application for registration and filing shall be submitted in accordance with the requirements for the registration and filing of new cosmetic ingredients.
If phenylethyl resorcinol is added for other intended purposes in the formulation of ordinary cosmetics, the registration or filing shall be completed in accordance with the requirements for registration and filing of new raw materials.
 

5-18. What raw materials are regulated as new cosmetic raw materials?


Answer: According to the provisions of the Regulations, a natural or artificial raw material that is first used in cosmetics within the territory of China is a new cosmetic raw material. Before a registered or filed new cosmetic raw material is included in the Catalogue of Used Cosmetic Raw Materials, it shall still be administered as a new cosmetic raw material.
It should be noted that only when the intended application method, application site and purpose of a raw material conform to the relevant attributes of cosmetics, can it be registered as a new cosmetic raw material or filed for the record. If a raw material functions through oral administration or injection, which does not conform to the description of cosmetic application methods in the Regulations, namely "rubbing, spraying or other similar methods", or if the application site or purpose of the raw material does not fall within the definition of cosmetics, it cannot be registered as a new cosmetic raw material or filed for the record.
Meanwhile, in accordance with the requirements of the Regulations, the registration and filing materials for new cosmetic ingredients shall be based on scientific research, and objectively and accurately describe the properties, characteristics and safe use requirements of the new ingredients. The components of new cosmetic ingredients for which registration is applied or filing is conducted shall be relatively clear, and the registrant, filer or domestic responsible party shall submit the registration and filing materials for new cosmetic ingredients as required, and be responsible for the legality, authenticity, accuracy, completeness and traceability of the submitted materials.
 

5-19. Which circumstances mean that a raw material does not fall into the category of new cosmetic raw materials?


Answer:(1) Raw materials included in the *Catalog of Used Cosmetic Ingredients (2021 Edition)*. When cosmetic registrants and filers select raw materials from this catalog, they shall comply with the relevant requirements of the state's laws and regulations, mandatory national standards, and technical specifications, and bear responsibility for product quality and safety. If it is necessary to use a raw material in excess of its "maximum historical usage level", its safety shall be verified in accordance with the procedures and requirements specified in the *Technical Guidelines for Cosmetic Safety Assessment*.
(2) Specific raw materials contained in the used category of raw materials. For example, if the catalog has included the category of raw material "collagen", namely collagen protein, which refers to a general term for a certain category of raw materials, this category of raw materials covers collagens derived from different processes such as extraction from animal tissues and genetic recombination, as well as collagens of different types such as type I collagen and type III collagen.In addition, for the raw material "XX plant extract" included in the *Catalog of Used Cosmetic Ingredients (2021 Edition)*, for example, "ginseng extract" indicates that the entire ginseng plant and its extracts are all used ingredients. If an applicant separately declares "ginseng juice" or a specific part of ginseng as a new ingredient, the application will not be accepted.
(3) Raw materials that have been specified as prohibited components in the *Safety and Technical Standards for Cosmetics*, such as human cells, tissues or human-derived products; antihistamines; hormonal substances, etc.
(4) Raw materials whose actual functions go beyond the definition scope of cosmetics, such as those with medical effects including "activating cells", "regenerating cells", "reducing pigment deposition at the wound site", "promoting wound healing", "facilitating the excretion of heavy metals" and the like.
 

5-20. How to correctly understand the filing of new cosmetic raw materials?


Answer: In accordance with the provisions of the Regulations, the state exercises classified administration over cosmetic raw materials based on their risk levels: registration administration is implemented for new cosmetic raw materials with relatively high risk levels, while filing administration is implemented for other new cosmetic raw materials. A filer of new cosmetic raw materials completes the filing once they submit the filing materials required by the Regulations through the online government service platform of the drug regulatory department under the State Council.
The true meaning of filing is that the filer of a new ingredient submits materials to the drug regulatory authority for future reference. After the filer of a new cosmetic ingredient completes the filing, the National Medical Products Administration publishes the filing information of the new ingredient, which only means that the ingredient has completed the submission of filing materials and meets the formal requirements, while the authenticity, scientificity and sufficiency of the content of the materials may not have been verified. The disclosure of relevant information about new cosmetic ingredients that have completed filing does not represent recognition of the safety and functionality of the new ingredients, nor is there any such thing as "successfully obtaining approval for filing".
Pursuant to the provisions of the Regulations and the Measures, after a new cosmetic ingredient completes the filing, the drug regulatory authority shall organize a technical assessment institution to conduct technical verification on the filing materials of the new ingredient, and carry out follow-up assessment on the use and safety of the new cosmetic ingredient. Where it is found that the filing materials of the filed new cosmetic ingredient fail to meet the requirements, the authority shall order rectification within a time limit; wherein, if the filing materials related to the safety of the new cosmetic ingredient do not meet the requirements, the authority may simultaneously order the suspension of the sale and use of the new ingredient;Where it is found that a new cosmetic raw material does not fall under the filing scope, or that false materials are submitted during filing, the filing of the new cosmetic raw material shall be revoked; where a new cosmetic raw material is ordered to suspend use or has its filing revoked, the cosmetic registrant or filer shall simultaneously suspend or cease the production and marketing of cosmetics using said new raw material.
 

5-21. After a new cosmetic ingredient completes registration or filing, what obligations shall the registrant or filing sponsor of the new cosmetic ingredient still perform?


Answer: According to the provisions of the Regulations and Measures, the registrant and filing sponsor of new cosmetic ingredients shall be responsible for the quality and safety of such new cosmetic ingredients. A safety monitoring period system shall be implemented for new cosmetic ingredients that have obtained registration and completed filing. During the safety monitoring period, the registrant and filing sponsor of new cosmetic ingredients shall pay close attention to the safe use of the new ingredients, collect and collate information and materials related to the use of the new ingredients in accordance with the requirements of the Provisions, prepare the Annual Report on Safety Monitoring of New Cosmetic Ingredients, and submit it to the technical evaluation institution through the information service platform within 30 working days before the expiration of each full year of the safety monitoring of the new cosmetic ingredients.
Where a registrant or filing sponsor of a new cosmetic raw material discovers, during the use of the new raw material, circumstances that require reporting to the technical assessment institution as stipulated in the Measures, or other circumstances that they deem necessary to report, they shall immediately formulate the Report on Safety Risk Control of New Cosmetic Raw Materials in accordance with the requirements of the Provisions, and submit it to the technical assessment institution via the information service platform.
 

5-22. How to determine whether a new cosmetic ingredient should be subject to registration application or filing based on its attributes?


A: According to the Regulations, new cosmetic ingredients with anti-corrosion, sun protection, coloring, hair dyeing, or spot-whitening functions may only be used after being registered with the drug regulatory authority of the State Council; other new cosmetic ingredients shall be filed with the drug regulatory authority of the State Council prior to use. This is based on the principle of risk management, whereby several types of relatively high-risk ingredients are subject to registration administration, while other ingredients are subject to filing administration. During the research and development of new cosmetic ingredients, it is often found that a single new ingredient may have multiple functions simultaneously.Prior to applying for registration or conducting filing, the registrant and filing entity of new cosmetic ingredients shall conduct a comprehensive review and sufficient research on the potential actual functions of the new ingredient, and make a scientific and reasonable judgment on whether the new ingredient falls under the circumstances subject to registration declaration.
In general, for a new cosmetic ingredient that has multiple functions simultaneously, if any one of its functions falls under the circumstances requiring registration application, the new ingredient shall be registered in accordance with the requirements of the Provisions, and may only be used after being approved for registration; if none of its multiple concurrent functions falls under the circumstances requiring registration application, regardless of the number of function types, it only needs to be filed with the National Medical Products Administration in accordance with the requirements of the Provisions before use. The registrant and filing applicant of a new cosmetic ingredient shall not deliberately conceal the actual functions of the new ingredient, nor shall they merely file a new cosmetic ingredient that is subject to registration application and then use it in cosmetic production.Once such act is verified, penalties will be imposed in accordance with the provisions of Item 3 of Article 59 of the Regulations.
 

5-23. The system prompts "There are new raw materials for which no authorization application information has been sent", how to deal with this?


A: If the product does not use any new raw materials, there is no need to fill in any content such as "/" in the options of "Using Registered New Raw Materials" and "Using Filed New Raw Materials"; otherwise, the system will prompt "There is new raw material for which no authorization application information has been sent".
 

5-24. Why does the formula show new ingredients even though no new ingredients were used?


A: The name of the raw material in the submitted formulation is inconsistent with the "Inventory of Existing Cosmetic Ingredients in China"(e. g., spaces, formatting issues, incorrect punctuation in parentheses in Chinese or English).
 

5-25. What should be noted when filing using new materials that are in the registration period or filing period?


Answer: If new raw materials that are in the registration period or filing period are added to the formula list, it is required to submit raw material safety information, registration number/filing number, authorization for new raw materials, and toxicological report of the filed product.
 

5-26. If a new raw material is ordered to be suspended from use, how should the relevant cosmetics be disposed of?


A: If a new cosmetic ingredient is ordered to suspend its use during the monitoring period, the Registration and Filing Information Service Platform will automatically identify cosmetics containing this new ingredient and issue a reminder. Relevant cosmetic registrants and filers shall simultaneously suspend the production and distribution of cosmetics that use this new ingredient.
 

5-27. How to register and file cosmetics containing new raw materials that are in the monitoring period?


A: After the registration or filing of a new cosmetic ingredient is completed, the NMPA will release relevant information on the administration of the registration and filing of the new ingredient to the public. Where other cosmetic registrants or filers use the new ingredient to produce cosmetics, they shall fill in the registration or filing number of the new ingredient when handling the registration or filing of the cosmetics, and may submit the registration application or filing materials only after being associated and confirmed by the registrant or filer of the new ingredient via the registration and filing information service platform. Cosmetic registrants or filers that use a new ingredient in the monitoring period to produce cosmetics shall perform the obligations concerning the use of the new ingredient and monitoring of relevant circumstances in accordance with the requirements specified in the Measures.
 

5-28. Can the fermentation product of a raw material listed in the *Catalog of Used Cosmetic Ingredients* be regarded as equivalent to the raw material itself?


Answer: After being fermented by microorganisms, the structure of raw materials will change, and special structures that are different from those produced by chemical synthesis methods are often formed. Therefore, the fermented product of raw materials cannot be equated with the raw materials before fermentation. For example, the actually used ingredient in the declared formula is the processed product of Cordyceps sinensis obtained through fermentation process, and its fermented product is not included in the Catalogue of Used Cosmetic Raw Materials, which belongs to a new raw material that has not been approved by the cosmetics supervision and administration department.
 

5-29. Is bimatoprost used to promote eyelash growth?


A: It is reported that some patients clinically develop longer, denser and thicker eyelashes after using intraocular pressure-lowering drugs such as bimatoprost and travoprost. These drugs are prostaglandin analogs, which should be used in accordance with the drug insert under the guidance of a doctor. For healthy people, the safety of long-term use of such drugs remains unclear.
In the *Catalog of Used Cosmetic Ingredients* revised and issued by the National Medical Products Administration in 2021, no cosmetic ingredient with "prostaglandin" in its name is included. The National Medical Products Administration has also not registered or filed any cosmetic ingredient related to "prostaglandin". Therefore, the use of prostaglandin analogs such as bimatoprost as cosmetic ingredients in cosmetic production violates the relevant provisions of the *Regulations on the Supervision and Administration of Cosmetics* and shall be prohibited.
 

5-30. How are new raw materials for toothpaste managed?


A: In accordance with Article 9 of the Measures (Requirements for the Management of Used Toothpaste Raw Materials), it is stipulated that new toothpaste raw materials shall be managed in accordance with standards, and the special features of the supervision of new toothpaste raw materials are put forward based on the characteristics of toothpaste.
These Measures adhere to the principle of respecting the inherent regulatory rules of toothpaste. While toothpaste and cosmetics share many common features, toothpaste also has its unique characteristics: for instance, new toothpaste raw materials only involve oral exposure, with no involvement of transdermal absorption or skin phototoxicity. Given that food additives or food raw materials that already have national standards have a history of consumption and a low level of risk, the access threshold for such raw materials has been lowered when they are used for the first time in toothpaste products for filing; they are not managed as new toothpaste raw materials, and only a safety assessment report on the use of such raw materials in toothpaste products is required.
 

5-31. What should be noted when declaring nano raw materials?


Answer: The *Specifications for Data Submission for Registration and Filing of New Cosmetic Ingredients* clearly stipulates that when registering or filing nano-ingredients and ingredients derived from biotechnology, relevant materials including data, results and conclusions of destructive tests, accelerated tests and long-term storage tests of at least one year shall be provided; the storage conditions and shelf life of the ingredients shall be determined based on stability tests, and the long-term storage test data of the remaining 3 batches of mass-produced ingredients shall be supplemented year by year within the 3-year monitoring period.
Meanwhile, in addition to providing all the toxicological test data covering 15 to 25 items, nano raw materials intended for application on the skin shall also provide data on skin absorption or transdermal absorption tests; for those that may be subject to inhalation exposure, data on inhalation toxicity tests shall be provided.
In addition to the above indicators, specific parameters such as particle size and distribution, aggregation and agglomeration characteristics of raw materials, surface chemical information (including Zeta potential/surface charge, surface coating, modification status, catalytic activity, etc.), morphological information (including shape, specific surface area, surface topology, crystal structure, etc.), porosity and porousness shall also be provided.
Where nano-scale raw materials are used in the formulation, the term "nano-scale" shall be indicated in parentheses next to the name of such ingredient.
 

5-32. What are the requirements for the declaration of raw materials derived from biotechnology?


Answer: The *Specifications for Data Submission for Registration and Filing of New Cosmetic Ingredients* clearly stipulates that when registering or filing nano-ingredients and ingredients derived from biotechnology, relevant materials including data, results and conclusions of destructive tests, accelerated tests and long-term storage tests of at least one year shall be provided; the storage conditions and shelf life of the ingredients shall be determined based on stability tests, and the long-term storage test data of the remaining 3 batches of mass-produced ingredients shall be supplemented year by year within the 3-year monitoring period.
The new raw material specifications put forward specific requirements for the data of raw materials derived from biotechnology, such as development reports, preparation processes, quality control standards, safety evaluation data and so on.
The specification states that for new oligopeptide, polypeptide and protein raw materials derived from biotechnology, the amino acid sequence and spatial conformation of the raw materials shall be clearly specified, and the relationship between the function of the raw materials and the amino acid sequence as well as the spatial structure shall be clarified.
At the same time, in addition to providing all the toxicological test data specified in items 15 to 25, for products intended for skin application, data on skin absorption/transdermal absorption tests shall also be provided; and data on immunogenicity/toxicity tests shall be provided as well.
 

5-33. Functions such as hair loss prevention, acne removal, anti-wrinkle, dandruff removal, and antiperspirant are relatively common, especially in some hair care and hair washing products. Why are the requirements for the declaration of such new raw materials consistent with those for new raw materials with functions like whitening and sun protection?


Answer: Based on a comparative study of the classification of functional cosmetics at home and abroad, as well as the efficacy claim classification terms specified in China's Classification Rules and Catalogue for Cosmetics, it is found that "cosmetics for hair loss prevention, acne treatment, anti-wrinkle, dandruff removal and antiperspiration" carry relatively high usage risks. Some of the aforementioned product categories are regulated as OTC drugs in the US; as quasi-drugs in Japan; or as quasi-medicinal products under strict control in South Korea.
Therefore, the "Specification" stipulates that the safety data requirements for new raw materials with functions of anti-hair loss, anti-acne, anti-wrinkle, anti-dandruff and antiperspirant shall be consistent with those for new raw materials with functions of antiseptic, sun protection, coloring, hair dyeing and spot-removing and whitening that are subject to registration.
This indicates that in the hair care sector, the most common shampoos claiming effects such as anti-hair loss and dandruff removal will be subject to the same regulatory standards as hair dyeing and perming products in the future.
 

5-34. What documents need to be provided when using extracts from animal organ tissues and blood products as new raw materials?


Answer: In addition to the materials related to the declaration of new raw materials, it is also necessary to provide information on their source, composition and preparation process, as well as the relevant documents proving that the use of such raw materials is permitted in the country of production.
 
 

6 Product Implementation Standards

 
 

6-1. What contents are included in the standards implemented by the product?


A: The standards implemented for the product cover contents such as full ingredients, brief description of production process, sensory indicators, microbiological and physical-chemical indicators as well as their quality control measures, directions for use, storage conditions, and shelf life, which shall comply with the requirements of relevant national laws and regulations, mandatory national standards and technical specifications.
 

6-2. What are the points for attention in the description of production process?


Answer:(1) It shall reflect the range of main production process parameters.
(2) All raw materials shall be clearly listed in the production steps.
(3) The name or serial number of the raw materials used shall be consistent with the raw materials listed in the product formula; if the same raw material is used in different process stages, it shall be distinguished; if auxiliaries such as water and volatile solvents that need to be used in the production process but are removed in subsequent production steps, they shall be clearly indicated.
(4) Where segmented production is involved, the production steps of each link shall be reflected.
 

6-3. Is it permissible to omit the canning step in the brief description of the production process?


Answer: No. According to the requirements of Article 30 of the Provisions on the Administration of Cosmetic Registration and Filing Materials, the brief description of the production process shall briefly describe the main steps of the actual production process, including feeding, mixing, filling, etc. If there are processes such as freeze-drying, they shall also be described in accordance with the actual production process.
 

6-4. How should the raw material phase separation information in the production process of the system be filled in?


A: The phase separation information of raw materials shall be filled in under the "Phase Separation Information" module of the production process; there is no need to repeatedly fill in the content related to phase separation in the "Steps" and "Remarks" columns of the production process.
 

6-5. Which process parameters need to be specified in the description of the production process?


Answer: The information should be filled in according to the actual production situation of the enterprise. The main process parameters include temperature, stirring rate, homogenization frequency, pressure, etc.
 

6-6. In the "Product Implementation Standard" module of the General Cosmetic Filing Management System, if the same raw material is used in different stages of the production process, how should it be distinguished?


Answer: The distinction is made by adding the labels "partial" or "remaining" after the serial number or name of the raw material. For example, if Raw Material No. 3 is used in both Step 1 and Step 2, it shall be marked as "3 (partial)" in Step 1, and as "3 (remaining)" in Step 2.
 

6-7. For products involving segmented production, how should they be indicated?


Answer: For cases involving segmented production, the production steps of each link shall be reflected.
Example: The semi-finished products obtained from steps 1 to 5 are manufactured at Manufacturer 1: [No. X, X Road, X District, X Country] or Manufacturer 2: [No. X, X Road, X District, X Country]. The finished product obtained from step 6 is manufactured at Manufacturer 3: [No. X, X Road, X Province, China]. (If the same manufacturer has multiple production addresses, they may be listed simultaneously.)
 

6-8. How to set the sensory indicators?


A: It shall at least include odor, color, properties, etc. For set products, the sensory indicators of each part shall be specified respectively in accordance with the relevant requirements of the *Provisions on the Administration of Cosmetic Registration and Filing Materials*.
 

6-9. How to set sensory indicators for mask-type cosmetics?


Answer: For products using patch or film-type carrier materials, the color, properties, and other characteristics of the patch/film materials and the immersion solution shall be described respectively.
 

6-10. How should the sensory indicators of set products be set?


A: For set products, the sensory indicators of each component shall be specified separately.
 

6-11. What should I do if the same product comes in multiple colors?


Answer: Color refers to the objective hue of the product's contents. If the same product has multiple distinguishable colors, each color shall be described one by one.
 

6-12. What should I do if the product color is hard to describe?


Answer: If it is difficult to distinguish the color, you may describe the main color of the product as visually presented or in use, or describe the color range.
 

6-13. Could you please advise whether the internal control indicators and documents formulated by an enterprise need to be publicly declared online, or they also require online filing?


A: No, it is not necessary.
 

6-14. If the quality control measures for microbial indicators and physicochemical indicators in the product execution standard include the description of "control of raw material-related indicators", shall the filing party provide a specific explanation for the "control of raw material-related indicators" in the brief description?


A: In accordance with the requirements of the *Provisions on the Administration of Cosmetic Registration and Filing Materials*(hereinafter referred to as the "Provisions"), "where non-inspection methods are adopted as quality control measures, specific implementation plans shall be clearly specified, and the rationality of the quality control measures shall be explained to ensure that the products comply with the requirements of the *Cosmetic Safety Technical Specifications*". Therefore, when filing for ordinary cosmetics, the filer shall explain the specific control measures for "control of raw material-related indicators" in the brief description.Appendix 16 of the Regulations provides illustrative examples of "control of raw material-related indicators and full-item testing"(including CoA for raw material acceptance, necessary raw material testing, specific testing methods, etc.), and the filing holder shall fill in the form based on the actual control status of the declared product in practical operation.
 

6-15. If the quality control measures for microbial indicators and physical and chemical indicators in the product implementation standards include the description of "production process flow control", briefly explain the reason why no specific interpretation has been provided for "production process flow control".


Answer: In accordance with the requirements of the *Provisions on the Administration of Cosmetic Registration and Filing Materials*, "where a non-test method is adopted as a quality control measure, the specific implementation plan shall be specified, and the rationality of the quality control measure shall be explained to ensure that the product complies with the requirements of the *Cosmetic Safety Technical Specifications*". Therefore, during the filing process, the specific control measures for "production process flow management and control" shall be explained in the brief description.Attachment 16 of the *Provisions on the Administration of Cosmetic Registration and Filing Materials* provides illustrative examples for "production process flow control and full-item inspection", including plant air cleanliness control, necessary environmental monitoring, and specific testing methods. When filling in the form in practice, the filer shall complete it based on the actual control status of the applied product instead of simply copying the examples.
 

6-16. If the quality control measures for microbial indicators and physical and chemical indicators in the product execution standards contain descriptions of "full inspection" and "entrusted inspection", is it necessary to provide an explanation on the inspection frequency?


A: According to the requirements of the Regulations, "where an inspection method is adopted as a quality control measure, the inspection frequency shall be specified". Therefore, when filing for the record, the registrants of general cosmetics shall specify the inspection frequency in the corresponding quality control measures. In addition, for expressions such as "type test" from which the specific frequency cannot be determined, the specific inspection frequency shall also be clearly specified.
 

6-17. Can the test method be inconsistent with the methods specified in the Technical Specification for Cosmetic Safety?


A: In accordance with the *Provisions on the Administration of Cosmetic Registration and Filing Materials*, if a test method is inconsistent with the methods specified in the *Cosmetic Safety Technical Specifications*, the name of the test method shall be filled in, a statement shall be made as to whether the method has been verified against the methods specified in the *Cosmetic Safety Technical Specifications*, and the complete test method and method verification materials shall be filed for future reference.
 

6-18. How to fill in quality management measures in compliance with regulations?


Answer: First, ensure that the report is filled out truthfully. Second, the inspection frequency shall be clearly indicated for both the control of raw material-related indicators and the management and control of the production process flow.
 

6-19. Is there any requirement for the inspection frequency of type test?


Answer: Most industries adopt a frequency of at least once a year.
 

6-20. The ingredient preparation date and the emulsification date are not the same day. There is a semi-finished product production date in the batch record. Which date should be taken as the standard? Is it the ingredient preparation date or the emulsification date?


A: The emulsification date shall be recognized as the production date of semi-finished products.
 

6-21. What are the key points for systematic form-filling that should be noted when inspection methods are adopted as quality control measures in the standards implemented for products?


Answer: Where an inspection method is adopted as a quality control measure, the inspection frequency shall be specified; if the method used is completely consistent with the method specified in the *Safety and Technical Standards for Cosmetics*, the name of the inspection method in the *Safety and Technical Standards for Cosmetics* shall be filled in; if it is inconsistent with the method specified in the *Safety and Technical Standards for Cosmetics*, the name of the inspection method shall be filled in, a description shall be made on whether the method has been verified against the method specified in the *Safety and Technical Standards for Cosmetics*, and the complete inspection method and method verification materials shall be filed for future reference.
 

6-22. What are the key points for systematic form-filling that should be noted when non-inspection methods are adopted as quality control measures in the standards implemented by products?


Answer: In accordance with the requirements of the Provisions on the Administration of Cosmetic Registration and Filing Materials, where a non-test method is adopted as a quality control measure, the specific implementation plan shall be specified, and the rationality of the quality control measure shall be explained to ensure that the product complies with the requirements of the Technical Specifications for Cosmetic Safety. For system filling, reference may be made to Table 3 and its notes in Appendix 16 to the Provisions on the Administration of Cosmetic Registration and Filing Materials.
 

6-23. What are the signs of microbially contaminated products?


Answer:(1) The product discolors both internally and externally. This is caused by pigments produced by bacteria.
(2) Mold spots in colors such as red, black and green form on the product surface, which is caused by different pigments produced by molds.
(3) The product exhibits gas swelling. This is caused by microorganisms, especially yeast, producing gas or unpleasant odors.
(4) The product emits a sour odor. This is because microorganisms decompose organic matter to produce acid, which lowers the pH value of the product.
(5) Destruction and delamination of the emulsion. This may be caused by bacteria and molds decomposing the organic nutrients in the paste, which damages the emulsion, degrades its stability, and leads to varying degrees of changes such as viscosity variation, delamination and loss of luster.
 

6-24. If the recommended national standards or industry standards set a relatively wide range for the pH value indicators of products in relevant categories such as facial cleansers, skin care lotions, and hair perm agents, can enterprises directly refer to the corresponding pH value indicators in the recommended national standards or industry standards when setting the pH value control range for specific products?


A: To ensure the universal applicability of standards, the recommended national standards or industry standards for relevant categories of cosmetics have set a relatively wide range of pH value indicators, some of which cover both acidic and alkaline regions, and some even reach the level of strong acid or strong alkali. When setting the pH value control range for specific products, enterprises shall, in light of factors such as product formula, production process and application method, establish a pH value control range that can characterize the safety control indicators of the product, and shall not completely copy the pH value indicators set in the recommended national standards or industry standards.
 

6-25. Ingredients with specified pH restrictions and requirements in the *Safety and Technical Standards for Cosmetics*, such as potassium hydroxide, sodium hydroxide, and α-hydroxy acids (and their salts and esters), are added to the product formula, yet the pH control is not specified in the standard implemented for the product.


Answer: In accordance with the requirements of the *Technical Specification for Cosmetic Safety*, if the product formula contains ingredients such as potassium hydroxide, sodium hydroxide, α-hydroxy acids (and their salts and esters) that are subject to pH restrictions and requirements in specific use, the pH control index shall be specified in the standards implemented for the product to ensure that it complies with regulatory requirements.
 

6-26. Regarding the requirements of Clause 6.4 in the implementation standard GB-T 34857-2017, where the type test items are the test items specified in 4.2 and 4.3, such as mercury, lead, arsenic and the like, is it mandatory to obtain a third-party test report? Can the company conduct the test by itself?


Answer: The standards marked above are recommended standards. If you do not have the qualification for the aforementioned testing items, the samples shall be sent to a third party for testing.
 

6-27. Which items in the microbiological and physicochemical indicators are mandatory to be tested?


Answer: Most ordinary cosmetics are subject to the following mandatory microbiological and physicochemical indicators:
Microbial indicators: Aerobic plate count, total number of molds and yeasts, thermotolerant coliforms, Staphylococcus aureus, Pseudomonas aeruginosa;
Physical and chemical indicators: mercury, lead, arsenic, cadmium.
For details, please refer to Table 1-1 and Table 1-2 in Appendix 1 of the *Specification for the Inspection of Cosmetic Registration and Filing*.
 

6-28. Is it mandatory to conduct microbiological testing on a batch-by-batch basis for products?


A: For the total number of bacterial colonies, molds and yeasts, products are required to be inspected batch by batch, while other items do not need to be inspected on a batch-by-batch basis.
 

6-29. If a facial mask has not been tested for methanol, is it ineligible for product filing?


A: Not necessarily. It depends on the specific formulation. If the contents of ethanol and isopropanol in the formulation do not exceed 10%, methanol testing is not required for filing inspection.
 

6-30. Do perfume products not need to undergo microbial testing items?


Answer: Not necessarily, it depends on the specific formula. Microbiological testing items are not required only when the ethanol content in the product is ≥75%(w/w).
 

6-31. How to test multi-shade series sunscreen cosmetics?


Answer: For multi-shade series of sunscreen cosmetics, if they share the same base formula and an application is filed for sampling inspection of their sun protection efficacy (SPF, PFA or PA), they may be submitted for registration as a group of products simultaneously. The registration dossier for each product shall be attached with the list of the series products, a summary table of the base formula and colorants, as well as the list of products selected for sampling inspection.
 

6-32. How to inspect multi-shade series of ordinary cosmetics?


Answer: A multi-shade series of ordinary cosmetics refers to ordinary cosmetics that share the same basic formula in terms of both types and content of ingredients (excluding the part for tone adjustment), have the same series name, and only differ in the types or content of colorants (the part for tone adjustment) in their product formulas.
Toxicological tests for such products may be conducted by means of sampling inspection, with a sampling rate of 30%; if the total number is less than 10, it shall be counted as 10.
During sampling inspection, products with the highest total content of organic colorants shall be given priority for testing;
When the total amount of organic colorants is the same, the product with the largest variety of organic colorants shall be selected for testing;
When the total amount and types of organic colorants are identical, the product with the highest total colorant content shall be selected for testing;
When the total colorant content is the same, the product with the largest variety of total colorants shall be selected for inspection.
 

6-33. Among the microbiological indicators, there are multiple requirements for the total bacterial count. How to determine which one is applicable?


Answer: For eye cosmetics, lip cosmetics and cosmetics for children, the required total bacterial count shall be ≤500 (CFU/g or CFU/mL), while for other cosmetics, the required total bacterial count shall be ≤1000 (CFU/g or CFU/mL).
 

6-34. Our company manufactures a facial mask, and our internal control standard for the total bacterial count is ≤500 (CFU/g or CFU/mL), while the "Safety and Technical Standards for Cosmetics" stipulates that for cosmetics not intended for eye area, lip area or children, the required total bacterial count shall be ≤1000 (CFU/g or CFU/mL). May I ask if such a filing can be approved?


A: The internal control indicators of an enterprise may be stricter than those required in the *Safety and Technical Standards for Cosmetics*, but the product after filing must comply with the indicators declared at the time of filing.
 

6-35. When is it necessary to add a methanol project?


Answer: For products with an ethanol and isopropanol content exceeding 10%(w/w), the methanol item shall be tested, with the limit specified as 2000 mg/ kg.
 

6-36. When is it necessary to add the dioxane item?


Answer: Products containing raw materials with ethoxy structures in their formula need to be tested for the dioxane item, such as polyethylene glycols, polysorbates, PEG fatty acid esters, fatty alcohol polyethers, phenoxyethanol, etc. The limit is 30 mg/ kg.
 

6-37. When is it necessary to add asbestos-related items?


Answer: Products containing talc powder in their formula are required to undergo dioxane testing, and dioxane shall not be detected in such products.
 

6-38. When is it necessary to add the free formaldehyde item?


A: Products containing formaldehyde and formaldehyde-releasing ingredients in their formula are required to undergo a free formaldehyde test, such as those containing imidazolidinyl urea, DMDM hydantoin, and bis (hydroxymethyl) imidazolidinyl urea.
 

6-39. When is it necessary to add chemical sunscreens?


Answer: For non-sunscreen products whose formula contains chemical sunscreens, the chemical sunscreens shall be tested.
 

6-40. When is it necessary to add the pH value item?


Answer: For products advertised as containing α-hydroxy acids, or products that claim to be free of α-hydroxy acids but have a total α-hydroxy acid content ≥ 3%(w/w), the α-hydroxy acid item and pH value shall be tested. Pure oil-based (including wax-based) products do not require pH testing; for multi-component products that need pH testing, in addition to testing each individual component, the pH value of the mixed sample shall also be tested in accordance with the instructions. Examples include tartaric acid, malic acid, glycolic acid, lactic acid, citric acid, etc.
 

6-41. When is it necessary to add the anti-dandruff agent item?


Answer: For products whose declared formula contains raw materials intended for use as anti-dandruff agents, the contained anti-dandruff agents shall be tested, such as salicylic acid, zinc pyrithione, and piroctone olamine.
 

6-42. What should be done if product sampling and testing cannot be conducted due to packaging issues?


Answer: If the finished product cannot be sampled due to packaging reasons or sampling may affect the test results (e. g., spray products, air-cushion products, etc.), while submitting complete test samples, the enterprise may additionally provide the semi-finished product from the final process before packaging, and the inspection and testing institution shall make a statement in the inspection report accordingly.
 

6-43. Can the expression "avoid environments with extremely high or low temperatures" be used for product storage conditions?


Answer: Its use is not recommended. If this expression is indeed used, the specific conditions of extreme high or low temperature shall be clearly defined.
 

6-44. How to clearly define the service life of a product?


Answer: The shelf life of a product shall be determined based on the product packaging, the inherent stability of the product, or relevant test results.
Where a product change involves an extension of the shelf life, a description shall be provided on how the shelf life of the product is determined based on the product packaging, the inherent stability of the product or relevant test results.
 

6-45. For some products, the implementation standard previously adopted was the industry standard, but now a new national standard has been released. How should the product be labeled in this case?


A: Currently, the standard number implemented for the product is consistent with the filing number, and national standard or industry standard numbers are no longer used. The number can be preset in the filing system for product labels.
 

6-46. Control measures for microbial contamination of cosmetics.


A: To control microbial contamination, on the one hand, we should target the sources of microbial contamination and exercise control throughout the product's manufacturing and usage processes; on the other hand, we should add an appropriate amount of preservatives to the product formula to build a sound anti-corrosion system inside the product, so as to inhibit the growth and reproduction of microorganisms.
 

6-47. Notes for filling in the product usage method in the product execution standard.


Answer: The usage method of cosmetics shall be specified; for those with special requirements on the target user group and application areas, such requirements shall be clearly stated.
 

6-48. Requirements for filling in safety warning terms.


A: Safety warning terms shall comply with the requirements of relevant regulations such as the Provisions on the Administration of Cosmetic Labels and the Cosmetic Safety Technical Specifications.
 

6-49. How should the product service life be set?


Answer: The shelf life of a product shall be set based on the product packaging, the inherent stability of the product, or relevant test results.
 

6-50. What needs to be done when making changes to the product implementation standards where the brief description of production process, microbiological and physical-chemical indicators and quality control measures, directions for use, safety warning statements, storage conditions, shelf life, etc. are altered?


Answer: The following materials shall be submitted:
(1) Application Form for Change of Special Cosmetics or Information Form for Change of General Cosmetics;
(2) The standards to be followed by the product proposed to be changed;
(3) Where a brief change to the production process is involved, a description of the change that has occurred shall be submitted, together with the microbiological and physical-chemical inspection reports of the product to be changed;
(4) Where the change involves the usage method of a product, the product safety assessment materials of the product to be changed shall be submitted;
(5) Where the extension of the shelf-life of a product is involved, the stability study data of the product to be changed shall be submitted;
(6) Where the content of the product safety assessment materials involved changes, the product safety assessment materials shall be submitted;
(7) Where there is a change to the original sales packaging and labels of an imported product, the Chinese translation of the original sales packaging (including instructions) and foreign language labels of the product to be changed shall be submitted;
(8) Where there is a change involving the draft product label, the draft product label shall also be amended in accordance with the requirements of Article 44 of the Provisions on the Administration of Cosmetic Registration and Filing Dossiers.
 
 

7 Product Labels

 

7-1. Requirements for content labeling of cosmetics labels and instructions.


Answer:(1) Cosmetic manufacturers shall label the content required by the Regulations on the labels and instructions of their products;
(2) Due to factors such as package size and packaging design, the labeled content may be presented on different visible surfaces.
 

7-2. What contents are required for Chinese labels of cosmetics?


Answer:(1) The Chinese name of the product and the registration certificate number of the special cosmetic;
(2) The name and address of the registrant or filing entity; where the registrant or filing entity is an overseas enterprise, the name and address of the domestic responsible person shall also be indicated;
(3) The name and address of the manufacturer; for domestic cosmetics, the number of the manufacturer's production license shall also be indicated;
(4) The standard number implemented for the product;
(5) Full ingredients;
(6) Net content;
(7) Service life;
(8) Instructions for use;
(9) Necessary safety warning phrases;
(10) Other contents that shall be labeled as required by laws, administrative regulations and mandatory national standards.
 

7-3. Notes on Labeling of Cosmetic Label Names


A: The Chinese name of the product shall be marked in a prominent position on the visible surface of the sales package, and at least one instance shall be introduced with a guiding phrase.
The Chinese name of a cosmetic product shall not be named using letters, Chinese pinyin, numerals, symbols or the like, except for registered trademarks, indications of sun protection factor, color numbers, serial numbers, or other circumstances where the use of letters, Chinese pinyin, numerals, symbols or the like is necessary. Where a registered trademark in the Chinese name of a product uses letters, Chinese pinyin, numerals, symbols or the like, its meaning shall be explained on the visible surface of the product's sales packaging.
 

7-4. Notes on labeling the name, address and other relevant information of the registrant, filing entity, domestic responsible party and manufacturer on cosmetic labels.


Answer:(1) The names and addresses of the registrant, filing entity, domestic responsible person, and manufacturing enterprise shall be consistent with the enterprise names and addresses specified in the product registration certificate or filing information, and shall be introduced by corresponding lead-in phrases respectively;
(2) Where the cosmetic registrant or filing entity is the same as the manufacturer, the phrases "Registrant/Manufacturer" or "Filing Entity/Manufacturer" may be used as introductory wording for simplified labeling;
(3) The name and address of the manufacturer shall be those of the manufacturer that completes the final process in which the product comes into contact with the contents. Where the registrant or filing entity entrusts multiple manufacturers to complete the said final process simultaneously, the names and addresses of all the entrusted manufacturers may be indicated at the same time, and the specific manufacturer of the product shall be specified by means of a code or other methods;
(4) Where the manufacturer is located within the territory of China, the number of the cosmetics production license shall also be indicated after the name and address of the manufacturer, preceded by an appropriate introductory phrase.
 

7-5. For cosmetic manufacturers (including registrants, filing entities that conduct self-production, and entrusted manufacturers), if the registered address is inconsistent with the actual production address, how should the address of the manufacturer be labeled?


A: In accordance with the Regulations on the Supervision and Administration of Cosmetics (hereinafter referred to as the "Regulations") and the Measures, cosmetics labels shall indicate the names and addresses of the registrant, filing entity, and entrusted manufacturer. If the registered address is inconsistent with the actual production address, the actual production address specified in the production license shall be indicated.
 

7-6. Notes on the full ingredient labeling of cosmetics.


A: The cosmetic label shall state the standard Chinese names of all raw material ingredients of the cosmetic on the visible surface of the sales packaging, introduced with the lead term "ingredients", and listed in descending order of their content in the product formula. If there are ingredients with a content of no more than 0.1%(w/w) in the cosmetic formula, all such ingredients shall be separately labeled with the lead term "other trace ingredients", and need not be listed in descending order of content.
For formulations submitted in the form of compounded or mixed raw materials, the content of each individual component in the formulation shall serve as the basis for sorting component contents and determining whether a component is a trace component.
 

7-7. Why is the full ingredient labeling regulation implemented?


Answer: The regulation on full ingredient labeling has existed and been implemented in foreign countries as early as over a decade ago. There are two main significances as follows:
(1) Comply with local laws and grant consumers the Right to be informed.
(2) Provide consumers with more comprehensive information to facilitate their selection of products they need and prefer.
 

7-8. Detailed Explanation of the Regulations on Full Ingredient Labeling


Answer: In the ingredient list for full ingredient labeling, ingredient names shall be arranged in descending order of their addition amount. The higher the position of an ingredient in the list, the larger the proportion it accounts for in the cosmetic. For example, water is the most commonly used medium in cosmetics, and in many cases it is the ingredient with the highest content, so it generally ranks first in the ingredient list.
Therefore, the order of ingredients in the ranking does not indicate their importance. For example, water and some other substances such as glycerin and butylene glycol are commonly used solvents. In addition to basic moisturizing, their more important function is to help dissolve the active ingredients in cosmetics, allowing these active ingredients to come into contact with our skin or hair to exert their effects. Many active ingredients are not as abundant as water and thus rank after water in the ingredient list, yet they are the key factors that enable cosmetics to deliver their intended benefits.
It is also worth noting that all flavor and fragrance substances are uniformly labeled as "flavor" in the full ingredient list, while pigments are labeled either by their colorant number or Chinese name.
 

7-9. Which cosmetics are subject to the full ingredient labeling requirement?


A: It includes all cosmetics manufactured and sold within China, such as skincare products, makeup products, hair care and hair wash products, hair styling products (including gel, hairspray, hair clay, styling spray, mousse, etc.), hair dye products, hair perm products, toothpaste and mouthwash, etc.
 

7-10. Should the ingredients added to cosmetic raw materials for protecting the raw materials, such as antioxidants, preservatives and stabilizers, be labeled on the product label?


A: The Measures stipulate that cosmetic labels shall indicate the standard Chinese names of all cosmetic ingredients on the visible surface of the sales packaging.
Cosmetic ingredients refer to substances that are intentionally added to product formulations during the production process and exert specific functions in the final product. Trace amounts of antioxidants, preservatives, stabilizers and other components added to raw materials to ensure the quality of cosmetic raw materials, although they are reported in the product formulation in the form of the compounded raw material during registration application or record-filing, are not classified as cosmetic ingredients and thus do not need to be indicated on the product label; enterprises may of course choose to label them on the product label to safeguard consumers' Right to be informed.
 

7-11. For products submitted to the new system prior to the implementation of the Administrative Measures for Cosmetic Labeling, shall their label markings be implemented in accordance with the current labeling requirements?


A: Basically, in accordance with the current standards, enterprises with relevant capabilities are recommended to make labels in compliance with the *Administrative Measures for Cosmetic Labels*.
 

7-12. After the implementation of the Administrative Measures for Cosmetic Labeling, is it necessary to modify the labels of products that have been filed in the new system?


Answer: Changes are required. Starting from May 1,2022, cosmetics applied for registration or filed must comply with the provisions and requirements of the Measures; for cosmetics that have been registered or filed prior to this date, if their labels do not conform to the provisions of these Measures, cosmetics registrants and filing parties must complete the update of product labels before May 1,2023 to make them meet the relevant provisions and requirements of the Measures.
 

7-13. What does the symbol "Little Golden Shield" for children's cosmetics mean?


Answer: Children's cosmetics refer to cosmetics suitable for children under the age of 12 (including 12 years old) with functions such as cleansing, moisturizing, talcum, and sun protection. Cosmetics that indicate by words such as "suitable for all groups" and "for the whole family" or use trademarks, patterns, packaging forms and the like to imply that the user groups of the cosmetics include children shall be administered as children's cosmetics.
The symbol for children's cosmetics, the "Little Golden Shield", is designed to convey that all sectors of society, including drug regulatory authorities, work together to continuously improve the quality and safety of children's cosmetics, provide a sound growth environment for infants and children, and safeguard and care for the healthy growth of children. The symbol as a whole adopts a golden shield shape: the golden color embodies the healthy, lively, optimistic, positive and upward state of children; the shield represents the protection and care for children as well as the resistance against illegal and non-compliant products, and meanwhile enhances the recognizability of the symbol; the center of the shield features a design of a child with outstretched hands, emphasizing the firm determination to safeguard the healthy growth of children.
 

7-14. When should the "Little Golden Shield" mark be added to already filed products?


Answer: According to the announcement of the National Medical Products Administration on the issuance of the Regulations on the Supervision and Administration of Cosmetics for Children, starting from May 1,2022, all children's cosmetics applied for registration or filing must be labeled with the "Little Golden Shield"; for children's cosmetics that were applied for registration or filing before this date and have not been labeled in accordance with the regulations, the cosmetics registrants and filers shall complete the update of product labels before May 1,2023. This means that more and more children's cosmetics labeled with the "Little Golden Shield" will appear on the market; all children's cosmetics produced or imported after May 1,2023 will be labeled with the "Little Golden Shield".
 

7-15. Can the "Little Golden Shield" logo indicate that a product has passed the quality certification of the relevant authorities?


A: According to the Regulations on the Supervision and Administration of Children's Cosmetics, which came into force on January 1 this year, children's cosmetics shall be labeled with the children's cosmetics mark ("Little Golden Shield") specified by the National Medical Products Administration on the display surface of the sales packaging. The "Little Golden Shield" is a distinctive mark that distinguishes children's cosmetics from other easily confusing products such as adult cosmetics, disinfection products and toys, and non-children's cosmetics shall not be labeled with this mark. It should be noted that China implements strict supervision over children's cosmetics, which is mainly reflected in putting forward higher regulatory requirements for the product formula design, safety assessment, production conditions and other aspects of children's cosmetics.Before being launched on the market, children's cosmetics shall be filed for the record, except for sunscreen products which are subject to registration. The "Little Golden Shield" marked on the cosmetic package only indicates that the product belongs to children's cosmetics, and does not mean that the product has been approved by the regulatory authority or its quality and safety have been certified.
 

7-16. What are the requirements for the font and color of the mark for children's cosmetics?


Answer: According to the Regulations on the Supervision and Administration of Cosmetics for Children, cosmetics for children shall be labeled with the mark for cosmetics for children on the display surface of the sales package. To facilitate consumer identification, the mark for cosmetics for children shall be proportionally labeled in the upper left corner of the main display surface of the sales package, and shall be clear and easy to identify. The mark for cosmetics for children is entirely in gold as a whole, and there is no mandatory requirement for the color matching information in the announcement. Enterprises producing cosmetics for children can make fine adjustments to the color and font according to the actual packaging conditions, provided that the mark shall be clear, durable, and easy to distinguish and read.
 

7-17. How to control the size of the child cosmetic label when the same product has different specifications?


Answer: In accordance with the Announcement on Issuing the Logo for Children's Cosmetics (No. 143 of 2021) released by the National Medical Products Administration, the logo for children's cosmetics shall be marked in the upper left corner of the easily observable display surface of the sales packaging (hereinafter referred to as the main display panel) in equal proportion as per the pattern specified by the National Medical Products Administration, so as to be clear and easily recognizable. When the surface area of the main display panel is larger than 100 square centimeters, the maximum width of the children's cosmetics logo shall not be less than 2 centimeters. When the surface area of the main display panel is equal to or less than 100 square centimeters, the maximum width of the children's cosmetics logo shall not be less than 1 centimeter.
 

7-18. What corrective measures can enterprises take if there are defects in cosmetic labels as stipulated in Article 20 of the Measures?


A: Where there are defects in the cosmetic labels that do not affect quality and safety and will not mislead consumers, the enterprise shall make corrections in a timely manner. It may either reprint the labels or correct the defects by means of pasting and covering, but the corrected labels shall be clear, durable, easy to identify and read, and shall not have such problems as printed characters falling off or insecure pasting.
 

7-19. How should ingredients with a content not exceeding 0.1%(w/w) in cosmetic formulations be labeled?


Answer: According to the provisions of the Measures, trace components refer to components with a content of no more than 0.1%(w/w) in the cosmetic formula. When a product formula contains trace components, the introductory phrase "other trace components" shall be used to introduce and label them separately, and it is not necessary to list them in descending order of component content. Trace components only need to be labeled once, and shall not be repeatedly labeled after the introductory phrase "ingredients".
 

7-20. What are the labeling requirements for packaging containers (inner packaging) that come into direct contact with the contents as specified in the Administrative Measures for Cosmetic Labeling?


Answer: According to Article 7 of the Administrative Measures for Cosmetic Labels, for products with outer packaging boxes, the Chinese name of the product and the shelf life shall also be marked on the packaging container that directly contacts the contents at the same time. According to Article 17, for small-sized packaged products with outer packaging boxes, the Chinese name of the product and the shelf life shall also be marked on the packaging container that directly contacts the contents at the same time.
For both domestic and imported products newly filed as of May 1,2022, their inner packaging must be labeled with the product's Chinese name and shelf life. Products filed prior to this date shall complete label updates before May 1,2023 to ensure compliance with the provisions and requirements of the Cosmetic Labeling Management Measures.
 

7-21. How to claim a patent on a label?


Answer: The patent type shall be clearly indicated on the label, such as China Invention Patent, China Utility Model Patent, and China Design Patent.
 

7-22. What are the tag guidelines?


A: The label guidance is implemented in accordance with the *Administrative Measures for Cosmetic Labels*, which you may consult on your own.
 

7-23. Can cosmetic labels make claims about medical research institutions and time-honored pharmaceutical brands?


Answer: The Regulations on the Supervision and Administration of Cosmetics clearly stipulate that the state encourages and supports the research and innovation of cosmetics, meets consumer demands, promotes the building of cosmetics brands, and gives play to the leading role of brands. Meanwhile, the Measures for the Administration of Cosmetic Labels provide that cosmetic labels are prohibited from using the names or images of state organs, public institutions, medical institutions, public welfare institutions and other entities as well as their staff and appointed experts to make certifications or recommendations. Enterprises should attach importance to product quality development and commit to brand building, but they must not use medical research and development institutions or time-honored pharmaceutical brands to imply that their products have medical effects so as to mislead consumers.
 

7-24. How to correctly understand the regulation that "the production process of labeling shall be completed within the cosmetics manufacturer that has finished the final production process involving contact with cosmetic contents"?


Answer: Article 63 of the Measures stipulates that the production process of labeling cosmetics shall be completed within the cosmetics manufacturer that has finished the final production process in contact with the cosmetic contents. The legislative intent of this clause is to prohibit cosmetics from leaving the factory before product labeling is completed, which would otherwise make the products untraceable. The term "the production process of labeling cosmetics" in this clause refers to the production process of labeling on the packaging materials that come into contact with the cosmetic contents.It is worth noting that, provided that the production process corresponding to the label marked on the original packaging of imported cosmetics has been completed and is traceable, the act of affixing a Chinese label does not need to be completed within the cosmetics manufacturer that has completed the final production process involving contact with the cosmetic contents.
 

7-25. Can the term "acid peeling" be labeled on cosmetics?


Answer: The "acids" used in "acid peeling" procedures are not cosmetic ingredients. Moreover, the concentration of such acids during acid peeling is typically relatively high, far exceeding the limit requirements for acid-based ingredients stipulated for cosmetics. Therefore, inappropriate claims such as "acid peeling" should be avoided.
The Notice of the National Medical Products Administration on Launching the Special Campaign of "Online Network Purification and Off-line Source Clearance" for Cosmetics (NMPA Cosmetics [2021] No. 47) requires the cleanup and rectification of cosmetics that illegally claim to be "cosmeceuticals", "stem cell cosmetics", "acid peeling cosmetics" and "medical skin care products". "Acid peeling" is classified as content that is false or misleading, and explicitly or implicitly indicates having medical effects.
 

7-26. Can the names of enterprise filing entities and manufacturing enterprises that contain medical-related terms such as "Li Shizhen Chinese Medicine" and "**Pharmaceutical" be marked on the label?


Answer: When "Li Shizhen Chinese Medicine", "** Pharmaceutical" and other such terms are used as part of the name of the filing entity or manufacturing enterprise without being marked in an emphasized manner, they may be normally indicated on the product packaging. However, they shall not be marked on the product packaging in a way that intentionally highlights or emphasizes them. Meanwhile, terms such as "Li Shizhen Chinese Medicine" and "** Pharmaceutical" shall not appear as trademark names in product names, as this constitutes suspected use of medical terminology in product names or claims.
 

7-27. What are the requirements for the floor plans and three-dimensional drawings uploaded for the filing of general cosmetics?


A: The floor plan and three-dimensional drawing uploaded for filing shall be commercially available packaging drawings, or renderings consistent with the actual product, but shall not be design drawings marked with information such as color and size. The floor plan shall cover all visible surfaces of the product; for special-shaped packaging such as cylindrical and spherical ones, partial photographing shall be conducted to ensure that the text information at the edges and light-shadow areas is clearly legible.
 

7-28. If a formulation only contains amino acid surfactants, such as sodium cocoyl glycinate, disodium lauroyl glutamate, sodium lauroyl sarcosinate, etc. , can it be labeled as "amino acid"?


Answer: According to the Administrative Measures for Cosmetic Labels, "Where specific ingredient names or terms indicating ingredient categories are used, they shall be consistent with the ingredients in the product formula, and the efficacy exerted by such ingredient in the product shall be consistent with the product's efficacy claims". Claiming "amino acid" is inconsistent with the "amino acid surfactant" ingredient in the formula, and the efficacies of the two are also different.
 

7-29. Can the content of the packaging of supplementary registered products be modified in accordance with the requirements of the new label management measures?


A: According to the Announcement of the National Medical Products Administration on Issuing and Implementing the Measures for the Administration of Cosmetic Labeling (No. 77 of 2021), cosmetic registrants and filing holders are encouraged to label cosmetics in accordance with the provisions of the Measures as of the date of issuance of this Announcement. The packaging of products to be supplemented and recorded may be modified in accordance with the requirements of the new Measures for the Administration of Cosmetic Labeling.
 

7-30. Are the precautions for cosmetics mandatory to be printed on the packaging box? Is it not allowed if they are not written?


Answer: According to the Administrative Measures for Cosmetic Labels, under any of the following circumstances, "Caution" or "Warning" shall be used as the introductory prompt, and safety warning statements shall be marked on the visible surface of the sales packaging:
(1) Where laws, administrative regulations, departmental rules, mandatory national standards, and technical specifications have labeling requirements related to warning statements and safety precautions for restricted components and permitted components in cosmetics;
(2) Where laws, administrative regulations, departmental rules, mandatory national standards, and technical specifications provide for relevant precautions that are required to be indicated for cosmetics applicable to special groups such as children;
(3) Where laws, administrative regulations, departmental rules, mandatory national standards, or technical specifications stipulate that other safety warning phrases and precautions shall be indicated.
 

7-31. A gift set contains multiple individual products. Is it necessary to label the shelf life for each individual product?


Answer: Yes. According to Article 7 of the Administrative Measures for Cosmetic Labels, for products with outer packaging boxes, the Chinese name and shelf life of the product shall also be marked on the packaging container that directly contacts the contents at the same time.
 

7-32. In cosmetic labeling, if a foreign entity entrusts a domestic entity to conduct filing, both the entrusting party and the entrusted party are required to be indicated. Is it allowed to additionally list a brand owner?


Answer: For overseas entities entrusting domestic parties, the entrusting party and the entrusted party shall be indicated. No mandatory provisions have been found for brand owners, distributors and other relevant entities for the time being.
 

7-33. If the packaging of a cosmetic product is changed while its ingredients remain unchanged, is it necessary to re-conduct the quality inspection report and re-file for the record?


Answer: It is required to modify the recordation, but there is no need to reissue the inspection report.
 

7-34. When filing for product registration, all ingredients were labeled in accordance with regulatory requirements, yet a random inspection by market regulators determined the product label to be non-compliant, on the grounds that the product listed preservatives that were not detected. The regulators have required that all undetectable preservatives be omitted from labeling. Should we revise the label as required by the market regulators, remove all undetectable preservatives, and re-submit for product registration?


Answer: Please label in accordance with the Measures for the Administration of Cosmetic Labels. (Article 12: The cosmetic labels shall indicate the standard Chinese names of all raw material ingredients of the cosmetics on the visible surface of the sales packaging. The labeling methods and requirements shall comply with the provisions of the corresponding standards.)
 

7-35. Is it mandatory to list all ingredients on the packaging of cosmetic products? Since our own formula contains certain raw materials that are not convenient to disclose, can we only list the basic ingredients instead?


A: According to the Regulations on the Supervision and Administration of Cosmetics, the labels of cosmetics shall indicate all ingredients.
 

7-36. The company name has been changed, and all relevant certificates have been processed. I would like to ask whether the packaging materials produced before the company name change can still be used? Is there a transition period? If they cannot be used, is there any legal or regulatory basis for this requirement?


A: According to Articles 39 and 41 of the Provisions on the Administration of Cosmetic Registration and Filing Materials, relevant entities shall update the information and make a one-off change to the aforesaid relevant information of the involved general cosmetic filing information and product label drafts. Therefore, the old packaging materials can no longer be used, but as stipulated in Article 38, products that have been manufactured, marketed or imported may be sold until the end of their shelf life.
 

7-37. Can traditional Chinese characters be used on the labels of domestically produced ordinary cosmetics?


Answer: No. According to Article 6 of the Administrative Measures for Cosmetic Labels, standardized Chinese characters shall be used for Chinese labels of cosmetics. At present, the standardized Chinese characters in China are simplified Chinese characters.
 

7-38. Is it allowed to use foreign languages on the outer packaging of domestically produced ordinary cosmetics with additional Chinese labels attached?


Answer: No, it is not allowed. Using foreign languages on the outer packaging with additional Chinese labels may easily mislead consumers into thinking that the cosmetics are imported ones.
 

7-39. What are the requirements for the uploaded product packaging images?


A: The floor plan is required to be a commercially available packaging drawing, with no traces of Photoshop editing or modifications.
 

7-40. The label information is inconsistent with the information filled in the filing system.


A: If the information such as the names and addresses of the entrusting party and the entrusted party marked on the label is inconsistent with the information filled in the system. The inconsistency of addresses refers to the inconsistency of information after the address actually changes. For example, if the address changes from City A to City B, the address information is inconsistent. Cases where the address is renamed due to administrative division adjustment without substantial change to the actual location shall not be included in this issue.
 

7-41. The address information of the manufacturer marked on the label is incomplete.


A: For example, the addresses of the principal and the entrusted party are marked in a confusing manner, the information of the entrusted enterprise is marked in an irregular way (such as marked as "supervised and manufactured", "general distributor", etc.), and the information of the principal is not clearly marked, etc.
 

7-42. The labeling of product shelf life is non-standard.


A: For example, if the shelf life of a product fails to be labeled as required with "production date and shelf life" or "production batch number and deadline for use".
 

7-43. Why can't the label "28ml × 10pcs" be approved for filing?


Answer:(1) pcs is not a Chinese counting unit.
(2) There is no Chinese introductory phrase for "net content".
 

7-44. Is it permissible to use the wording "upgraded formula" in product claims?


Answer: No, such usage is non-standard and likely to mislead consumers.
 

7-45. Is it acceptable for labels to claim "no chemical fragrances"?


Answer: No, this is suspected of demeaning a competing product.
 

7-46. What circumstances are suspected of involving false and exaggerated publicity?


A: For instance, the intended use, application site, method, etc. as claimed on the product packaging, labels, instructions, etc. fail to comply with cosmetic regulations, or the product explicitly or implicitly claims to have disease prevention or treatment functions;
 

7-47. How to label safety warning statements for children's cosmetics?


Answer: For children's cosmetics, warning statements such as "Use under adult supervision" shall be indicated on the label.
 

7-48. How should products containing chemical sunscreens be labeled with safety warning statements?

Answer: Products containing benzophenone-3 shall be labeled with "contains benzophenone-3".
 

7-49. How should safety warning statements be labeled for products containing preservatives?


Answer:(1) Products containing benzalkonium chloride, benzalkonium bromide, and benzalkonium saccharinate shall be labeled with "Avoid contact with eyes";
(2) Products containing iodopropynyl butylcarbamate shall be labeled "Do not use for children under the age of three";
(3) Products containing chlorobutanol shall be labeled as "contains chlorobutanol";
(4) Products containing salicylic acid and its salts shall be labeled with "Contains salicylic acid, not for children under 3 years old";
(5) Products containing thimerosal shall be labeled as "contains thimerosal".
 

7-50. How should safety warning statements be labeled for products containing raw materials that are both restricted substances and permitted preservatives?


Answer: When such raw materials are not used as preservatives, the name of the raw material and its purpose of use shall be indicated, for example: Zinc Pyrithione as an anti-dandruff agent.
 

7-51. How should safety warning statements be labeled for products that claim to contain alpha-hydroxy acids and their salts and esters (or products that do not make such a claim but have an alpha-hydroxy acid content of ≥3%(w/w))?


Answer: If it is used in non-sunscreen skincare cosmetics, the label "use together with sunscreen cosmetics" shall be indicated.
 

7-52. How should flammable cosmetics such as nail polish, nail polish remover, nail hardener, and pressure-packaged gel be labeled with safety warning statements?


Answer: The marking should read "Pay attention to fire prevention or explosion protection, and keep away from fire sources".
 

7-53. Issues concerning foreign languages in trademarks.


Answer: It is required to indicate on the packaging label: XX is a registered trademark, which means xxx. If there is no specific meaning, it shall be indicated as: XX is only a registered trademark with no specific meaning.
 

7-54. Is it permissible to use foreign patents for promotional purposes?


Answer: The filing for copy promotion using foreign patents will be rejected, and only domestic patent information can be used for promotion.
 

7-55. Several scenarios of non-standard label annotation guidance.


Answer:(1) The introductory phrase for "net content" is missing;(2) The introductory phrase "Ingredients:" is absent;(3) The introductory phrase for the production license number is incorrect;(4) The introductory phrase "entrusting party" for the general distributor is incorrect;(5) Irrelevant third-party enterprise: the supervisor shall not appear on the label;(6) It is recommended to standardize the label introductory phrase "manufacturer" to "production enterprise";(7) It is recommended to standardize the introductory phrases for safety warning terms, such as "Caution", "Precautions", "Warning";(8) It is recommended to delete the words "provided by" and "produced by" on the label, and meanwhile standardize the enterprise introductory phrases and address labeling, e. g. "Entrusting Party/Address, Entrusted Party/Address";(9) Please standardize the label introductory text "规格" to "Net Content: ";(10) It is recommended to standardize the introductory text "生产单位" to "Manufacturer";(11) The product is not marked with qualification information;(12) The label is not marked with origin information;(13) The label introductory text "产品型号" is inappropriate;(14) It is recommended to standardize "温馨提示" to "Precautions".
 

7-56. How to use the guiding texts on labels for production date and expiration date?


Answer: Choose one of the two combinations, either "production date and shelf life" or "production batch number and expiration date", and they shall not be mixed.
 

7-57. When labeling ingredients, should the names of various ingredients be separated by spaces?


Answer: When two or more ingredient names are listed in the same row of the ingredient list, they shall be separated by "、".
 

7-58. When multiple color shades share a unified ingredient list, how should the colorants be labeled?


Answer: When multiple shade numbers share the same ingredient list, the phrase "May contain colorants:" should be inserted at the end of the ingredient list as a lead-in, followed by the colorants within all applicable ranges listed in any order;
 

7-59. Does the packaging claim that food-grade raw materials are used?


Answer: This statement is misleading, and it is prohibited to label the material as food-grade raw material.
 

7-60. Our company's products use nano-scale raw materials, and we hope to promote this feature. How can we conduct such promotion in compliance with relevant regulations?


Answer: At present, the word "nano" is not allowed to appear in product names and labels, and "nanoscale" shall be indicated when relevant raw materials are used.
 

7-61. The rectification order states that "the manufacturer's address information indicated on the label is incomplete", but the address of our company is exactly the one we have filed. What's going on here?


Answer: The enterprise address on the packaging must be completely identical to that on the business license and production license, including all the information in the parentheses following the address.
 

7-62. Our company produces a type of nose patch which is black in color and advertised as using bamboo charcoal to remove blackheads. Is it mandatory to contain actual bamboo charcoal ingredients?


A: Yes, it is required. The product name or the claimed efficacy must be consistent with the formula ingredients. Such claims will exaggerate the product efficacy and mislead consumers.
 

7-63. Can a product claim to repair sunburn?


Answer: "Sunburn" is inappropriate, while "post-sun exposure" is acceptable;
 

7-64. Prohibited medical terms.


Answer: "pores"; soo the sensitive; counterfeit medical logos, specialization, agent, expert; medicine; soothing sensitive skin; counterfeit Red Cross logo; beauty therapist; claiming anti-fatigue effect; efficacy content "repair and regenerative capacity, improve cell metabolism, promote natural protein production", shall not explicitly or implicitly indicate medical efficacy; claiming "pure plant aromatherapy essence formula"; the foreign word "treatment" on the packaging; "physical therapy"; "sedation"; "acne"; "fade post-healing pigment marks and scars"; scan the QR code: AROMATHERAPY;Packaging "+" cross pattern; the capsule image of packaging materials is suspected of implying medical effects; "heal", healing; MEDICAL COSMETIC; Anmin; traditional Chinese prescription; medicine; aromatherapy; improving "skin redness, facial redness"; anti-allergic; "soothing sensitivity and repairing redness".
 

7-65. Among our branded products, there is one containing "medicinal Fomes officinalis extract" as an ingredient, and we promote this ingredient on the label, naming the product set "Medicinal Fomes officinalis Nourishing Set", with the main promotion focusing on the product's moisturizing and nourishing effects. We would like to ask: Can "medicinal Fomes officinalis" be directly used in the naming of a product set? Can this ingredient be promoted on the outer packaging? Can it be used for the filing of domestic ordinary cosmetics?


Answer: The use of cosmetic raw materials shall comply with the requirements of the Catalogue of Names of Cosmetic Raw Materials Already Used (2015 Edition) and the Technical Specification for Cosmetic Safety (2015 Edition). Please check by yourself whether the raw material is included in the Catalogue of Names of Cosmetic Raw Materials Already Used (2015 Edition) and meets the requirements of the Technical Specification for Cosmetic Safety (2015 Edition).
Indications, therapeutic claims and medical terminology shall not be printed on cosmetic labels, small packages or instructions.
 

7-66. If the business license of the entrusting party of a cosmetics enterprise has been changed, but the packaging of the involved special cosmetics and non-special cosmetics has not been changed online, can the packaging materials with the old address in stock be normally used up during the transition period?


Answer: The information on product labels shall be consistent with the registration and filing information.
 

7-67. Put words such as "developed by XX Company", "technical support by XX Company" or "supervised by XX Company" on the outer packaging of the product.


A: There are no explicit prohibitions against words and phrases such as "developed by", "technical support by" or "supervised by" a certain company on the outer packaging of products, but in principle, such wording must not create suggestive effects.
 

7-68. Can two trademarks appear on the outer packaging of a product?


Answer: There is no prohibition, but it is necessary to ensure that the product name is free of ambiguity.
 

7-69. Regarding the production of Chinese labels for products entrusted by domestic entities to overseas parties, can the "entrusting party" and "entrusted party" on the Chinese label be changed to "exporter (domestic responsible party)" and "actual manufacturing enterprise"?


A: The principle is to ensure that the agency relationship and the respective legal liabilities borne by each party can be clearly and unambiguously identified.
 

7-70. Can product packaging claim to be preservative-free?


Answer: No. "Free of" means the product absolutely contains no such substance, and generally, it is impossible for a product to be completely free of any preservative ingredient.
 

7-71. For the Chinese-English markings on the outer packaging of a product box, is it required that the Chinese and English texts correspond one-to-one vertically, or is it acceptable as long as the content on different surfaces matches each other?


A: The principle is that a one-to-one correspondence is required.
 

7-72. For the English part of the Chinese-English bilingual markings on the outer packaging of a product box, is it allowed to be distributed in different positions on the same plane?


A: Yes, as long as it does not cause ambiguity.
 

7-73. For products manufactured under entrustment, is it mandatory to label both the actual manufacturing enterprise and the repackaging enterprise on the product packaging simultaneously?


Answer: Whether semi-finished product enterprises are indicated on the packaging is subject to the independent choice of the enterprise.
 

7-74. If a product is labeled as "suitable for all skin types", will it be considered to include sensitive skin? Is it necessary to add a warning statement for use by people with sensitive skin?


Answer: It suits all skin types, including sensitive skin, and is safe for pregnant women and children—all these scenarios have been taken into full consideration.
 

7-75. If a product comes in two variants (e. g., a moisturizing type and a refreshing type with different formulas), can they use the same packaging and only affix an additional label to distinguish which one is the moisturizing type?


Answer: No. Products sold separately with different formulas shall be filed separately.
 

7-76. For the documents required to be uploaded in the online filing of domestic general cosmetics, in addition to the formula, product three-dimensional view and product plan view, is it necessary to upload the following materials in the additional materials, such as:(1) The proof of the origin claimed in the product;(2) If there is a foreign trademark in the product name, whether it is necessary to upload the trademark registration certificate;(3) Whether the organic product claim requires the upload of organic certification;(4) If it is claimed that the product is developed by a certain laboratory, whether supporting certification materials are required.


Answer:(1) Yes;
(2) Registered trademarks are acceptable, with Chinese descriptions in the specification;
(3) Sufficient supporting documents are required for claims concerning organic products, and the uploaded organic certification must be a widely recognized one;
(4) Requirements.
 

7-77. Is it mandatory to place the Chinese product name on the front side?


Answer: The Measures only require the labeling to be marked on the visible surface.
 

7-78. Is it mandatory to print warning statements on product packaging?


Answer: If the product standard requires the labeling of warning statements, such warning statements shall be mandatorily labeled; if the product raw materials used are subject to the requirement of labeling warning statements in the *2015 Edition Technical Specifications for Cosmetic Production*, such warning statements shall also be mandatorily labeled. For all other circumstances, the labeling shall be determined by the enterprise on its own.
 

7-79. Is it allowed to include wording such as "target population" on labels?


A: No relevant restrictions have been stipulated for the time being, and enterprises may label it on their own according to the actual situation.
 

7-80. What should be done if some of the ingredients indicated on the packaging are somewhat different from those actually submitted to the filing platform?


Answer: Enterprises shall ensure that the ingredients indicated on product packaging are consistent with those in the submitted filing materials, except for special circumstances. For example, compound ingredients can be directly labeled with their compound name on product packaging, but all their original ingredients shall be listed in the filing materials.
 

7-81. For some products, the previously implemented standard was an industry standard, but now a new national standard has been released. How should the product labeling be handled in this case?


A: Currently, the standard number implemented for the product is consistent with the filing number, and national standard or industry standard numbers are no longer used. The number can be preset in the filing system for product labels.
 

7-82. Should ingredients added to cosmetic raw materials for the purpose of protecting the raw materials, such as antioxidants, preservatives and stabilizers, be labeled on the product label?


A: The Measures stipulate that cosmetic labels shall indicate the standard Chinese names of all cosmetic ingredients on the visible surface of the sales packaging.
 

7-83. For products that have completed historical record filing and information supplementation, if the packaging is changed for the first time, is it only necessary to upload the new packaging images?


Answer: After the information of historically filed products is supplemented, the first change to filing materials such as packaging is a new filing activity. If the original filing materials are incomplete, materials such as safety assessment, efficacy evaluation, inspection report and raw material safety information shall be supplemented in accordance with the provisions of the *Provisions on the Administration of Cosmetic Registration and Filing Materials* and other relevant regulations.
 

7-84. If an enterprise's quality management system has obtained ISO and GMPC certifications, can the relevant marks be labeled on the product?


Answer: According to Article 25 of the Regulations of the People's Republic of China on Certification and Accreditation, "It is prohibited to use management system certification certificates, certification marks and relevant words and symbols to mislead the public into believing that their products have been certified. " Therefore, cosmetics labels shall not be marked with the quality management system certification certificates, certification marks and relevant words or symbols of the manufacturer.
 

7-85. Can the phrases "fade wrinkles" and "remove wrinkles" be used in product descriptions?


Answer: Product instructions also form part of the label and shall comply with China's regulations on labels. It is not recommended to use words such as "anti-wrinkle, anti-aging" that may imply medical effects.
 

7-86. Is it permissible to promote "**stock solution" on labels?


Answer: Terms like "stock solution" that can reflect the true attributes of a product should refer to "liquid cosmetics" which are composed of a single component or a single category of components plus necessary solvents, antioxidants and preservatives, can be used directly or after being diluted in the specified proportion, and meet the labeling requirements for cosmetics.
 

7-87. Are all terms containing the character for "white" prohibited for use? For example, whitening, brightening, radiance-boosting, antioxidant? Is a product description like "leaves skin smooth, supple and bright after application" acceptable?


A: In accordance with the requirements of the new policy, whitening products are included in the management of special cosmetics. If a product has been filed as a special cosmetic, it is permissible to promote its effects such as whitening; if no such filing has been completed, it is not recommended to use any promotional wording that is close or similar to whitening.
 

7-88. Can the product name or label contain the words "instant" and "repair"?


A: Except for the prohibited words, enterprises may choose and use other words as appropriate; some of them can be used in the product name but not for descriptive purposes.
 

7-89. Is it permissible to claim "gene-based brightening with no trace left" on labels?


Answer: Terms such as "gene", "factor", "stem cell" and "interferon" may involve "meanings that are not easy for consumers to understand", so please use them with caution; while "scar-free" may involve "implying medical effects", so please use it with caution.
 

7-90. How should colorants be labeled on product labels?


Answer: For products using colorants, the CI number shall be indicated on the product label, except for those without a CI number. For ingredients that can be used both as colorants and for other purposes, such as titanium dioxide, mica, zinc oxide, etc. , when they are used for other purposes, the label shall indicate their standard Chinese names.
 

7-91. How should the "Other Information" and "Labeled Label Content" fields in the product labels of the new filing platform be filled in?


Answer: It is required to fill in the information that is intended to be claimed or marked, in addition to the "basic content" on the Chinese label of the product.
 

7-92. A certain facial mask product claims on its original packaging: "Apply it to align with facial acupoints, press gently, it can improve circulation and reduce edema". Does this go beyond the specified usage method of cosmetics?


Answer: The application method of this product is "acupoint application", which does not conform to the application methods specified in the Regulations, namely "smearing, spraying or other similar methods"; its intended use purposes are "improving circulation" and "reducing edema", which do not conform to the use purposes of "cleansing, protecting, beautifying and modifying". The above concepts go beyond the definition of cosmetics, and thus the safety of this product cannot be determined.
 

7-93. What is the "minimum sales unit" of cosmetics? Do free gifts count as such?


Answer: It refers to the form of the smallest package of a product that is delivered to consumers together with the product's contents, packaging container, packaging box, product instruction manual, etc. , for the purpose of product sales.
Free gifts, which are delivered to consumers together with the product contents and other materials, naturally also count as minimum sales units.
 

7-94. What does "contents" refer to?


A: The product contained in the packaging container.
 

7-95. What are the display surface and visible surface of cosmetics?


Answer:(1) Display surface: Any surface of a cosmetic product that is visible to consumers during display, excluding the bottom surface;
Visible surface: Any surface of a cosmetic product that can be seen by consumers without damaging its sales packaging.
 

7-96. What is the guiding text on cosmetic labels?


Answer: Terms used to introduce label content, such as "product name", "net content" and the like.
 
 

8 Product Inspection Report

 

8-1. How to determine the test items for general cosmetics?


A: For general cosmetics, the test items shall be determined in accordance with Table 1-1,1-2,1-3,1-5 and 1-6 in Appendix 1 of the *Specifications for the Registration and Filing Testing of Cosmetics*.
 

8-2. How to determine the testing items for special cosmetics?


A: Special cosmetics shall have their test items determined in accordance with Tables 1-1,1-2,1-4,1-5 and 1-6 of Appendix 1 to the *Specifications for the Work of Cosmetics Registration and Filing Inspection*.
 

8-3. What do the nine routine items for cosmetic testing refer to?


Answer: The nine routine items for cosmetic testing refer to the nine mandatory indicators that cosmetic products are required to be tested for.
First of all, there are heavy metal components that have direct toxic effects on the human body, including mercury, arsenic, lead and cadmium. All these components are toxic to the human body and tend to accumulate in the body, so even trace intake should be avoided. Of course, in current cosmetic production technologies, these components are never directly used as raw materials, but even in regular raw materials, trace amounts of toxic components may still be present. In particular, products such as foundation or eye shadow that use natural minerals as pigments are more likely to have excessive heavy metal levels, so strict testing of raw materials and finished products is required to ensure that heavy metal content does not exceed the standard.
Apart from the toxic components that may be present in raw materials, the nine conventional items for cosmetic identification also include microbial components that can easily affect human health, namely the total number of bacterial colonies, the total number of molds and yeasts, Staphylococcus aureus, Pseudomonas aeruginosa, and heat-resistant Escherichia coli. These microorganisms vary from one another, and their hazards to humans are also manifested in different aspects. In professional laboratories, all of them are detected through culture methods, with respective data obtained and the actual figures recorded in the test report.If there is an excessive level of microorganisms, it indicates that there was a problem during the production, storage or transportation of the batch of products, which resulted in microbial contamination.
 

8-4. How to determine the test items for cosmetics using new raw materials?


A: In addition to the general routine testing items, the National Medical Products Administration may, when deeming it necessary after conducting a safety risk assessment on substances that may exist in cosmetics and pose safety risks based on the raw materials used and product characteristics, require the addition of relevant testing items.
 

8-5. How to inspect set samples of different packaging types?


Answer:(1) For a sample that contains two or more individual sub-packages or compartments within one package (e. g., pressed powder, eye shadow, blush, etc.), bears only one product name, and consists of components with different raw material compositions, the corresponding items shall be tested separately, and the product formula and test report shall be submitted; for a sample that consists of non-individual sub-packages or non-compartmentalized parts, and whose parts share the same raw material compositions except for colorants, whether separate testing shall be conducted shall be determined in accordance with the directions for use specified in the instruction manual.
(2) Where the sample is an indivisible combined package declared under a single product name, and the samples differ in physical state or raw material composition, the product formula and inspection report shall be submitted separately for each type.
(3) Products that must be used in combination in two or more doses shall be declared as a single product. Submit a mixing test report or separately submit the test reports for respective dosage forms in accordance with the actual situation of whether the multiple dosage forms are used after mixing; the toxicological test items shall be conducted in accordance with the usage method specified in the instructions.
 

8-6. For the filing of general cosmetics, under what circumstances is the submission of the product's toxicological test report exempted?


Answer: According to Article 33 of the Provisions on the Administration of Cosmetic Registration and Filing Materials: "Where the manufacturer of a general cosmetic has obtained the qualification certification related to 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 result can fully confirm the safety of the product, the toxicological test report of the product may be exempted from submission, except in any of the following circumstances:
(1) Products that are claimed to be for use by infants and children;
(2) New cosmetic ingredients whose use is still under safety monitoring;
(3) Where, based on the results of quantitative classification scoring, the filing entity, domestic responsible party and manufacturing enterprise are classified as key supervision targets.
Where a product is manufactured by multiple production enterprises, a toxicological test report may be exempted from submission only if all such production enterprises have obtained the qualification certification related to the production quality management system issued by the competent government department of the country (region) where they are located.
 

8-7. What are the requirements for toxicological tests when gaseous propellants are declared as new cosmetic ingredients?


Answer: When a gaseous raw material is declared as a new cosmetic raw material for use as a propellant, the following toxicological test data are generally required to be provided:
(1) Skin and acute eye irritation/corrosion test;
(2) Acute inhalation toxicity test;
(3) Subchronic inhalation toxicity test;
(4) Genotoxicity (under appropriate exposure routes).
 

8-8. What matters should be noted when applying for the filing of multi-color series of ordinary cosmetics that have undergone sampling toxicological tests?


Answer: In accordance with the requirements of Article 33 of the *Provisions on the Administration of Cosmetic Registration and Filing Materials*, "For ordinary cosmetics of multi-shade series that are subject to toxicological tests in accordance with the sampling requirements specified in the *Specifications for Cosmetic Registration and Filing Inspection*, they may be filed as a group of products, and each product shall be attached with a list of the series products, a list of basic formulas and colorants, as well as a list of sampled products. "
 

8-9. For ordinary cosmetics that need to be used in combination, how to conduct toxicological tests during the filing process?


Answer: According to the requirements for cosmetic registration and filing inspection items in Annex 1 of the Specifications for Cosmetic Registration and Filing Inspection Work, "toxicological tests, human safety and efficacy evaluation tests may be conducted in accordance with the usage methods specified in the instructions; if there is a possibility that each part is used separately, separate inspections shall be conducted. "
 

8-10. What sunscreen agent tests are required for sunscreen products?


A: Currently, there are multiple testing methods for sunscreens specified in the *Technical Specification for Cosmetic Safety*. When applicants submit applications for sunscreen products, they shall verify the application formula: if the sunscreen used in the formula is not among the "15 components including phenylbenzimidazole sulfonic acid" and there is a clear testing method for such sunscreen (excluding titanium dioxide and zinc oxide), additional testing for this item shall be conducted. For other products with a sunscreen content (excluding titanium dioxide and zinc oxide) of ≥0.5%(w/w) that require additional testing for the sunscreen item, the above requirements shall apply.
 

8-11. What are the requirements for cosmetic inspection reports?


Answer:(1) The test report for cosmetic product registration and filing (hereinafter referred to as the "test report") is an important review basis for cosmetic product registration and filing, as well as a legally binding technical document, which must feature complete information, accurate data, correct conclusions and standardized format.
(2) The inspection report shall conform to the required layout and format, covering contents such as the cover page, statement, and inspection results.
(3) The result page for each section of test items in the test report shall bear the signature, date and the special seal for inspection and testing, and the signatory shall be the authorized signatory of the inspection and testing institution confirmed by the qualification accreditation department. The date on the cover shall be the final issuance date signed by the authorized signatory of the inspection and testing institution. The blank space of the test report shall be marked with "Blank below this page". A multi-page test report shall also have an inter-leaf seal affixed.
(4) Where the inspection report issued by an inspection and testing institution fails to comply with relevant provisions, the drug regulatory department may require it to reissue an inspection report. The issuance date of the reissued inspection report shall be the actual date of issuance, with relevant explanations attached.
(5) No alteration, addition or deletion shall be made to an inspection report, and an inspection and testing institution shall not modify any inspection report that has already been issued.
 

8-12. Is there a standard format for cosmetic inspection reports?


A: Inspection and testing institutions shall issue inspection reports in accordance with the requirements and format for cosmetic registration and filing inspection reports (Appendix 2 to the Specifications for Cosmetic Registration and Filing Inspection Work). The inspection report shall be made in triplicate, one copy to be kept by the inspection and testing institution, and the other two copies to be submitted to the enterprise applying for inspection.
For the inspection reports issued by inspection and testing institutions, the inspection results shall be accurate and reliable. The original inspection records shall be authentic, standardized, complete and traceable, and shall be kept in accordance with relevant provisions. Inspection and testing institutions shall upload inspection reports to the inspection information system and input the inspection results at the same time.
 

8-13. What specific contents are included in the inspection report?


A: The inspection report consists of sections including microbiological inspection report, physical and chemical inspection report, toxicological test report, human safety inspection report, and human efficacy evaluation inspection report. Each section of the inspection report shall contain the inspection results, and they shall be bound in the aforementioned order.
 

8-14. How to handle the situation where the product name, applicant for inspection, and product registration/filing information in the inspection report are inconsistent?


Reply: According to Item 1, Paragraph 33 of the Provisions on the Administration of Cosmetic Registration and Filing Materials: 2. The product information specified in the product inspection report shall be consistent with the relevant information of the registered or filed product. If the information that does not affect the inspection results, such as the product name and enterprise name in the inspection report, is inconsistent with the registration and filing information due to reasons such as name change, explanation shall be provided, and the application form for inspection report change as well as the supplementary inspection report or correction letter issued by the inspection and testing institution shall be submitted.
 

8-15. For ordinary cosmetics registration, how should samples with different packaging types, different formulas for each part, and only one product name be tested?


Answer: In accordance with the Requirements for Cosmetic Registration and Filing Inspection Items (Appendix 1 to the Work Specifications for Cosmetic Registration and Filing Inspection), inspection shall be carried out in accordance with the following provisions:
(1) For microbiological items: if the components inside a single sample package are individually packaged, they shall be tested separately; if the components inside a single sample package are not individually packaged, mixed sampling and testing shall be conducted. If the product is a combination of different categories of color cosmetics, they shall be tested separately.
(2) Physical and chemical items shall be tested separately for each part; if separate sampling is not feasible and the test items do not involve the content of formulation raw materials, testing may be conducted in accordance with the instructions for use; if the test items involve the content of formulation raw materials, the enterprise may provide semi-finished products before packaging for testing, and the sampling method shall be specified in the test report.
(3) Toxicity tests, human safety assessment and efficacy evaluation tests may be conducted in accordance with the usage methods specified in the instructions; where there is a possibility that each component may be used separately, separate tests shall be conducted respectively.
 

8-16. For ordinary cosmetics added with chemical sunscreens, what tests shall be conducted?


Answer: According to Appendix 1 *Requirements for Cosmetic Registration and Filing Test Items* of the *Specifications for Cosmetic Registration and Filing Testing Work*, for non-sunscreen products containing chemical sunscreens in their formula, the contained chemical sunscreens shall be tested. Products with a chemical sunscreen content of ≥0.5%(w/w)(excluding rinse-off products, perfume products, and nail polish products) shall also undergo a skin phototoxicity test and a skin allergic reaction test. For non-sunscreen cosmetics with a total chemical sunscreen content of ≥0.5%(w/w)(excluding rinse-off products, perfume products, and nail polish products), the SPF value shall be tested.
 

8-17. If multiple manufacturers produce the same ordinary cosmetic, how should the test report be submitted during the product filing?


Answer: According to Article 33 of the Provisions on the Administration of Cosmetic Registration and Filing Materials, "Where the same product is manufactured by multiple manufacturers, a complete product inspection report of the sample from one of the manufacturers shall be provided, and the microbiological and physical-chemical inspection reports of the samples from the other manufacturers shall be submitted.
 

8-18. Does the filed inspection report have an "expiry date"?


A: The current Announcement of the National Medical Products Administration on Issuing and Implementing the Work Specifications for Cosmetics Registration and Filing Inspection (No. 72 of 2019) does not stipulate the validity period of inspection reports. The statement on the format of inspection reports in the former Notice of the State Food and Drug Administration on Issuing the Administrative License Inspection Measures for Cosmetics (Guo Shi Yao Jian Xu [2010] No. 82) specifies that "this inspection report is valid for two years from the date of issuance", which we believe means that the filing formalities shall be completed within two years after obtaining the filing inspection report.
 

8-19. What are the requirements for test reports when a cosmetics manufacturer applies for the filing of domestic ordinary cosmetics? Is it sufficient that the testing institution issuing the test report has CMA qualification?


Answer: The test report for general cosmetics is only valid if it is issued by a filing inspection institution for domestic general cosmetics. (The list of such institutions can be queried on the official website of the National Medical Products Administration.)
 

8-20. If the product formula is qualified but the product name does not comply with relevant regulations, can the test report issued under the non-compliant name still be used?


Answer: If the product name obviously fails to meet the requirements of current laws, regulations and standards, the filing may not be approved, and the filing testing institution will not accept it either.
 

8-21. If the product has already been sent for inspection first, and a formula discrepancy is found when submitting the filing materials, can this inspection report still be used?


Answer: The filing testing institution shall not be held responsible for the authenticity of the materials provided by the enterprise, and is unable to verify for the enterprise whether the formula can successfully pass the filing. It is recommended that when submitting the product formula, the enterprise should thoroughly understand the requirements for submitting the product formula for online filing, provide the product formula components truthfully and completely, and ensure that the product formula submitted when applying for filing inspection is consistent with the materials for online filing.
 

8-22. If a product is to be re-filed under a new name after its cancellation, can the original inspection report be used?


A: You shall make a judgment based on the specific circumstances of the product. If the original filed product involves changes in aspects such as product formula, production process, or manufacturer, the original inspection report shall not be used.
 

8-23. What materials should be submitted for the product inspection report items of the new filing platform?


Answer:(1) In accordance with the requirements of the *Provisions on the Administration of Cosmetic Registration and Filing Materials* and the *Specifications for Cosmetic Registration and Filing Inspection Work*, materials such as product inspection reports, inspection application forms, inspection acceptance notices, product instructions for use, and product formulas shall be submitted.
(2) Where the information such as the product name and enterprise name specified in the product inspection report that does not affect the inspection results is inconsistent with the relevant information of the filed product, an explanation shall be provided, and the application form for inspection report change as well as the supplementary inspection report or correction letter issued by the inspection and testing institution shall be submitted.
 

8-24. Is it possible to respectively commission two inspection and testing institutions to conduct microbiological testing and physical-chemical testing?


Answer: For the inspection items related to the registration or filing of the same product, they shall generally be completed independently by the same inspection body and the corresponding inspection report shall be issued thereby.
Where tests involving human safety and efficacy evaluation are required, or the scope of capabilities under the qualification accreditation (CMA) of the inspection and testing institution does not cover asbestos items, cosmetics enterprises may separately select other inspection and testing institutions that have obtained the qualification accreditation (CMA) and possess corresponding inspection capabilities to complete such tests simultaneously.
 

8-25. Can the formula confirmed by the inspection body be changed?


Answer: During the product application phase, the registrant shall submit the product to the cosmetics registration and filing inspection and testing institution, and the product formula confirmed with the seal of the inspection and testing institution generally cannot be altered. If a modification is indeed required due to clerical errors in formula filling, the registrant shall submit explanatory materials for reference and judgment during technical evaluation.
 

8-26. What are the requirements for inspection of imported products against registered products?


A: The materials submitted by the domestic responsible person when applying for product filing shall include a product inspection report, which shall be issued by a cosmetics administrative license inspection institution recognized by the former China Food and Drug Administration.
 

8-27. How to apply to become a cosmetics inspection and testing institution?


Reply: Inspection and testing institutions shall submit the following information through the Cosmetics Registration and Filing Inspection Information Management System established by the National Medical Products Administration:
(1) Documents certifying the name, nature, address, contact information, general scale profile and legal person qualification of the institution. For inspection and testing institutions that are not independent legal persons, an authorization document issued by the affiliated legal person entity shall be submitted simultaneously;
(2) The status of having obtained the qualification accreditation for inspection and testing in the cosmetics field;
(3) Cosmetic inspection items that can be carried out in accordance with the qualification accreditation;
(4) The establishment and operation status of the quality management system. Inspection and testing institutions engaged in cosmetic human safety and efficacy evaluation and testing shall also submit the informed consent management system for subjects, the establishment and operation status of the volunteer management system, and the status of cosmetic adverse reaction handling capacity;
(5) Overview of the cosmetics inspection team. Inspection and testing institutions engaged in cosmetics human safety and efficacy evaluation inspection shall also submit the qualification certificates of two or more (inclusive) full-time licensed physicians specializing in dermatology-related fields, as well as work resumes with more than five years (inclusive) of experience related to cosmetics human safety and efficacy evaluation;
(6) List of major instruments, equipment and facilities, and description of environmental conditions;
(7) Previous experience in cosmetics inspection work;
(8) A statement confirming no illegal or irregular acts and no major business accidents in the past three years;
(9) The emergency response to unexpected incidents and serious adverse events occurring in the inspection work for cosmetic registration and filing;
(10) Other circumstances requiring clarification.
 

8-28. What qualifications are required for cosmetics inspection and testing institutions?


A: Inspection and testing institutions shall generally have the status of an independent legal person. An inspection and testing institution that does not have the status of an independent legal person shall be authorized by the legal entity to which it belongs, and be capable of independently undertaking third-party impartial inspection and independently carrying out inspection and testing business activities.
Before conducting inspection and testing work for cosmetic registration and filing, an inspection and testing institution shall obtain the qualification certification (CMA) for inspection and testing institutions in the cosmetic field, and the scope of capabilities covered by the obtained qualification certification shall meet the requirements of the inspection and testing work for cosmetic registration and filing.A testing institution engaged in the safety and efficacy evaluation of cosmetics on humans shall also be equipped with no less than two full-time personnel who hold the qualification certificates of licensed physicians in dermatology-related specialties and have at least five years of work experience related to the safety and efficacy evaluation of cosmetics on humans, establish an informed consent management system for subjects and a volunteer management system, and have the ability to handle adverse reactions to cosmetics.
 

8-29. Do inspection and testing institutions need to retain sample reserves? If yes, what is the retention period?


Answer: Yes. According to Article 14 of the Specifications for the Work of Cosmetic Registration and Filing Inspection: The retention period of samples shall be two years from the date of issuance of the inspection report, or until the expiration of the shelf life or the period of use-by date of the samples. Samples exceeding the retention period shall be destroyed after being approved by the person in charge of the registration and filing inspection and testing institution in accordance with the prescribed procedures, and the environment shall not be polluted during the disposal.
 

8-30. How should cosmetics registrants and filing holders retain samples?


A: According to Article 36 of the Regulations, cosmetics registrants and filers shall retain samples of cosmetics produced in each batch for inspection. The quantity of retained samples shall be sufficient to meet the needs of registration and filing inspection, and may not include the sample quantity required for human efficacy tests such as sun protection and hair loss prevention.
 

8-31. What should a testing and inspection institution do when changes occur due to commercial activities?


Answer: The inspection and testing institution shall update the information in the inspection information system in a timely manner in accordance with the actual conditions of its own unit.
Where an inspection and testing institution no longer meets the corresponding capabilities and conditions for undertaking the inspection work for cosmetic registration and filing, or ceases to engage in such inspection work, it shall proactively cancel its information in the inspection information system.
 

8-32. Examine the relevant provisions on the preservation of archival materials.


Answer: Inspection and testing institutions shall file and properly keep the inspection files and materials for cosmetic registration and filing, with the retention period being no less than six years.
 

8-33. What inspection files and materials shall the inspection and testing institution retain?


Answer:(1) Relevant materials for the application and acceptance of registration or filing inspection;
(2) Inspect the records of sample handover and inspection procedures;
(3) Original inspection records;
(4) Inspection report;
(5) Other relevant materials such as the instruction manual submitted by the enterprise.
 

8-34. What matters should be noted when supplementary testing of the dioxane indicator is required for imported ordinary cosmetics?


A: For imported ordinary cosmetics containing raw materials with ethoxy structures in their formula, dioxane shall be tested. As a general rule, the testing items for the registration or filing of the same product shall be independently completed and the test report shall be issued by the same inspection and testing institution.
 

8-35. Our company is the domestic responsible person for cosmetics, and some of our products are sold at Hainan outlying island duty-free shops. Since the products at duty-free shops are directly shipped by the overseas filing entity, our company is unaware of the batch numbers of the imported products and cannot implement the sample retention system. Is it feasible for the duty-free shop to retain the samples instead?


A: Cosmetic filing holders shall establish and implement a sample retention management system and a product sales record system. Domestic responsible parties, which are entities designated by overseas filing holders to assume corresponding quality and safety responsibilities for cosmetics launched into the domestic market, shall fully grasp the product import situation and quality status, and fulfill relevant statutory obligations.
 

8-36. What are the requirements for cosmetic samples submitted for inspection?


A: Cosmetic enterprises shall provide all samples required for product inspection to the first inspection and testing agency that accepts the registration or filing inspection application in one go. The samples submitted for inspection shall be commercially available samples of the same batch with intact and unopened packaging.
The remaining shelf life of the sample at the time of submission for inspection shall be sufficient to meet the requirements of the cosmetic registration and filing inspection work.
 

8-37. When applying for cosmetic registration or filing, can trial-produced samples be used as the samples submitted for inspection?


Answer: According to Article 11 of the *Specifications for the Inspection Work of Cosmetic Registration and Filing*, "Products that have not yet been marketed for sale at the time of submission for inspection may be trial-produced samples. "
 

8-38. What should be done if product sampling and testing cannot be conducted due to packaging issues?


Answer: If the finished product cannot be sampled due to packaging reasons or sampling may affect the test results (e. g., spray products, air-cushion products, etc.), while submitting complete test samples, the enterprise may additionally provide the semi-finished product from the final process before packaging, and the inspection and testing institution shall make a statement in the inspection report accordingly.
 

8-39. What are the toxicological test items for ordinary cosmetics?


Answer: The toxicological tests for general cosmetics mainly include acute skin irritation test and repeated skin irritation test.
 

8-40. What are the toxicological test items for special cosmetics?


Answer: The toxicological tests for special cosmetics mainly include acute eye irritation test, acute skin irritation test, repeated skin irritation test, skin sensitization test, skin phototoxicity test, bacterial reverse mutation test, and in vitro mammalian cell chromosome aberration test.
 

8-41. How to determine the toxicological test items for products that are used in combination of two or more doses?


Answer: For products involving the combined use of two or more doses, testing shall be conducted in accordance with the instructions for use specified in the product manual. Where different usage methods related to safety exist, such as different concentrations and different formulation ratios, relevant toxicological tests shall be carried out for each scenario.
 

8-42. What are the items for human safety test? How to determine them?


Answer: The human safety test items include the human skin patch test and the safety evaluation of human application test.
(1) For freckle-removing and sunscreen cosmetics, when a human skin patch test yields an irritating result or the result is difficult to determine, a repeated open application test on the skin shall be added;
(2) For leave-on products where the physical and chemical test results show pH ≤ 3.5, or products with a specified pH ≤ 3.5 in the enterprise standard, a safety evaluation through human patch test shall be conducted;
(3) All rinse-off products claiming efficacy such as acne removal, anti-wrinkle, and spot removal shall undergo safety evaluation through human patch test;
(4) For products used in combination of two or more doses, tests shall be conducted in accordance with the instructions for use in the manual. Where there are different usage methods related to safety, such as different concentrations and different proportions, relevant human safety tests shall be carried out for each case.
 

9 Safety Assessment Documentation

9-1. What are the requirements for product safety assessment materials at the current stage?


Answer: At the current stage, the filing holder shall conduct cosmetic safety assessment in accordance with the requirements of the Technical Guidelines, and upload the risk assessment documents under the item of "Product Safety Assessment" documents.
 

9-2. What contents are included in the safety assessment report of cosmetic products?


Answer: The safety assessment report of cosmetic products usually covers contents such as summary, product introduction, product formula, formula design principles (only for children's cosmetics), safety assessment of each ingredient in the formula, assessment of possible risk substances, risk control measures or suggestions, conclusion of safety assessment, signature and resume of safety assessors, references and appendices.
 

9-3. What contents are included in the safety assessment report of cosmetic ingredients?


Answer: The safety assessment report of cosmetic ingredients usually covers contents such as executive summary, physical and chemical properties of the ingredient, assessment process, analysis of assessment results, risk control measures or suggestions, conclusion of safety assessment, signature and resume of safety assessors, references and appendices.
 

9-4. The new system requires the submission of product safety assessment materials for the filing of general cosmetics. For general cosmetics that have not submitted toxicological test reports, a product safety assessment report shall be submitted. What are the respective qualification requirements for internal company personnel or entrusted external testing institutions to issue the safety assessment report?


Answer: In accordance with the Technical Guidelines for Safety Assessment of Cosmetics (2021 Edition):
2.5 A cosmetic registrant or filing entity shall conduct safety assessment by itself or entrust a professional institution to do so, form a safety assessment report, and be responsible for the authenticity and scientificity thereof.
3. Requirements for Cosmetic Safety Assessors: Cosmetic safety assessors shall meet the following requirements:
3.1 Possess professional knowledge related to cosmetic quality and safety such as medicine, pharmacy, biology, chemistry or toxicology, understand the production process and quality safety control requirements of cosmetic finished products or raw materials, and have more than 5 years of relevant professional work experience.
3.2 Able to consult and analyze relevant literature such as chemistry and toxicology, as well as analyze, evaluate and interpret relevant data.
3.3 Able to analyze the safety of cosmetics fairly and objectively, conduct safety assessment on the basis of a comprehensive analysis of all available data and exposure conditions, and be responsible for the scientificity, accuracy, authenticity and reliability of the assessment report.
3.4 Be able to learn relevant knowledge of safety assessment by regularly receiving corresponding professional training, understand, master and apply new theories, technologies and methods of safety assessment in practice.
 

9-5. How to conduct a safety assessment for flavorings?


Answer: As a category of raw materials, fragrances cannot use the maximum historical usage amount of "fragrances" specified in the *Catalog of Used Cosmetic Raw Materials (2021 Edition)* as assessment evidence. Instead, fragrances shall be assessed in accordance with the principles and requirements of the *Technical Guidelines for Cosmetic Safety Assessment*, or supporting documents shall be provided to prove that the fragrances used in the product comply with the practice codes of the International Fragrance Association (IFRA) or the relevant national standards (for fragrances) of China.
 

9-6. When evaluating nanomaterials used in a formulation, what relevant information shall be provided?


Answer: When conducting a safety assessment for products containing nanomaterials in their formulation, the material quality specifications issued by the raw material manufacturer shall be provided, along with safety assessment documentation based on the said raw material quality specifications and supporting the usage amount in the formulation.
 

9-7. For cosmetics that must be used with instruments or tools, how to conduct product safety assessment?


Answer: In accordance with Article 34 of the Provisions on the Administration of Cosmetic Registration and Filing Dossiers:
Registrants and filing holders shall conduct product safety assessment in accordance with the requirements of relevant technical guidelines for cosmetic safety assessment, and form a product safety assessment report.
Cosmetics that must be used in conjunction with instruments or tools (excluding only auxiliary items such as brushes for smearing, air cushions, and perm tools) shall undergo safety assessment under the conditions of being used with such instruments or tools; and explanatory materials shall be provided regarding whether the instruments or tools have cosmetic functions during product use, whether they participate in the reproduction process of cosmetics, and whether they alter the action mechanism of the product on the skin.
 

9-8. What issues should be noted in the safety assessment data of children's cosmetics?


Answer: As stipulated in the *Technical Guidelines for Safety Assessment of Cosmetics (2021 Edition)*, the safety assessment documents for children's cosmetics shall reflect the following relevant contents:
(1) When conducting the assessment of children's cosmetics, factors such as hazard identification and exposure calculation shall be combined with the physiological characteristics of children.
(2) The principles for formula design shall be specified, and the necessity of raw materials used in the formula shall be explained, especially for raw materials such as flavors, colorants, preservatives and surfactants.
(3) In principle, raw materials intended for freckle-removing and whitening, acne removal, hair removal, deodorization, dandruff removal, anti-hair loss, hair dyeing and hair perming are not permitted for use. If raw materials that may have the above-mentioned effects are used for other purposes, an evaluation shall be conducted on the necessity of such use and the safety of the raw materials for use in children's cosmetics.
(4) Cosmetic raw materials with a relatively long history of safe use shall be selected. The use of raw materials prepared by new technologies such as genetic technology and nanotechnology is not encouraged. If such raw materials have to be used when there is no alternative, the reasons shall be stated, and a safety evaluation shall be conducted for the use of the raw materials in children's cosmetics.
 

9-9. Among the acceptable evidence for the simplified cosmetic product safety assessment report, if the concentration of the raw material in the products that have been marketed by the same enterprise with the same application method for at least 3 years (i. e. the historical use concentration of the enterprise) is taken as the evidence for assessment, how should such evidence be submitted?


Answer: In accordance with the provisions of Article 9.1 of the Technical Guidelines for the Safety Assessment of Cosmetics:
In the simplified version of the cosmetic product safety assessment report, the use of the concentration of the raw material in products that have been marketed by the same enterprise for at least 3 years with the same method of use (i. e., the historical use concentration of the enterprise) as the assessment evidence in section 9.1.3 shall meet the following requirements:
(1) For products with the same application site and method, the use concentration of raw materials in the formulation shall in principle not be higher than the historical use concentration of the said raw material in the enterprise; if it is higher than the historical use concentration, a safety assessment shall be conducted in accordance with the guidelines to verify its safety;
(2) The historically used concentrations of raw materials can be referenced mutually: products with high exposure and long contact duration can be used for the assessment of products with low exposure and short contact duration, but the rationality thereof shall be fully analyzed and explained in terms of target population, application site and application method, etc.
The supporting documents to be provided for the historical usage concentration of this enterprise shall include the following contents:
(1) Domestic special products and imported products: registered or filed formula (shall be consistent with the formula submitted at the time of application), product registration certificate or filing voucher, product marketing certification documents;
(2) Ordinary domestic products: production records with raw material content or allowing calculation of raw material content, process sheets, ingredient lists, filing certificates, and product marketing approval documents;
(3) Description of adverse reaction monitoring;
(4) Other supporting documents.
 

9-10. In the safety assessment report, what are the sources of the toxicological safety data of raw materials?


Answer: The *Technical Guidelines for Safety Assessment of Cosmetics (2021 Edition)* stipulates that the admissible evidence for the simplified version of the cosmetic product safety assessment report includes the requirements specified in the *Technical Specification for Cosmetics Safety*, assessment conclusions issued by authoritative institutions, historical usage data of raw materials by enterprises, and the maximum historical usage specified in the *Catalog of Used Raw Materials (2021 Edition)*.
 

9-11. Two Questions Concerning Safety Assessment


Answer:(1) The abstract of the safety assessment report will no longer be provided;
(2) After the launch of the new system, the overall analysis report of cosmetic formula shall be adopted during the transition period specified in the Guidelines; after the expiration of the transition period (starting from January 1,2022), the cosmetic safety assessment report shall be adopted.
 

9-12. What should be noted when uploading the safety assessment report?


Answer:(1) Affix the official seal of the filing party on each page;
(2) Signature of the safety assessor;
(3) The safety assessment materials shall be consistent with other relevant information and data;
(4) The materials of the safety assessment report shall be complete;
(5) A standard translation of foreign language materials shall be provided.
 

9-13. What is the relationship between cosmetic ingredients and their safety?


Answer: The safety of cosmetics depends on the concentration of their ingredients and the method of use. The *Cosmetics Safety Technical Specification (2015 Edition)* clearly stipulates the concentrations of ingredients for different purposes.
Take benzoic acid as an example: when used as an ingredient for bactericidal and pH-adjusting purposes, its concentration is required to be lower than 2.5% in personal care and washing products, and lower than 1.7% in oral care products; when used as a preservative, its concentration needs to be lower than 0.5%. Usage within these concentration ranges is safe for the human body, and safety issues will only arise when the maximum concentration limit is exceeded.
 

9-14. After the resume of the product safety assessor and the safety assessment report are affixed with the official seal of the assessment entity, is it still necessary to affix the official seal of the filing entity?


Answer: According to Article 5 of the Provisions on the Administration of Cosmetic Registration and Filing Materials, "Except for the original materials issued by government competent departments or relevant institutions, registration and filing inspection institutions, notarial organs, etc. , all cosmetic registration and filing materials shall be affixed with the official seal page by page by the domestic registrant, domestic filer or domestic responsible person. " The filing materials such as the resume of the cosmetic safety assessor and the assessment report in the filing materials shall comply with the requirements of this provision.
 

9-15. When our company conducts a safety assessment for a new product, we intend to use the maximum usage level of a certain raw material from our already marketed products as supporting documentation to prove the safe application of this raw material in the new product. What materials need to be submitted in this case?


Answer: In accordance with the *Technical Guidelines for Safety Assessment of Cosmetics*, where the concentration of a raw material in products that have been marketed by the same enterprise for at least 3 years with the same method of use (i. e., the historical use concentration of the enterprise) is taken as evidence for the assessment, the following materials shall be provided as a minimum:(1) For domestic special cosmetics and imported cosmetics: the registered or filed formula (which shall be consistent with the formula submitted at the time of application), the product registration certificate or filing voucher, and the product marketing certification document;(2) For domestic ordinary cosmetics: production records, process sheets and ingredient lists that indicate the raw material content or allow the calculation of the raw material content, the filing voucher, and the product marketing certification document;(3) A statement on the monitoring of adverse reactions;(4) Other supporting materials, such as relevant explanations proving that the new product has the same application site and usage method as the historical products, and that the usage concentration of raw materials in the product formula is lower than the historical usage concentration of such raw materials in this enterprise.
 

9-16. What are the current requirements for product safety assessment materials at this stage?


Answer: As of January 1,2022, before filing for the record of general cosmetics, cosmetics filers must conduct a safety assessment of cosmetics in accordance with the requirements of the Technical Guidelines for Cosmetics Safety Assessment (2021 Edition) and submit product safety assessment materials.
 

9-17. For rinse-off products claiming acne removal or anti-wrinkle effects, can the safety evaluation of human patch test be exempted after submitting a simplified safety assessment report?


Answer: No. In accordance with the requirements of the *Specifications for the Work of Cosmetic Registration and Filing Inspection*, all rinse-off products claiming acne-fighting or anti-wrinkle effects shall undergo safety evaluation through human patch test. Before conducting human safety and efficacy evaluation tests, microbial and physicochemical inspections as well as toxicological tests shall be completed first, and written reports shall be issued. Products that fail to meet the standards in the aforesaid inspection items shall not be subject to human safety evaluation tests.
 

9-18. For general cosmetics for children and pregnant women, if toxicological testing has already been conducted during the cosmetics filing process, is it still necessary to conduct a safety risk assessment, and is testing for risk substances still required?


A: Yes, it is required. The provision that "where the results of a risk assessment fully confirm the safety of a product, the relevant toxicological tests for the product may be exempted" should be interpreted as meaning that if a risk assessment can verify the safety of the product, the relevant toxicological tests may be exempted, rather than being interpreted the other way around that conducting the relevant toxicological tests can exempt the requirement for a risk assessment; the risk assessment of the product still needs to be carried out.
 

9-19. How to conduct toxicological tests for multi-color series of ordinary cosmetics?


Answer: For such products, toxicological tests can be conducted by means of sampling inspection. The sampling proportion is 30%, and if the total number is less than 10, it shall be counted as 10.
During sampling inspection, products with the highest total content of organic colorants shall be given priority for testing;
When the total amount of organic colorants is the same, the product with the largest variety of organic colorants shall be selected for testing;
When the total amount and types of organic colorants are identical, the product with the highest total colorant content shall be selected for testing;
When the total colorant content is the same, the product with the largest variety of total colorants shall be selected for inspection.
 

9-20. For imported ordinary cosmetics of a multi-shade series that undergo toxicology tests by sampling in accordance with the Specifications for Cosmetic Registration and Filing Inspection, is it permissible to use copies of the toxicology test reports?


A: Copies are acceptable. According to Article 33 of the Provisions on the Administration of Cosmetic Registration and Filing Materials, where a multi-shade series of ordinary cosmetics undergoes toxicological testing by sampling in accordance with the Specifications for Cosmetic Registration and Filing Inspection Work, they may be filed as a group of products, and each product shall be attached with a list of the series products, a list of basic formulas and colorants, as well as a list of sampled products.
 

9-21. How to provide supporting materials for the assessment of hazardous substances?


Answer: The materials provided shall be able to indicate the source of the laws, regulations or literature, and shall include key contents such as the assessed safe dose of hazardous substances. If the materials provided are in a foreign language, all the foreign language materials provided shall be translated into Chinese.
 

9-22. Requirements for reference materials cited in safety assessment.


A: The reference materials cited in cosmetic safety assessment shall be technical reports, circulars, professional books or academic papers published in full text, as well as data or risk assessment materials released by international authoritative institutions; when applying unpublished research results, the consent of the data owner shall be obtained, and the scientificity, accuracy, authenticity and reliability of the results shall be analyzed.
 

9-23. If certain raw materials have chemical, biological or other interactions with each other, how should such interactions be evaluated?


Answer: Cosmetic products are generally considered as combinations of various raw materials, and the assessment shall be conducted based on all raw materials and risk substances. If it is confirmed that there are chemical and/or biological interactions between certain raw materials, the risk substances generated therefrom and/or the potential safety risks arising from such interactions shall be assessed.
 

9-24. What are the requirements for retaining cosmetic safety assessment materials?


Answer: The retention period shall be no less than 10 years after the expiry date of the last batch of products marketed.
 

9-25. Is it necessary to update the safety assessment data of cosmetics?


Answer: According to the *Technical Guidelines for Safety Assessment of Cosmetics (2021 Edition)*, the safety assessment materials of cosmetics shall be updated in a timely manner as needed.
 

9-26. What contents are included in the resume of an assessor?


Answer: The main contents include the educational background of the assessors, their work experience related to cosmetics, professional training experience, etc.
 

9-27. The specific time for transitioning from the simplified version to the full version of the cosmetic safety assessment report.


A: The *Technical Guidelines for Safety Assessment of Cosmetics (2021 Edition)* provides examples of both the full version and the simplified version of the cosmetic product safety assessment report. Prior to May 1,2024, cosmetic registrants and filing holders may submit a simplified product safety assessment report in accordance with the relevant requirements of the aforementioned Technical Guidelines.
 

9-28. Requirements for the full version of the cosmetic safety assessment report?


Answer:(1) Safety assessment reports for each component: the results shall show that all components at the concentrations used in this product will not cause harm to human health;
(2) Test and assessment report on potentially existing safety risk substances: the required result shall show that it will not cause harm to human health;
(3) Preservative Challenge Report: the required results shall comply with relevant requirements;
(4) Microbiological test report: it is required that the test result shows that the microorganisms of the product meet the relevant requirements specified in the *Safety and Technical Standards for Cosmetics*(2015 Edition);
(5) Hazardous Substance Test Report: The test results shall show that the content of hazardous substances in the product complies with the relevant requirements specified in the *Safety and Technical Standards for Cosmetics*(2015 Edition);
(6) Physical and chemical property and stability test report of the product: the test results shall show that the product meets the relevant requirements;
(7) Compatibility assessment report of the product and packaging materials: it is required that the results show compliance with relevant requirements;
(8) A report on the absence of unforeseen harmful interactions between the components of the formulation.
 

9-29. What are the requirements for the simplified version of the cosmetic safety assessment report?


Answer:(1) Safety assessment reports for each component: The results shall show that all components at the concentrations present in this product will not cause harm to human health;
(2) Test and assessment report on potentially existing safety risk substances: the required result shall show that it will not cause harm to human health;
(3) Microbiological test report: The result shall show that the microorganisms of the product meet the relevant requirements specified in the *Safety and Technical Standards for Cosmetics*(2015 Edition);
(4) Hazardous Substance Test Report: The test results shall show that the hazardous substance content of the product complies with the relevant requirements specified in the *Technical Specification for Cosmetic Safety*(2015 Edition);
(5) A report on the absence of unforeseen harmful interactions between the components of the formulation.
 

9-30. What are the four procedures that should be followed in cosmetic risk assessment?


Answer:(1) Hazard Identification
Based on the results of toxicological tests, clinical studies, adverse reaction monitoring and population epidemiological studies, etc. , whether a raw material and/or hazardous substance poses a potential hazard to human health is determined from its physical, chemical and toxicological characteristics.
(2) Dose-response relationship assessment
It is used to determine the relationship between the toxic response of raw materials and/or hazardous substances and the exposure dose.
(3) Exposure Assessment
It refers to determining the exposure level of cosmetic raw materials and/or hazardous substances by assessing factors such as the parts of the human body they are exposed to, their concentration, frequency and duration of exposure.
(4) Risk Characterization
It refers to the description of the likelihood and severity of harm to human health caused by cosmetic raw materials and/or hazardous substances.
 

9-31. The relationship between toxicological research and cosmetic safety assessment.


Answer: A series of toxicological studies are conducted to determine the toxicological characteristics of cosmetic raw materials and/or risk substances, which serves as part of hazard identification and also forms the basis for cosmetic safety assessment. Toxicological studies shall generally be carried out in accordance with the toxicological test methods specified in the Technical Specifications for Safety of Cosmetics. When adopting toxicological test methods or standards released by other authoritative institutions at home and abroad that are not included in the Technical Specifications for Safety of Cosmetics, the source of the method and the principle for identifying toxicological hazards shall be clearly stated in the assessment report, and the scientificity, accuracy and reliability of the results shall be analyzed.
 

9-32. Under what circumstances is it necessary to re-conduct a safety assessment of cosmetics?


Answer:(1) Where there are new toxicological findings regarding the raw materials used in marketed products that would affect the existing assessment results;
(2) Where the quality specifications of raw materials for marketed products have changed to an extent sufficient to alter the existing safety assessment results;
(3) There is a marked increasing trend in the incidence of adverse reactions caused by the normal use of a marketed product, or serious adverse reactions resulting from the normal use of the product;
(4) Other circumstances that affect the quality and safety of products.
 

9-33. What evidence can be used in the simplified version of the cosmetic product safety assessment report?


Answer: Select at least one piece of evidence in the following order for assessment to determine its safety.
(1) The raw materials listed in the lists of restricted components, permitted preservatives, permitted sunscreens, permitted colorants and permitted hair dyes in the *Safety and Technical Standards for Cosmetics* shall comply with their corresponding usage requirements;
(2) Safety limits or conclusions already published by authoritative institutions at home and abroad, standards for fragrance ingredients issued by the International Fragrance Association (IFRA), etc. ;
(3) The historical use concentration of the enterprise can be used as evidence for the assessment;
(4) If none of the above three types of evidence can be used for assessment, the maximum historical usage level of the ingredient published by the cosmetics regulatory authority may serve as a reference for the assessment;
(5) For raw materials and/or hazardous substances for which none of the aforementioned evidence types are applicable, a safety assessment shall be conducted in accordance with the assessment procedures specified in the *Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)* to verify their safety.
 
 

10 Efficacy Claims

 

10-1. How to correctly understand the evaluation of cosmetic efficacy claims?


A: To implement the Regulations on the Supervision and Administration of Cosmetics, and standardize and guide the evaluation of cosmetic efficacy claims, the National Medical Products Administration has formulated and issued the Specifications for the Evaluation of Cosmetic Efficacy Claims (No. 50 of 2021, hereinafter referred to as the "Specifications"). According to the requirements of the Specifications, not all cosmetics are required to undergo efficacy claim evaluation.For the majority of claims on marketed cosmetics that can be directly identified via senses such as sight and smell (e. g., cleansing, makeup removal, cosmetic modification, fragrance, talcum, hair dyeing, hair perming, hair color care, depilation, deodorization, auxiliary shaving and hair trimming, or those that exert effects through simple physical means like covering, adhesion and friction, etc.), efficacy evaluation shall be exempted; only for a small number of claims with strong functions that are strictly regulated as drugs or quasi-drugs in most countries and regions (e. g., spot fading and whitening, sun protection, anti-hair loss, anti-acne, nourishing, repairing, etc.) shall human efficacy evaluation tests be required;Other efficacy claims may be evaluated by means such as literature research, research Data Analysis, or cosmetic efficacy claim evaluation tests as appropriate.
 

10-2. What is the significance of efficacy claims?


A: At present, there are more than 5,000 cosmetics manufacturers, over 70,000 brand owners and more than 1.6 million cosmetic products in China. The scale of China's cosmetics market reached 244.4 billion yuan in 2019, representing a year-on-year growth of 14.7%. Among them, functional cosmetics accounted for over 75%, contributing the majority of the market increment.
It strengthens the management of efficacy claims, promotes the standardization of the industry, facilitates the establishment of industry standards, and subjects product efficacy to public supervision on the publicity platform. Meanwhile, it prevents exaggerated advertising and fosters a sound environment for industrial development. It is accountable to consumers, enabling them to clearly understand product efficacy and purchase products that truly suit their needs. It also boosts consumers' confidence in domestic cosmetics and drives the rise of domestic brands.
 

10-3. What is the efficacy claim evaluation of cosmetics?


Answer: The efficacy claim evaluation of cosmetics refers to the process of conducting scientific tests and reasonable evaluations on the efficacy claim content of cosmetics under normal use conditions by means of literature research, research data analysis, or cosmetic efficacy claim evaluation tests, and drawing corresponding evaluation conclusions.
 

10-4. What should be done if the efficacy claims of a registered product fail to meet the requirements of the new regulations?


Answer: According to Article 36 of the Administrative Measures for the Registration and Filing of Cosmetics, for ordinary cosmetics that have already been filed, the product name shall not be arbitrarily changed without justifiable reasons; the efficacy claims shall not be arbitrarily changed without sufficient scientific basis.
For historical products that have completed filing before May 1,2021, the summary of the basis for the efficacy claims of relevant products shall be uploaded in accordance with the provisions of the transition period policy. After the filer conducts efficacy claim evaluation on relevant products in accordance with the requirements of the "Cosmetic Efficacy Claim Evaluation Standards", if the evaluation result cannot support the content of the efficacy claim involved in the product name or label, a change application may be submitted before the expiration of the transition period, adjust the product classification code according to the actual attributes of the product, and modify the relevant content of the product name or label at the same time to make it comply with regulatory requirements.
 

10-5. Is efficacy claim evaluation necessarily required to be conducted by a third party? What conditions should an efficacy claim evaluation institution meet?


Answer: In accordance with the requirements of the *Specification for the Evaluation of Cosmetic Efficacy Claims*, cosmetic registrants and filing holders may, by themselves or by entrusting an evaluation institution with corresponding capabilities, carry out the evaluation of cosmetic efficacy claims in accordance with the requirements of cosmetic efficacy claim evaluation items. Institutions undertaking the evaluation of cosmetic efficacy claims shall establish good laboratory practices, complete the efficacy claim evaluation work and issue reports, and be responsible for the authenticity and reliability of the issued reports.
Cosmetics with the functions of freckle-removing and whitening, sun protection and hair loss prevention shall be subject to human efficacy evaluation tests conducted by cosmetics registration and filing inspection institutions in accordance with the requirements of mandatory national standards and technical specifications, and relevant reports shall be issued.
 

10-6. How to fill in the product efficacy claims for products claiming physical exfoliation and physical blackhead removal?


Answer: In accordance with the requirements of the "Specification for the Evaluation of Cosmetic Efficacy Claims, for efficacy claims that achieve effects through simple physical means such as covering, adhesion, and friction (e. g., physical exfoliation and physical blackhead removal), and are clearly marked on the label as only having physical effects, the summary of the basis for the product efficacy claim may be exempted from disclosure.
After selecting "exfoliating" and "acne-fighting" as the product category codes, it is required to select "Yes [The exfoliating effect of this product is achieved through simple physical means, and the label shall clearly indicate that it only has physical effects]" or "Yes [The " acne-fighting" effect of this product is limited to blackhead removal, achieved through simple physical means, and the label shall clearly indicate that it only has physical effects]" in the [Product Label] section of the General Cosmetic Filing Administration System, and then select "Yes" at the "Exempted or not" option in the [Efficacy Claims] section of the system.
 

10-7. What contents need to be filled in the summary of the basis for cosmetic efficacy claims?


Answer: According to Article 19 of the *Specification for the Evaluation of Cosmetic Efficacy Claims*, the abstract serving as the basis for a cosmetic's efficacy claim shall concisely set forth the content of the basis for the product's efficacy claim, and shall include at least the following information:
(1) Basic product information;
(2) Efficacy claim evaluation items and evaluation institutions;
(3) Brief description of evaluation methods and results;
(4) The conclusion on the evaluation of efficacy claims shall clarify the correlation between the product's efficacy claims and the evaluation methods and results.
 

10-8. What preliminary preparations are required if a product is to undergo human safety and efficacy evaluation testing?


Answer: Before conducting human safety and efficacy evaluation tests, the microbiological and physicochemical tests as well as toxicological tests shall be completed first with written reports issued. Products that fail to meet the standards in the aforesaid test items shall not be subjected to human safety and efficacy evaluation tests.
 

10-9. What are the efficacy evaluation tests?


Answer:(1) Efficacy evaluation test on human body: It refers to the process of making an objective evaluation conclusion on product efficacy by means of subjective assessment, objective measurement and statistical analysis of human test results in accordance with prescribed methods and procedures under laboratory conditions;
(2) Consumer Usage Test: refers to the process of effectively collecting, collating and analyzing information on consumers' product usage and efficacy evaluations by means of interviews, questionnaires, consumer diaries and the like on the basis of objective and scientific methods;
(3) Laboratory test: refers to an experiment conducted under specific environmental conditions in accordance with prescribed methods and procedures, including but not limited to animal tests, in vitro tests (including isolated organs, tissues, cells, microorganisms, physical and chemical tests, computer simulations), etc. ;
Efficacy evaluation tests shall be supported by a reasonable test protocol, which shall be designed in compliance with statistical principles, generate test data that meet statistical requirements, and be formulated in accordance with specified rules. Human efficacy evaluation tests and consumer use tests shall abide by ethical principles, and necessary product safety evaluation shall be completed prior to the conduct of such tests. Laboratory tests shall conform to animal ethical principles.
 

10-10. For cosmetics whose effects can be directly recognized through senses or only produced by physical means, how to apply for exemption from publishing the summary of the basis for product efficacy claims on the filing system?


Products exempted from publishing the summary of the basis for product efficacy claims shall complete the filling of product efficacy claims in the "Efficacy Claims" module of the General Cosmetic Filing Administration System. Based on the product's classification code, fill in the efficacy name in the "Product Efficacy Claims" field, tick "Yes" in the "Whether Exempted" column, and the "Remarks" column will automatically display the note "According to the 'Specification for the Evaluation of Cosmetic Efficacy Claims', products whose efficacy can be directly identified through senses such as vision and smell are exempted from publishing the summary of the basis for product efficacy claims", then submit the efficacy claim.
 

10-11. How to conduct efficacy promotion evaluation for cosmetics with specific claims?


Answer: Cosmetics making specific claims (such as claims of being suitable for sensitive skin or tear-free formula) shall undergo efficacy claim evaluation via human efficacy evaluation tests or consumer usage tests.
 

10-12. Cosmetics that make efficacy claims based on the efficacy of their raw materials.


Answer: Where the product efficacy claim is made by claiming the efficacy of the raw material, literature research, research Data Analysis, or efficacy claim evaluation tests shall be conducted to verify that the raw material has the claimed efficacy, and the efficacy claim of the raw material shall be fully relevant to the efficacy claim of the product.
 

10-13. How should cosmetics claiming new efficacy undergo efficacy claim evaluation?


A: Cosmetics claiming new efficacy shall be subject to scientific and reasonable analysis in accordance with the specific circumstances of the product's efficacy claim.
(1) New efficacy that can be directly identified through senses such as vision and smell, or produces effects via physical means, and is clearly marked on the label as only having physical effects, may be exempted from submitting efficacy claim evaluation materials.
(2) Where it is required to submit materials for the evaluation of product efficacy claims, the cosmetic registration and filing inspection institution shall conduct the product efficacy evaluation in accordance with the test methods specified in the mandatory national standards and technical specifications, and issue a report.
(3) Where test methods other than mandatory national standards and technical specifications are adopted, two or more cosmetics registration and filing inspection institutions shall be entrusted to conduct method validation; only those that pass the validation and meet the requirements can be used for the evaluation of new efficacy, and parameters such as the validity and reliability of the method shall be specified in the product efficacy claim evaluation report.
 

10-14. Can a wrongly submitted summary of efficacy claims be withdrawn and modified?


A: Once the summary documents for efficacy claims are submitted, they cannot be withdrawn. The registrant may recompile and resubmit such summary documents, and the public notice system will publish the content of the latest submitted summary of efficacy claims. All the summary documents for efficacy claims submitted by the registrant will be retained in the system for future reference.
 

10-15. Which cosmetics are exempted from the requirement of publishing the summary of the basis for product efficacy claims?


Answer: According to Article 7 of the *Specification for the Evaluation of Cosmetic Efficacy Claims*, efficacy claims that can be directly recognized through senses such as vision and olfaction (e. g., cleansing, makeup removal, cosmetic modification, fragrance, talc application, hair dyeing, hair perming, hair color care, depilation, deodorization, and auxiliary shaving), or that produce effects through simple physical means such as covering, adhesion, and friction (e. g., physical covering for spot fading and whitening, physical exfoliation, and physical blackhead removal), and are clearly labeled on the label as having only physical effects, may be exempted from disclosing the summary of the basis for the product's efficacy claims.
 

10-16. Which cosmetics can undergo efficacy claim evaluation through methods such as literature research, research Data Analysis, or cosmetic efficacy claim evaluation tests?


Answer: According to Article 8 of the *Specification for the Evaluation of Cosmetic Efficacy Claims*, cosmetics that only have moisturizing and hair care effects may undergo efficacy claim evaluation by means of literature research, research Data Analysis, or cosmetic efficacy claim evaluation tests.
 

10-17. Which cosmetics shall undergo efficacy claim evaluation by means of cosmetic efficacy claim evaluation tests, in combination with the results of literature review or research Data Analysis?


Answer: According to Article 9 of the Specification for the Evaluation of Cosmetic Efficacy Claims, cosmetics with anti-wrinkle, firming, soothing, oil-controlling, exfoliating, anti-hair breakage and dandruff-relieving effects, as well as those that claim to be mild (e. g., non-irritating) or have quantitative indicators (e. g., the duration of efficacy claims, Statistical Data related to efficacy claims, etc.), shall be evaluated for their efficacy by means of cosmetic efficacy claim tests, which may be combined with literature data or Data Analysis results at the same time.
 

10-18. Which cosmetics shall undergo efficacy claim evaluation via human efficacy evaluation tests?


Answer: According to Article 10 of the *Specification for the Evaluation of Cosmetic Efficacy Claims*, cosmetics with functions such as spot-removing and whitening, sun protection, anti-hair loss, anti-acne, nourishing and repairing shall undergo efficacy claim evaluation via human efficacy evaluation tests.
Cosmetics with the functions of freckle-removing and whitening, sun protection and hair loss prevention shall be subject to human efficacy evaluation tests conducted by cosmetics registration and filing inspection institutions in accordance with the requirements of mandatory national standards and technical specifications, and relevant reports shall be issued.
 

10-19. For cosmetics belonging to the same series that only differ in shade numbers due to different added colorants, is it necessary to conduct multiple efficacy claim evaluations?


Answer: For cosmetic products of the same makeup series for which the same cosmetic registrant or filing applicant applies for registration or conducts filing, when the conditions and requirements for equivalent evaluation are met, the efficacy claim evaluation may be carried out in accordance with the guiding principles for equivalent evaluation.
 

10-20. Requirements for equivalent evaluation of cosmetic efficacy claims.


A: For multi-shade series cosmetic products from the same cosmetic registrant or filing sponsor, efficacy claim evaluation tests may be conducted by means of spot check. The number of spot-checked products shall be no less than 20% of the total number of products in the series; if the total number is less than 5, it shall be counted as 5. Products with the lowest colorant content shall be prioritized for efficacy claim evaluation tests and test reports shall be issued accordingly. For products subject to equivalence evaluation, the equivalence evaluation report and the test report of the products used for efficacy claim evaluation tests shall be retained for inspection; when compiling the summary of the basis for efficacy claims, the situation of sharing efficacy claim evaluation test data shall be specified.
 

10-21. For products applying for initial filing as of January 1,2022, is it required to timely fill in the summary of the basis for product efficacy claims?


Answer: In accordance with the requirements of the Announcement of the National Medical Products Administration on Issuing the Specifications for the Evaluation of Cosmetic Efficacy Claims (No. 50): "As of January 1,2022, where cosmetic registrants and filers apply for the registration of special cosmetics or file for the recordation of ordinary cosmetics, they shall evaluate the efficacy claims of cosmetics in accordance with the requirements of the Specifications, and upload the summary of the basis for product efficacy claims on the dedicated website designated by the National Medical Products Administration. "
In accordance with Article 62 of the Regulations on the Supervision and Administration of Cosmetics: anyone who fails to publish the summary of the basis for cosmetic efficacy claims in accordance with the provisions of these Regulations shall be ordered by the drug regulatory department to make corrections, be given a warning, and concurrently be imposed with corresponding penalties.
 

10-22. By what deadline should the summary of the basis for cosmetic efficacy claims be uploaded?


Answer: In accordance with the requirements of the Announcement of the National Medical Products Administration on Issuing the Specifications for the Evaluation of Cosmetic Efficacy Claims (No. 50), as of January 1,2022, when a cosmetic filer applies for the filing of ordinary cosmetics, it shall evaluate the efficacy claims of the cosmetics in accordance with the requirements of the Specifications, and upload the summary of the basis for the product efficacy claims on the dedicated website designated by the National Medical Products Administration.
For cosmetics that have completed the filing before May 1,2021, the filer shall, before May 1,2023, conduct an evaluation on the efficacy claims of the cosmetics and upload the summary of the basis for the product efficacy claims.
For cosmetics that completed the filing between May 1,2021 and December 31,2021, the filer shall, prior to May 1,2022, conduct an evaluation on the efficacy claims of the cosmetics and upload the summary of the supporting evidence for the product's efficacy claims.
 

10-23. For product efficacy, are enterprises allowed to comply with industry standards, group standards or enterprise standards as the basis?


A: Article 15 of the *Specification for the Evaluation of Cosmetic Efficacy Claims* stipulates that, unless otherwise specified, the test methods listed in items (1) and (2) below shall be given priority for the efficacy claim evaluation tests of cosmetics; where no provisions are specified in items (1) and (2), any of the test methods listed in items (3) and (4) below may be selected:
the methods specified in the mandatory national standards and technical specifications for cosmetics of China;
the methods specified in other relevant laws and regulations, national standards and industry standards of China
Methods specified in relevant foreign laws, regulations or technical standards;
For methods released in technical guidelines by authoritative organizations, technical institutions and industry associations at home and abroad, methods publicly published in professional academic magazines and journals, or self-developed methods, before conducting efficacy evaluation, the evaluation institution shall complete the necessary test method transfer, confirmation or verification to ensure the scientificity and reliability of the evaluation work.
 

10-24. Common Circumstances of Non-Standard Claims


Answer:(1) For non-coverage cosmetics such as BB creams and CC creams, the claim of "improving uneven skin tone".
(2) The product is underwritten by the Pacific Insurance Company.
(3) The product claims to have obtained an import patent.
(4) The product claims to "contain no common chemical preservatives" and "be gentle on hands", which demeans competing products.
(5) The product claims to "deeply repair cells".
(6) The product is named "Resurrection Grass", and its ingredient is "Selaginella Extract", but the label does not include a note stating that "Resurrection Grass refers to Selaginella Extract".
 

10-25. The product is suspected of having issues involving false or non-compliant claims.


Answer:(1) Claiming therapeutic effects. For example, claiming effects such as "sterilization" and "treating athlete's foot";
(2) Medical terms are used in the product name or claims.Such claims include: medicinal affinity, activating collaterals, extraordinary pulse, prevention, medical, *Compendium of Materia Medica*, traditional Chinese medicine, Zhuang medicine, traditional Dai medicine, eight diagnostic methods, affected area, caring for damaged skin, solving the problem of itchy scalp, acne, pimples, desquamation, outer packaging bearing the label for external medication, background, red cross, English name anti-sensitive cream, trademark name Lixin Yi, being skin care products recognized by dermatologists, aromatherapists, DR. ACNE, traditional Chinese medicine practitioners, micro-engraving, "containing Shuanghuanglian", "intraocular pressure", "acne", "mosquito bites", "affected area", "Jiejietong";"Cold Compress Patch" Facial Mask.
 

10-26. Several key time points in efficacy test reports for skin whitening, spot fading and hair anti-loss products.


Answer:(1) Starting from January 1,2022, newly applied cosmetics for skin whitening and freckle removal, and hair anti-loss shall submit human efficacy test reports;
(2) For special cosmetics that apply for registration and obtain a registration certificate as of May 1,2021, a human efficacy test report shall be additionally submitted before August 1,2022;
(3) For other special cosmetics that have already obtained the registration certificate, the human efficacy test report shall be supplemented before May 1,2023.
 

10-27. For products that have been filed in the current historical record and are undergoing their first efficacy claim change after completing information supplementation, is it only necessary to upload images of the new packaging?


A: After the information of historically filed products is supplemented, the first change to filing materials such as packaging or efficacy constitutes a new filing activity. If the original filing materials are incomplete, materials including safety assessment, efficacy evaluation, inspection reports, and raw material safety information shall be supplemented in accordance with the Provisions on the Administration of Cosmetic Registration and Filing Materials and other relevant regulations.
 

10-28. The product has already obtained the special cosmetic certificate for sun protection or the special cosmetic certificate for spot fading, but words related to whitening are also used in the product name and label claims. Can such a product still be sold normally? Is it compliant?


A: The new policy requires whitening products to be included in the management of special cosmetics for spot-fading. If a product already holds the special approval certificate for spot-fading, it may promote its whitening effect in accordance with the requirements for special cosmetics.
 

10-29. What is your view on the inconsistent classification standards for efficacy claims and the phenomenon of "double standards" existing in different regions and cities?


Answer: This is because different reviewers have inconsistent grasp of the review standards, and the phenomenon of "double standards" may arise for issues not explicitly specified in regulations. Relevant regulatory authorities have planned to address the current problem of inconsistent regulatory standards by establishing a dynamic banned word database. For example, during the review process in the Guangzhou area, if a certain word is deemed unusable, it can be submitted to the dynamic banned word database for voting by regulatory authorities across the country; if it is unanimously agreed that the word cannot be used, it will be included in the banned word database.
 

10-30. Our company intends to import a batch of wax products and declare them as depilatory cosmetics. Is it permissible to claim "get rid of the troubles caused by fine facial hairs" and "facial hair removal" on the labels?


Answer: This product does not conform to the definition of depilatory cosmetics and falls outside the scope of depilatory cosmetics. In accordance with the testing requirements under the framework of the Regulations on the Supervision and Administration of Cosmetics, depilatory products are required to undergo physical and chemical testing items such as mercury, lead, arsenic and cadmium; for toxicological tests, only skin sensitization test is required; and physical depilatory products need to undergo microbiological testing.
The above test cannot guarantee the safety of the product when applied to areas such as "around the eyebrows, around the lips, the chin, and the cheeks". It should be noted that in the Regulations and its supporting document Rules and Catalogue for Cosmetics Classification, depilatory cosmetics are classified as ordinary cosmetics; in the "Efficacy Claim Classification Catalogue" of the Rules and Catalogue for Cosmetics Classification, the definition and description of the "depilation" efficacy claim interprets "depilation" as "used to reduce or remove body hair"; in the "Cosmetic Application Site Classification Catalogue", body hair as an application site "does not include hair on the head and face".
Therefore, under the framework of the Regulations, body hair removal products are subject to a filing system, while facial hair removal products are regulated as special cosmetics claiming new efficacy.
 

10-31. Does mascara have the effect of "promoting eyelash growth"?


Answer: Some products on the market such as eyelash serums and eyelash essences that claim to make eyelashes "thicker" and "longer" usually work by attaching film-forming agents, colorants and other ingredients to eyelashes, so as to achieve the effects of coloring, thickening and lengthening eyelashes through physical action. Such products belong to general cosmetics, and shall complete product filing before being launched on the market or imported. The aforementioned eyelash products do not have the effect of promoting eyelash growth.
In fact, in the "Classification Rules and Classification Catalogue for Cosmetics" issued by the National Medical Products Administration, there is no efficacy category for "promoting eyelash growth". Up to now, the National Medical Products Administration has not approved any cosmetics that claim to have the effect of promoting eyelash growth.
 

10-32. What efficacy claims can be made for toothpaste?


A: According to Article 16 (Efficacy Evaluation) of the Measures, the efficacy claims of toothpaste shall be supported by sufficient scientific evidence. With the exception of toothpaste for basic cleaning purposes, toothpaste claiming other efficacies shall undergo efficacy evaluation in accordance with the specified requirements. After undergoing efficacy evaluation in accordance with national standards or industry standards, a toothpaste may be claimed to have efficacies including caries prevention, dental plaque inhibition, dentin hypersensitivity relief, and gingival problem alleviation.
 

10-33. Cosmetics for hair loss prevention, acne removal, anti-wrinkle, dandruff removal and antiperspiration shall be subject to strict administration.


Answer: Based on the classification of functional cosmetics at home and abroad as well as the efficacy claim terminology specified in China's *Classification Rules and Catalogue for Cosmetics*, a comparative study shows that "cosmetics for hair loss prevention, acne treatment, anti-wrinkle, dandruff removal and antiperspiration" carry relatively high usage risks. Some of the aforementioned product categories are regulated as OTC drugs in the US; as quasi-drugs in Japan; or as quasi-medicinal products under strict control in South Korea. Therefore, China has included them in the category of special cosmetics for strict administration.
 

10-34. Requirements for the summary of the basis for cosmetic efficacy claims.


Answer: In accordance with the requirements of the National Medical Products Administration's Announcement on Issuing the "Specification for the Evaluation of Cosmetic Efficacy Claims"(No. 50 of 2021):
Starting from 1 January 2022, when cosmetics registrants and filers apply for the registration of special cosmetics or file for the recordation of ordinary cosmetics, they shall evaluate the efficacy claims of cosmetics in accordance with the requirements of the Specifications, and upload the summary of the basis for product efficacy claims on the dedicated website designated by the National Medical Products Administration.
For cosmetics that have obtained registration or completed filing before May 1,2021, the cosmetics registrants and filing holders shall, in accordance with the requirements of the Specifications, evaluate the efficacy claims of the cosmetics and upload the summary of the basis for product efficacy claims before May 1,2023.
For cosmetics that obtained registration or completed filing between 1 May 2021 and 31 December 2021, the cosmetics registrants and filing holders shall, before 1 May 2022, evaluate the efficacy claims of the cosmetics in accordance with the requirements of the *Specification*, and upload the summary of the basis for the product efficacy claims.
For cosmetics that have been registered and filed prior to May 1,2021, cosmetics registrants and filing parties shall upload the summary of the basis for the efficacy claims of relevant products in accordance with the provisions of the transition period policy. After the registrants and filing parties conduct efficacy claim evaluation on relevant products in accordance with the requirements of the Specifications, if the evaluation results cannot support the content of the efficacy claims involved in the product name or label, they may file an application for modification before the expiration of the transition period, adjust the product classification code according to the actual attributes of the product, and meanwhile modify the relevant content of the product name or label to make it comply with regulatory requirements.
 

10-35. What contents does the efficacy claim report include?


A: The efficacy claim evaluation report shall feature complete information, standardized format and clear conclusion, and be confirmed with the seal and signature of the evaluation institution. The report shall generally include the following contents:
(1) Relevant information such as the name and address of the cosmetic registrant, filing holder, or domestic responsible party;
(2) Relevant information such as the name and address of the efficacy claim evaluation institution;
(3) Relevant information such as product name, quantity and specifications, production date or batch number, color and physical state, etc. ;
(4) Relevant information such as test items and their basis, start and completion dates of the test, materials and methods, test results, and test conclusions.
Where the method text or test report is in a foreign language, a translation into standard Chinese shall additionally be provided.
 

10-36. What kind of literature materials can support the efficacy claims of cosmetics?


A: It refers to publicly available scientific research, investigation, evaluation reports, works and the like obtained through means such as literature retrieval, including currently valid laws, regulations and technical documents at home and abroad. Literature materials shall be clearly marked with their sources to ensure traceability, and relevant conclusions shall fully support the efficacy claims of the product.
 

10-38. What kind of research data can support the efficacy claims of cosmetics?


A: It refers to the unpublished research results related to product efficacy claims obtained through scientific research and other means. The research data shall be accurate and reliable, and the relevant research results can fully support the product's efficacy claims.
 

10-39. What is a human efficacy evaluation test that can support the efficacy claims of cosmetics?


Answer: It refers to the process of making an objective evaluation conclusion on the efficacy claims of a product by means of subjective assessment, objective measurement and statistical analysis of the results of human trials in accordance with the prescribed methods and procedures under laboratory conditions.
 

10-40. What is a consumer use test that can support efficacy claims for cosmetics?


Answer: It refers to the process of effectively collecting, collating and analyzing consumers' product usage and efficacy claim evaluation information on the basis of objective and scientific methods.
 

10-41. What are laboratory tests that can support efficacy claims for cosmetics?

A: It refers to tests conducted in accordance with prescribed methods and procedures under specific environmental conditions, including but not limited to animal tests, in vitro tests (including isolated organ, tissue, cell, microorganism, and physicochemical tests), etc.
Requirements for Cosmetic Efficacy Claim Evaluation Items.
Serial No. Efficacy Claims Human Efficacy Assessment Test Consumer Usage Test Laboratory test Literature materials or research data
1 Spot-removing and Brightening①      
2 Sun Protection      
3 hair loss prevention      
4 acne removal      
5 Nourish ②      
6 Repair ②      
7 Anti-wrinkle * * *
8 firming * * *
9 soothing * * *
10 Oil Control * * *
11 exfoliation * * *
12 Prevent hair breakage * * *
13 Dandruff removal * * *
14 Moisturizing * * * *
15 Hair Care * * * *
16 Specific claims (claims of being suitable for sensitive skin and tear-free formula) * *    
17 Specific Claims (Ingredient Efficacy) * * * *
18 Claiming to be mild (non-irritating) * * *
19 Those claiming quantitative indicators (time, Statistical Data, etc.) * * *
20 Claim new efficacy Select appropriate evaluation criteria based on the specific efficacy claims.
Notes: 1. Items marked with √ in the option column are mandatory; items marked with * in the option column are optional, but at least one must be selected; 3. Items marked with △ in the option column are combinable items, which must be used in conjunction with human efficacy evaluation tests, consumer usage tests or laboratory tests. Comments: ① Products that exert freckle-whitening efficacy solely through physical covering effect and clearly indicate physical action on the label are exempt from submitting product efficacy claim evaluation materials; ② If the action site of the efficacy claim is only for hair, in vitro real hair can be selected for evaluation.
 

10-42. What are the points for attention when filling in the summary of the basis for cosmetic efficacy claims?


Answer:(1) Except for circumstances where foreign languages or other characters are necessarily required, the abstract serving as the basis for cosmetic efficacy claims shall use standard Chinese characters.
(2) The summary of the basis for cosmetic efficacy claims shall concisely set forth the content of the basis for the product's efficacy claims, including at least relevant information such as basic product information, efficacy claim evaluation items and evaluation institutions, evaluation methods and results, and evaluation conclusions. Where multiple evaluation methods are adopted, they shall be listed one by one in sequence.
(3) There shall be a correlation between the basis for efficacy evaluation and the evaluation conclusion, and neither shall go beyond the scope of the product's efficacy claims.
(4) The relevant content of the brief description of the evaluation method shall be as comprehensive, accurate and objective as possible, so as to ensure that the information provided can reflect the situation of the evaluation of product efficacy claims.
 

10-43. There are only 19 efficacy claim terms specified in the current regulations, which is far too few. What if we accidentally end up making a new efficacy claim?


A: Currently, the 19 efficacy terms plus 1 new efficacy claim have basically covered the efficacy summaries involved in cosmetics at present. From the perspective of new product development, under each efficacy category, product differentiation can be achieved from multiple dimensions including raw materials, technology, packaging, mechanism, and fragrance respectively.
 

10-44. If efficacy-related terms are used, one must either select 19 qualifying terms or classify the claim under "new efficacy" — does this mean efficacy claims are being "forcefully categorized"?


A: The restriction on efficacy-related terms is not a mandatory requirement. Instead, when filing for product registration, enterprises need to first assess their own products. If there are efficacy claims, they only need to select the category closest to their product's efficacy from the 19 specified efficacy terms; if it involves a "new efficacy", corresponding supporting "evidence" shall be provided.
The so-called "evidence" refers to the sufficient scientific basis that cosmetic efficacy claims shall have as stipulated in Article 5 of the Specifications, which includes literature materials, research data, or the results of cosmetic efficacy claim evaluation tests, etc. The methods for cosmetic efficacy claim evaluation shall be scientific, reasonable and feasible, and be able to meet the purposes of cosmetic efficacy claim evaluation.
 

10-45. Can a product be modified if one or more efficacy claims are added or removed based on its original efficacy?

Answer: Changes can be made now, but sufficient scientific basis must be provided.