CIRS Group has compiled Q&A guidance issued by various regulatory authorities, focusing on two core areas: new cosmetic ingredient registration and general cosmetic filing. This compilation provides clear explanations of key compliance details including new ingredient information updates, document submission and rectification procedures, electronic label display and packaging labeling requirements, as well as common issues related to electronic filing, quality and safety responsible person qualifications, and changes to foreign enterprise addresses — serving as a one-stop reference to help companies navigate filing, labeling, and account compliance requirements efficiently.
New Cosmetic Ingredient Registration
Q1: What is the scope of application of the Technical Guidelines for Updating Filed Information on New Cosmetic Ingredients (hereinafter referred to as the "Guidelines")?
A: The Guidelines apply to the updating of filed information for new cosmetic ingredients that have been filed but have not yet been included in the Inventory of Existing Cosmetic Ingredients in China (hereinafter referred to as the "Inventory"). Within one month before the expiration of the new ingredient monitoring period, no information updates shall be made except for self-maintained information updates and enterprise information updates. If the new ingredient filer discovers substantial safety risks during subsequent studies, the filer shall not alter the relevant information on its own, but shall promptly report to the authorities and take risk control measures in accordance with the Supervision and Administration Regulation on Cosmetics and the Measures for the Administration of Cosmetic Registration and Filing.
For registered new cosmetic ingredients whose registration information changes before being included in the Inventory, the registrant may conduct studies in accordance with the technical requirements of these Guidelines and submit application materials for registration changes.
Q2: What are the main scenarios for updating new ingredient filing information?
A: There are three main categories:
- Category 1: Self-maintained information updates.
- Category 2: Enterprise information updates, including updating filer/domestic responsible person information (where the entity remains unchanged), updating manufacturer information (where the production site remains unchanged), changing the filer, and changing the domestic responsible person. In these scenarios, the actual production and research data of the new ingredient remain unchanged.
- Category 3: New ingredient information updates, including updating basic ingredient information, changing/adding production sites, adding/adjusting manufacturing process descriptions, updating quality control standards, extending the period of use, adjusting the purpose of use, and updating precautions/warning statements.
Apart from the three categories specified above, other types of new ingredient information updates are generally not permitted. If an update is indeed necessary, the filer shall apply to communicate with the review department to confirm the reasonableness, necessity, and scientific validity of the update.
Q3: What should be noted when submitting rectification materials in response to post-filing technical review comments?
A: Upon receiving post-filing technical review comments, the filer shall study and respond to each comment item by item. When submitting rectification materials, a statement of explanation shall be provided simultaneously, describing the modifications and improvements made in response to each technical review comment.
When sending post-filing technical review comments, the technical review institution will open necessary filing data modification permissions based on the comments. If the filer needs to modify other data content based on actual research circumstances, the filer may submit a request through the Cosmetic Smart Application and Review System, explaining the reasons and applying for expanded filing data modification permissions. The submission path is: New Ingredient Filing → Application Management → Expand Modification Permissions.
After submitting rectification materials, the filer shall promptly monitor the receipt status. During the data compilation stage, rectification materials that do not meet the requirements after review (e.g., failing to respond to all review comments) will be returned. The filer shall promptly check the return reasons (path: New Ingredient Filing → Application Management → Return Reasons), supplement and improve the materials, and resubmit within the time limit specified in the post-filing technical review comment notice.
Q4: What materials should be submitted for new ingredient information updates?
A: The Technical Guidelines for Updating Filed Information on New Cosmetic Ingredients specify the technical requirements and document requirements for each type of new ingredient filing information update. For Category 1 self-maintained information, the filer shall update the information promptly through the information system; for Category 2 enterprise information updates, necessary supporting documents shall be submitted as required; for Category 3 new ingredient information updates, the filer shall conduct sufficient studies and submit necessary supporting documents and/or research data as required. To reduce the burden on enterprises, certain documents may be retained on file for future reference.
Q5: What are the submission channels for new ingredient information update materials?
A: New ingredient filers shall submit relevant information and materials through the "Enterprise Information Data Management System" or the "Cosmetic Smart Application and Review System" within the Cosmetic Information Service Platform, in the corresponding module for new ingredient information updates. Filers shall not submit update matters and related materials through channels such as new ingredient annual reports, risk control reports, or ordered rectification materials.
If adjustments to new ingredient data content are required based on post-filing technical review comments, the relevant data may be adjusted and improved in the ordered rectification materials.
Q6: If the filer is genuinely unable to complete a certain study within the specified time limit due to objective reasons such as testing cycles, how should rectification materials be submitted?
A: Upon receiving the order for rectification, the filer shall initiate the study work as soon as possible. If it is genuinely unable to submit all research data within the specified time limit due to objective reasons such as testing cycles, the filer shall still submit rectification materials on time, provide a truthful explanation in the rectification materials regarding the reasons for inability to submit on time, and provide necessary supporting documents, including a scientifically reasonable analysis and explanation addressing the specific technical review comment, research plan, research progress, and estimated completion time. The filer shall fully analyze and assess the potential impact on the quality and safety evaluation of the new ingredient, and promptly submit supplementary materials upon completion of the study.
Ordinary Cosmetic Filing — Electronic Labels
Q1: What content should be displayed on cosmetic electronic labels?
A: The content of electronic labels shall be displayed directly on the page after scanning, without any additional display conditions or interference factors such as pop-ups that may affect normal reading. Pilot enterprises shall fully display the content required to be labeled under Article 7 of the Measures for the Administration of Cosmetic Labels in the electronic label. Any other displayed content shall not exceed the content specified in the product label draft. Pilot enterprises are encouraged to configure functions such as text enlargement and voice broadcast in the electronic label system to facilitate consumer identification and reading.
Pilot enterprises shall, based on consumer needs, provide complete product Chinese label information in written or electronic form to consumers through on-site provision, mailing, email, or other means.
Q2: Can cosmetic electronic labels display product anti-counterfeiting, traceability, or official promotional content?
A: Pilot enterprises may display product anti-counterfeiting and traceability information, as well as website links to official product promotional pages, on a secondary page accessed via redirect links after scanning, provided that the page clearly states: "The content displayed on this page does not constitute part of the cosmetic electronic label information and is the sole responsibility of the enterprise."
Q3: What content must still be marked on the product sales packaging of cosmetics that use electronic labels for Chinese labeling?
A: For cosmetics that use electronic labels for Chinese product labeling, in addition to the electronic label QR code, the following content shall be marked using standard Chinese characters on at least one visible surface of the product sales packaging:
- Product Chinese name and special cosmetic registration certificate number;
- Name of the registrant or filer;
- Net content;
- Period of use (expiration date);
- Safety warning statements required by laws, regulations, mandatory national standards, and technical specifications (small-packaged products with a net content not exceeding 15 g or 15 mL may be exempt from this requirement on the physical label);
- Children's cosmetics shall display the children's cosmetic mark.
Q4: Before cosmetics using electronic labels are placed on the market, is it necessary to upload electronic label sales packaging images to the Cosmetic Registration and Filing Information Service Platform?
A: Before placing on the market, pilot enterprises shall upload the electronic label URL data structure encoding information, electronic label display content, and images of product sales packaging bearing the electronic label to the Cosmetic Registration and Filing Information Service Platform. Pilot enterprises shall generate electronic label URL data structure encoding information in accordance with the Technical Specifications for Cosmetic Electronic Label QR Codes, and the uploaded encoding information shall be specific to the product identification unit.
Q5: If electronic label information is changed, is it necessary to update the information on the Cosmetic Registration and Filing Information Service Platform?
A: If the electronic label information of a cosmetic is changed, pilot enterprises shall upload the proposed changed electronic label related information to the Cosmetic Registration and Filing Information Service Platform before placing on the market the cosmetics bearing the changed electronic label.
Ordinary Cosmetic Filing — User Account Permissions
Q1: Following the comprehensive implementation of electronic filing for cosmetic registration and filing materials, what are the changes to user permission-related document requirements?
A: The NMPA Announcement on Matters Related to the Comprehensive Implementation of Electronic Filing for Cosmetic and New Cosmetic Ingredient Registration and Filing Materials (No. 91 of 2024) stipulates that for original documents, third-party certification documents, and other paper-based materials that were required to be submitted under the Provisions on the Administration of Cosmetic Registration and Filing Materials and the Technical Guidelines for the Submission of Cosmetic Registration and Filing Materials (Trial), the domestic cosmetic registrant, filer, or domestic responsible person shall sign and seal to confirm the authenticity of the materials and submit the relevant electronic versions through the information service platform.
Q2: How should changes to the quality and safety responsible person information of cosmetic registrants, filers, and manufacturing enterprises be updated on the Cosmetic Registration and Filing Information Service Platform?
A: Article 19 of the Provisions on the Administration of Cosmetic Registration and Filing Materials provides that among user permission-related documents, the information that may be self-updated includes the legal representative's information, the quality and safety responsible person's information, and contact information.
Q3: Can experience in the production or quality management of pharmaceuticals, medical devices, or special foods be considered equivalent to relevant experience for a cosmetic quality and safety responsible person?
A: According to the NMPA Comprehensive Department's Reply Letter on Issues Concerning the Quality and Safety Responsible Person for Cosmetics (Yao Jian Zong Zhuang Han [2022] No. 224), given that the principles of production or quality and safety management for pharmaceuticals, medical devices, and special foods are fundamentally consistent with those for cosmetics, in regulatory practice, where the cosmetic quality and safety responsible person possesses the relevant professional knowledge of cosmetic quality and safety, their experience in the production or quality management of pharmaceuticals, medical devices, or special foods may be regarded as equivalent to experience in cosmetic production or quality and safety management.
Q4: What supporting documents are required if a foreign manufacturing enterprise has only undergone a textual change to its address?
A: Article 20 of the Provisions on the Administration of Cosmetic Registration and Filing Materials provides that if only the address text of a foreign manufacturing enterprise's production site has changed, the enterprise shall provide an original certificate issued by the competent government authority or relevant agency of the country (or region) confirming that the production site has not changed. If the original document cannot be provided, a notarized copy confirmed by a Chinese notary authority or by the Chinese embassy (consulate) shall be provided.
Q5: What materials need to be submitted if the domestic responsible person authorization letter has expired?
A: Article 24 of the Provisions on the Administration of Cosmetic Registration and Filing Materials provides that upon expiration of the authorization period stated in the domestic responsible person authorization letter, an updated authorization letter shall be resubmitted to extend the authorization period. If not resubmitted within the specified time limit, the domestic responsible person will be unable to process new registration or filing matters on behalf of the corresponding overseas registrant or filer, although ongoing registration or filing matters already initiated may continue to be completed.
CIRS Reminder
There are numerous detailed rules governing filing and declaration procedures, label preparation, and account permission changes. Enterprises should closely follow regulatory requirements in their daily operations. Pay attention to the rules for document submission and information updating, maintain relevant qualification information in a timely manner, retain supporting documents, minimize compliance issues, and ensure the smooth market launch and operation of products.
If you have any needs related to new ingredient registration and filing, or cosmetic registration and filing in China, please feel free to contact us via service@cirs-group.com!
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