1. Requirements for submitting the annual report of filed cosmetics
According to the NMPA Announcement on Matters Related to Implement the Rules for Registration and Notification Dossiers of Cosmetics (No.35, 2021), the filers shall submit the annual report of general cosmetics that have completed filing for one year through the new registration and filing platform between January 1 and March 31 of each year. Those who fail to submit the annual report as required will be disposed according to the relevant provisions of the Cosmetics Supervision and Administration Regulations (CSAR) and the Provisions for Registration and Filing of Cosmetics.
2. In the fifth label option of the filing system, what is the relationship between the contents of the product label sample and the contents of the label image?
According to Article 32 (3) of the Rules for Registration and Notification Dossiers of Cosmetics, the contents of the uploaded label image and the instructions shall not exceed the contents specified in the product label sample. Therefore, the contents of the label image shall not exceed the scope of contents of product label samples.
3. NMPA announcement on optimizing the management measures for filing inspection of general cosmetics
According to the NMPA Announcement on Optimizing the Management Measures for Filing Inspection of General Cosmetics (No.13, 2023), as of January 13, general cosmetics that have adopted the inspection method as the quality control measure with production process that has been included in the daily supervision scope of the provincial drug regulatory department and the product safety risk assessment results can fully confirm the product safety, the filing person can submit the inspection report issued by itself or the entrusted manufacturing enterprise according to the relevant requirements of the cosmetics technical specification when conducting cosmetic notification.
Except under one of the following circumstances:
The product is claimed to be used by infants and children;
The product uses new cosmetic ingredients within the safety monitoring period;
The product claims anti-acne, nourishment, repair, anti-wrinkle, anti-dandruff, deodorant, and other cosmetic efficacy;
Other situations where the product may have high safety risks.
4. Requirements for uploading the summary of efficacy claims basis
According to the NMPA Announcement on Issuance of the Standard for the Evaluation of Efficacy Claims of Cosmetics (No.50, 2021), for cosmetics that have been registered or filed prior to May 1, 2021, the cosmetics registrants or filers shall evaluate the efficacy claims of cosmetics prior to May 1, 2023, in accordance with the Standard for the Evaluation of Efficacy Claims of Cosmetics, and upload the summary of efficacy claims basis.
After the registrant or filer evaluates the efficacy claims of the relevant products according to the Standard, if the evaluation results cannot support the efficacy claims involved in the product name or label, they can apply for change before the expiration of the transition period, adjust the classification code of the product according to the actual properties of the product, and modify the relevant content of the product name or label to make it meet the requirements of the regulations.
5. Tips on changes in safety-related information about cosmetic product ingredients
According to Article 42 (1) of the Rules for Registration and Notification Dossiers of Cosmetics, if the manufacturer and quality specifications of ingredients used in registered or filed products are increased or changed, and the content of the ingredients used in the formula and the category and proportion of the specific components in the ingredients have not changed, the information of ingredient manufacturer and the ingredient safety information should be updated and maintained through the registration and filing information platform. At present, the filer can update and maintain the information through the "self-update of ingredient safety information" function of the platform.
According to Article 42 (2) of the Rules for Registration and Notification Dossiers of Cosmetics, if the manufacturer and quality specifications of ingredients used in the registered or filed products are increased or changed, the content of ingredients in the formula and the content of main functional components and solvents in the ingredients have not changed, and the type or content of micro-stabilizers, antioxidants, preservatives and other components added to ensure the quality of ingredients have changed, change application for information modification should be submitted through the platform, and the following materials should be submitted:
（1） Special cosmetics change application form or general cosmetics change information form;
（2） Product formula;
（3） Description of the information change, including the reason for the change, the purpose of using the changed ingredients in raw materials, etc.;
（4） Product safety assessment data of products to be changed;
（5） In case of any change in the product implementation standards, the standards to be changed shall be submitted;
（6） If the items to be changed involve changes in the full ingredient labeling and safety warning terms in the product label sample, the label sample of the product to be changed shall be submitted.