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According to the Administrative Measures on Cosmetics Registration and Notification and the Provisions for Management of Cosmetic Registration and Notification Dossiers, China no longer sets validity period for the notification of general cosmetics, but introduces an annual report system.
Specifically, starting from January 1, 2022, notifiers shall submit the annual report of general cosmetics notified over one year ago through the new cosmetics registration and notification information service platform (“new platform”) from January 1 to March 31 of each year.
2023 Annual Report
1) Time
This year’s annual report started on January 1, 2023. It should be noted that due to the gradual elimination of the pandemic, the 2023 annual report submission period will no longer be postponed. Cosmetic notifiers must complete the reporting before March 31, 2023. 1
2) Targets
The products subject to annual report submission are general cosmetics notified before December 31, 2021, including Chinese domestic and imported products.
3) Procedures
Notifiers can log in to the new platform, enter the "General Cosmetics Notification Management" module, and click the “Annual Report” button to enter the submission interface. 2
Source: NMPA Information Center
All general cosmetics notified over one year ago will be listed on the interface. Notifiers shall check and fill in the required contents item by item according to the actual situation. After filling in, the “Submit” button shall be clicked to complete the whole process.
Source: NMPA Information Center
4) Reporting Contents
Notifiers shall be responsible for the authenticity and accuracy of the information in the annual report, which shall include the following:
The general situation of the production and import of products, as well as the suspension of production during the reporting period;
Self-inspection on the conformity of products with laws and regulations, mandatory national standards and technical specifications.
To be specific, stakeholders can self-review the required contents by checking the following four questions. 3
Questions | Notes |
Q1: Has the product been ordered to correct? | / |
Q2: Has the product been discontinued or suspended for import? | The specific start and end time of suspension shall be specified for any products whose production/import is suspended for more than six consecutive months. The suspension of production generally includes voluntary suspension and ordered suspension:
|
Q3: Has the notifier conducted a comprehensive self-inspection of the product, and do the results of the self-inspection meet the requirements? | If the product has any non-compliance with current laws and regulations, mandatory national standards, and/or technical specifications, and can be revised through notification change application, it is recommended to complete the relevant changes before the annual report. If the product has any non-compliance with current laws and regulations, mandatory national standards, and/or technical specifications but cannot be updated through adjustments or notification change application, it is not recommended to conduct annual reporting. |
Q4: Has the product been subject to sampling inspections, administrative penalties, or recalls? | If the product has failed to pass the sampling inspection, been subject to administrative penalties, or been recalled, the specific situation should also be clarified. If the reason for product recall is the existence of adverse reactions or safety problems that cannot be rectified, it is not recommended to conduct annual reporting. |
5) Consequences of Failure to Submit Annual Reports as Required
The notification of general cosmetics that fail to complete the annual report in time will be forcibly cancelled by the regulatory authorities. Such products shall not be sold or imported from the date of cancellation. Otherwise, strict penalties will be imposed in accordance with the law.
Basis of Punishment
Paragraph 3, Article 65 of the Cosmetic Supervision and Administration Regulation (CSAR): "After the notification department cancels the notification, if it still uses such new cosmetics ingredients in cosmetics production, or it still markets and imports such general cosmetics, it shall be punished in accordance with the provisions of Article 60 and Article 61 herein."
Article 61 of CSAR: "If any of the following circumstances occurs, the medical products administration departments shall confiscate the illegal income, illegally produced and operated cosmetics, and the ingredients, packaging materials, tools, equipment and other items specifically used for illegal production and operation; if the illegally produced and operated cosmetics have a value of less than 10,000 yuan, a fine of more than 10,000 yuan and less than 30,000 yuan shall be imposed; if the illegally produced and operated cosmetics have a value of more than 10,000 yuan, a fine of more than 3 times and less than 10 times the value shall be imposed; in serious circumstances, it shall be ordered to suspend the production and operation, and the notification shall be canceled by the notification department or the cosmetics license shall be revoked by the original license-issuing department, and the legal representative or the main responsible person, person who is directly in charge and other directly responsible persons of the illegal unit shall be fined more than 1 time and less than 2 times the income they obtained from the unit in the previous year, and shall be prohibited from engaging in cosmetics production and operation activities in 5 years:
Marketing, operation or import of unnotified general cosmetics;
Failure to assign a person in charge of quality and safety as prescribed herein;
Cosmetics registrants and notifiers not supervising the production activities of the entrusted production enterprise;
Failure to establish and implement a health management system for employees as prescribed herein;
Production and operation of cosmetics whose labels do not comply with the provisions herein.
Where the labels of the cosmetics produced and operated have defects that do not affect the quality and safety and will not cause any misleading to consumers, the medical products administration departments shall order it to correct; those who refuse to make corrections shall be fined not more than 2,000 yuan."
ChemLinked Comments
The annual report system is of great significance for both regulators and enterprises. Many general products have not been put into production for a long time or have been withdrawn from the market, but their information is still kept on the notification platform. The accumulation of these products' information has brought great inconvenience to the supervision work and public inquiries. By annual report, products with potential safety hazards can be effectively cleaned up. Notifiers can better manage their own products and fulfil the main responsibility for quality and safety as the notifier.
As the submission deadline for this year's annual report is approaching, relevant notifiers shall sort out their notified products as soon as possible, conduct a series of self-inspection, and complete the reporting in time after confirming that the products meet the annual report requirements, so as not to affect the normal production and sales of subsequent notified products.
For the notified products that are no longer produced or imported, the notifiers can take the initiative to cancel the notification through the new platform before March 31, 2023. In this way, if there is no violation of laws and regulations, the related products that have been put on the market before the cancellation can be sold until the end of their shelf life. In contrast, notifiers failing to submit the annual report by the deadline will face the cancellation of product notification by the local regulatory authorities, and the relevant products cannot be imported or sold.
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