CBO reporter Li Siyang
In response to the relevant announcements of the state last year, the annual report system of ordinary cosmetics will be implemented from this year, and Shandong, Shanghai and other places have issued announcements to notify related matters. For the common questions of the annual reporting system, the State Food and Drug Administration also answered today (April 8).
01
Shandong and Shanghai responded to the new regulations
From this year onwards, the annual report on the record of cosmetics will be submitted on time
Recently, the Drug Administration of Shandong, Shanghai and other places has issued notices on matters related to the annual report of cosmetics filing.
In order to further standardize the filing management of cosmetics, in accordance with the Announcement of the State Food and Drug Administration on Relevant Matters Concerning the Implementation of the Provisions on the Administration of Cosmetics Registration and Filing Data (No. 35 [2021]) and the Announcement of the State Food and Drug Administration on the Issuance of the Classification Rules and Classification Catalogue of Cosmetics (No. 49 [2021]), the annual reporting system for ordinary cosmetics shall be implemented from January 1, 2022, and the recorder shall implement the annual reporting system for ordinary cosmetics from January 1 to March 31 of each year. Submit an annual report on ordinary cosmetics that has been filed for one year.
For those who fail to complete the annual report as required before March 31, 2022, the drug supervision and management department responsible for the filing management work will be ordered to make corrections within a time limit in accordance with law, and the relevant recorder shall complete the rectification before June 30, 2022. Where corrections are not made within the time limit as required, they shall be disposed of in accordance with law. If due to the impact of the new crown epidemic, it is impossible to complete rectification within the prescribed time limit, a written explanation shall be submitted and corresponding supporting materials shall be attached.
For ordinary cosmetics that have completed filing on the original filing platform, the recorder shall submit the standards for product implementation, sample product labels, product classification codes, and product formulas for domestic ordinary cosmetics before May 1, 2022 through the new filing platform.
The Announcement of the State Food and Drug Administration on Issuing the Specification for the Evaluation of Cosmetic Efficacy Claims (No. 50 [2021]) clarifies that for cosmetics that have been registered or completed for filing between May 1, 2021 and December 31, 2021, the registrant and the recorder shall evaluate the efficacy claims of cosmetics before May 1, 2022 and upload a summary of the basis for the product efficacy claims. The relevant recorder shall carry out relevant work as soon as possible to ensure that the collation and reporting of the summary data of the efficacy evaluation of cosmetics is completed on time.
At present, the filing information of ordinary cosmetics in Shandong Province has been migrated from the original filing platform to the new filing platform, and the relevant recorders should claim and confirm the relevant products on the new filing platform as soon as possible in accordance with the relevant requirements of the State Food and Drug Administration's "Notice on Doing a Good Job in Connecting the New and Old Cosmetics Registration and Filing Information Management Platform" (Drug Administration Comprehensive Makeup Letter [2021] No. 264), and do a good job in relevant information maintenance and data upload. Before May 1, 2022, products that have not been claimed and confirmed will be cancelled in accordance with the procedures.
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The NmPA answers common questions
Reminder to submit the relevant information of the annual report as soon as possible
Industry insiders have doubts about a number of common questions, including the annual report system, and the official website of the State Food and Drug Administration also issued an announcement today (April 8) to answer them.
Regarding why the annual reporting system is set up for the filing of ordinary cosmetics, the State Food and Drug Administration said that since the implementation of the online filing of domestic non-special-purpose cosmetics on June 30, 2014, the filing platform has formed more than 2.2 million pieces of filing product information. Due to the imperfection of the original cosmetics regulatory system and the functional limitations of the old filing platform, some of the products that were completed before the promulgation and implementation of the new "Cosmetics Supervision and Administration Regulations" (hereinafter referred to as the "Regulations") have been no longer produced, but the product information is still accumulating more and more on the filing platform, gradually forming "zombie" products, which has brought great inconvenience to the regulatory work and the public inquiry.
In the supervision work, it was found that some products could not even find a recorder, and the main responsibility for the quality and safety of the product could not be implemented, and these products brought hidden dangers to the health and safety of consumers, and it was urgent to clean up through legal means. After the promulgation and implementation of the Regulations, good legislative practice has been provided in the design of the filing management system, and the main responsibility of the recorder has been further clarified, and the recorder should be responsible for product quality and safety in accordance with the law.
For the registered products why need to fill in the relevant information, the State Food and Drug Administration said that before the implementation of the Regulations and related supporting regulations, the registration and filing information submitted by enterprises through the old platform is relatively simple, taking the domestic product filing as an example, in addition to the product formula ingredient information, sales packaging, other related information is archived by the enterprise for future reference, resulting in some necessary product information missing, bringing hidden dangers to consumer health and safety.
After the implementation of the new regulations on registration and filing management, it is necessary to supplement and improve the data of the registered products of the old platform that still continue to be produced and sold. It should be noted that the supplementary information submitted on the new platform is the registration and filing information originally filed by the enterprise for reference, and no new requirements have been added to the registrant and the recorder.
At the same time, taking into account the need to connect the old and new laws and regulations, the State Food and Drug Administration has set a reasonable transition period for registrants and filing supplementary information. Supplementary information is used as a necessary condition to prove that the relevant products comply with the provisions of the Regulations and its supporting regulations, and the products that are not supplemented as required shall not continue to be produced or imported until the supplementary report is completed.
For products that are no longer produced or imported, the recorder may take the initiative to apply for cancellation on the filing platform. Products that apply for active cancellation, if there is no violation of laws and regulations, the relevant products that have been listed before the cancellation of the filing information can be sold until the end of the shelf life.
The State Food and Drug Administration recommends that ordinary cosmetics recorders and domestic responsible persons sort out the products that have been filed as soon as possible, and those who intend to continue production and import should submit annual reports and supplement relevant information as required; those who are no longer produced or imported should take the initiative to apply for cancellation of product filings.