Product Compliance
Test/Filing/Registration
In order to further standardize the supervision and management of cosmetics and protect the legitimate rights and interests of consumers, the Cosmetics supervision Department of the State Food and Drug Administration sorted out the annual report of ordinary cosmetics filing and other related issues that the industry is concerned about, and answered them one by one according to China's current cosmetics laws and regulations and relevant technical specifications:
Q: Why should common cosmetics put on record set annual report system?
A: Since the online filing of domestic non-special use cosmetics was implemented on June 30, 2014, more than 2.2 million pieces of product information have been filed on the platform. Due to the imperfections of the original cosmetics regulatory laws and regulations and the limitations of the old filing platform. For the products that have been put on record before the promulgation and implementation of the new Regulations on Supervision and Administration of Cosmetics (hereinafter referred to as the Regulations). Although some of the product are no longer continue to produce, product information on the record platform still build up, gradually formed "zombie" products(unavailable product). These products have brought great inconvenience to the supervision work and social public inquiry. In the supervision work, it was found that some products could not even find the record holder, and the main responsibility of product quality and safety could not be implemented. These products bring hidden dangers to the health and safety of consumers, and it is 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 record management system, and the main responsibility of the record holder has been further clarified. The record holder should be responsible for product quality and safety in accordance with the law. Article 37 of the Measures for the Administration of Cosmetics Registration and Archival Filing (hereinafter referred to as the Measures) stipulates that the archival filing person of ordinary cosmetics shall report annually to the drug regulatory department responsible for the administration of archival filing the production and import, as well as the compliance with laws and regulations, compulsory national standards and technical specifications.
The archival filing person shall submit the annual report of ordinary cosmetics whose archival filing period has been over one year through the new registration platform from January 1 to March 31 of each year. For products that are overdue or fail to file annual reports as required within the time limit, the supervision department shall order them to rectify within a time limit according to Article 58 of the Measures. If the archival filing person still fails to correct within the prescribed time limit, the supervision department will cancel the record-keeping of the product in accordance with Article 59 of the Measures.
Q: Why do I need to supplement the relevant information for registered products?
A: In order to standardize the production and operation of cosmetics, strengthen the supervision and administration of cosmetics, and ensure the quality and safety of cosmetics, the Regulations, the Measures and the Provisions on the administration of registration and filing materials of cosmetics are explicitly stipulated on the materials that should be submitted for registration and archival filing of cosmetics. Before the implementation of the Regulations and related laws and regulations, the enterprise through the old platform to submit the registration for the record data is relatively simple, in domestic product for the record, for example, in addition to the product ingredient information, sales packaging and other related information on file for future reference, by the enterprise creates some necessary product information is missing, brings to the consumer health and safety hazards.
After the implementation of the new regulations on registration and filing management, in order to improve the efficiency of registration and filing and safeguard the health rights and interests of consumers, it is necessary to supplement and improve the data of registered products on the old platform that still continue to produce and sell. It should be noted that the supplementary materials submitted on the new platform are the original registration and filing materials filed by enterprises for future reference, and there are no new requirements for registrants and record holders. or the convergence of new and old laws and regulations, the SFDA has set a reasonable transitional period for supplementary information filling by registrants and record holders. The supplementary materials shall be used to prove that the relevant products meet the necessary conditions stipulated in the Regulations and its supporting regulations. The products that have not been supplementary materials as required shall not continue to be manufactured and imported before the supplementary materials are completed.
Q: What is the difference between the record-keeping person canceling the record-keeping initiative and the record-keeping management department canceling the record-keeping? Do the registered products that are no longer produced or imported need to be cancelled on their own initiative?
According to the the Regulations and the Measures and relevant laws and regulations on registration and filing of cosmetics, for products that are no longer produced or imported, the record holder may apply for cancellation on the record platform on his own initiative. The record holder's initiative to cancel the product is not only conducive to maintaining consumers' right to know, but also improves the efficiency of supervision department. For the products that actively apply for cancellation, if there is no violation of laws and regulations, the relevant products that have been on the market before the cancellation of the record information can be sold to the end of the shelf life. According to article 65 of the Regulations, products canceled by the supervision department shall not be marketed, sold or imported from the date of cancellation of the filing. If the products are still marketed, sold or imported, the supervision department will punish them according to the provisions.
It is recommended that ordinary cosmetics archival applicants and domestic responsible persons should sort out the products that have been archival as soon as possible. If they plan to continue produce the product and import, they shall submit annual reports and fill in relevant materials as required. Where the products are no longer produced or imported, the company shall actively apply for cancellation of the record of the products. Considering the cohesion in the process of old and new platform, some for the record, those responsible have not yet registered within the territory of the new platform account, to better serve enterprises, these men, domestic responsibility to record with the drug regulatory department at the provincial level of the place take the initiative to cancel the record of the written application, done by filing management department to assist on the new platform for the record active cancellation of the product and the public information updates, In order to avoid affecting the continued marketing and import of relevant products.