According to the Regulations on the Supervision and Administration of Cosmetics (hereinafter referred to as the Regulations), the Measures for the Administration of Cosmetics Registration and Filing (hereinafter referred to as the Measures) and the Provisions on the Administration of Cosmetics Registration and Filing Information (hereinafter referred to as the Provisions), the Cosmetic Supervision Department of the State Food and Drug Administration sorted out the problems reflected by the cosmetics industry on the relevant provisions for the registration and filing of cosmetics and answered them one by one.

　　Q: How to obtain cosmetics registration and filing information service platform users?

　　A: According to the requirements of the "Regulations", the domestic registrant, the record holder, the domestic responsible person and the cosmetics manufacturer shall obtain the cosmetics registration and record user through the registration and record information service platform before they can handle the cosmetics registration and record. Overseas registrants and recordholders shall carry out cosmetics registration and recordkeeping related businesses through users of their domestic responsible persons.

Article 18 of the Regulations on the requirements of cosmetics registrants and recordholders are consistent, and enterprises or other organizations that meet the requirements can carry out cosmetics registration and recordkeeping work after submitting relevant information and opening registrants and recordholders users, without the need to open registrants and recordholders' rights respectively.

　  Q: Which cosmetics registrants and record holders need to designate domestic responsible persons?

　　A: Where the registrant or recordholder of cosmetics is overseas, the responsible person shall be designated in China to handle the registration and record of cosmetics, assist in the monitoring of adverse reactions of cosmetics and the implementation of product recalls.

Where an overseas registrant or recordholder entrusts a domestic cosmetics manufacturer to produce cosmetics, the cosmetics are domestic cosmetics, but because the registrant or recordholder is overseas, a domestic responsible person needs to be designated; Where a domestic registrant or record holder entrusts an overseas cosmetics manufacturer to produce cosmetics, the cosmetics are imported cosmetics, but because the registrant or record holder is in China, it is not necessary to designate a domestic responsible person.

　　Q: What are the differences between the domestic responsible person and the original responsible entity in China?

　　A: Compared with the original "Regulations on the Supervision and Administration of Cosmetics Hygiene" and relevant regulations, the domestic responsible person not only needs to register and record in the name of the registrant and recordholder, but also needs to perform obligations such as assisting in the monitoring of adverse reactions, implementing product recalls, and undertaking corresponding quality and safety responsibilities in accordance with the agreement.

If the reporting responsibility unit in China does not have the ability to fulfill the corresponding obligations of the domestic responsible person, it cannot carry out the registration and filing work of cosmetics as the domestic responsible person.

    Q: What should be specified in the authorization letter of the domestic responsible person?

　　A: The content of the authorization letter of the domestic responsible person shall at least reflect the following contents and information: the name of the registrant, the record and the domestic responsible person, the relationship between authorization and authorization, the scope of authorization, and the authorization period.

If the term of authorization is not clear, it shall be deemed as permanent authorization; Regardless of whether the authorization letter reflects the content of assisting in the monitoring of adverse reactions of cosmetics, implementing product recalls and cooperating with supervision and inspection, the domestic responsible persons shall fulfill the obligations of assisting in the monitoring of adverse reactions, implementing product recalls and cooperating with supervision and inspection in accordance with the requirements of laws and regulations.

　　Q: Can the authorization letter of the domestic responsible person use the original authorization letter?

    A: The original authorization letter of the responsible unit for the declaration of imported special cosmetics in China cannot be used any longer. The authorization letter of the domestic responsible person for the original import of ordinary cosmetics can continue to be used (only for the import record of ordinary cosmetics). If the original authorization letter of the domestic responsible person has been submitted to the acceptance department before and cannot provide the original document again, the domestic responsible person shall upload the scanned copy of the original authorization letter through the registration and filing information service platform when opening the domestic responsible person user, and the copy of the authorization letter can be submitted when submitting the paper document.

    Where an overseas registrant or record holder intends to expand the scope of authorization of the original domestic responsible person, a new authorization letter shall be issued. The domestic responsible person can first upload a scanned copy of the original letter of authorization through the registration and filing information service platform for cosmetics registration and filing users, and shall supplement the original letter of authorization and its notarized documents before September 30, 2021.

　　Q: How to register and record cosmetics that use new raw materials during the safety monitoring period?

　　A: After the registration and filing of new raw materials for cosmetics, the State Food and Drug Administration will announce the relevant information about the registration and filing management of new raw materials to the public. Other cosmetics registrants and recordpersons who use new raw materials to produce cosmetics shall fill in the new raw material registration and recordkeeping number when cosmetics are registered and recordkeeping, and can submit registration applications and recordkeeping information after being confirmed by the new raw material registrant and recordkeeping person through the registration and recordkeeping information service platform.

    Cosmetics registrants and record holders who use new raw materials to produce cosmetics during the safety monitoring period shall fulfill the obligations of monitoring the use of new raw materials and safety conditions in accordance with the provisions of the Measures.

　　Q: New raw materials have been ordered to suspend the use of cosmetics, how to dispose of related cosmetics?

    A: If the new raw materials of cosmetics during the safety monitoring period are ordered to suspend the use, the registration and filing information service platform will automatically identify the cosmetics using the new raw materials and give prompts, and the relevant cosmetics registrant and filing person shall suspend the production and operation of the cosmetics using the new raw materials at the same time.

　　Q: How to register and record cosmetics with commissioned production?

    A: Where the cosmetics registrant or recordholder entrusts the production of domestic cosmetics, the cosmetics registrant, recordholder or domestic responsible person shall submit the registration application and record after the cosmetics manufacturer confirms the entrusted production relationship through the registration recordholder information service platform; Where a cosmetics registrant or recordholder entrusts the production of imported cosmetics, the cosmetics registrant or recordholder or the domestic responsible person shall submit relevant materials proving the entrusted production relationship when applying for registration or filing.

　　Q: How do cosmetics registrants and record holders retain samples?

    A: Article 36 of the Provisions stipulates that the registrant of cosmetics shall keep the samples of each batch of cosmetics produced for reference. The number of retained samples should be able to meet the requirements of registration and filing inspection, and may not include the number of samples required for human efficacy tests such as sun protection, freckle whitening, and hair loss prevention.