China National Medical Products Administration (NMPA) has sorted out the questions raised by the cosmetics industry on the the “Cosmetics Supervision and Administration Regulations” (CSAR), the “Administrative Measures for Cosmetics Registration and Filing” and “Regulations on the Administration of Cosmetics Registration and Filing Documents”.
Question: Should I obtain an account through cosmetics registration and filing information service platform?
Answer: Domestic registrants, filing persons, domestic responsible persons and cosmetics manufacturing enterprises shall obtain cosmetics registration accounts through the registration filing information service platform. Overseas brands (registrants and filing persons) shall carry out cosmetics registration filing-related businesses through their domestic responsible persons account.
Question: Which cosmetics registrants and filing persons need to appoint a responsible person in China?
Answer: If the cosmetics registrant or filing person is overseas, he should designate a domestic responsible person in China to handle cosmetics registration filing, assist in the monitoring of cosmetic adverse reactions, and implement product recalls.
If an overseas brand entrusts a domestic cosmetics manufacturer to produce cosmetics, the product belongs to a domestic cosmetic. But since it is an overseas brands, the domestic responsible person needs to be designated;
If a domestic brand entrusts an overseas cosmetic manufacturer to produce cosmetics, the cosmetics belong to imported cosmetics, but since the brand is local, there is no need to designate the domestic responsible person.
Question: What are the differences between the domestic responsible person and previous Responsible Agent during cosmetics registration.
Answer: Compared with the responsible agent, the current new role as domestic responsible person under new regulation not only needs to register and file the products in the name of oversea brands, but also needs to perform and assist in the development of adverse reactions monitoring, implement product recalls, and undertake corresponding quality and safety responsibilities.
Question: What content should be stated in the authorization letter of the domestic responsible person?
Answer: The content of the authorization letter of the domestic responsible person should at least reflect the following content and information: the names of the registrant, the filing person and the domestic responsible person, the authorization and the authorized relationship, the authorization scope, and the authorization period.
If the authorization period is not clear, it shall be deemed as a permanent authorization; regardless of whether the authorization includes assisting in the development of cosmetic adverse reaction monitoring, implementing product recalls, and cooperating with supervision and inspection, the domestic responsible person shall perform the assistance in the implementation of adverse reaction monitoring and implement product recalls in accordance with the requirements of laws and regulations and cooperate with the supervision and inspection obligations.
Question: Can the Previous power of attorney (POA) for responsible agents be used for the new domestic responsible person application?
Answer: The POA for special cosmetics registration cannot continue to be used. The POA for general cosmetics filing/notification can continue to be used (only for general cosmetics import registration). If the original domestic responsible person’s power of attorney has been submitted to the department before and cannot provide the original again, the domestic responsible person should upload a scanned copy of the original POA through the registration and filing information service platform when applying the account, and submit the photocopy as hardcopy when submit.
If an overseas registrant or filing person (Brands) intends to expand the scope of authorization of the original domestic responsible person, it shall issue a new authorization letter. The domestic responsible person can first upload a scanned copy of the new authorization letter through the registration and filing information service platform to apply for a Responsible person account, and should supplement the original authorization letter and its notarized copy and other materials before September 30, 2021.
Question: How to register and file/notify for cosmetics that use new raw materials during the safety monitoring period?
Answer: After the new cosmetic raw materials are registered and filed, the NMPA will announce the new raw material registration and filing management information to the public. If other cosmetics registrants and filing person use new raw materials to produce cosmetics, they should fill in the new raw material registration and filing number when registering and filing cosmetic products, and submit them through the platform after the new raw material registrant and filing person have associated confirmation.
Cosmetic registrants and filing who use new raw materials during the safety monitoring period to produce cosmetics shall perform their duties to monitor the use of new raw materials and safety conditions in accordance with the requirements of the Measures.
Question: The new raw material is ordered to suspend the use, how to deal with the related cosmetics
Answer: If a new cosmetic raw material is ordered to be suspended during the safety monitoring period, the registration and filing information service platform will automatically identify the cosmetics that use the new raw material and give a reminder. The relevant cosmetic registrant and filing person should also suspend the production, operation and use of the new raw material.
Q: How to apply for registration and filing for cosmetics that have been commissioned for production?
Answer: For domestic cosmetics, the cosmetics registrant, filing person shall submit the registration application and filing after the cosmetic manufacturer confirms the entrusted production relationship through the registration and filing information service platform; If the cosmetics registrant or filing person entrusts the production of imported cosmetics, their domestic person responsible in China shall submit toll manufacturing agreement for the account application.
Q: How to keep samples for cosmetics registrants and fiiling person?
Answer: Article 36 of the “Regulations” stipulates that the cosmetics registrant should keep samples of each batch of cosmetics for future reference. The number of retained samples should be able to meet the requirements for conducting registration inspections, and may not include the number of samples required for human efficacy tests such as sunscreen, freckle whitening, and anti-hair loss.
Q: How to register the cosmetics that must be used with equipment or tools?
Answer: Except for brushes, air cushions, and perm tools that only assist in rubbing, as well as cosmetics that must be used with equipment or tools, the safety of the equipment or tools should be evaluated during the product safety evaluation process.
In principle, the tools used in conjunction should not have cosmetic functions, should not participate in the reproduction process of cosmetics, and cannot change the mode and mechanism of action between cosmetics and skin.
Q: Is the cosmetic formula allowed to be changed?
Answer: The formula of registered cosmetics is not allowed to be changed. However, If cosmetics may inevitably undergo minor changes in product formulations due to the replacement of suppliers of raw materials, it is allowed in such cases,
Question: How to deal with the change of the filing management department of General cosmetics?
Answer: If the addresses of general cosmetics filing persons and domestic responsible persons change across provinces, which results in the change of the filing management department, it is necessary to re-do the filing/notification. The original filing materials can still be used when re-filing, and the registration filing information service platform will also set up corresponding functions to facilitate the filing person and the domestic responsible person to re-file.
