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Cosmetics
FAQs of the State Food and Drug Administration on the filing and registration of cosmetics

#Q1    How to obtain users of cosmetics registration information service platform

answer     according to Regulations on the administration of cosmetics registration and filing materials requirement,Domestic registrant Filed by The domestic responsible person and cosmetics production enterprise shall obtain the registration and filing users of cosmetics through the registration and filing information service platform,Cosmetics can only be registered and filed.Overseas registrant Filed by,Carry out cosmetics registration and filing related business through the users of its domestic responsible person.

Regulations on the supervision and administration of cosmetics Article 18 for cosmetic registrants The requirements of the filer are consistent,After the enterprises or other organizations that meet the requirements submit relevant materials and open the users of registrants and recorders together,Cosmetics registration can be carried out Filing related work,There is no need to open registrants separately Authority of filer.


#Q2     Which cosmetics registrants The filing person needs to designate the domestic responsible person

answer     Cosmetic registrant The filing person is abroad,The domestic responsible person shall be designated within the territory of China,Handle the registration and filing of cosmetics,Assist in monitoring adverse reactions of cosmetics Implement product recall.

Overseas registrant The applicant entrusts a domestic cosmetics production enterprise to produce cosmetics,The cosmetics are domestic cosmetics,But because of the registrant The recorder is overseas,Domestic responsible person needs to be designated Domestic registrant The filing party entrusts an overseas cosmetics production enterprise to produce cosmetics,The cosmetics are imported cosmetics,But because of the registrant The recorder is in China,There is no need to designate a domestic responsible person.


#Q3     What are the differences between the domestic responsible person and the original reporting responsible unit in China

answer    Domestic responsible person and original Regulations on hygienic supervision and administration of cosmetics Compared with the reporting responsible units in China in relevant laws and regulations,Not only need to be registered Register in the name of the filer keep on record,There is also a need to assist in adverse reaction monitoring Implement product recall Undertake corresponding quality and safety responsibilities and other obligations in accordance with the agreement.

If the responsible reporting unit in China does not have the ability to perform the corresponding obligations of the responsible person in China,It is not allowed to carry out the registration and filing of cosmetics as the domestic responsible person.


#Q4     What should be stated in the power of attorney of the domestic responsible person

answer     The contents of the power of attorney of the domestic responsible person shall at least reflect the following contents and information Registrant Name of filer and domestic responsible person,Authorization and authorized relationship,Scope of authorization,Authorization period.

The authorization period is not clear,Deemed permanent authorization No matter whether the letter of authorization is reflected or not, assist in the monitoring of adverse reactions of cosmetics Implement product recall and cooperate with supervision and inspection,All responsible persons in China shall perform their duties and assist in adverse reaction monitoring in accordance with the requirements of laws and regulations Implement product recall and cooperate with supervision and inspection.


#Q5     Can the power of attorney of the domestic responsible person use the original power of attorney

answer     Letter of authorization from the unit responsible for the declaration of the original imported special cosmetics in China,Cannot continue to use.Letter of authorization of the person responsible for the original import of ordinary cosmetics,Can continue to use Only the import record of ordinary cosmetics shall be handled .The original power of attorney of the original domestic responsible person has been submitted to the acceptance department before, and the acceptance department is unable to provide the original again,When opening the domestic responsible person user, the domestic responsible person shall upload the scanned copy of the original power of attorney through the registration and filing information service platform,When submitting paper documents, a copy of the power of attorney may be submitted.

Overseas registrant The filing person intends to expand the scope of authorization of the original domestic responsible person,The power of attorney shall be reissued.The domestic responsible person can first upload the scanned copy of the original of the new power of attorney through the registration and filing information service platform to handle the registration and filing of cosmetics users,And shall2021year9month30The original power of attorney and its notarized copy and other materials shall be supplemented and submitted a few days ago.


#Q6     How to register cosmetics using new raw materials during the safety monitoring period keep on record

answer     Registration of new cosmetics raw materials After filing,The State Food and Drug Administration will announce the registration of new raw materials to the public Information related to filing management.Other cosmetic registrants The applicant uses new raw materials to produce cosmetics,Cosmetics should be registered Fill in the registration of new raw materials at the time of filing Filing No,New raw material registrant through registration and filing information service platform Related party confirmation of the filer,Before submitting the registration application Filing materials.

Cosmetic registrants who use new raw materials during the safety monitoring period to produce cosmetics Filed by,Should be in accordance with Administrative measures for registration and filing of cosmetics It is required to fulfill the obligation of monitoring the use and safety of new raw materials.


#Q7     New raw materials were ordered to suspend use,How to dispose of relevant cosmetics

answer     The use of new cosmetic raw materials within the safety monitoring period is ordered to be suspended,The registration information service platform will automatically identify the cosmetics using the new raw material and give a prompt,Relevant cosmetic registrant The recorder shall suspend production at the same time Operate cosmetics using the new raw materials.


#Q8      How to register cosmetics with entrusted production keep on record

answer      Cosmetic registrant The applicant entrusts the production of domestic cosmetics,Cosmetic registrant The filing person or domestic responsible person shall confirm the entrusted production relationship through the registration and filing information service platform and the cosmetics production enterprise,Before submitting the registration application Filing Cosmetic registrant The filing party entrusts the production of imported cosmetics,Cosmetic registrant The filing person or domestic responsible person shall apply for registration at When filing,Submit relevant materials to prove the entrusted production relationship.


#Q9     mustCooperate with instruments or tools to makeUsefulHow to register cosmetics

answer     Except for brushes that only assist in wiping air cushion Perm tools, etc,Cosmetics that must be used with instruments or tools,In the process of product safety evaluation, the safety under the use conditions of cooperating instruments or tools shall be evaluated.

In principle,Instruments or tools used together,It shall not have cosmetic function,Should not participate in the reproduction process of cosmetics,It can not change the action mode and mechanism of cosmetics and skin.


#Q10     Is the formula allowed to change

answer     The formula of registered cosmetics cannot be changed.according to Administrative measures for registration and filing of cosmetics and Regulations on the administration of cosmetics registration and filing materials ,Registered Registered cosmetics,Due to the change of raw materials and suppliers, the product formula will inevitably change slightly,Minor changes in the formulation in this case are allowed,However, it should be performed way and regulations Specified obligations.Product formulation changes other than this,In essence, it constitutes a new product,They should re apply for registration Filing.


#Q11     How to deal with the change of filing management department of ordinary cosmetics

answer     General cosmetics filer The address of the domestic responsible person changes across provinces,Change of filing management department,The filing number and regulatory responsibility of ordinary cosmetics will also change,Therefore, it needs to be re filed.When filing again, the original filing materials can still be used,The registration and filing information service platform will also set corresponding functions,Convenient for the filer The domestic responsible person shall file again.