Q1   For sunscreen spray products with propellant in the formula,How to correctly fill in the control range of physical and chemical indicators of sunscreen in the standards implemented by products

There are two filling methods With or without propellant,However, it is necessary to indicate whether it contains propellant after the control range of sunscreen index.

For example, the propellant tank capacity of sunscreen spray products is Total mass of propellant : Total mass of formula raw materials =60 40 ,Sunscreen Ethylhexyl salicylate  The declared amount of formula is4.5% Without propellant ,Its control range can be set to3.6%-5.0% Without propellant ,or1.44%-2.0% Containing propellant .

Q2   For hair dyeing products,How to correctly fill in the control range of physical and chemical indicators of hair dyes in the standards implemented by products

It should be filled in according to the formula declaration amount of hair dye.There are two ways to fill in and submit two or more mixed hair dye products First, according toⅠFill in the control range of hair dye indicators for the concentration of each hair dye in the agent or dye Second, fill in the control range of hair dye indicators according to the concentration of each hair dye when mixed,And indicate the mixing proportion.

Q3   Standards implemented by products Microorganism, physical and chemical indexes and quality control measures How to fill in the form correctly if the inspection method is used as a quality control measure in

according to Regulations on the administration of cosmetics registration and filing materials Article 30 five 3regulations,Using inspection method as quality control measure,The specific name of the inspection method should be correctly filled in,And indicate the reasonable inspection frequency use Safety technical specifications for cosmetics Other inspection methods are used as quality control measures,This method should also be combined with Safety technical specifications for cosmetics Verify the specific inspection methods contained,The verification results shall meet the requirements,Complete inspection methods and method validation data shall be kept on file for future reference.

Q1   Hair dyeing products containⅠagent Ⅱagent,There are two recipes,How to apply for registration

according to Regulations on the administration of cosmetics registration and filing materials Article 35,Cosmetics containing two or more independent formulas that must be used together or whose packaging containers cannot be separated,The formula should be filled in separately,Apply for registration by one product.The two agents of hair dyeing products must be matched,You need to fill in the formula separately,Apply for registration by one product.

Q2   What are the requirements for foreign language materials in cosmetics registration documents

Regulations on the administration of cosmetics registration and filing materials Article 4 Provisions,The registration and filing materials of cosmetics shall use standardized Chinese characters published by the state.Except registered trademark website Patent name The name and address of the overseas enterprise must be in other words,Or conventional technical terms asSPF PFA PA UVA UVB vitaminCetc. ,All other words shall be complete Standardized translation into Chinese,And attach the original text to the corresponding translation.

Q3   What are the requirements for foreign language materials in the documents when registering new cosmetics raw materials

Regulations on the administration of registration and filing materials of new cosmetics raw materials Article 4 Provisions,The registration and filing materials of new cosmetics raw materials shall use standardized Chinese characters published by the state.Except registered trademark website Patent name Other words that must be used for the name and address of overseas enterprises,And English abbreviations used in Chinese regulatory documents,All materials in other languages should be complete Standardized translation into Chinese,And attach the original text to the corresponding translation.

Q4   Not reflected in the original product registration certificatePAvalue,Need to increasePAValue labeled,How to apply

according to Regulations on the administration of cosmetics registration and filing materials Article 44,Product increaseSPF/PAThe value should change according to the content of the label sample,Apply for change,And provide the corresponding efficacy test report of the product to be changed.

Q5   Hair development Depilation beautiful breast Bodybuilding Can deodorizing cosmetics be changed Reissue Application for continuation, etc

According to the State Drug Administration About implementation Regulations on the supervision and administration of cosmetics Announcement of relevant matters  2020Year144number  Announcement of the State Food and Drug Administration on further clarifying the transitional period management of original cosmetics for special purposes and other related matters 2021year Section150number regulations,During the transition period,The registrant of cosmetics can apply to the State Food and Drug Administration for the cancellation of the administrative license of five categories of original special-purpose cosmetics such as Yufa,in addition to,The State Food and Drug Administration will no longer accept the changes of relevant products Other administrative license applications such as reissue or renewal.If any, safety is not involved The items of efficacy claim have changed,The registrant of cosmetics shall file with the State Food and Drug Administration in a timely manner.For matters that can be applied for,Applicants can apply by submitting paper materials offline.

Q6   What materials need to be submitted to apply for changing the domestic responsible person

according to Regulations on the administration of cosmetics registration and filing materials Article 48,To apply for changing the domestic responsible person, a list of products to be changed shall be submitted The informed consent of the original domestic responsible person or the judgment document that can prove the effectiveness of the change of the domestic responsible person Ruling judgment Mediation statement, etc  Letter of commitment of domestic responsible person to be changed.

Q7   Imported ordinary cosmetics are filed in the form of boxes and sold on the market,Do you need to submit the single products in the box and the box packaging when filing

according to Regulations on the administration of cosmetics registration and filing materials Article 32 provisions,When filing ordinary cosmetics Before the launch of special cosmetics,Registrant The filer or domestic responsible person shall upload the label image of the product sales package, Therefore, the submitted and uploaded pictures should be products registered in the form of boxes.

Q8   After the filing of several imported ordinary cosmetics,When sold in boxes,Do you need to submit the label picture of the box sales package

according to Regulations on the administration of cosmetics registration and filing materials Article 32 requirements,Products that have been registered or filed shall be packaged Combined sales in the form of gift box,The combination process does not touch the contents of the product,In addition to adding the name of combined packaging products,The content of other labels does not exceed the content of each product label,And the label information of the combined packaging covers the label content of each internal product,There is no need to upload label pictures repeatedly when filing composite packaging products.

Q9   When filing ordinary cosmetics,Under what circumstances can the toxicology test report of the product be exempted What are the exceptions

according to Regulations on the administration of cosmetics registration and filing materials Article 33 two regulations,The manufacturer of ordinary cosmetics has obtained the host country region Relevant qualification certificates of production quality management system issued by competent government departments,And the product safety risk assessment results can fully confirm the product safety,The toxicological test report of the product is exempted,Except for the following circumstances

1.The product claims to be used by infants and children
2.The product uses new cosmetic raw materials that are still under safety monitoring
3.Score results according to quantitative grading,Filed by Domestic responsible person Production enterprises are listed as key regulatory objects.

Produced by multiple manufacturers,All production enterprises have obtained the host country region Relevant qualification certificates of the production quality management system issued by the competent government department,Can be exempted from submitting toxicological test reports.

Q10   Is it necessary to upload the summary of the basis of product efficacy Declaration on the special website designated by the State Food and drug administration when all cosmetics are registered

according to Evaluation specifications for efficacy claims of cosmetics Article 7, Through vision Directly recognized by sense organs such as smell Such as cleaning Remove makeup Cosmetic modification aromatic Refreshing dye one 's hair Perm Hair color care Depilation Deodorization and auxiliary shaving, etc ,Or by simple physical masking Attachment Friction, etc Such as physical covering, freckle removing and whitening Physical exfoliation and physical blackhead removal, etc And clearly mark on the label the efficacy claim that only has physical effect,The summary of the basis of product efficacy claim can be exempted from publication .Other efficacy claims should be in accordance with the requirements of the State Food and Drug Administration on Evaluation specifications for efficacy claims of cosmetics Announcement of 2021Year50number Evaluate,While applying for registration or filing,Upload the summary of the basis of product efficacy claim.