State Food and Drug Administration | Q & A on registration and filing management policies of new cosmetics raw materials
basis Regulations on the supervision and administration of cosmetics hereinafter referred to as regulations Administrative measures for registration and filing of cosmetics hereinafter referred to as way and Regulations on the administration of registration and filing materials of new cosmetics raw materials hereinafter referred to as regulations ,Collected by the cosmetics Supervision Department of the State Food and Drug Administration Sorted out the issues related to the registration and filing of new cosmetics raw materials that are concerned by the cosmetics industry,And answer them one by one.
ask What raw materials are managed according to new cosmetic raw materials
answer according to regulations regulations,The natural or artificial raw materials used in cosmetics for the first time in China are new cosmetic raw materials,Registered Before the new cosmetic raw materials filed are included in the catalogue of used cosmetic raw materials,It is still managed according to new cosmetics raw materials.
It should be noted that,Only the intended use of raw materials Application site The purpose of use conforms to the relevant attributes of cosmetics,Only then can we apply for registration or filing according to the new cosmetics raw materials.For example, the use method of a certain raw material is oral or injection,Non conformity regulations Description of the use of cosmetics,Namely Wipe Spraying or other similar methods ,Or the use part of the raw material The purpose of use does not fall within the definition of cosmetics,It is not possible to apply for registration or filing according to new cosmetics raw materials. meanwhile,according to regulations requirement,The registration and filing materials of new cosmetic raw materials shall be based on scientific research,objective Accurately describe the properties of new raw materials Characteristics and safe use requirements.The ingredients of new cosmetic raw materials applied for registration or filing shall be relatively clear,Registrant The filing person or domestic responsible person shall submit the registration and filing materials of new cosmetic raw materials as required,And the legality of the information submitted Authenticity accuracy Responsible for integrity and traceability.ask What kind of raw materials are not new cosmetic raw materials
answer Raw materials meeting one of the following conditions,It is not a new raw material for cosmetics 1.Included in List of used cosmetic raw materials 2021Annual Edition Raw materials.Cosmetic registrant When the filer selects the raw materials in the catalogue,It shall comply with relevant national laws and regulations Mandatory national standards Relevant requirements of technical specifications,And bear the responsibility for product quality and safety.To exceed Maximum historical usage When used,Should be in accordance with Technical guidelines for safety assessment of cosmetics Procedures and requirements to prove its safety.2.Specific raw materials included in the used category of raw materials.If the category of raw materials has been included in the catalogue collagen ,Collagen,It refers to the general name of a certain category of raw materials,This category of raw materials includes different process sources, such as animal tissue extraction Recombinant collagen,It also includes different subtypes, such asIType collagen IIIType I collagen, etc.in addition, List of used cosmetic raw materials 2021edition Included in XX plant extract raw material,for example ginseng extract It indicates that the whole ginseng plant and its extract are used raw materials,If declared separately Ginseng juice Or a specific part of ginseng as a new raw material,Will not be accepted.3. Safety technical specification for cosmetics Raw materials specified as prohibited components.Like human cells Organization or human products Antihistamines Hormones, etc.4.Raw materials with actual functions beyond the definition of cosmetics.If yes Activated cell Regenerative cell Reduce pigment deposition at the wound site Healing promoting effect Promote the efflux of heavy metals And other medical raw materials.ask How to correctly understand the filing of new cosmetic raw materials
answer according to regulations regulations,The State implements classified management of cosmetic raw materials according to the degree of risk,Registration management shall be implemented for new cosmetic raw materials with high risk,Other new cosmetic raw materials shall be subject to filing management.The registrant of new cosmetic raw materials shall complete the filing after submitting the filing materials specified in these regulations through the online government service platform of the drug regulatory department of the State Council.The true meaning of filing is that the new raw material filer submits materials to the drug regulatory department for future reference.After the filing of new cosmetic raw materials is completed by the filing person,The State Food and Drug Administration announces the filing information of new raw materials,It only represents that the filing materials of the raw material have been submitted,Conform to form requirements,And the authenticity of its data content Scientific nature Adequacy may not have been verified.The disclosure of relevant information of new cosmetic raw materials that have been filed does not mean that the safety and functionality of the new raw materials are recognized,It doesn't matter Successfully approved for filing Statement of. according to regulations way regulations,After the filing of new cosmetics raw materials,The drug regulatory department will organize the technical evaluation institution to carry out technical verification on the filing materials of new raw materials,And track and evaluate the use and safety of new cosmetics raw materials,It is found that the filed materials of new cosmetic raw materials do not meet the requirements,Will be ordered to make corrections within a time limit,among,The filing materials related to the safety of new cosmetic raw materials do not meet the requirements,At the same time, it may be ordered to suspend the sales of new raw materials use The discovery of new cosmetic raw materials does not fall within the scope of filing,Or submitting false materials when filing,The filing of new cosmetic raw materials will be cancelled New cosmetic raw materials are ordered to suspend use or cancel the record,Cosmetic registrant The recorder shall suspend or stop production at the same time Operate cosmetics using the new raw materials.ask After the registration and filing of new raw materials,Registrant of new cosmetic raw materials What other obligations should the recorder fulfill
answer according to regulations way regulations,Registrant of new cosmetic raw materials The filer shall be responsible for the quality and safety of new cosmetic raw materials.Registered The safety monitoring period system shall be implemented for the new cosmetic raw materials that have been filed,During the safety monitoring period,Registrant of new cosmetic raw materials The filer shall pay close attention to the safe use of new raw materials,according to regulations Request collection Sort out information related to the use of new raw materials,organization Annual report on safety monitoring of new cosmetics raw materials ,Before the safety monitoring of new cosmetics raw materials every year30Within working days,Submitted to the technical review body through the information service platform.
E.g. registrant of new cosmetic raw materials The filer found problems in the use of new raw materials way Information required to be reported to the technical review body,Or other situations that need to be reported,It shall be carried out immediately in accordance with regulations Required preparation Safety risk control report of new cosmetics raw materials ,Submitted to the technical review body through the information service platform.ask How to according to the properties of new cosmetic raw materials,New cosmetic raw materials shall be applied for registration or filed
answer according to regulations regulations,Anti corrosion Sunscreen to color dye one 's hair New cosmetic raw materials with freckle removing and whitening function,It can only be used after being registered by the drug regulatory department under the State Council Other new cosmetic raw materials shall be filed with the drug regulatory department under the State Council before use.This is based on the principle of risk management,Registration management shall be implemented for several types of raw materials with relatively high risk,Other raw materials shall be subject to filing management.In the research and development of new cosmetics raw materials,It is often found that a new raw material may have multiple functions at the same time.Registrant of new cosmetic raw materials Before applying for registration or filing,The possible practical functions of new raw materials should be comprehensively combed and fully studied,science Make a reasonable judgment on whether the new raw material belongs to the situation that should be reported for registration.
generally speaking,For new raw materials with multiple functions at the same time,As long as one of the functions belongs to the situation that should be reported for registration,The new raw material should be in accordance with regulations Registration required,It can only be used after being approved and registered If it has multiple functions at the same time, it does not belong to the situation that it should apply for registration,Regardless of the type of function,Before use, follow regulations It is required to file with the State Food and drug administration.Registrant of new cosmetic raw materials The filer shall not deliberately conceal the actual functions of new raw materials,New cosmetic raw materials that should be applied for registration shall not be used in cosmetic production only after filing.Once such behavior is verified,Will follow regulations Penalties shall be imposed in accordance with the provisions of item 3 of Article 59.
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