Product Compliance
Test/Filing/Registration
In order to further standardize the supervision and management of cosmetics,Protect the legitimate rights and interests of consumers,The cosmetics Supervision Department of the State Food and Drug Administration sorted out the issues of concern to the industry,According to China's current cosmetics laws and regulations and relevant technical specifications,Answer them one by one:
ask:
How to correctly fill in the safety information of cosmetic raw materials in the process of cosmetic registration and filing
answer:
according to Regulations on the supervision and administration of cosmetics Administrative measures for registration and filing of cosmetics Safety technical specification for cosmetics And other regulations and technical specifications,Cosmetic registrant The filer shall assess the safety risk of cosmetic raw materials,Fill in the raw material safety information used in the product formula during the registration and filing process.In order to promote the safety management level of raw materials in China's cosmetics industry,SFDA makes full use of information means,Organize the establishment of cosmetics raw material safety information submission platform,It is convenient for raw material enterprises to fill in and submit raw material safety information uniformly,Generate raw material submission code.Cosmetic registrant The filer can only fill in the raw material submission code provided by the raw material manufacturer, which will be associated by the platform,There is no need to fill in detailed raw material safety information repeatedly,Improve the efficiency of cosmetics registration and filing.
Based on the consideration of protecting trade secrets,The raw material safety information platform is only for cosmetic raw material enterprises to fill in and use.Raw material enterprises are registering with cosmetics When the filer provides the raw material submission code,Necessary safety information of cosmetic raw materials shall also be provided.For those without raw material submission code,It does not affect the registration and filing of cosmetics,Cosmetic registrant The filing person may, according to the raw material safety information document issued by the raw material manufacturer,Fill in the information related to the safety of raw materials on the cosmetics registration platform.
ask:
How to correctly understand the efficacy evaluation of cosmetics How to deal with registered and filed products before they can meet the regulatory requirements of cosmetic efficacy declaration
answer:
To implement Regulations on the supervision and administration of cosmetics ,Standardize and guide the efficacy evaluation of cosmetics,The State Food and Drug Administration formulated and issued Standard for evaluation of cosmetic efficacy claims 2021year The first50number,hereinafter referred to as standard .according to standard requirement,Not all cosmetics need efficacy evaluation.The majority of cosmetics on the market can be seen through vision Directly recognized by senses such as smell Such as cleaning Remove makeup Cosmetic modification aromatic Refreshing dye one 's hair Perm Hair color care Depilation Deodorization and assisted shaving or by simple physical covering Attach Friction, etc declare,All patients were exempted from efficacy evaluation Only a few have strong functions and are strictly managed according to drugs or foreign products of the Ministry of medicine in most countries and regions Such as freckle whitening Sunscreen Anti hair loss acne treatment nourish Repair, etc declare,Just now, it is required to conduct human efficacy evaluation test Other efficacy claims,According to the situation, through literature research Evaluate the efficacy of cosmetics by means of analysis or test.
about2021year5month1Cosmetics that have been registered and filed recently,Cosmetic registrant The filer shall comply with the transitional period policy,Upload the summary of the basis for the efficacy claim of relevant products.Registrant Filed by standard It is required to evaluate the efficacy of relevant products,The evaluation results cannot support the content of efficacy claims involved in the product name or label,Application for change may be made before the expiration of the transition period,Adjust the product classification code according to the actual attributes of the product,At the same time, the relevant contents of the product name or label shall be modified,Make it comply with regulatory requirements.
ask:
Cosmetic registrant How should the recorder keep samples of products How to determine the quantity of reserved samples
answer:
basis Measures for the supervision and administration of the production and operation of cosmetics Regulations on the administration of registration and filing materials of cosmetics Specification for quality management of cosmetics production ,Cosmetic registrant The recorder shall keep samples for each batch of products that leave the factory.The purpose of the sample retention system is to ensure product quality, safety and traceability,Registered person of cosmetics The main responsibility of the recorder for product quality and safety At the same time, when the sold products have quality and safety problems and are counterfeited,It is convenient to check the legitimacy and safety of each batch of products.
In the actual implementation of the sample retention system,According to the above regulations,At the same time, in order to save the operating cost of enterprises,Comprehensive consideration of different product categories Package specification Finished product status and other factors,The cosmetics Supervision Department of the State Food and Drug Administration referred to the actual supervision work and combined with the industry research,Sort out the sample quantity of common products sold in the market See the table below ,It can be used as a reference for enterprises in production and operation practice.For product types not listed in the following table,Please register cosmetics The recorder shall determine the quantity of reserved samples according to the requirements of laws and regulations.
Cosmetic registrant Reference table for reserved sample quantity of products of the filer
ask:
Registrant of imported cosmetics Where should the filer keep samples of the cosmetics imported into China
answer: 2021year11month,Issued by the State Food and Drug Administration About implementation Measures for the supervision and administration of the production and operation of cosmetics Announcement of relevant matters 2021Year140number ,to make clear2022year1month1Future overseas cosmetics registrant The recorder shall keep samples of each batch of products imported into China,Samples and records shall be kept by the responsible person in China.Importing products of the same production batch several times,Samples shall be kept at least once during the first import. basis Specification for quality management of cosmetics production ,Registrant of commissioned cosmetics The recorder shall keep samples at his domicile or main business place,Samples may also be kept at their domicile or other business premises where their main business premises are located.yes The location of its domicile or main business place in Location Understanding of,It is generally recognized as not exceeding the administrative area of the same prefecture level city or the same municipality directly under the central government.The domestic responsible person keeps the reserved samples,The selection of sample retention sites shall be carried out with reference to the above provisions.Selection of sample retention location,It shall be able to meet the provisions of laws and regulations and the product storage requirements marked on the label.