Annex I Administrative measures for sampling inspection of cosmetics Draft for comments

Chapter I  total  be

Article 1 Formulation basis   

In order to strengthen the supervision and management of cosmetics,Standardize sampling inspection of cosmetics,according to Regulations on the supervision and administration of cosmetics  Measures for the supervision and administration of the production and operation of cosmetics And relevant laws and regulations,Formulate the measures.

Article 2 Scope of application   

The Department in charge of drug supervision and administration shall organize and implement the sampling inspection of cosmetics within the territory of the people's Republic of China,These Measures apply.

Article 3 General requirements   

The Department responsible for drug supervision and administration shall follow the scientific standard legitimate The principle of Justice,Guided by finding problems and troubleshooting potential risks,Organize and implement sampling inspection of cosmetics,Strengthen sampling test Re inspection and objection handling Whole process management of verification, disposal and information disclosure.

Article 4 Division of responsibilities   

The state drug administration organizes the sampling inspection of national cosmetics every year.

province Autonomous Region The drug supervision and Administration Department of the municipality directly under the central government organizes the sampling inspection of cosmetics within its administrative region every year,And in accordance with the requirements of the State Drug Administration,Undertake the task of national cosmetics sampling inspection.

Municipal level The Department in charge of drug supervision and administration at the county level shall comply with the requirements of the Department in charge of drug supervision and administration at a higher level,Undertake sampling inspection of cosmetics And according to work needs,Organize the sampling inspection of cosmetics in the administrative area.

Article 5 Obligations of producers and operators   

Cosmetics producers and operators shall accept the sampling inspection of cosmetics organized and implemented by the Department in charge of drug supervision and administration according to law,No interference Hinder or refuse sampling inspection,Do not provide false information.

Article 6 Source of funds   

The cost of sampling cosmetics shall be paid,The cost of sampling inspection shall be included in the government budget in accordance with the relevant provisions of the state.

Article 7 information system   

The State Drug Administration is responsible for establishing the national cosmetics sampling inspection information system,Strengthen the informatization construction of cosmetics sampling inspection.

The departments responsible for drug supervision and administration are encouraged to adopt information-based means to promote the sharing of sampling inspection information and data.

Chapter II Planning

Article 8 Plan category   

The State Drug Administration shall formulate an annual national cosmetics sampling inspection plan every year.province Autonomous Region The drug regulatory department of the municipality directly under the central government shall, in accordance with the annual national sampling inspection plan for cosmetics,Formulate the implementation plan of the Administrative Region.

Province Autonomous Region The drug regulatory department of the municipality directly under the central government shall formulate an annual sampling inspection plan for cosmetics in its administrative region every year.The provincial cosmetics sampling inspection plan shall be connected with the national cosmetics sampling inspection plan,Each has its own emphasis,Expand sampling coverage,Avoid repeated sampling.

Municipal level The Department in charge of drug supervision and administration at the county level shall, according to work needs,Formulate the sampling inspection plan for cosmetics within the administrative region.

Article 9 Plan content   

The sampling inspection plan for cosmetics shall include the following contents

one Category sampled

two Sampling link place quantity Sampling requirements such as time limit

three Inspection items Inspection method Judgment basis Inspection requirements such as inspection time limit

four Submission method and time limit of inspection report

five The inspection and disposal requirements for products whose inspection conclusion is that they do not conform to the regulations and have problems

six Other work requirements.

Article 10 Key categories   

The sampling inspection of cosmetics should focus on the following products

one Children's cosmetics and special cosmetics

two Cosmetics using new raw materials

three Supervision and inspection Adverse reaction monitoring Safety risk monitoring Complaints Report  There are many problems found in public opinion monitoring and other regulatory work

four The unqualified rate of previous sampling inspection is high

five Wide circulation range Frequently used

six Other products with high safety risks.

Chapter III  Draw  kind

Article 11 General requirements   

Sampling work should adhere to problem orientation Extensive coverage The principle of combining supervision and inspection with sampling inspection.

Article 12 Sampling subject   

The Department in charge of drug supervision and administration may sample by itself,It can also entrust units with corresponding capabilities set up or determined by the Department in charge of drug supervision and administration to undertake sampling tasks.

Commissioned sampling,The Department in charge of drug supervision and administration shall be responsible for the units that undertake the sampling task hereinafter referred to as Sampling unit  Supervise the work of.

Article 13 Sampling personnel requirements   

The sampling unit shall formulate a specific sampling implementation plan according to the cosmetics sampling inspection plan,Organize training for sampling personnel,Ensure the quality of sampling work.The sampling personnel should be familiar with the professional knowledge of cosmetics and laws and regulations related to the sampling work.

The sampling personnel shall not undertake the inspection of the samples they take.

Article 14 Sampling classification   

Sampling is divided into on-site sampling and network sampling.

The sampling personnel shall not inform the cosmetics producers and operators in advance before sampling.When sampling,The sampling personnel shall not be less than2people.

At the time of on-site sampling, the manufacturer or operator of the cosmetics to be sampled shall show the sampling work certificate.Online sampling should simulate the online shopping process,The manufacturer or operator of the sampled cosmetics shall not be informed of the purpose of purchase.

Article 15 Prohibited behaviors of sampling personnel   

The sampling personnel shall not have the following behaviors during the sampling process

one Unpack or replace the sample without authorization after the sample is sealed

two Disclose the trade secrets of the sampled cosmetics producers and operators

three Other behaviors that affect the fairness of sampling.

Article 16 Pre sampling inspection  

Before sampling,The sampling personnel shall register the market entities of the sampled cosmetics producers and operators Cosmetics production license Check the necessary information of cosmetics labels On site sampling of business links,If necessary, check the establishment and implementation of the incoming inspection record system.

Article 17 Sampling abnormality   

In sampling,It is found that the following circumstances are suspected:,It is a sampling anomaly,The sampling unit shall file a case for investigation or report the problem clues to the competent department in charge of drug supervision and administration according to law

one Unregistered special cosmetics or unregistered marketed products Imported ordinary cosmetics

two Cosmetics that have expired

three Imported cosmetics without Chinese label

four Cosmetics with prohibited contents on the label

five Other suspected illegal situations.

In addition to the previous paragraph two Except for the circumstances specified in item,For products with abnormal sampling conditions,The sampling department deems it necessary,Sampling can continue.

Article 18 Sampling process requirements  

The samples in the sampling inspection of cosmetics are divided into inspection samples and re inspection backup samples.In principle, the sampling quantity should meet the minimum demand of inspection and re inspection.

Field sampled,The sampling personnel shall collect the products to be sold from the sampled cosmetics producers and operators Samples are randomly selected from the reserved products,It shall not be provided by the sampled cosmetics producers and operators at their own choice.The sampling personnel shall keep the bills for purchasing samples,If necessary, check the sampling place storage environment  Sample information and other evidence shall be retained by taking photos or videos.

Network sampled,The sampling personnel shall record the registered account number of the samples purchased Payment account Receiving address Contact information and other information,And through the screenshot Record the information of the sampled cosmetics producers and operators by taking photos or videos Sample purchase website Sample web page display information,And order information Payment records, etc.After the sampling personnel receive the samples,The unpacking process shall be recorded by taking photos or videos,Label the sample Sample packaging, etc.

Article 19 No sampling   

Under one of the following circumstances,In principle, no sampling is allowed

one Products for export only

two The product has been opened Damaged or contaminated,Which may affect the inspection results

three The remaining service life of the product is insufficient6Months old,The service life of the product is less than6Except months

four Other situations where sampling is not allowed.

Article 20 Sample sealing requirements   

Sampling personnel shall take effective anti unsealing measures,Seal the test samples and recheck backup samples respectively.After sealing the sample, it should be possible without unpacking,Check the appearance of the sample Status, etc.

Article 21 Sampling documents and signature confirmation   

Sampling personnel shall use standardized sampling documents,clear complete Accurately record sampling information.The retention period of sampling documents shall not be less than2year.

Field sampled,The sampling personnel shall inform the sampled cosmetics producers and operators of their rights and obligations according to law.The sampling personnel and the person in charge or relevant personnel of the sampled cosmetics manufacturer or operator shall sign the cosmetics sampling document and the sampling seal Confirm by stamping, etc.The person in charge or relevant personnel of the sampled cosmetics manufacturer or operator refuses to confirm,The sampling personnel shall obtain evidence on site,And indicate and sign on the cosmetics sampling document.

Network sampled,The sampling personnel shall sign the sampling document and the sampling seal and affix the seal of the unit,Do not need to be signed and sealed by the manufacturer and operator of the sampled cosmetics.

Article 22 Sampling payment method   

Field sampled,The payment of sample fees is divided into on-site settlement and off-site settlement.Settled on site,The manufacturer or operator of the sampled cosmetics issues an invoice on the spot or pays the sampling fee hereinafter referred to as Payment unit  Approved certification materials,The sampling personnel shall pay the sample fee on the spot.Off site settlement,After the payment unit receives the invoice or the supporting materials approved by the payment unit,The manufacturer or operator of the cosmetics to be sampled shall pay the sample fee in time.

Network sampling cannot obtain invoices,You can use the screenshot of online payment and order details as the reimbursement voucher for purchasing samples.

Financial reimbursement system formulated by the Department responsible for drug supervision and Administration,Invoices should be supported Reimbursement of sampling expenses in the form of receipts and screenshots of online payment.

Article 23 Sample payment price   

To the cosmetic registrant Filed by The entrusted production enterprise pays the sample fee,Generally, it is paid according to the ex factory price of the sample Pay the sample fee to the cosmetics operator,Generally, it is paid according to the market sales price of the sample The sales price marked by the cosmetics operator includes service and other expenses,Should be deducted.

After sampling,Unable to test for justified reasons,And the samples cannot be returned to the sampled cosmetics producers and operators,The payer shall still pay the sample fee,And record the reasons for failure to inspect and the payment of expenses.

Article 24 Sample submission for inspection   

The sampling unit shall, after completing the sampling5Within working days,Sample Sampling documents and relevant data shall be delivered to the inspection institution.It is necessary to extend the sample submission period for special reasons,The Department in charge of drug supervision and administration that should be subject to sampling inspection hereinafter referred to as Organization sampling Department  agree.Field sampled,The manufacturer or operator of the cosmetics to be sampled shall not send samples by itself.

The sampling unit shall store in accordance with the provisions of laws and regulations and the requirements of cosmetics labels Transportation of cosmetics.

Chapter IV Inspection and result submission

Article 25 Inspection subject   

The Department in charge of drug supervision and administration shall set up or determine inspection institutions with corresponding qualifications and capabilities,Undertake the inspection task of sampled products.  

The Department in charge of drug supervision and administration shall be responsible for the institutions that undertake inspection tasks hereinafter referred to as Inspection organization  Supervise and manage the work of.

Article 26 Obligations of The Inspection Institution

Inspection institutions and inspection personnel shall follow the principles of objectivity, independence, fairness and fairness in carrying out inspection, ensure that the inspection results are true and accurate, and be responsible for the cosmetics inspection report issued.

While undertaking the task of sampling inspection, the accepting institution shall not accept the entrusted inspection of the same products of the cosmetics producers and operators to be sampled.

Article 27 [Sample Acceptance]

When receiving the samples, the inspection acceptance institution shall check the appearance, state and seal of the samples for breakage and other conditions that may affect the inspection results, and check the information of the samples and sampling documents, and store them as required.

Article 28 Samples shall not be accepted

Under any of the following circumstances, the testing institution may refuse to accept the sample after giving reasons to the sampling unit:

(1) damaged or contaminated samples;

(2) incomplete sample sealing information or non-standard sample sealing, which may affect the impartiality of inspection results;

(3) the information in the sample documents is incomplete or inaccurate, or obviously inconsistent with the sample;

(4) the storage and transportation conditions of samples do not meet the requirements, which may affect the inspection results;

(5) the varieties of samples are confused or the batch numbers are inconsistent;

(6) the number of samples does not obviously meet the inspection requirements;

(7) other circumstances that may affect sample quality and test results.

Article 29 [Inspection Standards]

The acceptance institution shall conduct inspection in accordance with the national standards, technical specifications, supplementary inspection methods and inspection items of cosmetics, and issue inspection conclusions.

Article 30 [Inspection Conclusion]

Inspection conclusion is to point to undertake inspection orgnaization will compulsory national standard, technical standard, cosmetics register or the technical requirement that puts on record data carries clearly to wait as judge basis, whether the inspection result that is sampled product accords with a regulation makes judge. In addition to the compliance and non-compliance of the inspection conclusions, if the compliance can be determined only after further verification by the department responsible for drug supervision and control, the inspection conclusions shall be deemed as having problems.

The inspection conclusion is the judgment made by the acceptance institution on the quality and safety risk of the sampled products from the technical point of view, which can be used for reference by the sampling inspection department and verification and disposal department.

Article 31 [Requirements for Inspection Report]

Unless otherwise stipulated in the sampling inspection plan, the inspection acceptance institution shall issue an inspection report within 30 working days from the date when the sampling unit delivers the samples; If an extension is needed under special circumstances, it shall be approved by the sampling inspection department. For those unqualified inspection items or unable to complete the inspection task on time due to special reasons, other cosmetics inspection institutions with corresponding qualifications may be entrusted to complete the inspection task with the consent of the sampling inspection department.

The inspection report shall be in standard format, with true and complete contents and accurate data, affixed with the official seal of the inspection acceptance institution or the special seal for inspection and testing, marked with the qualification identification mark of the inspection institution according to law, and signed or sealed by the authorized signatory. The preservation period of the original inspection records and inspection reports shall be no less than 6 years from the date of issuance of the inspection reports.

Article 32 Termination of Inspection

In the event of sample failure or other circumstances that make the inspection impossible, the acceptance institution shall terminate the inspection, truthfully record the situation and report to the sampling inspection department.

Article 33 Retention Period of Samples

The inspection accepting institution shall properly keep the backup samples for reinspection. If the inspection conclusion is in conformity with the provisions, the retention period of the sample shall be one year from the date of issuance of the inspection report; If the remaining service life of the sample is less than one year, it shall be kept until the end of the service life. If the inspection conclusion is not in conformity with the provisions or there are problems, the samples shall be kept until the end of their service life.

Article 34 [Inspection Report Submission]

If the inspection conclusion is in conformity with the provisions, the inspection acceptance institution shall submit the inspection report to the sampling inspection department within 7 working days from the date of issuing the inspection report.

If the inspection conclusion is not in conformity with the provisions or there are problems, the acceptance institution shall, within 2 working days from the date of issuing the inspection report, submit the inspection report, the copy of the sampling certificate, the photos of the outer package of the samples and other materials to the sampling inspection department.

In the course of inspection, the acceptance inspection institution shall immediately report to the sampling inspection department if it discovers that the samples may be adulterated or adulterated or illegally added forbidden materials, which may harm human health.

The acceptance institution may not disclose the sampling inspection results without authorization.

Article 35 [Push Verification and Disposal]

Tissue sampling inspection department shall receive inspection conclusion is not conform to the regulations or there is a problem of material such as inspection report within 5 working days from the date of the inspection report and other materials delivered by sampling the product label cosmetics registrant, for the record, entrusted responsibility in production enterprises, the local pharmaceutical supervisory and administrative departments at the provincial level, And the provincial drug regulatory department where the product operator and the e-commerce platform operator are located.

Responsible for checking the pharmaceutical supervisory and administrative department is responsible for the disposal of the work (hereinafter referred to as the departments for disposal of "verification") shall be the date of receipt of all the inspection reports and other materials within 5 working days, the inspection report and other material and sampling inspection results notice served by sampling production operators within their respective administrative areas, and involves the e-commerce platform operators, And inform them of their legal rights and obligations.

Chapter V Reinspection and Objections

Article 36 [Application for Reinspection]

By sampling the product cosmetics registrant, for the record, the production enterprises, domestic responsibility, operators to object to the inspection conclusion, shall receive inspection report and other material and sampling inspection results notice, within 7 working days from the date of the implementation of sampling inspection department at the next higher level or the pharmaceutical supervisory and administrative department responsible for apply for reexamination in writing; If the case is filed within the time limit, it shall not be accepted.

The application for reinspection of the same sample shall be made only once, and shall be made by one party after the producers and operators concerned with the sampled products reach a consensus. Where the entrusted manufacturer, domestic responsible person or business operator of the sampled product applies for re-inspection, the informed consent of the cosmetics registration and filing person of the product shall be submitted at the same time.

Where an application for re-inspection is submitted to the SDA, the SDA may entrust the provincial pharmaceutical supervisory and administrative department conducting sampling inspection to handle the application.

Article 37 [Circumstances of Non-Reinspection]

No reinspection shall be conducted under any of the following circumstances:

(1) the items of microbial examination do not conform to the provisions;

(2) The reinspection of the backup samples cannot be carried out due to special reasons;

(3) the sample has exceeded the service period;

(4) Other circumstances in which reinspection is not allowed as provided for by laws and regulations.

Article 38 When applying for reinspection, the applicant shall submit the following materials:

(1) Copies of the reinspection application form, the power of attorney of the legal representative or the person in charge, and the identity certificate of the person in charge;

(2) A copy of the inspection report and receipt for delivery of the inspection result notification;

(3) other information to be explained.

Article 39 [Acceptance of Reinspection]

The department responsible for drug supervision and administration accepting the reinspection application (hereinafter referred to as the "reinspection acceptance department") shall issue a notice of acceptance or rejection to the applicant within 5 working days from the date of receiving the reinspection application materials.

If the reinspection application materials do not meet the requirements, the reinspection acceptance department shall inform the applicant of the contents to be corrected once and for all; The applicant shall submit the supplementary materials within 5 working days. If the applicant fails to submit the supplementary materials within 5 working days without justifiable reasons, the application shall be deemed to have been abandoned. If the supplementary materials are provided, the acceptance period shall be recalculated from the date when the re-inspection accepting department receives the supplementary materials.

Article 40 [Confirmation of Reinspection Institution]

The accepting department of reinspection shall, within 5 working days from the date of acceptance, randomly determine the reinspection institutions in the list of cosmetics sampling inspection and reinspection institutions published by the SDA, issue a notice of reinspection to the applicant, and send a copy to the initial inspection institution, the reinspection institution and the organization of sampling inspection department. If the reinspection institution cannot be determined in time due to special reasons, it may be extended by 5 working days and explain the reasons to the applicant.

The re-inspection institution and the preliminary inspection institution shall not be the same institution. The re-inspection institution may not refuse the re-inspection task without justified reasons. Where the re-inspection institution has an interest relationship with the re-inspection applicant, such as entrustment of inspection, it may not accept the re-inspection task.

Article 41 [Reinspection payment]

The applicant for reinspection shall pay the reinspection fee to the reinspection institution in time after receiving the notice of reinspection, failing to pay the reinspection fee as required, the reinspection shall be deemed to have been abandoned.

If the reinspection conclusion is consistent with the preliminary inspection conclusion, the reinspection fee shall be borne by the reinspection applicant. If the conclusions of the reinspection are inconsistent with those of the preliminary inspection, the expenses of the reinspection shall be borne by the department conducting the sampling inspection.

Article 42 [Implementation of Reinspection]

The initial inspection institution shall, within 5 working days from the date of receiving the notice of re-inspection, send the reinspection backup sample to the re-inspection institution.

After receiving the sample, the reinspection institution shall confirm the completeness of the package and seal of the sample by taking photos or video, and make receiving records. If any damage is found in the package or seal of the sample, or any other situation that may affect the inspection results, the reinspection institution shall promptly report in writing to the reinspection acceptance department.

When conducting the re-inspection, the re-inspection institution shall use the same inspection method and judgment basis as the primary inspection institution. If there are any new regulations on inspection methods during the re-inspection, such regulations shall be followed.

Article 43 Time limit for Reinspection

The reinspection institution shall submit the reinspection report to the reinspection acceptance department within 20 working days from the date of receiving the reinspection backup samples. If the inspection cannot be completed within the prescribed time limit due to special circumstances, it shall notify the department accepting the re-inspection in advance and explain the reasons.

Article 44 [Notification of Reinspection Results]

The reinspection conclusion issued by the reinspection institution shall be the final inspection conclusion. The accepting department of reinspection shall, within 2 working days from the date of receiving the reinspection report, deliver the reinspection report to the applicant for reinspection, the initial inspection institution and the verification and disposal department.

Article 45 Objection Application

Cosmetic producers and operators may raise objections to the sampling process, authenticity of samples, inspection methods and application of standards. The objection application shall be submitted within the prescribed time, and the overdue submission shall not be accepted. For the same sample, if the cosmetics producer or operator raises an objection to the authenticity of the sample, the inspection method or the application of the standard, it shall not apply for re-inspection.

If the cosmetics producers and operators to be sampled have any objection to the sampling process of spot sampling, they shall, within 7 working days from the date of sampling, submit a written application for objection to the department conducting sampling inspection and submit relevant certification materials.

In case of any objection to the inspection method, standard application and other matters, the producers and operators of the sampled cosmetics shall, within 7 working days from the date of receiving the inspection report and other materials and the notification letter of the sampling inspection results, file an objection application to the department conducting the sampling inspection and submit relevant certification materials.

Cosmetics registrant, for the record, the production enterprises, domestic partners have objections to the authenticity of the sample, shall receive inspection report and other material and sampling inspection results notice, within 7 working days from the date of sampling inspection results to the service of notice of verification disposal department put forward objection application, and submit the relevant certificates.

Article 46 [Objection to the Sampling Process]

In case of any objection to the sampling process, the applicant shall submit the following materials:

(1) Copies of the objection application form, the power of attorney of the legal representative or the person in charge, and the identity certificate of the person handling the objection;

(2) a copy of the sampling certificate;

(3) other information to be explained.

Article 47 [Objections to inspection Methods, etc.]

Where there are objections to the inspection method, application of standards, authenticity of samples and other matters, the applicant shall submit the following materials:

(1) Copies of the objection application form, the power of attorney of the legal representative or the person in charge, and the identity certificate of the person handling the objection;

(2) A copy of the inspection report and receipt for delivery of the inspection result notification;

(3) If there is any objection to the authenticity of the sample, a description of the authenticity of the product and relevant certification materials shall be submitted together;

(4) Other information to be explained.

If the entrusted cosmetics manufacturer, domestic responsible person or business operator has any objection to the application of inspection methods and standards, they shall submit the informed consent of the cosmetics registrant and record holder with sample labels at the same time.

Article 48 Acceptance of Objections

The department responsible for drug supervision and administration accepting the objection application (hereinafter referred to as the objection acceptance department) shall issue a notice of acceptance or rejection within 5 working days from the date of receiving the objection application materials; If the case is rejected, it shall give reasons in writing. If the objection application materials do not meet the requirements, the objection acceptance department shall inform the applicant of the contents to be corrected once and for all. The applicant shall submit the supplementary materials within 5 working days. If the applicant fails to submit the supplementary materials within 5 working days without justifiable reasons, the application shall be deemed to have been abandoned. If the supplementary and corrected materials are provided, the acceptance period shall be recalculated from the date when the department accepting the objection receives the supplementary and corrected materials.

Article 49 [Examination of Objections]

In case of any objection to the sampling process, inspection method, standard application and other matters, the department accepting the objection shall, within 20 working days from the date of acceptance, complete the examination of the objection, and inform the applicant of the examination result in writing, and notify the verification and disposal department; If it is necessary to request relevant departments to put forward opinions, it may extend 10 working days to complete the examination of objections.

If there is any objection to the authenticity of the sample, the department accepting the objection shall, within 30 working days from the date of acceptance, issue the examination result of the objection, and inform the applicant of the examination result in writing, and notify the department organizing the sampling inspection.

Chapter VI Verification and Disposal

Article 50 [Investigation]

The verification and disposal department shall, within 15 working days from the date of receiving the inspection report of non-conforming or problematic products, file a case for investigation on the cosmetics producers and operators involved in accordance with the law; Where prohibited raw materials or substances possibly harmful to human health are detected, the cosmetics producers and operators involved shall be immediately put on file for investigation.

During the period of reinspection and objection handling, the verification and disposal department shall not stop the investigation and risk control of products that do not conform to the provisions or have problems.

Article 51 Investigation and Risk Control on registrants and record holders

In the investigation of cosmetics registrants, record holders, entrusted manufacturers and domestic responsible persons, the verification and disposal departments shall focus on the inspection records of raw materials purchased, raw materials in stock or retained samples, production records, retained samples and sales records of products involved in non-conforming or problematic products. Where the detection of banned raw materials or substances that may harm human health is involved, the verification and disposal department shall conduct sampling inspection of other batches or similar products and raw materials in stock or samples retained by the above-mentioned enterprises.

If the products are found to cause harm to human health or there is evidence of possible harm to human health, the verification and disposal departments shall take emergency control measures to order the enterprises to suspend production and business operations according to law; At the same time, if serious risks and hidden dangers exist in the cosmetic production quality management system, emergency control measures shall be taken to order the suspension of production and operation of all products of the enterprise according to law.

When the verification and disposal departments carry out investigations on overseas cosmetics registrants and record holders, such overseas cosmetics registrants and record holders may entrust their domestic responsible persons to assist in the investigation and sign for relevant law enforcement documents. Overseas cosmetics registrants and record holders who refuse to implement relevant administrative punishment decisions shall be prohibited from importing cosmetics within 10 years according to law.

Article 52 Investigation and Risk Control of Business Operators

In the investigation of cosmetic operators, the verification and disposal departments shall focus on the inspection records of the products whose inspection results are not in conformity with the provisions or have problems, and trace the above-mentioned products step by step. Where the source or flow of the product involves other provinces (autonomous regions or municipalities), an application for assistance in investigation or notification of illegal clues shall be submitted to the competent department responsible for drug supervision and control according to law.

Where a product is found to cause harm to human body or there is evidence of possible harm to human health, the verification and disposal department shall take emergency control measures to order the operator of the product to suspend business according to law.

Article 53 Investigation on Denial of Production/Import

If the cosmetics registrant, record holder, entrusted production enterprise or domestic responsible person raises an objection to the authenticity of the sample and denies that the product with the inspection conclusion not conforming to the provisions or having problems is produced or imported, the verification and disposal department shall focus on the investigation of the production records, product retention samples and sales records of the products involved. Other batches or similar products and raw materials in stock or retained samples of the above-mentioned enterprises shall be sampled for inspection. The verification and disposal department shall make a comprehensive judgment on whether the product is produced or imported by the enterprise based on on-site investigation, sampling inspection, product traceability in the business process, and materials of objection application submitted by the enterprise.

Where, after investigation and verification, cosmetics registrants, record holders, entrusted manufacturers or domestic responsible persons provide false information or conceal the true situation, the verification and disposal departments shall, in accordance with the serious circumstances stipulated in the Regulations on the Supervision and administration of Cosmetics, impose heavier and stricter punishments on them according to law.

Article 54 [Applicable to exemption of liability of operators]

Meet the following conditions of cosmetics operators at the same time, as to fulfill the obligations such as incoming inspection record, there is evidence to prove that it does not know the purchase of cosmetics is not conform to the compulsory national standards, technical specifications or does not conform to the cosmetic registration, registration data set forth the technical requirements, according to the provisions of article sixty-eight of the supervision and administration of cosmetics regulations, may be exempted from administrative punishment:

(1) Inspect and keep relevant certificates of the direct supplier's market subject registration certificate, registration certificate of special cosmetics or record information of ordinary cosmetics and product quality inspection certificate. Children's cosmetics shall also check the marks of children's cosmetics. Truthfully record the name of the cosmetics, special number or ordinary cosmetics for the record number of cosmetics registration, use period, net content, purchase quantity, supplier name, address, contact number, date of purchase, such as content, can by recording information and related documents to verify the conclusion is not conform to the rules and problems of product and its direct suppliers to carry on the back;

(2) to run cosmetics label information and inspection by the special registration certificate or ordinary cosmetics sure the same record information relating to the corresponding product information, including: name of cosmetics, special number or ordinary cosmetics for the record number of cosmetics registration, cosmetics registrant or for the record the name of the people, entrusted production enterprises, domestic person name.

Cosmetic operators that do not meet the above conditions shall not be exempted from administrative punishment in accordance with article 68 of the Regulations on the Supervision and Administration of Cosmetics.

Article 55 [Verification of disposal Time limit]

The verification and disposal department shall complete the verification and disposal work within 90 days from the date of receiving the inspection report of non-conforming products or existing problems, and impose administrative penalties on the cosmetics producers and operators involved according to law. If it is necessary to extend the working time limit due to special reasons, a written report shall be made in advance to the sampling inspection department.

Article 56 Recall, Self-Inspection and Rectification of Producers and Operators

Cosmetics registrant, for the record who received do not conform to the rules and existing problems of product inspection reports and sampling inspection results told book, shall, in accordance with the "cosmetics production and business operation supervision and management method" article 53, distinguish between the following situations, to immediately stop production, recall has been on sale of cosmetics, inform the relevant operators and consumers to stop operation, use:

(1) Where banned raw materials are found in the sampled products, the production of all products that may involve the banned raw materials shall be stopped;

(2) Where the microbiological test items of the sampled product do not meet the requirements, the production of all products in the workshop producing the product shall be stopped;

(3) Where the inspection items other than forbidden raw materials and microorganisms of the sampled products are found not in conformity with the provisions, the cosmetics registrant or archival filing person shall evaluate the quality defects or other problems of the products and whether they may endanger human health, and decide the scope of the products to be stopped by themselves.

Cosmetics registrants and record holders shall immediately carry out self-examination to find out the causes of the quality and safety risks of the products and make rectification; Where serious risks and hidden dangers are found in the cosmetics production quality management system through self-examination, the production and operation of all products shall be suspended immediately. After the self-inspection and rectification is completed, the cosmetics registrant and record-keeping person shall evaluate the cosmetics production quality management system, and the production can be resumed only after the risk factors affecting the quality and safety are eliminated.

Upon receipt of the recall notice from the cosmetics registrant or record holder, the entrusted manufacturer or cosmetic operator shall immediately stop the production and operation of the products involved and cooperate with the recall.

During the period of reinspection and handling of objections, cosmetics producers and operators shall not stop the risk control of products that do not conform to regulations or have problems.

Article 57 Supervise recall and Rectification

The verification and disposal departments shall supervise the recall, self-examination and rectification work of cosmetics producers and operators, and organize on-site inspections according to the actual situation.

Chapter VII Information Disclosure

Article 58 Subject of Information Disclosure

The department responsible for drug supervision and control shall be responsible for publishing the results of sample tests organized by the department.

No unit or individual shall release cosmetics sampling inspection information without authorization.

Article 59 [Public Contents]

The departments that organize sampling inspection shall publicize the sampling inspection results to the public in a timely manner through the government websites and other media. For the products whose inspection conclusion is not in conformity with the provisions, or the products whose inspection conclusion is problematic and whose illegal behavior is confirmed after verification, the disclosure of information shall at least include: Name, packing specifications, production date or batch number of the sampled products, non-conforming inspection items, labels indicating names and addresses of cosmetics registrants, record holders, entrusted manufacturers and domestic responsible persons, names and addresses of cosmetics producers and operators to be sampled, and names of inspection institutions, etc.

Where the cosmetics registrant, record holder, entrusted production enterprise or domestic responsible person raises objections and denies that the products that do not conform to the provisions or have problems are manufactured or imported by them, and the verification and disposal department makes a comprehensive judgment that the products are counterfeit, the sampling inspection department shall make an explanation when making public the sampling inspection results. If the cosmetics registrant, record holder, entrusted manufacturer or domestic responsible person provides false information or conceals the true situation after investigation and verification, the pharmaceutical supervisory and administrative department shall expose the false information.

Article 60 [Public Procedure]

The disclosure of sampling inspection information shall be carried out in accordance with the Regulations of the People's Republic of China on Government Information Disclosure and other laws and regulations.

With regard to the sampling inspection information of cosmetics that may have a major impact on the public interest, the disclosing department shall, prior to the disclosure of the information, strengthen the analysis, research and judgment, properly and accurately disclose the information, and, if necessary, report it in advance to the people's government at the same level and the drug regulatory department at the next higher level.

Chapter VIII Supplementary Provisions

Article 61 Supplementary Inspection

For cosmetics that may be adulterated or manufactured with raw materials that are forbidden to be used in cosmetics production and cannot be inspected according to the inspection items and methods prescribed in the national standards for cosmetics, the SDA may formulate supplementary inspection items and methods for sampling inspection of cosmetics.

Article 62 special Sampling Inspection

According to the needs of regulatory work, the department responsible for drug supervision and administration may organize special sampling inspection, and may also carry out sampling inspection on whether cosmetics meet the technical requirements stipulated in the registration and archival data. Relevant working procedures shall be carried out by reference to these Measures.

Sampling tests shall be carried out for supervision and inspection, complaint reporting, case investigation, adverse reaction monitoring and other regulatory work, and shall not be restricted by sampling quantity, sampling location, sample status, or disclosure of sampling test results.

Article 63 These Measures shall come into force as of 2022. The Notice of the General Office of the STATE Food and Drug Administration on Printing and Distributing the Work Norms for Sampling Inspection of Cosmetics (CFDA Pharmaceutical And Chemical Supervision [2017] No. 103) shall be abolished at the same time.

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