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 agency  

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