Product Compliance
Test/Filing/Registration
Food and Drug Administration Office drug and chemical supervision 2018 4number
every province Autonomous Region Municipal Food and Drug Administration,China Institute for food and drug control
in recent years,To strengthen the supervision of cosmetics,Improve the initiative and pertinence of cosmetics supervision,The General Administration has organized and carried out cosmetics risk monitoring.On the basis of summarizing experience and in-depth investigation,The General Administration has formulated Procedures for risk monitoring of cosmetics See Annex .In order to further standardize and strengthen the risk monitoring of cosmetics,The relevant requirements are hereby notified as follows
one The pharmaceutical and chemical supervision department of the general administration is responsible for organizing and carrying out national cosmetics risk monitoring,Establishment of cosmetics risk monitoring Secretariat.
two The Secretariat is located in China Institute for food and drug control,Be responsible for the organization, coordination and daily management of cosmetics risk monitoring.
three The Department of pharmaceutical and chemical supervision of the State Administration of the people's Republic of China organized the establishment of a cosmetics risk monitoring working group,Member units are responsible for collecting risk information about cosmetics,Carry out cosmetics risk monitoring according to the plan,And put forward relevant suggestions to the Secretariat on improving and strengthening sampling inspection and monitoring.
four every province area city The food and drug administration is responsible for organizing the inspection institutions within its administrative region to declare the member units of the risk monitoring working group,And report according to the risk monitoring work of the general administration,Take relevant risk control measures in time.
enclosure Procedures for risk monitoring of cosmetics
Procedures for risk monitoring of cosmetics
To implement the State Food and Drug Administration Hereinafter referred to as the general administration Cosmetics supervision and management function,Standardize cosmetics safety risk monitoring Hereinafter referred to as risk monitoring work,This procedure is hereby formulated.
Risk monitoring in this procedure,Means through systematic Continuously collect information on risk factors in cosmetics Sample collection test Result analysis,Early detection of cosmetic quality and safety problems,Supervise sampling inspection for cosmetics Activities providing basis for risk research, judgment and disposal.
1.Working principle
The food and drug supervision and administration department shall be scientific Carry out cosmetics risk monitoring fairly,Ensure that the risk monitoring results are objective real accuracy.
2.plan
2.1The cosmetics risk monitoring Secretariat is responsible for organizing the formulation of the risk monitoring work plan,After discussion and adoption by members of the risk monitoring working group, the following contents are determined
Monitoring items Name of member company and its sampling area Inspection tasks of member companies Type of sample collected source batch Inspection items and basis Summary of monitoring data analysis Reporting requirements Completion time limit, etc.
2.2Risk monitoring focuses on the following situations:
2.2.1Products that may contain potential hazards
2.2.2Wide circulation range High consumption products
2.2.3Products causing cosmetic safety accidents or concerned by consumers
2.2.4Products suspected of false and exaggerated publicity to mislead consumers
2.2.5Products with potential risks according to adverse reaction monitoring results
2.2.6Technically unavoidable,Products that cause risk substances to be brought in as impurities.
3.sampling
3.1Member units shall comply with the requirements of the risk monitoring work plan,Collect samples by purchase.In principle, the same variety shall not be collected repeatedly.The number of samples shall meet the needs of inspection.
3.2The sampling location shall be determined according to the actual situation of sample collection,It is generally a cosmetics business place.
3.3The samples collected shall be the products with finalized packaging.Sample collection information includes but is not limited to product name batch number date of manufacture/quality guarantee period/Limited use date Specifications Sampling point address Name and address of manufacturer, etc.
3.4The collected samples shall be properly transported and stored,Prevent sample deterioration Pollution situation.Samples with special requirements for storage conditions,Save as required.
4.test
4.1Member units shall carry out testing in accordance with the requirements of the risk monitoring plan.When necessary,Exploratory research can be carried out.
4.2The member unit finds problems in the inspection method,Relevant information should be reported to the Secretariat in a timely manner,And put forward solutions.
5.Monitoring Report
5.1Member units shall meet the requirements of the plan,Risk monitoring data Analyze and judge the results,Write a work report and submit it to the Secretariat.
5.2Summary of risk monitoring results by the Secretariat,Write monitoring summary report and submit it to the State Administration.
6.Result utilization
6.1The risk monitoring results shall not be used as the basis for supervision and law enforcement.
6.2In risk monitoring,Illegal behaviors or potential safety hazards of products are found,It shall be reported to the Secretariat in a timely manner,The Secretariat shall report to the general administration,The general administration organizes investigation and verification,Take necessary measures to mitigate risks.
7.Job requirements
7.1Member units shall conduct sampling in strict accordance with the plan requirements Inspection and result reporting,No concealment is allowed Lie Missing monitoring data,Ensure the authenticity of monitoring results Objective and accurate.
7.2Member units shall not release monitoring information without authorization,It is not allowed to inform the sampled unit in advance of the monitoring work,Gifts from sampled units shall not be accepted,The monitoring results shall not be used to carry out paid activities.