Market Supervision Bureaus of Each District Market Supervision Bureau of Lingang New Area,Relevant departments of the Municipal Drug Administration Inspection Bureau All relevant directly affiliated units

   Management Measures for Quality and Safety Risk Grading of Cosmetics Production Enterprises in Shanghai Already approved by the Shanghai Drug Administration2024Year's Day25Approved by the Office Meeting of the Deputy Director,Now issued to you,Please follow and execute accordingly.

  Shanghai Drug Administration

  2025year1month13day

Public Scope Proactively disclose

Management Measures for Quality and Safety Risk Grading of Cosmetics Production Enterprises in Shanghai

Article 1 Purpose and Basis

  To strengthen the supervision of cosmetics production enterprises,Strengthen the quality, safety, and risk awareness of cosmetics production enterprises,Reasonably allocate regulatory resources,Enhance regulatory efficiency,according to Regulations on the Supervision and Administration of Cosmetics Regulations on the Supervision and Administration of Cosmetics Production and Operation Management Measures for Registration and Filing of Cosmetics Management Measures for Cosmetics Inspection Waiting for regulations rules,Based on the actual situation of this city,Develop this method.

Article 2 Scope of application

  Collection of information on quality and safety risks of cosmetics production enterprises within the administrative area of this city Grading evaluation This method applies to management activities such as application of results.

Article 3 Working principles

  The classification management of quality and safety risks in cosmetics production enterprises should follow objective and fair principles Scientific accuracy Quantitative evaluation Principles of dynamic management.

Article 4 Division of Responsibilities

  Shanghai Drug Administration Hereinafter referred to as the Municipal Drug Administration Responsible for formulating quality and safety risk classification indicators for cosmetics production enterprises,Establish a unified quality and safety risk classification management system for cosmetics production enterprises throughout the city,Organize the implementation of quality and safety risk classification management for cosmetics production enterprises in the city.

  city The department responsible for drug supervision and management in the district shall follow the responsibilities and division of labor for cosmetics supervision,Timely input Collect basic data related to quality and safety risk classification management of cosmetics production enterprises.

Article 5 Industry association participation

  Encourage relevant cosmetics industry associations in this city to participate in the quality and safety risk classification of cosmetics production enterprises,Urge cosmetics manufacturers to submit truthful information Complete self-assessment information on quality and safety risk classification.

Article 6 Dynamic updates and result queries

  The quality and safety risk classification of cosmetics production enterprises is dynamically updated annually,Grading cannot be upgraded beyond the level.If there are serious issues that affect the classification of enterprises,Should be updated immediately.

  Cosmetics production enterprises can query the grading results of their own enterprises through the cosmetics production enterprise quality and safety risk grading management system.

Article 7 Grading indicators

  The Municipal Drug Administration follows the risk+credit Classification regulatory requirements,Combining the implementation of corporate main responsibility Classification of quality and safety risk levels for cosmetics production enterprises based on regulatory and credit risk situations,formulate Quality and Safety Risk Grading Index for Cosmetics Production Enterprises in Shanghai See attachment ,Establish system compliance Credit risk and other two primary indicators,There are several sub indicators under the first level indicator Third level indicators,Adjustments can be made in a timely manner based on regulatory reality.

Article 8 Grading Settings

  The total score of quality and safety risk classification for cosmetics production enterprises is100branch,Set four levels

   one Alevel 90branch contain Above and above

   two Blevel 75branch contain to90branch

   three Clevel 60branch contain to75branch

   four Dlevel 60Below divided.

  accord with Quality and Safety Risk Grading Index for Cosmetics Production Enterprises in Shanghai Administrative penalties in China Malicious behavior Serious consequences and other prescribed situations,Should be assessed immediately asDlevel.

Article 9 Evaluation time

  The quality and safety risk classification of cosmetics production enterprises is evaluated once a year.For the current fiscal year11month30Starting from the date, tracing back one year is considered as one evaluation year.In the evaluation year5month31Enterprises that obtain cosmetics production licenses in the future or enterprises that have been continuously shut down for more than six months,Not participating in the annual evaluation,The evaluation information during this period will be included in the next evaluation year.

Article 10 Evaluation process

  The quality and safety risk grading assessment of cosmetics production enterprises shall be carried out in accordance with the grading indicators stipulated in Article 7 of these Measures,Divided into self-assessment Information verification preliminary assessment Result publicity and objection application Five stages of objection handling and final evaluation.

   one Self evaluation.Cosmetics production enterprises shall12month1Solstice12month15Submit self-evaluation information within the specified timeframe and provide a commitment of authenticity.

   two Information verification.The Municipal Drug Administration conducts annual inspections12month30Recently, the organization verified the self-evaluation information of the enterprise.

   three preliminary assessment.The Municipal Drug Administration announced the following year1month15The preliminary evaluation and grading results were recently formed.

   four Result notification and objection application.The Municipal Drug Administration shall1month20The preliminary evaluation grading results were recently formed.Cosmetics production enterprises can query the grading results of their own enterprises in the system,And can apply for objections to the grading results through the quality and safety risk grading management system of cosmetics production enterprises,And provide corresponding explanations and evidence materials.

   five Objection handling and final evaluation.The Municipal Drug Administration shall, after receiving the objection application from the cosmetics production enterprise7Review within one working day,And make a final evaluation conclusion to maintain or adjust the grading level results.

Article 11 Information correction

  The administrative penalty or other administrative decision based on the quality and safety risk classification of cosmetics production enterprises has been revoked Confirm illegality or invalidity,May affect the grading results,Cosmetics production enterprises can apply to the Municipal Drug Administration,The Municipal Drug Administration shall make corresponding adjustments in accordance with these Measures,And make corrections in the system.

Article 12 Application of grading results

  The Municipal Drug Administration and the District Market Supervision Bureau authorized or commissioned to undertake regulatory responsibilities for cosmetics production enterprises,We should strengthen the comprehensive application of the quality and safety risk classification results of cosmetics production enterprises,Reasonably determine regulatory priorities Regulatory measures Sampling ratio and regulatory frequency, etc.

  yesAImplementation of trigger based inspections in level cosmetics manufacturing enterprises.yesBGrade cosmetics manufacturing enterprise,Implement regular supervision and inspection frequency.yesCGrade orDGrade cosmetics manufacturing enterprise,Listed as a key regulatory object,Strengthen supervision and inspection.

  For the first time, the grading results have been downgraded toCGrade orDA level cosmetics manufacturing enterprise,The Municipal Drug Administration and the district market supervision bureaus authorized or entrusted to undertake the regulatory responsibilities of cosmetics production enterprises may conduct responsibility interviews with their legal representatives or main responsible persons in accordance with the law.

Article 13 Graded supervision

  The Municipal Drug Administration and the district market supervision bureaus authorized or commissioned to undertake the supervision responsibilities of cosmetics production enterprises shall reasonably determine the quality and safety risk classification results of cosmetics production enterprises based on the results of the classification Dynamically adjust the frequency of supervision and inspection,Implement differentiated and graded supervision

   one yesAGrade cosmetics manufacturing enterprise,Implement trigger based inspection

   two yesBGrade cosmetics manufacturing enterprise,Conduct daily supervision and inspection at least once every three years

   three yesCGrade cosmetics manufacturing enterprise,Conduct daily supervision and inspection at least once every two years

   four yesDGrade cosmetics manufacturing enterprise,Conduct daily supervision and inspection at least once a year.

  License inspection Due to inspection, it is not included in the inspection frequency,Daily supervision and inspection conducted through non site inspections shall be included in the inspection frequency,Related laws statute Regulations and other provisions have other provisions,According to its regulations.

Article 14 Implementation date

  This method is from2025year2month13Effective from [date],Valid for five years,to2030year2month12Day end.

    enclosure Quality and Safety Risk Grading Index for Cosmetics Production Enterprises in Shanghai