1. Accessories

Shanghai Cosmetics Manufacturing Enterprises Quality and Safety Risk Classification Management Measures (for Trial Implementation)

Article 1 (Purpose and Basis)

In order to strengthen the supervision of cosmetic production enterprises, strengthen the quality safety and risk awareness of cosmetic production enterprises, reasonably allocate supervision resources, and improve supervision efficiency, according to the "Cosmetics Supervision and Administration Regulations", "Cosmetics Production and Operation Supervision and Management Measures", "Cosmetics Registration and Filing Management Measures" and other regulations , regulations, and in light of the actual situation of this city, formulate these measures.

Article 2 (Scope of Application)

These Measures shall apply to the management activities of information collection, grading evaluation, and result application of the quality and safety risks of cosmetic production enterprises within the administrative region of this Municipality.

Article 3 (Working Principles)

The quality and safety risk classification management of cosmetic production enterprises should follow the principles of objectivity, fairness, scientific accuracy, quantitative evaluation, and dynamic management.

Article 4 (Division of Responsibilities)

The Municipal Drug Administration (hereinafter referred to as the Municipal Drug Administration) is responsible for formulating the quality and safety risk classification indicators of cosmetic production enterprises, building a unified quality and safety risk classification management system for cosmetic production enterprises in the city, and organizing the quality and safety risk classification management of cosmetics production enterprises in the city. .

The municipal and district departments in charge of drug supervision and administration shall, in accordance with the responsibilities and division of labor for cosmetics supervision, timely enter and collect the basic data related to the quality and safety risk classification management of cosmetics production enterprises.

Article 5 (Industry Association Participation)

Relevant cosmetic industry associations in this city are responsible for urging cosmetic manufacturers to submit true and complete quality and safety risk grading self-assessment information on time, and undertake the verification work of cosmetic manufacturers' self-assessment information.

Article 6 (Dynamic update and result query)

The quality and safety risk classification of cosmetic production enterprises is updated dynamically on an annual basis, and the classification shall not be raised by leaps and bounds. If any matter that seriously affects the enterprise classification occurs, it should be updated immediately.

Cosmetics production enterprises can query the classification results of their enterprises through the quality and safety risk classification management system of cosmetic production enterprises.

Article 7 (Grading Index)

According to the implementation of the main responsibilities of the enterprise and the supervision situation, the Municipal Drug Administration has carried out the classification of quality and safety risk levels for cosmetic production enterprises, formulated the "Shanghai Cosmetics Production There are three first-level indicators such as social impact, and there are several second-level indicators under the first-level indicators, which can be adjusted in time according to the actual supervision.

Article 8 (Grading Setting)

The total quality and safety risk classification of cosmetic production enterprises is 100 points, and four levels are set:

 (1) Grade A: 90 points (inclusive) and above; 

(2) Grade B: 75 points (inclusive) to 90 points; 

(3) Grade C: 60 points (inclusive) to 75 points; 

(4) Grade D: below 60 points.

 Those that meet the requirements of administrative punishment, malicious behavior, serious consequences, etc. in the "Shanghai Cosmetics Production Enterprise Quality and Safety Risk Grading Index" shall be immediately rated as D grade.

Article 9 (Assessment Time)

The quality and safety risk classification of cosmetic production enterprises is assessed once a year. An assessment year starts from November 30 of the current year and goes back one year. Enterprises that have obtained a cosmetic production license after May 31 of the assessment year or enterprises that have been out of production for more than half a year will not participate in the assessment of the current year, and the assessment information during this period will be included in the next assessment year.

Article 10 (Assessment Process)

The quality and safety risk grading assessment of cosmetic production enterprises is carried out according to the grading indicators stipulated in Article 7 of these measures, and is divided into five stages: self-assessment, information verification, initial assessment, result notification and objection application, objection handling and final assessment.

(1) Self-assessment. Cosmetics manufacturers should submit self-assessment information with authenticity commitments from December 1 to December 15 each year.

 (2) Information verification. Relevant cosmetic industry associations should complete the verification of enterprise self-assessment information before December 30 each year, and should make corresponding remarks if any problems are found.

 (3) Preliminary evaluation. The Municipal Drug Administration shall form the preliminary grading results before January 15 of the following year.

 (4) Notification of results and application for objection. The Municipal Drug Administration shall notify the cosmetic manufacturer of the preliminary grading result before January 20 of the following year. If the cosmetic manufacturer has any objection to the grading result, it shall raise an objection to the Municipal Drug Administration within 7 working days after receiving the notification result. Application, and provide corresponding description and evidence materials.

 (5) Objection handling and final evaluation. The Municipal Drug Administration shall review the application within 7 working days after receiving the objection application from the cosmetics manufacturer, and make a final evaluation conclusion to maintain or adjust the grading result.

 If it is immediately assessed as Grade D, the Municipal Drug Administration shall notify the cosmetic manufacturer of the results of the grading within 5 working days after the assessment, and the application and handling of objections shall be handled in accordance with the provisions of the preceding paragraph.

 Article 11 (Correction of Information)

If the administrative punishment or other administrative treatment decision on which the quality and safety risk classification of a cosmetic production enterprise is based is revoked, confirmed to be illegal or invalid, which may affect the classification result, the cosmetic production enterprise may apply to the Municipal Drug Administration, and the Municipal Drug Administration shall This method shall be adjusted accordingly and corrected in the system.

 Article 12 (Application of Grading Results)

The Municipal Drug Administration and the District Market Supervision Bureau authorized or entrusted to undertake the supervision of cosmetic production enterprises shall strengthen the comprehensive application of the results of the quality and safety risk classification of cosmetic production enterprises, and reasonably determine the supervision focus, supervision measures, random inspection ratio and supervision frequency, etc. .

For A-level cosmetics production enterprises, optimize the frequency of supervision. For B-level cosmetics production enterprises, the regular supervision frequency is implemented. For C-level or D-level cosmetics production enterprises, it is listed as a key supervision object, and the frequency of supervision is increased.

For a cosmetic production enterprise whose grading result has been downgraded to Grade C or Grade D for the first time, the Municipal Drug Administration and the District Market Supervision Bureau authorized or entrusted to undertake the supervision of cosmetic production enterprises may make a liability agreement with its legal representative or principal in accordance with the law. talk.

Article 13 (Graded Supervision)

The Municipal Drug Administration and the district market supervision bureau authorized or entrusted to undertake the supervision of cosmetic production enterprises shall reasonably determine and dynamically adjust the frequency of supervision and inspection according to the results of the quality and safety risk classification of cosmetic production enterprises, and implement differentiated and graded supervision:

(1) For A-level cosmetics production enterprises, at least once every five years, carry out a production quality management standard compliance inspection and a daily supervision and inspection;

 (2) For B-level cosmetics production enterprises, at least once every three years, carry out a production quality management standard compliance inspection and a daily supervision and inspection;

 (3) For C-level cosmetics production enterprises, at least once every two years, carry out a production quality management standard compliance inspection and a daily supervision and inspection;

 (4) For D-level cosmetics production enterprises, at least one inspection of compliance with production quality management standards and one daily supervision inspection shall be carried out every year.

Article 14 (Date of Implementation)

These measures will be implemented from September 1, 2022, and will be valid for 2 years until August 31, 2024.

Attachment: Quality and Safety Risk Grading Indicators for Shanghai Cosmetics Manufacturers

2. Accessories

Shanghai Cosmetics Manufacturer Quality and Safety Risk Classification Index