"Cosmetics production and operation supervision and management approach" officially released!

Order of the State Administration of Market Supervision and Administration

No. 46

The Measures for the Supervision and Administration of the Production and Operation of Cosmetics, as adopted at the 12th executive meeting of the State Administration for Market Regulation on July 26, 2021, are hereby issued and shall come into force on January 1, 2022.

Director Zhang Gong

August 2, 2021

The following text and original link:

Measures for the Supervision and Administration of the Production and Operation of Cosmetics

(Promulgated by Order No. 46 of the State Administration for Market Regulation on August 2, 2021)

Chapter I General Provisions

Article 1 In order to regulate the production and operation of cosmetics, strengthen the supervision and management of cosmetics, and ensure the quality and safety of cosmetics, these measures are formulated in accordance with the Regulations on the Supervision and Administration of Cosmetics.

Article 2 Those engaged in the production and operation of cosmetics within the territory of the People's Republic of China and the supervision and administration thereof shall abide by these Measures.

Article 3 The SDA shall be responsible for the supervision and administration of cosmetics throughout the country.

The departments responsible for the supervision and administration of pharmaceuticals under the local people's governments at or above the county level shall be responsible for the supervision and administration of cosmetics within their respective administrative regions.

Article 4 Cosmetics registrants and filers shall establish a cosmetics production quality management system in accordance with the law, fulfill the obligations of product adverse reaction monitoring, risk control, product recall, etc., and claim to be responsible for the quality, safety and efficacy of cosmetics. Cosmetic producers and operators shall engage in production and business activities in accordance with laws, regulations, rules, mandatory national standards, and technical specifications, strengthen management, integrity and self-discipline, and ensure the quality and safety of cosmetics.

Article 5 The State shall exercise licensing administration over the production of cosmetics. Engaged in cosmetics production activities, shall obtain a cosmetics production license in accordance with the law.

Article 6 Cosmetic producers and operators shall establish systems such as purchase inspection records and product sales records in accordance with the law to ensure the traceability of products.

Encourage cosmetics producers and operators to use information technology to collect and save production and operation information, and establish a cosmetics quality and safety traceability system.

Article 7 The State Drug Administration shall strengthen the construction of informatization and provide convenient services for the public to inquire about cosmetic information.

The department responsible for the supervision and administration of drugs shall promptly publish the supervision and management information such as the production license, supervision and inspection, and administrative punishment of cosmetics in accordance with the law.

Article 8 The departments responsible for drug supervision and administration shall give full play to the role of industry associations, consumer associations and other consumer organizations, news media, etc., promote the construction of a credit system, and promote the social co-governance of cosmetics safety.

Chapter II Production License

Article 9 To apply for a cosmetic production license, the following conditions shall be met:

(I) are enterprises established in accordance with the law;

The (II) has a production site suitable for the variety, quantity and production license items of cosmetics produced, and keeps a prescribed distance from toxic and harmful places and other pollution sources;

The (III) has production facilities and equipment suitable for the variety, quantity and production license items of cosmetics produced, and the layout is reasonable, and the facilities and equipment such as air purification and water treatment meet the specified requirements;

(IV) have technical personnel suitable for the variety, quantity and production license items of cosmetics produced;

(V) have inspectors and inspection equipment suitable for the variety and quantity of cosmetics produced and capable of inspecting the cosmetics produced;

(VI) has a management system to ensure the quality and safety of cosmetics.

Article 10 An applicant for a cosmetic production license shall apply to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where it is located, submit the certification materials that meet the conditions specified in Article 9 of these Measures, and be responsible for the authenticity of the materials.

Article 11 The pharmaceutical supervisory and administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government shall handle the cosmetics production license applications filed by the applicants according to the following circumstances:

If the (I) application does not need to obtain permission according to law, it shall make a decision not to accept the application and issue a notice of rejection;

If the (II) application does not fall within the scope of the powers of the pharmaceutical supervisory and administrative department in accordance with the law, it shall make a decision not to accept the application, issue a notice of rejection, and inform the applicant to apply to the relevant administrative organ;

If there are errors in the (III) application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot, and the applicant shall sign or seal the correction place and indicate the date of correction;

(IV) the application materials are incomplete or do not conform to the legal form, the applicant shall be informed on the spot or within 5 working days of all the contents that need to be supplemented and the time limit for submitting the supplemented materials. If the application is not notified within the time limit, it shall be accepted from the date of receipt of the application materials;

(V) the application materials are complete and conform to the legal form, or if the applicant submits all the supplementary materials as required, the application for cosmetic production license shall be accepted.

If the pharmaceutical supervisory and administrative department of a province, autonomous region or municipality directly under the Central Government accepts or retreats an application for a production license for cosmetics, it shall issue a notice of acceptance or rejection. If the decision is not accepted, the reasons for the inadmissibility shall be stated, and the applicant shall be informed of the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with the law.

Article 12 The pharmaceutical supervisory and administrative department of a province, autonomous region or municipality directly under the Central Government shall examine the application materials submitted by the applicant, conduct on-site verification of the production site of the applicant, and make a decision within 30 working days from the date of accepting the application for a production license for cosmetics.

Article 13 The pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall, on the basis of the examination of application materials and on-site verification, make a decision on granting permission to those who meet the prescribed conditions, and issue a cosmetic production license to the applicant within 5 working days from the date of making the decision. For those who do not meet the prescribed conditions, they shall promptly make a written decision on not granting permission and explain the reasons, at the same time, the applicant shall be informed of the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with the law.

The date of issuance of the cosmetic production license is the date of the licensing decision and is valid for 5 years.

14th cosmetics production license is divided into the original, copy. The original and copy shall have the same legal effect.

The State Drug Administration is responsible for formulating the format of the cosmetics production license. The pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the printing and issuance of cosmetics production licenses.

The electronic certificate of the cosmetic production license produced by the pharmaceutical supervisory and administrative department shall have the same legal effect as the printed cosmetic production license.

Article 15 A cosmetic production license shall state the license number, the name of the production enterprise, the domicile, the production address, the unified social credit code, the legal representative or the person in charge, the production license item, the validity period, the issuing authority, the date of issuing the license, etc.

The copy of the cosmetic production license shall also indicate the change of the cosmetic production license.

Article 16 Cosmetic production license items are divided into general liquid unit, cream lotion unit, powder unit, aerosol and organic solvent unit, wax-based unit, toothpaste unit, soap-based unit and other units according to the production process, finished product state and use of cosmetics. The SDA may adjust the division units of the production license items according to the actual needs of the supervision and management of the quality and safety of cosmetics.

With children's skin care, eye skin care cosmetics production conditions, should be specially marked in the production license project.

Article 17 Within the validity period of a cosmetic production license, if the licensing conditions of the applicant change, or if it is necessary to change the items stated in the license, it shall apply to the drug regulatory authority that originally issued the license for the change.

Article 18 If the production license items change, the production facilities and equipment that may affect the product quality and safety change, or the new, rebuilt, or expanded workshop is built on the original site of the cosmetics production site, the cosmetics manufacturer shall, before putting into production, issue the original license to the drug The supervisory and administrative department applies for the change, and submits the information related to the change in accordance with the provisions of Article 10 of these Measures. The drug regulatory department that originally issued the license shall conduct an examination, make a decision on whether to approve the change within 30 working days from the date of accepting the change application, and record it on the copy of the cosmetic production license. Where on-site verification is required, it shall be handled in accordance with the provisions of Article 12 of these Measures.

Due to the change of production license items, comprehensive on-site verification is required. If the drug supervision and administration department of the province, autonomous region or municipality directly under the central government has on-site verification and meets the requirements, a new cosmetic production license will be issued with the license number unchanged and the validity period will be recalculated from the date of issuance.

If the same cosmetics production enterprise applies for increasing the production address of cosmetics in the same province, autonomous region, or municipality directly under the Central Government, it may go through the change procedures in accordance with the provisions of these Measures.

Article 19 Where the name, domicile, legal representative or person in charge of the production enterprise changes, the cosmetics production enterprise shall, within 30 working days from the date of the change, apply for the change to the drug regulatory department that originally issued the license, and submit information related to the change. The pharmaceutical supervisory and administrative department that originally issued the license shall go through the formalities of change within 3 working days from the date of accepting the application.

If the person in charge of quality and safety, the reserved contact information, etc. change, the cosmetics manufacturer shall report to the original drug regulatory authority within 10 working days after the change.

Article 20 If the validity period of the production license of cosmetics needs to be renewed, the applicant shall submit an application for renewal of the license to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government within 90 to 30 working days before the expiration of the validity period of the production license, and promise that it meets the conditions for the production license of cosmetics stipulated in these Measures. The applicant shall be responsible for the authenticity and legality of the information submitted and the commitment made.

If the application for renewal of the license is not filed within the time limit, the application for renewal of the license shall no longer be accepted.

Article 21 The pharmaceutical supervisory and administrative department of a province, autonomous region, or municipality directly under the Central Government shall conduct a formal review of the application materials within 5 working days after receiving the application for renewal of the license, and accept the application if it meets the requirements, and within 10 working days from the date of acceptance A new cosmetic production license is issued to the applicant. The validity period of the license shall be recalculated from the day following the date of expiration of the original license.

Article 22 The pharmaceutical supervisory and administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government shall supervise the application materials and commitments of cosmetics manufacturers that have renewed their licenses, and if they find that they do not meet the conditions for cosmetics production licenses specified in Article 9 of these Measures, they shall revoke them in accordance with the law. Cosmetic production license.

Article 23 If a cosmetics production enterprise has one of the following circumstances, the drug regulatory department that originally issued the license shall cancel its cosmetics production license according to law and publish it on the government website:

(I) enterprises apply for cancellation on their own initiative;

The qualification of the main body of the (II) enterprise is terminated according to law;

(III) cosmetics production license expires without applying for renewal;

The production license of (IV) cosmetics is withdrawn or revoked according to law or the production license of cosmetics is revoked according to law;

Other circumstances under which the production license of cosmetics shall be canceled in (V) with the provisions of laws and regulations.

When a cosmetics manufacturer applies for cancellation of the production license, if the drug supervision and administration department that originally issued the license finds that the cancellation may affect the investigation and handling of the case, it may suspend the cancellation procedures.

Chapter III Production of Cosmetics

Article 24 The State Drug Administration shall formulate the quality management standards for cosmetics production, and specify the requirements for quality management institutions and personnel, quality assurance and control, plant facilities and equipment management, materials and product management, production process management, product sales management, etc.

Cosmetics registrants, filers, and entrusted production enterprises shall organize the production of cosmetics in accordance with the requirements of the cosmetics production quality management standards, establish a cosmetics production quality management system and ensure continuous and effective operation. Production workshops and other places shall not store or produce products that have adverse effects on the quality of cosmetics.

Article 25 Cosmetics registrants, filers and entrusted production enterprises shall establish and implement management systems to ensure the quality and safety of cosmetics, such as supplier selection, raw material acceptance, production process and quality control, equipment management, product inspection and sample retention.

Article 26 Where a registrant or recordholder of cosmetics entrusts the production of cosmetics, it shall entrust the production enterprise that has obtained the corresponding cosmetics production license to produce, supervise the whole process of its production activities, and be responsible for the quality and safety of the cosmetics commissioned. The entrusted production enterprise shall have the corresponding production conditions, organize production in accordance with laws, regulations, mandatory national standards, technical specifications and contractual agreements, be responsible for production activities and accept the supervision of the entrusting party.

Article 27 Cosmetics registrants, filers and entrusted production enterprises shall establish a responsibility system for the quality and safety of cosmetics and implement the main responsibility for the quality and safety of cosmetics.

The registrant, the filing person, the legal representative and the principal responsible person of the entrusted production enterprise shall be fully responsible for the quality and safety of cosmetics.

Article 28 The person in charge of quality and safety shall, in accordance with the requirements of the cosmetics quality and safety responsibility system, assist the cosmetics registrant, the filing person, the legal representative of the entrusted production enterprise, and the main person in charge to undertake the following corresponding product quality and safety management and product release responsibilities:

(I) establish and organize the implementation of the enterprise quality management system, and implement the quality and safety management responsibilities;

(II) the audit management of product formula, production process, material suppliers, etc;

(III) material release management and product release;

(IV) cosmetics adverse reaction monitoring management;

(V) the supervision and management of the production activities of entrusted production enterprises.

The person in charge of quality and safety shall have professional knowledge and legal knowledge related to the quality and safety of cosmetics, such as cosmetics, chemistry, chemical industry, biology, medicine, pharmacy, food, public health or law, be familiar with relevant laws, regulations, rules, mandatory national standards and technical specifications, and have more than 5 years of experience in cosmetics production or quality management.

Article 29 Cosmetics registrants, filers, and entrusted production enterprises shall establish and implement a health management system for employees, and establish health records for employees. Health records are kept for at least three years.

Persons directly engaged in cosmetic production activities shall undergo annual health examinations. Persons suffering from diseases that hinder the quality and safety of cosmetics as prescribed by the administrative department of health under the State Council shall not directly engage in cosmetics production activities.

Article 30 Cosmetics registrants, filers, and entrusted production enterprises shall formulate annual training plans for employees, carry out knowledge training on cosmetics laws, regulations, rules, mandatory national standards, technical specifications, etc., and establish training files. Operators and inspectors in production posts shall have corresponding knowledge and practical operation skills.

Article 31 Cosmetics can only be sold on the market after passing the factory inspection.

Cosmetic registrants and filers shall keep samples of cosmetics leaving the factory and record them in accordance with regulations. The retained samples shall be kept in the original sales packaging and the quantity shall meet the requirements of product quality inspection. The retention period of retained samples shall not be less than 6 months after the expiration of the product use period.

If the production of cosmetics is entrusted, the entrusted production enterprise shall also keep samples and record them in accordance with the provisions of the preceding paragraph.

Article 32 Cosmetics registrants, filers, and entrusted production enterprises shall establish and implement a record system for the inspection of raw materials and packaging materials that directly contact cosmetics, and a system for product sales records. The purchase inspection records and product sales records shall be true, complete and traceable, and the retention period shall not be less than 1 year after the expiration of the product use period; if the product use period is less than 1 year, the record retention period shall not be less than 2 years.

If the production of cosmetics is entrusted, records such as the purchase inspection of raw materials and packaging materials that directly contact cosmetics may be kept by the entrusted production enterprise.

Article 33 Cosmetics registrants, filers and entrusted production enterprises shall conduct self-examination on the implementation of the cosmetics production quality management norms every year. The self-inspection report shall include the problems found, product quality and safety evaluation, corrective measures, etc., and the shelf life shall not be less than 2 years.

If it is found through self-examination that the production conditions have changed and no longer meet the requirements of the cosmetics production quality management standards, the cosmetics registrant, the filing person, and the entrusted production enterprise shall immediately take corrective measures; if it is found that it may affect the quality and safety of cosmetics, it shall immediately stop production and Report to the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where it is located. Production can be resumed only after the risk factors affecting quality and safety are eliminated. The pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government may organize on-site inspections according to the actual situation.

Article 34 Cosmetics registrants, filers, and entrusted production enterprises have continuously stopped production for more than one year. Before re-production, they shall conduct a comprehensive self-examination and confirm that they meet the requirements before resuming production. The situation of self-examination and rectification shall be reported to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government within 10 working days from the date of resumption of production.

Article 35 The smallest sales unit of cosmetics shall have a Chinese label. The content of the label shall be consistent with the sample product label in the cosmetic registration or filing materials.

The names, ingredients, efficacy and other labels of cosmetics shall be true and legal, and shall not contain contents that violate laws and regulations, such as express or implied medical effects, false or misleading, and contrary to social public order and good customs. Where a trademark is used in a cosmetic name, it shall also comply with the relevant laws and regulations of the State on the administration of trademarks.

Article 36 Cosmetics for children shall comply with the requirements on the quality and safety of children's cosmetics, such as laws, regulations, mandatory national standards, technical specifications and cosmetic production quality management standards, and shall be marked on the product label in accordance with the provisions of the State Drug Administration.

Article 37 If the following circumstances are minor in the labeling of cosmetics, which does not affect product quality and safety and does not mislead consumers, it may be determined as a label defect as stipulated in the second paragraph of Article 61 of the Regulations on the Supervision and Administration of Cosmetics:

The font size of (I) characters, symbols and numbers is not standard, or there are many characters, missing characters, wrong characters or non-standard Chinese characters;

The marking method and format of (II) service life and net content are not standardized;

(III) cosmetic labels are unclear and difficult to identify or read, or some of the printed characters fall off or are not firmly pasted;

(IV) cosmetic ingredient names are not standardized or ingredients are not listed in descending order of formula content;

(V) other cases that violate the label management regulations but do not affect product quality and safety and will not mislead consumers.

Article 38 The registrant, recordation person and entrusted production enterprise of cosmetics shall take measures to avoid confusion between the product character and appearance form and food, drugs and other products, and prevent accidental ingestion and misuse.

The production and sale of toys and utensils for minors shall be marked with precautions in accordance with the law, and measures shall be taken to prevent the products from being misused as children's cosmetics.

Ordinary cosmetics may not claim special cosmetic related effects.

Chapter IV Operation of Cosmetics

Article 39 Cosmetic operators shall establish and implement a purchase inspection record system, check the direct supplier's market entity registration certificate, special cosmetic registration certificate or ordinary cosmetic filing information, cosmetic product quality inspection certificate and keep relevant certificates, truthfully record the name of cosmetics, special cosmetic registration certificate number or ordinary cosmetic filing number, service life, net content, purchase quantity, supplier name, address, contact information, purchase date, etc.

Article 40 For cosmetics operators that implement unified distribution, the headquarters of the operators may establish and implement a unified purchase inspection record system, and in accordance with the provisions of these Measures, conduct unified inspection records and keep relevant certificates. The operator's headquarters shall ensure that the branch stores can provide the relevant records and vouchers of the cosmetics they operate.

Article 41 Beauty salons, hotels, etc. that use cosmetics in business services or provide cosmetics to consumers shall perform the obligations of cosmetics operators as stipulated in the Regulations on the Supervision and Administration of Cosmetics and these Measures in accordance with the law.

Cosmetics used in the operation of beauty salons and cosmetics provided to consumers by hotels shall comply with the provisions of the minimum sales unit label.

Beauty salons shall display the sales packaging of the cosmetics they operate and use in a prominent position in their service places, so as to facilitate consumers to consult all the information on the cosmetics labels, and in accordance with the requirements of the cosmetics labels or instructions, correctly use or guide consumers to correctly use cosmetics.

Article 42 The organizers of the centralized cosmetics trading market and the organizers of the exhibition shall establish and effectively implement a management system to ensure the quality and safety of cosmetics, assume the management responsibility of the cosmetics operators entering the market, and urge the cosmetics operators entering the market to perform their obligations in accordance with the law. Organize at least one training on cosmetics quality and safety knowledge during the fair.

The organizers of the centralized cosmetics trading market and the organizers of the fair shall establish the files of the cosmetics operators entering the market, examine the registration certificates of the market entities of the cosmetics operators entering the market, and truthfully record the names or names, contact information, residence and other information of the operators. The archival information of the admission cosmetics operators shall be verified and updated in a timely manner to ensure authenticity, accuracy and integrity, and the retention period shall not be less than 2 years after the operators stop operating on the site.

The organizer of the cosmetics fair shall report the time, location and other basic information of the fair to the department in charge of drug supervision and administration at the county level before the fair is held.

Article 43 The organizers of the centralized cosmetics trading market and the organizers of the fair shall establish a cosmetics inspection system to inspect the operating conditions of the operators and the quality and safety of cosmetics. If it is found that the cosmetics business operators have violated the regulations on the supervision and administration of cosmetics and the provisions of these measures, they shall be stopped in time and dealt with in accordance with the regulations on the management of the centralized trading market or the agreement signed with the operators, and report to the department responsible for drug supervision and administration at the county level where they are located.

Encourage cosmetics centralized trading market organizers, fair organizers to establish cosmetics sampling inspection, unified sales voucher format and other systems.

Article 44 Cosmetics operators in e-commerce platforms and e-commerce operators operating cosmetics through self-built websites and other network services shall fully, truthfully and accurately disclose cosmetics that are consistent with cosmetics registration or filing materials on the main page of their business activities. Label and other information.

Article 45: Cosmetics e-commerce platform operators shall register their real names on the cosmetics operators in the platform that apply for entry, and require them to submit real information such as identity, address, contact information, etc., for verification and registration, establish registration files, and at least every 6 Verification and update once a month. Cosmetics e-commerce platform operators on the platform of cosmetics operator identity information preservation time from the date of withdrawal from the platform shall not be less than 3 years.

Article 46 Operators of cosmetics e-commerce platforms shall set up cosmetics quality management institutions or be equipped with full-time and part-time management personnel, establish and effectively implement cosmetics quality and safety management systems such as daily inspection of cosmetics, suppression and reporting of illegal acts, and handling of complaints and reports, and strengthen the publicity of relevant laws and regulations of cosmetics operators on the platform. Encourage cosmetics e-commerce platform operators to carry out sampling inspection.

The operator of the cosmetics e-commerce platform shall bear the responsibility for the management of the cosmetics operators on the platform in accordance with the law, conduct daily inspections on the business activities of the cosmetics operators on the platform, and urge the cosmetics operators on the platform to perform the obligations of the Cosmetics Supervision and Administration Regulations and these Measures in accordance with the law. If illegal operation of cosmetics is found, necessary measures such as deletion, blocking and disconnection shall be taken in accordance with the law or in accordance with the platform service agreement and trading rules to stop it in a timely manner, and report to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where it is located.

Article 47: Where an operator of a cosmetics e-commerce platform receives information on adverse reactions or complaints and reports of cosmetics, it shall record and promptly transfer it to the cosmetics operator on the platform for processing; major information related to product quality and safety shall be promptly reported to the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where it is located.

If the department responsible for drug supervision and administration requires the operator of the cosmetics e-commerce platform to provide relevant information in accordance with the law due to the needs of supervision and inspection, case investigation, etc., the operator of the cosmetics e-commerce platform shall assist and cooperate.

Article 48 If an operator of an e-commerce platform for cosmetics discovers any of the following serious violations, it shall immediately stop providing e-commerce platform services to the operators of cosmetics on the platform:

(I) being sentenced by a people's court for crimes related to the quality and safety of cosmetics;

(II) being detained by a public security organ or given other public security administrative penalties due to illegal acts on the quality and safety of cosmetics;

(III) being punished by the pharmaceutical supervisory and administrative department in accordance with the law, such as revoking the license or ordering to suspend production or business;

(IV) other serious violations.

If a case is filed for investigation or public prosecution due to suspected cosmetics quality and safety crimes, and there is evidence to prove that it may endanger human health, the cosmetics e-commerce platform operator may suspend the provision of e-commerce platform services to the cosmetics operators on the platform in accordance with the law or in accordance with the platform service agreement and transaction rules.

Cosmetics e-commerce platform operators who know or should know that cosmetics operators in the platform are prohibited from engaging in cosmetics production and business activities according to law shall not provide e-commerce platform services to them.

Article 49 Where cosmetics are provided to consumers in the form of free trial, gift, exchange, etc., the obligations of cosmetics operators as stipulated in the Regulations on the Supervision and Administration of Cosmetics and these Measures shall be fulfilled in accordance with the law.

Chapter V Supervision and Administration

Article 50 The department responsible for drug supervision and administration shall, in accordance with the principle of risk management, determine the key varieties, key links, inspection methods and inspection frequency of supervision and inspection, and strengthen the supervision and inspection of cosmetics producers and operators.

When necessary, the department in charge of drug supervision and administration may carry out extended inspection on suppliers and manufacturers of cosmetic raw materials and packaging materials that directly contact cosmetics.

Article 51 The SDA shall, in accordance with laws, regulations, rules, mandatory national standards, technical specifications and other relevant provisions, formulate the key points of supervision and inspection such as the inspection points of the national cosmetics production quality management standards, and clarify the key items and general items of supervision and inspection, as well as the judgment principles of supervision and inspection. The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government may, in combination with the actual situation, refine and supplement the main points of supervision and inspection of cosmetics in their respective administrative regions.

Article 52 The SDA shall organize the national sampling inspection of cosmetics. The pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall organize the sampling inspection of cosmetics within their respective administrative areas. The departments in charge of drug supervision of the people's governments at the municipal and county levels divided into districts may, according to the needs of their work, organize and carry out sampling inspection of cosmetics within their respective administrative areas.

For cosmetics that are reported or found to have many problems in daily supervision and inspection, as well as cosmetics that may have quality and safety problems through adverse reaction monitoring, safety risk monitoring and evaluation, the department responsible for drug supervision and administration may conduct special sampling inspection.

The department responsible for the supervision and administration of drugs shall, in accordance with the provisions, publish the results of the sampling inspection of cosmetics in a timely manner.

Article 53 If the sampling inspection results of cosmetics are unqualified, the cosmetics registrant and the filing person shall, in accordance with the provisions of Article 44 of the regulations on the supervision and administration of cosmetics, immediately stop production, recall the cosmetics that have been sold on the market, notify the relevant operators and consumers to stop operation and use, carry out self inspection and rectification in accordance with the provisions of the second paragraph of Article 33 of these measures.

Article 54 If there is any objection to the conclusion of the sampling inspection and applies for re-inspection, the applicant shall pay the re-inspection fee to the re-inspection institution in advance. If the reexamination conclusion is consistent with the preliminary examination conclusion, the reexamination fee shall be borne by the reexamination applicant. If the conclusion of the re-examination is inconsistent with the conclusion of the initial examination, the cost of the re-examination shall be borne by the drug supervision and administration department that implements the sampling inspection.

Article 55 The reporting of adverse reactions of cosmetics shall follow the principle of reporting when suspicious. The State Drug Administration shall establish and improve the monitoring system for adverse reactions of cosmetics and the monitoring information system for adverse reactions of cosmetics.

Article 56 Without the consent of cosmetics producers and operators, the departments responsible for drug supervision and administration, professional technical institutions and their staff shall not disclose the trade secrets of cosmetics producers and operators known in the supervision and inspection, unless otherwise provided by law or involving national security and major social and public interests.

Chapter VI Legal Liability

Article 57 Where there are provisions in laws and regulations such as the Regulations on the Supervision and Administration of Cosmetics for illegal acts in the production and operation of cosmetics, such provisions shall be followed.

Article 58 in violation of Article 17, paragraph 1 of Article 18 and paragraph 1 of Article 19 of these measures, if the licensing conditions of cosmetics production enterprises change, or the matters specified in the license need to be changed, and if they fail to apply for change in accordance with the provisions, the drug regulatory department that originally issued the license shall order them to make corrections, give them a warning and impose a fine of not less than 10000 yuan but not more than 30000 yuan.

In violation of the second paragraph of Article 19 of these Measures, if the person in charge of quality and safety and the reserved contact information change and fail to report as required, the drug regulatory department that originally issued the license shall order it to make corrections; if it refuses to make corrections, it shall be given a warning and imposed a fine of less than 5000 yuan.

If the cosmetics produced by a cosmetics production enterprise do not belong to the division unit of the licensed items specified in the cosmetics production license, and move without permission, or if the validity period of the cosmetics production license expires and the renewal license is not obtained, it shall be deemed to be engaged in cosmetics production activities without permission.

Article 59 If it is found in the supervision and inspection that the registered person, the filing person or the entrusted production enterprise of cosmetics violates the inspection points of the cosmetics production quality management standard and fails to organize the production in accordance with the requirements of the cosmetics production quality management standard, the department responsible for the supervision and administration of drugs shall be punished in accordance with the provisions of item 3 of Article 60 of the regulations on the supervision and administration of cosmetics.

During the supervision and inspection, it is found that the registered person, the filing person or the entrusted production enterprise of cosmetics violates the general items in the inspection points of the national cosmetics production quality management standard, and the illegal act is minor and corrected in time, and no harmful consequences are caused, no administrative penalty shall be imposed.

Article 60 If, in violation of the third paragraph of Article 42 of these Measures, the organizer of the fair fails to report the basic information of the fair to the local department responsible for drug supervision and administration as required, the department responsible for drug supervision and administration shall order it to make corrections and give a warning; if it refuses to make corrections, it shall be fined not less than 5000 yuan but not more than 30000 yuan.

61st one of the following circumstances, belong to the cosmetics supervision and management regulations of serious circumstances:

(I) the use of raw materials that are prohibited from being used in the production of cosmetics, new raw materials that should be registered but have not been registered to produce children's cosmetics, or illegally adding substances that may harm human health to children's cosmetics;

(II) intentionally providing false information or concealing the true situation;

(III) refusal and evasion of supervision and inspection;

(IV) commit an illegal act of the same nature within one year after being subject to administrative punishment for an illegal act of cosmetics, or commit an illegal act of cosmetics quality and safety after being subject to criminal punishment for violating laws and regulations on cosmetics quality and safety;

(V) other serious circumstances.

When a fine is imposed for a serious violation of the law, it shall be severe and severe in accordance with the law.

Article 62 If a producer or business operator of cosmetics violates laws, regulations, rules, mandatory national standards and technical specifications, which is an initial violation of the law and has minor harmful consequences and is corrected in a timely manner, no administrative penalty may be imposed.

If the party has evidence sufficient to prove that there is no subjective fault, no administrative penalty shall be imposed. Where laws and administrative regulations provide otherwise, such provisions shall prevail.

Chapter VII Supplementary Provisions

Article 63 A cosmetic production license shall be obtained for the preparation, filling and filling of the contents of cosmetics. The production process of labeling shall be completed in the cosmetics production enterprise that has completed the production process of the last contact with the contents of cosmetics.

Article 64 The technical requirements specified in the registration and filing materials of cosmetics specified in Item 2 of Article 60 of the Regulations on the Supervision and Administration of Cosmetics refer to the technical requirements that have a substantial impact on the quality and safety of cosmetics.

Article 65 The arrangement of the number of the production license of cosmetics is: X makeup XXXXXXXX. Among them, the first X represents the abbreviation of the province, autonomous region, or municipality where the licensing department is located, the second to fifth X represents the 4-digit license year, and the sixth to ninth X represents the 4-digit license serial number.

Article 66 These Measures shall come into force on January 1, 2022.

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1. Cosmetic raw material quality and safety information submission service

2. Supervision services for physicochemical/toxicological/efficacy tests of new cosmetic materials

3. Cosmetic new raw material safety assessment service

4. Tracking the whole process of filing/registration of new cosmetic raw materials

2. cosmetics existing raw material safety information submitted

1. Cosmetic raw material quality and safety information submission service

3. cosmetics registration

1. Filing and registration service of finished cosmetics products

New Anrun Chemical Regulations Advisory Services:

Declaration of new domestic chemical substances

Registration of hazardous chemicals and business license for hazardous chemicals

SDS/GHS Labeling

Declaration of cosmetic finished products and raw materials

EU REACH, Taiwan REACH, South Korea K-REACH Registration

Pharmaceutical, food contact materials regulatory consultation

Compliance services in countries where epidemic prevention materials are exported

Laboratory Testing Services

Environmental regulations consulting services

Including park environmental protection housekeeper, solid waste and hazardous waste comprehensive solution design, etc.

Contact: Miss Ann

Mobile phone number: 15801695345 (WeChat with the same number)

QQ: 1798064165

Electronic E-mail: nar@china-reach.net