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化妆品监督管理条例

化妆品监督管理条例

Cosmetics Supervision and Administration Ordinance

第一章　总　　则

Chapter 1 General

第一条　为了规范化妆品生产经营活动，加强化妆品监督管理，保证化妆品质量安全，保障消费者健康，促进化妆品产业健康发展，制定本条例。

Article 1 In order to standardize the production and operation of cosmetics, strengthen the supervision and management of cosmetics, ensure the quality and safety of cosmetics, ensure the health of consumers, and promote the healthy development of cosmetics industry, these regulations are formulated.

第二条　在中华人民共和国境内从事化妆品生产经营活动及其监督管理，应当遵守本条例。

Article 2 These regulations shall be observed when engaging in cosmetics production and business operation within the territory of the People’s Republic of China and its supervision and administration.

第三条　本条例所称化妆品，是指以涂擦、喷洒或者其他类似方法，施用于皮肤、毛发、指甲、口唇等人体表面，以清洁、保护、美化、修饰为目的的日用化学工业产品。

Article 3 Cosmetics referred to in these regulations refer to daily chemical industrial products which are applied to the skin, hair, nails, lips and other human surfaces by rubbing, spraying or other similar methods for the purpose of cleaning, protecting, beautifying and modifying.

第四条　国家按照风险程度对化妆品、化妆品原料实行分类管理。

Article 4 The State carries out classified management of cosmetics and cosmetics raw materials according to the degree of risk.

化妆品分为特殊化妆品和普通化妆品。国家对特殊化妆品实行注册管理，对普通化妆品实行备案管理。

Cosmetics are divided into special cosmetics and ordinary cosmetics. The State shall administer the registration of special cosmetics and the filing of ordinary cosmetics.

化妆品原料分为新原料和已使用的原料。国家对风险程度较高的化妆品新原料实行注册管理，对其他化妆品新原料实行备案管理。

Cosmetics raw materials are divided into new raw materials and used materials. The State carries out registration management for cosmetics raw materials with high risk degree, and records management for other new cosmetics raw materials.

第五条　国务院药品监督管理部门负责全国化妆品监督管理工作。国务院有关部门在各自职责范围内负责与化妆品有关的监督管理工作。

Article 5 The department of drug supervision and administration under the State Council shall be responsible for the supervision and administration of cosmetics throughout the country. The relevant departments under the State Council shall be responsible for the supervision and administration of cosmetics within the scope of their respective duties.

县级以上地方人民政府负责药品监督管理的部门负责本行政区域的化妆品监督管理工作。县级以上地方人民政府有关部门在各自职责范围内负责与化妆品有关的监督管理工作。

The departments of the local people’s governments at or above the county level responsible for drug supervision and administration shall be responsible for the supervision and administration of cosmetics in their respective administration areas. The relevant departments of the local people’s government at or above the county level shall be responsible for the supervision and administration of cosmetics within the scope of their respective duties.

第六条　化妆品注册人、备案人对化妆品的质量安全和功效宣称负责。

Article 6 Cosmetics registrants and filing persons are responsible for the quality, safety and efficacy claims of cosmetics.

化妆品生产经营者应当依照法律、法规、强制性国家标准、技术规范从事生产经营活动，加强管理，诚信自律，保证化妆品质量安全。

Cosmetics producers and operators shall be engage in production and business activities in accordance with laws, regulations, mandatory national standards and technical specifications, strengthen management, honesty and self-discipline, and ensure the quality and safety of cosmetics.

第七条　化妆品行业协会应当加强行业自律，督促引导化妆品生产经营者依法从事生产经营活动，推动行业诚信建设。

Article 7 Cosmetics trade association should strengthen industry self-discipline, urge and guide cosmetics producers and operators to engage in production and business activities according to law, and promote the construction of industry integrity.

第八条　消费者协会和其他消费者组织对违反本条例规定损害消费者合法权益的行为，依法进行社会监督。

Article 8 Consumer association and other consumer organizations shall, in accordance with the law, exercise social supervision over acts that violate the previsions of these Regulations and damage the legitimate rights and interests of consumers.

第九条　国家鼓励和支持开展化妆品研究、创新，满足消费者需求，推进化妆品品牌建设，发挥品牌引领作用。国家保护单位和个人开展化妆品研究、创新的合法权益。

Article 9 The State encourages and supports the development of cosmetics research, innovation, meet the needs of consumers, promote the construction of cosmetics brands, play a leading role in brand. The State protects the legitimate rights and interests of units and individuals in carrying out cosmetic research and innovation.

国家鼓励和支持化妆品生产经营者采用先进技术和先进管理规范，提高化妆品质量安全水平；鼓励和支持运用现代科学技术，结合我国传统优势项目和特色植物资源研究开发化妆品。

The State encourages and supports cosmetics producers and operators to adopt advanced technology and advanced management norms to improve the quality and safety level of cosmetics; encourages and supports the use of modern science and technology to study and develop cosmetics in combination with traditional superior projects and characteristic plant resources in China.

第十条　国家加强化妆品监督管理信息化建设，提高在线政务服务水平，为办理化妆品行政许可、备案提供便利，推进监督管理信息共享。

Article 10 The State strengthens the information construction of cosmetics supervision and management, improves the level of online government service, provides convenience for handling cosmetics administrative license and filing, and promotes the sharing of supervision and management information.

第二章　原料与产品

Chapter 2 Raw Materials and Products

第十一条　在我国境内首次使用于化妆品的天然或者人工原料为化妆品新原料。具有防腐、防晒、着色、染发、祛斑美白功能的化妆品新原料，经国务院药品监督管理部门注册后方可使用；其他化妆品新原料应当在使用前向国务院药品监督管理部门备案。国务院药品监督管理部门可以根据科学研究的发展，调整实行注册管理的化妆品新原料的范围，经国务院批准后实施。

Article 11 The natural or artificial raw materials used in cosmetics for the first time in China are new raw materials for cosmetics. New raw materials for cosmetics with functions of anti-corrosion, sun protection, coloring, hair dyeing and freckle whitening shall be registered by the drug regulatory department under the State Council before they can be used; other new raw materials for cosmetics shall be filed with the drug regulatory department under the State Council before they are used. The department of drug supervision and administration under the State Council may, in accordance with the development of scientific research, adjust the scope of new raw materials for cosmetics under registration administration and implement them after approval by the State Council.

第十二条　申请化妆品新原料注册或者进行化妆品新原料备案，应当提交下列资料：

Article 12 An application for the registration of new raw materials for cosmetics or the filing of new raw materials for cosmetics shall submit the following information:

（一）注册申请人、备案人的名称、地址、联系方式；

(1) the name, address and contact information of the applicant for registration and the filing person;

（二）新原料研制报告；

(2) development report of new raw materials;

（三）新原料的制备工艺、稳定性及其质量控制标准的研究资料；

(3) research data on the preparation process, stability and quality control standards of new raw materials;

（四）新原料安全评估资料。

(4) new raw material safety assessment data.

注册申请人、备案人应当对所提交资料的真实性、科学性负责。

The applicant for registration and the filing person shall be responsible for the authenticity and scientific nature of the materials submitted.

第十三条　国务院药品监督管理部门应当自受理化妆品新原料注册申请之日起3个工作日内将申请资料转交技术审评机构。技术审评机构应当自收到申请资料之日起90个工作日内完成技术审评，向国务院药品监督管理部门提交审评意见。国务院药品监督管理部门应当自收到审评意见之日起20个工作日内作出决定。对符合要求的，准予注册并发给化妆品新原料注册证；对不符合要求的，不予注册并书面说明理由。

Article 13 The department of drug supervision and administration under the State Council shall, within 3 working days from the date of accepting the application for registration of new raw materials for cosmetics, transmit the application materials to the technical review institution. The technical review institution shall complete the technical review within 90 working days from the date of receipt of the application materials and submit the review opinions to the drug regulatory department under the State Council. The drug regulatory department under the State Council shall make a decision within 20 working days from the date of receipt of the review opinions. For those who meet the requirements, they shall be allowed to register and issue a registration certificate for new raw materials for cosmetics; for those who do not meet the requirements, they shall not register and give reasons in writing.

化妆品新原料备案人通过国务院药品监督管理部门在线政务服务平台提交本条例规定的备案资料后即完成备案。

The filing person of new cosmetics raw materials shall complete the filing after submitting the filing materials stipulated in these regulations through the online government affairs service platform of the drug regulatory department under the State Council.

国务院药品监督管理部门应当自化妆品新原料准予注册之日起、备案人提交备案资料之日起5个工作日内向社会公布注册、备案有关信息。

The department of drug supervision and administration under the State Council shall, within 5 working days from the date on which the new raw materials for cosmetics are permitted to be registered and the date on which the filing person submits the filing materials, publish the relevant information for registration and filing to the public.

第十四条　经注册、备案的化妆品新原料投入使用后3年内，新原料注册人、备案人应当每年向国务院药品监督管理部门报告新原料的使用和安全情况。对存在安全问题的化妆品新原料，由国务院药品监督管理部门撤销注册或者取消备案。3年期满未发生安全问题的化妆品新原料，纳入国务院药品监督管理部门制定的已使用的化妆品原料目录。

Article 14Within 3 years after the new raw materials for cosmetics registered and put on record are put into use, the registrant and the filer of the new raw materials shall report annually to the drug regulatory department under the State Council on the use and safety of the new raw materials. New raw materials for cosmetics with safety problems shall be revoked by the department of drug supervision and administration under the State Council for registration or for filing. The new raw materials for cosmetics that do not have safety problems at the expiration of 3 years shall be included in the catalogue of raw materials for cosmetics that have been used formulated by the drug supervision and administration department under the State Council.

经注册、备案的化妆品新原料纳入已使用的化妆品原料目录前，仍然按照化妆品新原料进行管理。

The new raw materials of cosmetics registered and put on record are still managed according to the new raw materials of cosmetics before they are included in the catalogue of used cosmetics raw materials.

第十五条　禁止用于化妆品生产的原料目录由国务院药品监督管理部门制定、公布。

Article 15The catalogue of raw materials prohibited for use in the production of cosmetics shall be formulated and published by the drug regulatory department under the State Council.

第十六条　用于染发、烫发、祛斑美白、防晒、防脱发的化妆品以及宣称新功效的化妆品为特殊化妆品。特殊化妆品以外的化妆品为普通化妆品。

Article 16 Cosmetics used for hair dyeing, perm, freckle whitening, sun protection, prevention of hair loss and cosmetics claiming new efficacy are special cosmetics.cosmetics other than specialcosmetics are ordinary cosmetics.

国务院药品监督管理部门根据化妆品的功效宣称、作用部位、产品剂型、使用人群等因素，制定、公布化妆品分类规则和分类目录。

The department of drug supervision and administration under the State Council shall formulate and publish the classification rules and catalogue of cosmetics according to the factors such as the functional declaration, the position of action, the dosage form of the product, and the crowd of users.

第十七条　特殊化妆品经国务院药品监督管理部门注册后方可生产、进口。国产普通化妆品应当在上市销售前向备案人所在地省、自治区、直辖市人民政府药品监督管理部门备案。进口普通化妆品应当在进口前向国务院药品监督管理部门备案。

Article 17 Special cosmetics may be produced or imported only after registration by the drug regulatory department under the State Council. General cosmetics made in China shall be put on record with the drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government in the place where the record holder is located before being put on the market for sale. The import of general cosmetics shall be filed with the drug regulatory department under the State Council before import.

第十八条　化妆品注册申请人、备案人应当具备下列条件：

Article 18 The applicant for registration and filing of cosmetics shall meet the following requirements:

（一）是依法设立的企业或者其他组织；

(1) an enterprise or other organization established according to law;

（二）有与申请注册、进行备案的产品相适应的质量管理体系；

(2) having a quality management system appropriate to the products for registration and filing;

（三）有化妆品不良反应监测与评价能力。

(3) ability to monitor and evaluate adverse reactions of cosmetics.

第十九条　申请特殊化妆品注册或者进行普通化妆品备案，应当提交下列资料：

Article 19 Application for registration of special cosmetics or filing of general cosmetics shall be made with the following information:

（一）注册申请人、备案人的名称、地址、联系方式；

(1) the name, address and contact information of the applicant for registration and the filing person;

（二）生产企业的名称、地址、联系方式；

(2) the name, address and contact information of the manufacturing enterprise;

（三）产品名称；

(3) Product name;

（四）产品配方或者产品全成分；

(4)the product formulation or the full composition of the product;

（五）产品执行的标准；

(5) standards for product implementation;

（六）产品标签样稿；

(6) Sample product labels;

（七）产品检验报告；

(7) Product inspection report;

（八）产品安全评估资料。

(8) product safety assessment data.

注册申请人首次申请特殊化妆品注册或者备案人首次进行普通化妆品备案的，应当提交其符合本条例第十八条规定条件的证明资料。申请进口特殊化妆品注册或者进行进口普通化妆品备案的，应当同时提交产品在生产国（地区）已经上市销售的证明文件以及境外生产企业符合化妆品生产质量管理规范的证明资料；专为向我国出口生产、无法提交产品在生产国（地区）已经上市销售的证明文件的，应当提交面向我国消费者开展的相关研究和试验的资料。

Where a registered applicant applies for the registration of special cosmetics for the first time or the filing person carries out the filing of ordinary cosmetics for the first time, it shall submit the supporting materials which meet the conditions stipulated in Article 18 of these Regulations. Where an application is made for the registration of imported special cosmetics or for the filing of imported ordinary cosmetics, it shall at the same time submit the documents certifying that the products have been sold on the market in the producing country (region) and the documents certifying that the overseas manufacturing enterprises comply with the standards for the quality control of cosmetics production; where the documents certifying the products produced for export to China and the products sold on the market in the producing country (region) are not available, the relevant research and test materials for Chinese consumers shall be submitted .

注册申请人、备案人应当对所提交资料的真实性、科学性负责。

The registered applicant and the filing person shall be responsible for the authenticity and scientific nature of the materials submitted.

第二十条　国务院药品监督管理部门依照本条例第十三条第一款规定的化妆品新原料注册审查程序对特殊化妆品注册申请进行审查。对符合要求的，准予注册并发给特殊化妆品注册证；对不符合要求的，不予注册并书面说明理由。已经注册的特殊化妆品在生产工艺、功效宣称等方面发生实质性变化的，注册人应当向原注册部门申请变更注册。

Article 20The department of drug supervision and administration under the State Council shall examine the application for registration of special cosmetics in accordance with the procedures for examination of the registration of new cosmetics raw materials as stipulated in Article 13, paragraph 1, of these Regulations. For those who meet the requirements, registration is granted and a special cosmetic registration certificate is issued; for those who do not meet the requirements, registration is not allowed and reasons are stated in writing. Where a registered special cosmetic has undergone substantial changes in the production process, the declaration of efficacy, etc., the registrant shall apply to the original registration department for change registration.

普通化妆品备案人通过国务院药品监督管理部门在线政务服务平台提交本条例规定的备案资料后即完成备案。

The general cosmetic filing person shall complete the filing after submitting the filing materials stipulated in these regulations through the online government affairs service platform of the drug regulatory department under the State Council.

省级以上人民政府药品监督管理部门应当自特殊化妆品准予注册之日起、普通化妆品备案人提交备案资料之日起5个工作日内向社会公布注册、备案有关信息。

The department of drug supervision and administration of the people's government at or above the provincial level shall, within 5 working days from the date on which the registration of special cosmetics is granted and the date on which the filing materials of ordinary cosmetics are submitted, publish the relevant information on registration and filing to the public.

第二十一条　化妆品新原料和化妆品注册、备案前，注册申请人、备案人应当自行或者委托专业机构开展安全评估。

Article 21 Prior to the registration and filing of new cosmetics raw materials and cosmetics, the applicant for registration and the filing person shall carry out safety assessment on his own or by entrusting a professional institution.

从事安全评估的人员应当具备化妆品质量安全相关专业知识，并具有5年以上相关专业从业经历。

Personnel engaged in safety assessment shall have relevant professional knowledge of cosmetic quality and safety and have more than 5 years relevant professional experience.

第二十二条　化妆品的功效宣称应当有充分的科学依据。化妆品注册人、备案人应当在国务院药品监督管理部门规定的专门网站公布功效宣称所依据的文献资料、研究数据或者产品功效评价资料的摘要，接受社会监督。

Article 22 The claim of the efficacy of cosmetics shall have sufficient scientific basis. The cosmetic registrant or record holder shall, on a special website prescribed by the drug regulatory department under the State Council, publish a summary of the documents, research data or product efficacy evaluation data on which the efficacy claim is based, and accept social supervision.

第二十三条　境外化妆品注册人、备案人应当指定我国境内的企业法人办理化妆品注册、备案，协助开展化妆品不良反应监测、实施产品召回。

Article 23 The overseas cosmetic registrant and the filing person shall appoint an enterprise legal person within the territory of China to handle the registration and filing of cosmetics, assist in the monitoring of adverse reactions of cosmetics and implement product recalls.

第二十四条　特殊化妆品注册证有效期为5年。有效期届满需要延续注册的，应当在有效期届满30个工作日前提出延续注册的申请。除有本条第二款规定情形外，国务院药品监督管理部门应当在特殊化妆品注册证有效期届满前作出准予延续的决定；逾期未作决定的，视为准予延续。

Article 24 The registration certificate of special cosmetics shall be valid for 5 years. Where registration needs to be renewed at the expiration of the validity period, an application for renewal of registration shall be submitted 30 working days before the expiry date. Except as provided in paragraph 2 of this Article, the drug regulatory department under the State Council shall make a decision on granting extension before the expiration of the validity period of the special cosmetics registration certificate; if the decision is not made within the time limit, the extension shall be deemed to be granted.

有下列情形之一的，不予延续注册：

Registration shall not be renewed if:

（一）注册人未在规定期限内提出延续注册申请；

(1) the registrant has not applied for renewal of registration within the prescribed time limit;

（二）强制性国家标准、技术规范已经修订，申请延续注册的化妆品不能达到修订后标准、技术规范的要求。

(2) the mandatory national standards and technical specifications have been revised, and the cosmetics applying for renewal of registration can not meet the requirements of the revised standards and technical specifications.

第二十五条　国务院药品监督管理部门负责化妆品强制性国家标准的项目提出、组织起草、征求意见和技术审查。国务院标准化行政部门负责化妆品强制性国家标准的立项、编号和对外通报。

Article 25 The department of drug supervision and administration under the State Council shall be responsible for proposing, organizing, drafting, soliciting opinions and technical examination of compulsory national standards for cosmetics. The administrative department of standardization under the State Council shall be responsible for the establishment, numbering and external notification of compulsory national standards for cosmetics.

化妆品国家标准文本应当免费向社会公开。

The national standard version of cosmetics should be made public free of charge.

化妆品应当符合强制性国家标准。鼓励企业制定严于强制性国家标准的企业标准。

Cosmetics shall conform to mandatory national standards. Enterprises are encouraged to establish enterprise standards that are more strict than mandatory national standards.

第三章　生产经营

Chapter 3 Production and Operation

第二十六条　从事化妆品生产活动，应当具备下列条件：

Article 26To engage in cosmetic production activities, the following conditions shall be met:

（一）是依法设立的企业；

(1) an enterprise established by law;

（二）有与生产的化妆品相适应的生产场地、环境条件、生产设施设备；

(2)having production sites, environmental conditions, production facilities and equipment appropriate to the cosmetics produced;

（三）有与生产的化妆品相适应的技术人员；

(3) having technicians suitable for the production of cosmetics;

（四）有能对生产的化妆品进行检验的检验人员和检验设备；

(4)having inspectors and inspection equipment capable of inspecting cosmetics produced;

（五）有保证化妆品质量安全的管理制度。

(5) there is a management system to ensure the quality and safety of cosmetics.

第二十七条　从事化妆品生产活动，应当向所在地省、自治区、直辖市人民政府药品监督管理部门提出申请，提交其符合本条例第二十六条规定条件的证明资料，并对资料的真实性负责。

Article 27 To engage in cosmetic production activities, an application shall be submitted to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located, and the supporting materials which meet the conditions stipulated in Article 26 of these Regulations shall be submitted, and shall be responsible for the authenticity of the materials.

省、自治区、直辖市人民政府药品监督管理部门应当对申请资料进行审核，对申请人的生产场所进行现场核查，并自受理化妆品生产许可申请之日起30个工作日内作出决定。对符合规定条件的，准予许可并发给化妆品生产许可证；对不符合规定条件的，不予许可并书面说明理由。

The drug supervision and administration departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall examine and verify the application materials, conduct on-site verification of the applicant's production sites, and make a decision within 30 working days from the date of accepting the application for a production license for cosmetics. For those who meet the prescribed conditions, permission shall be granted and a cosmetic production license shall be issued; for those who do not meet the prescribed conditions, permission shall not be granted and reasons shall be stated in writing.

化妆品生产许可证有效期为5年。有效期届满需要延续的，依照《中华人民共和国行政许可法》的规定办理。

Cosmetic production license valid for 5 years. Where the expiration of the validity period requires renewal, it shall be handled in accordance with the provisions of the Administrative Licensing Law of the People's Republic of China.

第二十八条　化妆品注册人、备案人可以自行生产化妆品，也可以委托其他企业生产化妆品。

Article 28 A cosmetic registrant or record holder may produce cosmetics on his own or entrust other enterprises to produce cosmetics.

委托生产化妆品的，化妆品注册人、备案人应当委托取得相应化妆品生产许可的企业，并对受委托企业（以下称受托生产企业）的生产活动进行监督，保证其按照法定要求进行生产。受托生产企业应当依照法律、法规、强制性国家标准、技术规范以及合同约定进行生产，对生产活动负责，并接受化妆品注册人、备案人的监督。

Where a cosmetics product is commissioned to be produced, the cosmetic registrant or record holder shall entrust the enterprise that obtains the corresponding cosmetic production license to as the production activities of the entrusted enterprise(here in after referred to as the entrusted manufacturing enterprise) to ensure that it carries out production in accordance with the statutory requirements. The entrusted production enterprise shall carry out production in accordance with the laws, regulations, mandatory national standards, technical specifications and the contract agreement, be responsible for the production activities, and accept the supervision of the cosmetics registrant and the filing person.

第二十九条　化妆品注册人、备案人、受托生产企业应当按照国务院药品监督管理部门制定的化妆品生产质量管理规范的要求组织生产化妆品，建立化妆品生产质量管理体系，建立并执行供应商遴选、原料验收、生产过程及质量控制、设备管理、产品检验及留样等管理制度。

Article 29 A cosmetic registrant, a filing person or a entrusted manufacturing enterprise shall organize the production of cosmetics in accordance with the requirements of the standards for the quality control of cosmetic production formulated by the department of drug supervision and administration under the State Council, establish a quality control system for the production of cosmetics, and establish and implement management systems for supplier selection, raw material acceptance, production process and quality control, equipment management, product inspection and retention of samples.

化妆品注册人、备案人、受托生产企业应当按照化妆品注册或者备案资料载明的技术要求生产化妆品。

Cosmetics registrants, filing persons and entrusted manufacturing enterprises shall produce cosmeticsinaccordance with the technical requirements specified in the cosmetic registration or filing materials.

第三十条　化妆品原料、直接接触化妆品的包装材料应当符合强制性国家标准、技术规范。

Article 30 Raw materials for cosmetics and packaging materials in direct contact with cosmetics shall conform to the mandatory national standards and technical specifications.

不得使用超过使用期限、废弃、回收的化妆品或者化妆品原料生产化妆品。

Cosmetics shall not be produced using cosmetics or raw materials of cosmetics that exceed the service life, waste or recycle.

第三十一条　化妆品注册人、备案人、受托生产企业应当建立并执行原料以及直接接触化妆品的包装材料进货查验记录制度、产品销售记录制度。进货查验记录和产品销售记录应当真实、完整，保证可追溯，保存期限不得少于产品使用期限届满后1年；产品使用期限不足1年的，记录保存期限不得少于2年。

Article 31 The cosmetic registrant, the record holder and the entrusted manufacturing enterprise shall establish and implement the inspection record system and the product sales record system for the purchase of raw materials and packaging materials directly in contact with cosmetics. The inspection records of incoming goods and the sales records of products shall be true and complete, and shall be traceable, and the period of preservation shall not be less than one year after the expiration of the service period of the products; if the service period of the products is less than one year, the period of record preservation shall not be less than two years.

化妆品经出厂检验合格后方可上市销售。

Cosmetics after factory inspection before the market.

第三十二条　化妆品注册人、备案人、受托生产企业应当设质量安全负责人，承担相应的产品质量安全管理和产品放行职责。

Article 32 The cosmetic registrant, the filing person and the entrusted production enterprise shall establish a person in charge of quality and safety and undertake the corresponding duties of product quality and safety management and product release.

质量安全负责人应当具备化妆品质量安全相关专业知识，并具有5年以上化妆品生产或者质量安全管理经验。

The person in charge of quality and safety shall have relevant professional knowledge of cosmetic quality and safety, and have more than 5 years experience in cosmetic production or quality and safety management.

第三十三条　化妆品注册人、备案人、受托生产企业应当建立并执行从业人员健康管理制度。患有国务院卫生主管部门规定的有碍化妆品质量安全疾病的人员不得直接从事化妆品生产活动。

Article 33 A cosmetic registrant, filing person or entrusted manufacturing enterprise shall establish and implement a health management system for employees. Persons suffering from diseases that hinder the quality and safety of cosmetics prescribed by the competent department of health under the State Council may not directly engage in cosmetic production activities.

第三十四条　化妆品注册人、备案人、受托生产企业应当定期对化妆品生产质量管理规范的执行情况进行自查；生产条件发生变化，不再符合化妆品生产质量管理规范要求的，应当立即采取整改措施；可能影响化妆品质量安全的，应当立即停止生产并向所在地省、自治区、直辖市人民政府药品监督管理部门报告。

Article 34 A cosmetic registrant, a filing person or a entrusted manufacturing enterprise shall conduct regular self-inspection on the implementation of the standards for the quality control of cosmetics production; if the production conditions change and no longer meet the requirements of the standards for the quality control of cosmetics production, corrective measures shall be taken immediately; if the quality and safety of cosmetics may be affected, production shall be stopped immediately and reported to the drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government of the locality.

第三十五条　化妆品的最小销售单元应当有标签。标签应当符合相关法律、行政法规、强制性国家标准，内容真实、完整、准确。

Article 35 The minimum selling unit of cosmetics shall have labels. The label shall conform to the relevant laws, administrative regulations and mandatory national standards, and the contents shall be true, complete and accurate.

进口化妆品可以直接使用中文标签，也可以加贴中文标签；加贴中文标签的，中文标签内容应当与原标签内容一致。

Imported cosmetics can be labeled directly in Chinese or Chinese; if labeled in Chinese, the content of Chinese label should be consistent with the original label.

第三十六条　化妆品标签应当标注下列内容：

Article 36 Cosmetic labels shall be marked as follows:

（一）产品名称、特殊化妆品注册证编号；

(1) Product name, registration certificate number of special cosmetics;

（二）注册人、备案人、受托生产企业的名称、地址；

(2) the name and address of the registered person, the filing person or the entrusted production enterprise;

（三）化妆品生产许可证编号；

(3) cosmetic production license number;

（四）产品执行的标准编号；

(4) standard number for product execution;

（五）全成分；

(5) full composition;

（六）净含量；

(6) net content;

（七）使用期限、使用方法以及必要的安全警示；

(7) the duration of use, the methods of use and the necessary safety warnings;

（八）法律、行政法规和强制性国家标准规定应当标注的其他内容。

(8) other contents to be marked in the provisions of laws, administrative regulations and mandatory national standards.

第三十七条　化妆品标签禁止标注下列内容：

Article 37 The following contents are prohibited for labeling cosmetics:

（一）明示或者暗示具有医疗作用的内容；

(1) An express or implied content having a medical effect;

（二）虚假或者引人误解的内容；

(2) the content of falsehood or misleading;

（三）违反社会公序良俗的内容；

(3) content that violates public order and good customs;

（四）法律、行政法规禁止标注的其他内容。

(4) other contents prohibited by laws and administrative regulations.

第三十八条　化妆品经营者应当建立并执行进货查验记录制度，查验供货者的市场主体登记证明、化妆品注册或者备案情况、产品出厂检验合格证明，如实记录并保存相关凭证。记录和凭证保存期限应当符合本条例第三十一条第一款的规定。

Article 38 Cosmetic operators shall establish and implement a system of inspection records for incoming goods, check the registration certificates of the market subjects of the suppliers, the registration or filing of cosmetics, and the certificate of conformity for the inspection of products leaving the factory, and record truthfully and keep relevant certificates. The time limit for keeping records and vouchers shall conform to the provisions of Article 31, paragraph 1, of these Regulations.

化妆品经营者不得自行配制化妆品。

Cosmetic operators shall not prepare cosmetics on their own.

第三十九条　化妆品生产经营者应当依照有关法律、法规的规定和化妆品标签标示的要求贮存、运输化妆品，定期检查并及时处理变质或者超过使用期限的化妆品。

Article 39Cosmetics producers and operators shall store and transport cosmetics in accordance with the provisions of relevant laws and regulations and the requirements of labels and labels of cosmetics, and regularly inspect and promptly handle cosmetics that have deteriorated or have exceeded their service life.

第四十条　化妆品集中交易市场开办者、展销会举办者应当审查入场化妆品经营者的市场主体登记证明，承担入场化妆品经营者管理责任，定期对入场化妆品经营者进行检查；发现入场化妆品经营者有违反本条例规定行为的，应当及时制止并报告所在地县级人民政府负责药品监督管理的部门。

Article 40 A market operator or a trade fair organizer of a centralized trading market for cosmetics shall examine the registration certificate of the market subject of the cosmetics operator entering the market, assume the administrative responsibility of the cosmetics operator entering the market, and regularly inspect the of the cosmetic operator entering the market.

第四十一条　电子商务平台经营者应当对平台内化妆品经营者进行实名登记，承担平台内化妆品经营者管理责任，发现平台内化妆品经营者有违反本条例规定行为的，应当及时制止并报告电子商务平台经营者所在地省、自治区、直辖市人民政府药品监督管理部门；发现严重违法行为的，应当立即停止向违法的化妆品经营者提供电子商务平台服务。

Article 41 The operator of an e-commerce platform shall register the real name of the cosmetic operator in the platform, assume the responsibility for the management of the cosmetic operator in the platform, and find that the cosmetic operator in the platform has violated the provisions of these Regulations, and shall promptly stop and report to the drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government where the e-commerce platform operator is located; if serious illegal acts are found, it shall immediately stop providing e-commerce platform services to the illegal cosmetic operator.

平台内化妆品经营者应当全面、真实、准确、及时披露所经营化妆品的信息。

Cosmetics operators in the platform shall disclose the information of the cosmetics they operate in a comprehensive, true, accurate and timely manner.

第四十二条　美容美发机构、宾馆等在经营中使用化妆品或者为消费者提供化妆品的，应当履行本条例规定的化妆品经营者义务。

Article 42 Where a hairdressing institution or hotel uses cosmetics in its operation or provides cosmetics to consumers, it shall fulfill the obligations of the cosmetic operator stipulated in these Regulations.

第四十三条　化妆品广告的内容应当真实、合法。

Article 43The contents of cosmetic advertisements shall be true and lawful.

化妆品广告不得明示或者暗示产品具有医疗作用，不得含有虚假或者引人误解的内容，不得欺骗、误导消费者。

Cosmetic advertising shall not express or imply that the product has a medical effect, may not contain false or misleading content, and may not deceive or mislead consumers.

第四十四条　化妆品注册人、备案人发现化妆品存在质量缺陷或者其他问题，可能危害人体健康的，应当立即停止生产，召回已经上市销售的化妆品，通知相关化妆品经营者和消费者停止经营、使用，并记录召回和通知情况。化妆品注册人、备案人应当对召回的化妆品采取补救、无害化处理、销毁等措施，并将化妆品召回和处理情况向所在地省、自治区、直辖市人民政府药品监督管理部门报告。

Article 44 Where a cosmetic registrant or filing person discovers that a cosmetic product has a quality defect or other problem which may endanger human health, he shall immediately stop production, recall the cosmetics already sold on the market, notify the relevant cosmetic operators and consumers to stop operation and use, and record the recall and notification. The cosmetic registrant or record holder shall take remedial, harmless treatment and destruction measures for the recalled cosmetics, and shall report the recall and handling to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where the cosmetics are located.

受托生产企业、化妆品经营者发现其生产、经营的化妆品有前款规定情形的，应当立即停止生产、经营，通知相关化妆品注册人、备案人。化妆品注册人、备案人应当立即实施召回。

If a entrusted manufacturing enterprise or cosmetic operator discovers that the cosmetics produced or operated by it have the circumstances specified in the preceding paragraph, it shall immediately stop the production or operation and notify the relevant cosmetic registrant or filing person. The cosmetic registrant or the filing person shall immediately implement the recall.

负责药品监督管理的部门在监督检查中发现化妆品有本条第一款规定情形的，应当通知化妆品注册人、备案人实施召回，通知受托生产企业、化妆品经营者停止生产、经营。

If the department in charge of drug supervision and administration finds that cosmetics have the circumstances specified in the first paragraph of this article in the course of supervision and inspection, it shall notify the cosmetic registrant or the filing person to carry out the recall and notify the entrusted production enterprise or the cosmetic operator to stop the production and operation.

化妆品注册人、备案人实施召回的，受托生产企业、化妆品经营者应当予以配合。

Where a cosmetic registrant or filing person carries out a recall, the entrusted manufacturing enterprise or cosmetic operator shall cooperate.

化妆品注册人、备案人、受托生产企业、经营者未依照本条规定实施召回或者停止生产、经营的，负责药品监督管理的部门责令其实施召回或者停止生产、经营。

Where a cosmetic registrant, a filing person, a entrusted manufacturing enterprise or an operator fails to carry out a recall or stop production or business operations in accordance with the provisions of this Article, the department in charge of drug supervision and administration shall order him to carry out a recall or stop production or business operations.

第四十五条　出入境检验检疫机构依照《中华人民共和国进出口商品检验法》的规定对进口的化妆品实施检验；检验不合格的，不得进口。

Article 45 Entry-exit inspection and quarantine institutions shall carry out inspection of imported cosmetics in accordance with the provisions of the Law of the People's Republic of China on the Inspection of Import and Export Commodities.

进口商应当对拟进口的化妆品是否已经注册或者备案以及是否符合本条例和强制性国家标准、技术规范进行审核；审核不合格的，不得进口。进口商应当如实记录进口化妆品的信息，记录保存期限应当符合本条例第三十一条第一款的规定。

The importer shall examine whether the cosmetics to be imported have been registered or put on record, and whether they conform to these regulations and mandatory national standards and technical specifications; if the examination is not qualified, they shall not be imported. The importer shall record the information of imported cosmetics truthfully, and the period of record keeping shall conform to the provisions of Article 31, paragraph 1, of these Regulations.

出口的化妆品应当符合进口国（地区）的标准或者合同要求。

The cosmetics exported shall conform to the standards or contract requirements of the importing country (region).

第四章　监督管理

Chapter 4 Supervision and Administration

第四十六条　负责药品监督管理的部门对化妆品生产经营进行监督检查时，有权采取下列措施：

Article 46 The department responsible for drug supervision and administration shall have the right to take the following measures when supervising and inspecting the production and operation of cosmetics:

（一）进入生产经营场所实施现场检查；

(1) to carry out on-site inspection at the place of production and operation;

（二）对生产经营的化妆品进行抽样检验；

(2) sampling inspection of cosmetics produced and operated;

（三）查阅、复制有关合同、票据、账簿以及其他有关资料；

(3) to consult and reproduce relevant contracts, bills, books and other relevant information;

（四）查封、扣押不符合强制性国家标准、技术规范或者有证据证明可能危害人体健康的化妆品及其原料、直接接触化妆品的包装材料，以及有证据证明用于违法生产经营的工具、设备；

(4) seizing or seizing cosmetics and their raw materials that do not meet the mandatory national standards or technical specifications or have evidence to prove that they may endanger human health, packaging materials in direct contact with cosmetics, and tools and equipment used in illegal production and operation;

（五）查封违法从事生产经营活动的场所。

(5) to seize places that engage in illegal production and business operations.

第四十七条　负责药品监督管理的部门对化妆品生产经营进行监督检查时，监督检查人员不得少于2人，并应当出示执法证件。监督检查人员对监督检查中知悉的被检查单位的商业秘密，应当依法予以保密。被检查单位对监督检查应当予以配合，不得隐瞒有关情况。

Article 47 When the department in charge of drug supervision and administration carries out supervision and inspection on the production and operation of cosmetics, the supervisory and inspection personnel shall not be less than 2 persons and shall produce the law enforcement certificates.Thesupervising and inspecting personnel shall keep confidential the trade secrets of the inspected units known in the supervision and inspection according to law. The inspected unit shall cooperate with the supervision and inspection and shall not conceal the relevant information.

负责药品监督管理的部门应当对监督检查情况和处理结果予以记录，由监督检查人员和被检查单位负责人签字；被检查单位负责人拒绝签字的，应当予以注明。

The department in charge of drug supervision and administration shall record the situation of supervision and inspection and the results of handling, which shall be signed by the person in charge of supervision and inspection and the person in charge of the unit under inspection; if the person in charge of the unit under inspection refuses to sign, it shall be noted.

第四十八条　省级以上人民政府药品监督管理部门应当组织对化妆品进行抽样检验；对举报反映或者日常监督检查中发现问题较多的化妆品，负责药品监督管理的部门可以进行专项抽样检验。

Article 48 The department of drug supervision and administration of the people's government at or above the provincial level shall organize sampling inspection of cosmetics; the department in charge of drug supervision and administration may conduct special sampling inspection of cosmetics that report or find more problems in the routine supervision and inspection.

进行抽样检验，应当支付抽取样品的费用，所需费用纳入本级政府预算。

To carry out sampling inspection, the cost of sampling samples shall be paid, and the required expenses shall be included in the budget of the government at the corresponding level.

负责药品监督管理的部门应当按照规定及时公布化妆品抽样检验结果。

The department in charge of drug supervision and administration shall, in accordance with the regulations, promptly publish the results of sampling inspection of cosmetics.

第四十九条　化妆品检验机构按照国家有关认证认可的规定取得资质认定后，方可从事化妆品检验活动。化妆品检验机构的资质认定条件由国务院药品监督管理部门、国务院市场监督管理部门制定。

Article 49 A cosmetic inspection institution may engage in cosmetic inspection activities only after obtaining qualification confirmation in accordance with the relevant regulations of the State on certification and approval. The qualification determination conditions of cosmetic inspection institutions shall be formulated by the drug regulatory department under the State Council and the market regulatory department under the State Council.

化妆品检验规范以及化妆品检验相关标准品管理规定，由国务院药品监督管理部门制定。

The standards for the inspection of cosmetics and the regulations on the administration of related standard products for the inspection of cosmetics shall be formulated by the department of drug supervision and administration under the State Council.

第五十条　对可能掺杂掺假或者使用禁止用于化妆品生产的原料生产的化妆品，按照化妆品国家标准规定的检验项目和检验方法无法检验的，国务院药品监督管理部门可以制定补充检验项目和检验方法，用于对化妆品的抽样检验、化妆品质量安全案件调查处理和不良反应调查处置。

Article 50 Where cosmetics that may be adulterated or produced using raw materials prohibited for use in the production of cosmetics can not be inspected in accordance with the inspection items and inspection methods prescribed in the national standards for cosmetics, the department of drug supervision and administration under the State Council may formulate supplementary inspection items and inspection methods for sampling inspection of cosmetics, investigation and handling of cosmetic quality and safety cases and investigation and disposal of adverse reactions.

第五十一条　对依照本条例规定实施的检验结论有异议的，化妆品生产经营者可以自收到检验结论之日起7个工作日内向实施抽样检验的部门或者其上一级负责药品监督管理的部门提出复检申请，由受理复检申请的部门在复检机构名录中随机确定复检机构进行复检。复检机构出具的复检结论为最终检验结论。复检机构与初检机构不得为同一机构。复检机构名录由国务院药品监督管理部门公布。

Article 51 If there is any objection to the conclusion of the inspection carried out in accordance with the provisions of these Regulations, the cosmetic manufacturer or operator may, within 7 working days from the date of receipt of the conclusion of the inspection, submit an application for re-inspection to the department carrying out the sampling inspection or to the department responsible for drug supervision and administration at the next higher level. The re-inspection conclusion issued by the re-inspection organization is the final inspection conclusion. The re-inspection institution and the initial inspection institution shall not be the same institution. The list of re-inspection institutions shall be published by the drug regulatory department under the State Council.

第五十二条　国家建立化妆品不良反应监测制度。化妆品注册人、备案人应当监测其上市销售化妆品的不良反应，及时开展评价，按照国务院药品监督管理部门的规定向化妆品不良反应监测机构报告。受托生产企业、化妆品经营者和医疗机构发现可能与使用化妆品有关的不良反应的，应当报告化妆品不良反应监测机构。鼓励其他单位和个人向化妆品不良反应监测机构或者负责药品监督管理的部门报告可能与使用化妆品有关的不良反应。

Article 52 The State shall establish a system for monitoring adverse reactions of cosmetics. The cosmetic registrant or filing person shall monitor the adverse reactions of the cosmetics listed and sold on the market, carry out timely evaluation, and report to the cosmetic adverse reaction monitoring institution in accordance with the regulations of the drug supervision and administration department under the State Council. If a entrusted manufacturing enterprise, cosmetic operator or medical institution discovers adverse reactions that may be related to the use of cosmetics, it shall report to the cosmetic adverse reaction monitoring institution. other units and individuals are encouraged to report adverse reactions that may be related to the use of cosmetics to the cosmetic adverse reaction monitoring agency or the department responsible for drug supervision and administration.

化妆品不良反应监测机构负责化妆品不良反应信息的收集、分析和评价，并向负责药品监督管理的部门提出处理建议。

The cosmetics adverse reaction monitoring organization is responsible for the collection, analysis and evaluation of cosmetic adverse reaction information, and makes suggestions to the department responsible for drug supervision and management.

化妆品生产经营者应当配合化妆品不良反应监测机构、负责药品监督管理的部门开展化妆品不良反应调查。

Cosmetics producers and operators shall cooperate with cosmetic adverse reaction monitoring agencies and departments responsible for drug supervision and administration to carry out cosmetic adverse reaction investigation.

化妆品不良反应是指正常使用化妆品所引起的皮肤及其附属器官的病变，以及人体局部或者全身性的损害。

The adverse reaction of cosmetics refers to the lesions of the skin and its accessory organs caused by the normal use of cosmetics, as well as the local or systemic damage of the human body.

第五十三条　国家建立化妆品安全风险监测和评价制度，对影响化妆品质量安全的风险因素进行监测和评价，为制定化妆品质量安全风险控制措施和标准、开展化妆品抽样检验提供科学依据。

Article 53 The State shall establish a system for monitoring and evaluating the safety risks of cosmetics, monitor and evaluate the risk factors that affect the quality and safety of cosmetics, and provide scientific basis for formulating measures and standards for controlling the quality and safety risks of cosmetics and carrying out sampling inspection of cosmetics.

国家化妆品安全风险监测计划由国务院药品监督管理部门制定、发布并组织实施。国家化妆品安全风险监测计划应当明确重点监测的品种、项目和地域等。

The national cosmetic safety risk monitoring plan shall be formulated, issued and organized by the drug regulatory department under the State Council. The national cosmetics safety risk monitoring plan should clearly focus on the variety, project and geographical monitoring.

国务院药品监督管理部门建立化妆品质量安全风险信息交流机制，组织化妆品生产经营者、检验机构、行业协会、消费者协会以及新闻媒体等就化妆品质量安全风险信息进行交流沟通。

The department of drug supervision and administration under the State Council shall establish a mechanism for the exchange of information on the quality and safety risks of cosmetics, and organize the exchange and communication of information on the quality and safety risks of cosmetics between producers and operators, inspection agencies, trade associations, consumer associations and the news media.

第五十四条　对造成人体伤害或者有证据证明可能危害人体健康的化妆品，负责药品监督管理的部门可以采取责令暂停生产、经营的紧急控制措施，并发布安全警示信息；属于进口化妆品的，国家出入境检验检疫部门可以暂停进口。

Article 54For cosmetics that cause human injury or have evidence to prove that they may endanger human health, the department in charge of drug supervision and administration may take emergency control measures to suspend production and business operations and issue safety warning information.

第五十五条　根据科学研究的发展，对化妆品、化妆品原料的安全性有认识上的改变的，或者有证据表明化妆品、化妆品原料可能存在缺陷的，省级以上人民政府药品监督管理部门可以责令化妆品、化妆品新原料的注册人、备案人开展安全再评估或者直接组织开展安全再评估。再评估结果表明化妆品、化妆品原料不能保证安全的，由原注册部门撤销注册、备案部门取消备案，由国务院药品监督管理部门将该化妆品原料纳入禁止用于化妆品生产的原料目录，并向社会公布。

Article 55According to the the development of scientific research, if there is a change in the understanding of the safety of cosmetics or cosmetic raw materials, or there is evidence that cosmetics or cosmetic raw materials may be defective, the drug supervision and administration department of the people's government at or above the provincial level may order the registrant or record holder of new cosmetic raw materials to carry out safety re-evaluation or directly organize safety re-evaluation. If the re-evaluation results show that cosmetics and cosmetics raw materials can not guarantee safety, the original registration department shall revoke the registration and the filing department shall cancel the record, and the drug supervision and administration department under the State Council shall incorporate the cosmetic raw materials into the prohibited raw materials forcosmetic production catalogue, and published to the society.

第五十六条　负责药品监督管理的部门应当依法及时公布化妆品行政许可、备案、日常监督检查结果、违法行为查处等监督管理信息。公布监督管理信息时，应当保守当事人的商业秘密。

Article 56 The department responsible for the supervision and administration of drugs shall, in accordance with law, promptly publish such supervision and administration information as the administrative license for cosmetics, the record keeping, the results of daily supervision and inspection, and the investigation and punishment of illegal acts. When publishing information on supervision and administration, the parties concerned shall keep their trade secrets.

负责药品监督管理的部门应当建立化妆品生产经营者信用档案。对有不良信用记录的化妆品生产经营者，增加监督检查频次；对有严重不良信用记录的生产经营者，按照规定实施联合惩戒。

The department in charge of drug supervision and administration shall establish the credit files of the cosmetics producers and operators. To the cosmetics producers and operators with bad credit records, increase the frequency of supervision and inspection; to the producers and operators with serious bad credit records, joint punishment shall be carried out in accordance with the regulations.

第五十七条　化妆品生产经营过程中存在安全隐患，未及时采取措施消除的，负责药品监督管理的部门可以对化妆品生产经营者的法定代表人或者主要负责人进行责任约谈。化妆品生产经营者应当立即采取措施，进行整改，消除隐患。责任约谈情况和整改情况应当纳入化妆品生产经营者信用档案。

Article 57 Where there are hidden dangers of safety in the production and operation of cosmetics and no measures have been taken to eliminate them in time, the department in charge of drug supervision and administration may conduct a responsible interview with the legal representative of the cosmetics producer or operator or the principal responsible person. Cosmetics producers and operators shall immediately take measures to rectify and eliminate hidden dangers. The situation of responsibility interview and rectification shall be included in the credit files of cosmetics producers and operators.

第五十八条　负责药品监督管理的部门应当公布本部门的网站地址、电子邮件地址或者电话，接受咨询、投诉、举报，并及时答复或者处理。对查证属实的举报，按照国家有关规定给予举报人奖励。

Article 58 The department in charge of drug supervision and administration shall publish the website address, e-mail address or telephone number of the department, receive consultation, complaint or report, and reply or deal with it. To verify the truth of the report, in accordance with the relevant provisions of the State to give informantsincentives.

第五章　法律责任

Chapter 5 Legal liability

第五十九条　有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的化妆品和专门用于违法生产经营的原料、包装材料、工具、设备等物品；违法生产经营的化妆品货值金额不足1万元的，并处5万元以上15万元以下罚款；货值金额1万元以上的，并处货值金额15倍以上30倍以下罚款；情节严重的，责令停产停业、由备案部门取消备案或者由原发证部门吊销化妆品许可证件，10年内不予办理其提出的化妆品备案或者受理其提出的化妆品行政许可申请，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的3倍以上5倍以下罚款，终身禁止其从事化妆品生产经营活动；构成犯罪的，依法追究刑事责任：

Article 59 Under any of the following circumstances, the department in charge of drug supervision and administration shall confiscate the illegal income, cosmetics illegally produced and operated, and raw materials, packaging materials, tools and equipment specially used for illegal production and operation; if the value of cosmetics illegally produced and operated is less than 10,000 yuan, it shall also be fined not less than 50,000 yuan but not more than 150,000 yuan; if the value is more than 10,000 yuan, it shall also be fined not less than 15 times but not more than 30 times the value; if the circumstances are serious, it shall be ordered to suspend production or business, the filing department shall cancel the record keeping or the original license department shall revoke the license certificate for cosmetics, and shall not handle the filing or licensing of cosmetics submitted by it within 10 years To accept an application for an administrative license for cosmetics submitted by him, the legal representative or principal person in charge of an illegal unit, the person in charge directly in charge and other persons directly responsible shall be fined not less than three times but not more than five times of the income they received from the unit in the previous year, and shall be prohibited from engaging in cosmetic production and business activities for life; if a crime is constituted, criminal responsibility shall be investigated according to law:

（一）未经许可从事化妆品生产活动，或者化妆品注册人、备案人委托未取得相应化妆品生产许可的企业生产化妆品；

(1) to engage in cosmetics production activities without permission, or to entrust an enterprise that has not obtained the corresponding cosmetics production license to produce cosmetics by the registered person or the filing person;

（二）生产经营或者进口未经注册的特殊化妆品；

(2) the production, operation or import of unregistered special cosmetics;

（三）使用禁止用于化妆品生产的原料、应当注册但未经注册的新原料生产化妆品，在化妆品中非法添加可能危害人体健康的物质，或者使用超过使用期限、废弃、回收的化妆品或者原料生产化妆品。

(3) the use of raw materials prohibited for the production of cosmetics, new raw materials that should be registered but not registered for the production of cosmetics, the illegal addition of substances in cosmetics that may endanger human health, or the use of cosmetics or raw materials that exceed the use period, waste or recycle to produce cosmetics.

第六十条　有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的化妆品和专门用于违法生产经营的原料、包装材料、工具、设备等物品；违法生产经营的化妆品货值金额不足1万元的，并处1万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，责令停产停业、由备案部门取消备案或者由原发证部门吊销化妆品许可证件，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的1倍以上3倍以下罚款，10年内禁止其从事化妆品生产经营活动；构成犯罪的，依法追究刑事责任：

Article 60 In any of the following cases, the department in charge of drug supervision and administration shall confiscate the illegal income, cosmetics illegally produced and operated, and raw materials, packaging materials, tools and equipment specially used for illegal production and operation; if the value of cosmetics illegally produced and operated is less than 10,000 yuan, it shall also be fined not less than 10,000 yuan but not more than 50,000 yuan; if the value is more than 10,000 yuan, it shall also be fined not less than five times but not more than 20 times the value; if the circumstances are serious, it shall be ordered to suspend production and business, cancel the record keeping by the filing department or revoke the cosmetic license certificate by the original issuing department, and the legal representative or principal person in charge of the illegal unit shall be directly responsible The responsible person in charge and other persons directly responsible shall be fined not less than 1 times but not more than 3 times of the income they received from the unit in the previous year, and shall be prohibited from engaging in cosmetic production and business activities within 10 years; if a crime is constituted, criminal responsibility shall be investigated according to law:

（一）使用不符合强制性国家标准、技术规范的原料、直接接触化妆品的包装材料，应当备案但未备案的新原料生产化妆品，或者不按照强制性国家标准或者技术规范使用原料；

(1) The use of raw materials that do not meet the mandatory national standards or technical specifications or packaging materials that are in direct contact with cosmetics shall produce cosmetics from new raw materials that are on record but not on record, or the use of raw materials in accordance with the mandatory national standards or technical specifications;

（二）生产经营不符合强制性国家标准、技术规范或者不符合化妆品注册、备案资料载明的技术要求的化妆品；

(2) the production and operation of cosmetics that do not meet the mandatory national standards, technical specifications or the technical requirements specified in the registration and filing materials of cosmetics;

（三）未按照化妆品生产质量管理规范的要求组织生产；

(3) failing to organize production in accordance with the requirements of the quality standards for cosmetics production;

（四）更改化妆品使用期限；

(4) changing the term of use of cosmetics;

（五）化妆品经营者擅自配制化妆品，或者经营变质、超过使用期限的化妆品；

(5) cosmetics operators prepare cosmetics without authorization, or engage in cosmetics that have deteriorated or have exceeded their service life;

（六）在负责药品监督管理的部门责令其实施召回后拒不召回，或者在负责药品监督管理的部门责令停止或者暂停生产、经营后拒不停止或者暂停生产、经营。

(6) refusing to recall after the department in charge of drug supervision and administration orders it to carry out the recall, or refusing to stop or suspend production or operation after the department in charge of drug supervision and administration orders it to stop or suspend production or operation.

第六十一条　有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的化妆品，并可以没收专门用于违法生产经营的原料、包装材料、工具、设备等物品；违法生产经营的化妆品货值金额不足1万元的，并处1万元以上3万元以下罚款；货值金额1万元以上的，并处货值金额3倍以上10倍以下罚款；情节严重的，责令停产停业、由备案部门取消备案或者由原发证部门吊销化妆品许可证件，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的1倍以上2倍以下罚款，5年内禁止其从事化妆品生产经营活动：

Article 61 In any of the following cases, the department in charge of drug supervision and administration shall confiscate the illegal income, the illegal production and operation of cosmetics, and may confiscate the raw materials, packaging materials, tools and equipment specially used for illegal production and operation; if the value of cosmetics illegally produced and operated is less than 10,000 yuan, it shall also be fined not less than 10,000 yuan but not more than 30,000 yuan; if the value is more than 10,000 yuan, it shall also be fined not less than 3 times but not more than 10 times the value; if the circumstances are serious, it shall be ordered to suspend production or business, the filing department shall cancel the record keeping or the license certificate of cosmetics revoked by the original licensing department, and the legal representative or the principal negative person of the illegal unit shall be fined The responsible person, the person in charge directly in charge and other persons directly responsible shall be fined not less than twice the amount of income they received from the unit in the previous year, and shall be prohibited from engaging in cosmetic production and business activities within five years:

（一）上市销售、经营或者进口未备案的普通化妆品；

(1) to sell, operate or import unrecorded ordinary cosmetics;

（二）未依照本条例规定设质量安全负责人；

(2) failing to establish a person in charge of quality and safety in accordance with the provisions of these Regulations;

（三）化妆品注册人、备案人未对受托生产企业的生产活动进行监督；

(3) The registered person or the filing person of cosmetics has not supervised the production activities of the entrusted production enterprise;

（四）未依照本条例规定建立并执行从业人员健康管理制度；

(4) failing to establish and implement a health management system for employees in accordance with the provisions of these Regulations;

（五）生产经营标签不符合本条例规定的化妆品。

(5) Cosmetics whose production and operation labels do not conform to the provisions of these Regulations.

生产经营的化妆品的标签存在瑕疵但不影响质量安全且不会对消费者造成误导的，由负责药品监督管理的部门责令改正；拒不改正的，处2000元以下罚款。

If the label of cosmetics produced and operated has defects but does not affect the quality and safety and does not mislead consumers, the department in charge of drug supervision and administration shall order them to correct; if they refuse to do so, they shall be fined not less than 2000 yuan.

第六十二条　有下列情形之一的，由负责药品监督管理的部门责令改正，给予警告，并处1万元以上3万元以下罚款；情节严重的，责令停产停业，并处3万元以上5万元以下罚款，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处1万元以上3万元以下罚款：

Article 62 In any of the following cases, the department in charge of drug supervision and administration shall order correction, give a warning, and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan; if the circumstances are serious, it shall be ordered to suspend production and business, and shall also impose a fine of not less than 30,000 yuan but not more than 50,000 yuan, and a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed on the legal representative or principal responsible person of the illegal unit, the person in charge directly responsible and other persons directly responsible for the violation:

（一）未依照本条例规定公布化妆品功效宣称依据的摘要；

(1) failing to publish a summary of the basis for the declaration of cosmetic efficacy in accordance with the provisions of these Regulations;

（二）未依照本条例规定建立并执行进货查验记录制度、产品销售记录制度；

(2) failing to establish and implement the inspection record system for incoming goods and the record system for product sales in accordance with the provisions of these Regulations;

（三）未依照本条例规定对化妆品生产质量管理规范的执行情况进行自查；

(3) failing to conduct self-inspection on the implementation of the quality control standards for cosmetics production in accordance with the provisions of these Regulations;

（四）未依照本条例规定贮存、运输化妆品；

(4) failure to store and transport cosmetics in accordance with the provisions of these Regulations;

（五）未依照本条例规定监测、报告化妆品不良反应，或者对化妆品不良反应监测机构、负责药品监督管理的部门开展的化妆品不良反应调查不予配合。

(5) Failure to monitor or report adverse reactions to cosmetics in accordance with the provisions of these Regulations, or failing to cooperate with the investigation of adverse reactions to cosmetics carried out by the monitoring institutions for adverse reactions to cosmetics and the departments responsible for drug supervision and administration.

进口商未依照本条例规定记录、保存进口化妆品信息的，由出入境检验检疫机构依照前款规定给予处罚。

If the importer fails to record and keep the imported cosmetic information in accordance with the provisions of these Regulations, the entry-exit inspection and quarantine institution shall impose penalties in accordance with the provisions of the preceding paragraph.

第六十三条　化妆品新原料注册人、备案人未依照本条例规定报告化妆品新原料使用和安全情况的，由国务院药品监督管理部门责令改正，处5万元以上20万元以下罚款；情节严重的，吊销化妆品新原料注册证或者取消化妆品新原料备案，并处20万元以上50万元以下罚款。

Article 63 If the registrant or record holder of a new cosmetic raw material fails to report on the use and safety of the new cosmetic raw material in accordance with the provisions of these Regulations, the department of drug supervision and administration under the State Council shall order correction and impose a fine of not less than 50,000 yuan but not more than 200,000 yuan; if the circumstances are serious, the registration certificate of the new cosmetic raw material shall be revoked or the record of the new cosmetic raw material shall be cancelled of not less than 200,000 yuan but not more than 500,000 yuan shall be imposed.

第六十四条　在申请化妆品行政许可时提供虚假资料或者采取其他欺骗手段的，不予行政许可，已经取得行政许可的，由作出行政许可决定的部门撤销行政许可，5年内不受理其提出的化妆品相关许可申请，没收违法所得和已经生产、进口的化妆品；已经生产、进口的化妆品货值金额不足1万元的，并处5万元以上15万元以下罚款；货值金额1万元以上的，并处货值金额15倍以上30倍以下罚款；对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的3倍以上5倍以下罚款，终身禁止其从事化妆品生产经营活动。

Article 64 Where an application for an administrative license for cosmetics is made with false information or other means of deception, the administrative license shall be revoked by the department making the decision on the administrative license, and the application for the relevant license for cosmetics submitted by the department shall not be accepted within five years, and the illegal income and the cosmetics produced or imported shall be confiscated; if the value of cosmetics produced or imported is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 150,000 yuan shall be imposed; if the value is more than 10,000 yuan, a fine of not less than 15 times but not more than 30 times the value shall be imposed; and the legal representative or principal person in charge of direct person in charge of the illegal unit shall be fined The person in charge and other persons directly responsible shall be fined not less than 3 times but not more than 5 times the income they received from the unit in the previous year, and shall be prohibited from engaging in cosmetic production and business activities for life.

伪造、变造、出租、出借或者转让化妆品许可证件的，由负责药品监督管理的部门或者原发证部门予以收缴或者吊销，没收违法所得；违法所得不足1万元的，并处5万元以上10万元以下罚款；违法所得1万元以上的，并处违法所得10倍以上20倍以下罚款；构成违反治安管理行为的，由公安机关依法给予治安管理处罚；构成犯罪的，依法追究刑事责任。

Whoever forges, alters, rents, lends or transfers a permit for cosmetics shall be collected or revoked by the department in charge of drug supervision and administration or the department that issued the original license, and the illegal income shall be confiscated; if the illegal income is less than 10,000 yuan, he shall also be fined not less than 50,000 yuan but not more than 100,000 yuan; if the illegal income is more than 10,000 yuan, he shall also be fined not less than 10 times but not more than 20 times the illegal income; if the violation of the administrative act of public security is constituted, the public security organ shall give the public security administration punishment according to law; if the crime is constituted, criminal responsibility shall be investigated according to law.

第六十五条　备案时提供虚假资料的，由备案部门取消备案，3年内不予办理其提出的该项备案，没收违法所得和已经生产、进口的化妆品；已经生产、进口的化妆品货值金额不足1万元的，并处1万元以上3万元以下罚款；货值金额1万元以上的，并处货值金额3倍以上10倍以下罚款；情节严重的，责令停产停业直至由原发证部门吊销化妆品生产许可证，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的1倍以上2倍以下罚款，5年内禁止其从事化妆品生产经营活动。

Article 65 Where false information is provided at the time of filing, the filing department shall cancel the filing and shall not handle the filing within three years, confiscate the illegal income and the cosmetics already produced or imported; if the value of cosmetics already produced or imported is less than 10,000 yuan, a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed; if the value is more than 10,000 yuan, a fine of not less than three times but not more than 10 times the value shall be imposed; if the circumstances are serious, the suspension of production or business shall be ordered until the production license of cosmetics is revoked by the original licensing department, and the legal representative or principal person in charge of the illegal unit, the person in charge directly responsible and other persons directly responsible shall be imposed upon him The last year from the unit to obtain income of more than 1 times more than 2 times the fine, within 5 years prohibited to engage in cosmetics production and business activities.

已经备案的资料不符合要求的，由备案部门责令限期改正，其中，与化妆品、化妆品新原料安全性有关的备案资料不符合要求的，备案部门可以同时责令暂停销售、使用；逾期不改正的，由备案部门取消备案。

Where the filed data do not meet the requirements, the filing department shall order them to make corrections within a time limit. Where the filed data related to the safety of new cosmetics and cosmetics raw materials do not meet the requirements, the filing department may simultaneously order the suspension of sales and use; if the filing department fails to make corrections within the time limit, the filing department shall cancel the filing.

备案部门取消备案后，仍然使用该化妆品新原料生产化妆品或者仍然上市销售、进口该普通化妆品的，分别依照本条例第六十条、第六十一条的规定给予处罚。

After the filing department cancels the filing, if it still uses the new raw materials of the cosmetics to produce cosmetics or is still on the market for sale or imports the ordinary cosmetics, it shall be punished in accordance with the provisions of Article 60 and Article 61 of these Regulations respectively.

第六十六条　化妆品集中交易市场开办者、展销会举办者未依照本条例规定履行审查、检查、制止、报告等管理义务的，由负责药品监督管理的部门处2万元以上10万元以下罚款；情节严重的，责令停业，并处10万元以上50万元以下罚款。

Article 66 If the operator of a centralized cosmetic trading market or the organizer of a trade fair fails to fulfill the administrative obligations of examination, inspection, suppression and reporting in accordance with the provisions of these Regulations, the department in charge of drug supervision and administration shall be fined not less than 20,000 yuan but not more than 100,000 yuan; if the circumstances are serious, it shall be ordered to suspend business and shall be fined not less than 100,000 yuan but not more than 500,000 yuan.

第六十七条　电子商务平台经营者未依照本条例规定履行实名登记、制止、报告、停止提供电子商务平台服务等管理义务的，由省、自治区、直辖市人民政府药品监督管理部门依照《中华人民共和国电子商务法》的规定给予处罚。

Article 67 Where an e-commerce platform operator fails to fulfill the administrative obligations of registering, stopping, reporting or stopping the provision of e-commerce platform services in accordance with the provisions of these Regulations, the drug supervision and administration department of the people's government of a province, autonomous region or municipality directly under the Central Government shall impose penalties in accordance with the provisions of the Electronic Commerce Law of the People's Republic of China.

第六十八条　化妆品经营者履行了本条例规定的进货查验记录等义务，有证据证明其不知道所采购的化妆品是不符合强制性国家标准、技术规范或者不符合化妆品注册、备案资料载明的技术要求的，收缴其经营的不符合强制性国家标准、技术规范或者不符合化妆品注册、备案资料载明的技术要求的化妆品，可以免除行政处罚。

Article 68 Cosmetics business operators have fulfilled their obligations such as inspection records for incoming goods as stipulated in these Regulations, and have evidence to prove that they do not know that the cosmetics purchased do not meet the mandatory national standards, technical specifications or the technical requirements specified in the registration and filing materials for cosmetics, and that they may be exempted from administrative punishment if they operate cosmetics that do not meet the mandatory national standards, technical specifications or technical requirements specified in the registration and filing materials for cosmetics.

第六十九条　化妆品广告违反本条例规定的，依照《中华人民共和国广告法》的规定给予处罚；采用其他方式对化妆品作虚假或者引人误解的宣传的，依照有关法律的规定给予处罚；构成犯罪的，依法追究刑事责任。

Article 69 Where cosmetic advertisements violate the provisions of these Regulations, they shall be punished in accordance with the provisions of the Advertising Law of the People's Republic of China; where cosmetic advertisements are made false or misleading by other means, they shall be punished in accordance with the provisions of the relevant laws; if a crime is constituted, criminal responsibility shall be investigated according to law.

第七十条　境外化妆品注册人、备案人指定的在我国境内的企业法人未协助开展化妆品不良反应监测、实施产品召回的，由省、自治区、直辖市人民政府药品监督管理部门责令改正，给予警告，并处2万元以上10万元以下罚款；情节严重的，处10万元以上50万元以下罚款，5年内禁止其法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员从事化妆品生产经营活动。

Article 70 Where an enterprise legal person designated by an overseas cosmetic registrant or a filing person within the territory of China fails to assist in the monitoring of adverse reactions to cosmetics and the implementation of product recalls, the drug regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government shall order correction, give a warning and impose a fine of not less than 20,000 yuan but not more than 100,000 yuan; if the circumstances are serious, a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed, and its legal representative or principal person in charge, the person in charge directly responsible and other persons directly responsible for the production and operation of cosmetics shall be prohibited within five years.

境外化妆品注册人、备案人拒不履行依据本条例作出的行政处罚决定的，10年内禁止其化妆品进口。

Ifthe overseas cosmetic registrant or filing person refuses to fulfill the administrative penalty decision made in accordance with these Regulations, the import of cosmetics shall be prohibited within 10 years.

第七十一条　化妆品检验机构出具虚假检验报告的，由认证认可监督管理部门吊销检验机构资质证书，10年内不受理其资质认定申请，没收所收取的检验费用，并处5万元以上10万元以下罚款；对其法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的1倍以上3倍以下罚款，依法给予或者责令给予降低岗位等级、撤职或者开除的处分，受到开除处分的，10年内禁止其从事化妆品检验工作；构成犯罪的，依法追究刑事责任。

Article 71 Where a cosmetic inspection institution issues a false inspection report, the certification and approval supervisory and administrative department shall revoke the qualification certificate of the inspection institution, refuse to accept its application for qualification determination within 10 years, confiscate the inspection fee collected, and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan; if the legal representative or principal responsible person, the person in charge directly responsible and other persons directly responsible shall be fined not less than one time but not more than three times the income they received from the unit in the previous year, and shall be given or ordered to be given punishment according to law for lowering the post grade, dismissing the post or dismissing the post, and shall be expelled for 10 years; if they are prohibited from performing cosmetic inspection work; If a crime is constituted, criminal responsibility shall be investigated according to law.

第七十二条　化妆品技术审评机构、化妆品不良反应监测机构和负责化妆品安全风险监测的机构未依照本条例规定履行职责，致使技术审评、不良反应监测、安全风险监测工作出现重大失误的，由负责药品监督管理的部门责令改正，给予警告，通报批评；造成严重后果的，对其法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员，依法给予或者责令给予降低岗位等级、撤职或者开除的处分。

Article 72 Where a cosmetic technical review institution, a cosmetic adverse reaction monitoring institution or an agency responsible for cosmetic safety risk monitoring fails to perform its duties in accordance with the provisions of these Regulations, resulting in major mistakes in technical review, adverse reaction monitoring and safety risk monitoring, the department in charge of drug supervision and administration shall order correction, give warning and report criticism; if serious consequences are caused, the legal representative or principal responsible person, the person in charge directly responsible and other persons directly responsible shall be given or ordered to be punished according to law for lowering the post grade, removing the post or dismissing the post.

第七十三条　化妆品生产经营者、检验机构招用、聘用不得从事化妆品生产经营活动的人员或者不得从事化妆品检验工作的人员从事化妆品生产经营或者检验的，由负责药品监督管理的部门或者其他有关部门责令改正，给予警告；拒不改正的，责令停产停业直至吊销化妆品许可证件、检验机构资质证书。

Article 73 Where a cosmetics producer or operator, an inspection institution recruits or employs persons who are not allowed to engage in cosmetic production and business operations or persons who are not allowed to engage in cosmetic inspection work to engage in cosmetic production and business operations or inspection, the department in charge of drug supervision and administration or other relevant departments shall order correction and give a warning; if they refuse to make corrections, they shall be ordered to suspend production and business operations until license of cosmetics and the qualification certificate of the inspection institution are revoked.

第七十四条　有下列情形之一，构成违反治安管理行为的，由公安机关依法给予治安管理处罚；构成犯罪的，依法追究刑事责任：

Article 74 If one of the following circumstances constitutes a violation of the administration of public security, the public security organ shall, according to law, punish the administration of public security; if the crime is constituted, criminal responsibility shall be investigated according to law:

（一）阻碍负责药品监督管理的部门工作人员依法执行职务；

(1) obstructing the staff of the department in charge of drug supervision and administration from performing their duties according to law;

（二）伪造、销毁、隐匿证据或者隐藏、转移、变卖、损毁依法查封、扣押的物品。

(2) forging, destroying, concealing evidence or concealing, transferring, selling or damaging articles seized or impounded according to law.

第七十五条　负责药品监督管理的部门工作人员违反本条例规定，滥用职权、玩忽职守、徇私舞弊的，依法给予警告、记过或者记大过的处分；造成严重后果的，依法给予降级、撤职或者开除的处分；构成犯罪的，依法追究刑事责任。

Article 75 Any staff member of a department in charge of drug supervision and administration who, in violation of the provisions of these Regulations, abuses his power, neglects his duty or engages in malpractices for personal gain shall be given a warning, demerit or demerit according to law; if serious consequences are caused, he shall be given a punishment of demotion, dismissal or dismissal according to law; if a crime is constituted, criminal responsibility shall be investigated according to law.

第七十六条　违反本条例规定，造成人身、财产或者其他损害的，依法承担赔偿责任。

Article 76 Whoever violates the provisions of these Regulations and causes personal, property or other damage shall be liable for compensation according to law.

第六章　附　　则

Chapter 6 Supplementary Provisions

第七十七条　牙膏参照本条例有关普通化妆品的规定进行管理。牙膏备案人按照国家标准、行业标准进行功效评价后，可以宣称牙膏具有防龋、抑牙菌斑、抗牙本质敏感、减轻牙龈问题等功效。牙膏的具体管理办法由国务院药品监督管理部门拟订，报国务院市场监督管理部门审核、发布。

Article 77 Toothpaste shall be administered with reference to the provisions of these Regulations concerning general cosmetics. Toothpaste filing person according to national standards, industry standards for efficacy evaluation, can claim toothpaste has anti-caries, dental plaque, anti-dentin sensitivity, reduce gum problems and other effects. The specific measures for the administration of toothpaste shall be formulated by the drug regulatory department under the State Council and submitted to the market regulatory department under the State Council for examination and publication.

香皂不适用本条例，但是宣称具有特殊化妆品功效的适用本条例。

This Regulation does not apply to soap, but applies to those that claim special cosmetic effects.

第七十八条　对本条例施行前已经注册的用于育发、脱毛、美乳、健美、除臭的化妆品自本条例施行之日起设置5年的过渡期，过渡期内可以继续生产、进口、销售，过渡期满后不得生产、进口、销售该化妆品。

Article 78 A period of five years shall be set up for cosmetics registered before the entry into force of these Regulations for the purpose of raising, hair removal, beauty breast, bodybuilding and deodorization. During the period of transition, the cosmetics may continue to be produced, imported or sold.

第七十九条　本条例所称技术规范，是指尚未制定强制性国家标准、国务院药品监督管理部门结合监督管理工作需要制定的化妆品质量安全补充技术要求。

Article 79 The term "technical specifications" as mentioned in these Regulations refers to the supplementary technical requirements for the quality and safety of cosmetics that have not yet been formulated by the compulsory state standards and formulated by the drug regulatory department under the State Council in conjunction with the work of supervision and administration.

第八十条　本条例自2021年1月1日起施行。《化妆品卫生监督条例》同时废止。

Article 80 These Regulations shall enter into force on January 1,2021. The Regulations on Health Supervision of Cosmetics shall be repealed at the sam