KYB CHINA(2020年1月3日国务院第77次常务会议通过 2020年6月16日中华人民共和国国务院令第727号公布 自2021年1月1日起施行)
(Adopted at the 77th Executive Meeting of the State Council on January 3, 2020, promulgated by Order No. 727 of the State Council of the People's Republic of China on June 16, 2020, and effective as of January 1, 2021)
总则
General Provisions
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。
These Regulations are formulated to regulate the production and operation activities of cosmetics, strengthen the supervision and administration of cosmetics, ensure the quality and safety of cosmetics, protect the health of consumers, and promote the healthy development of the cosmetics industry.
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。
The production and operation activities of cosmetics and their supervision and administration within the territory of the People's Republic of China shall comply with these Regulations.
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。
For the purposes of these Regulations, cosmetics refer to daily chemical industrial products applied to the surface of the human body such as skin, hair, nails, and lips by means of rubbing, spraying, or other similar methods, for the purposes of cleaning, protection, beautification, and modification.
国家按照风险程度对化妆品、化妆品原料实行分类管理。
The State implements classified management of cosmetics and cosmetic ingredients based on 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 implements registration management for special cosmetics and filing management for 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。
Cosmetic ingredients are divided into new ingredients and already-used ingredients. The State implements registration management for new cosmetic ingredients with a higher degree of risk, and filing management for other new cosmetic ingredients.
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。
The drug regulatory department of the State Council is responsible for the supervision and administration of cosmetics nationwide. The relevant departments of the State Council are responsible for the supervision and administration related to cosmetics within 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 responsible for drug regulation of local people's governments at or above the county level are responsible for the supervision and administration of cosmetics within their administrative regions. The relevant departments of local people's governments at or above the county level are responsible for the supervision and administration related to cosmetics within their respective duties.
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。
Cosmetic registrants and filers shall be responsible for the quality and safety of cosmetics and the efficacy claims thereof.
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。
Cosmetic producers and operators shall engage in production and operation activities in accordance with laws, regulations, mandatory national standards, and technical specifications, strengthen management, act with integrity and self-discipline, and ensure the quality and safety of cosmetics.
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。
Cosmetic industry associations shall strengthen industry self-discipline, urge and guide cosmetic producers and operators to engage in production and operation activities in accordance with the law, and promote the construction of industry integrity.
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。
Consumer associations and other consumer organizations shall conduct social supervision in accordance with the law over acts that violate the provisions of these Regulations and harm the legitimate rights and interests of consumers.
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。
The State encourages and supports the conduct of cosmetic research and innovation to meet consumer needs, promote the building of cosmetic brands, and give play to the leading role of brands. The State protects the legitimate rights and interests of units and individuals in conducting 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 cosmetic producers and operators to adopt advanced technologies and advanced management norms to improve the quality and safety level of cosmetics; encourages and supports the use of modern science and technology, combined with China's traditional advantageous projects and characteristic plant resources, to research and develop cosmetics.
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。
The State strengthens the informatization construction of cosmetic supervision and administration, improves the level of online government services, provides convenience for handling cosmetic administrative licensing and filing, and promotes the sharing of supervision and administration information.
原料与产品
Ingredients and Products
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。
Natural or artificial ingredients used for the first time in cosmetics within China are new cosmetic ingredients. New cosmetic ingredients with functions of preservation, sun protection, coloring, hair dyeing, and freckle removal and whitening may be used only after registration with the drug regulatory department of the State Council; other new cosmetic ingredients shall be filed with the drug regulatory department of the State Council before use. The drug regulatory department of the State Council may, based on the development of scientific research, adjust the scope of new cosmetic ingredients subject to registration management, and implement such adjustment after approval by the State Council.
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：
To apply for registration of a new cosmetic ingredient or to file a new cosmetic ingredient, the following materials shall be submitted:
(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 registration applicant or filer;
(二)新原料研制报告；
(2) A research report on the new ingredient;
(三)新原料的制备工艺、稳定性及其质量控制标准等研究资料；
(3) Research materials on the preparation process, stability, and quality control standards of the new ingredient;
(四)新原料安全评估资料。
(4) Safety assessment materials for the new ingredient.
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 registration applicant or filer shall be responsible for the authenticity and scientific nature of the submitted materials.
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。
The drug regulatory department of the State Council shall, within 3 working days from the date of accepting an application for registration of a new cosmetic ingredient, transfer the application materials to a technical review institution. The technical review institution shall complete the technical review within 90 working days from the date of receiving the application materials and submit a review opinion to the drug regulatory department of the State Council. The drug regulatory department of the State Council shall make a decision within 20 working days from the date of receiving the review opinion. If the requirements are met, registration shall be granted and a registration certificate for the new cosmetic ingredient shall be issued; if the requirements are not met, registration shall be refused and reasons shall be provided 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。
A filer of a new cosmetic ingredient completes the filing upon submitting the filing materials specified in these Regulations through the online government service platform of the drug regulatory department of 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 drug regulatory department of the State Council shall, within 5 working days from the date of granting registration of a new cosmetic ingredient or from the date the filer submits the filing materials, publish the relevant registration or filing information to the public.
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。
Within 3 years after a registered or filed new cosmetic ingredient is put into use, the registrant or filer of the new ingredient shall report annually to the drug regulatory department of the State Council on the use and safety of the new ingredient. For a new cosmetic ingredient with safety problems, the drug regulatory department of the State Council shall revoke the registration or cancel the filing. A new cosmetic ingredient that has not had safety problems upon expiration of the 3-year period shall be included in the catalogue of already-used cosmetic ingredients formulated by the drug regulatory department of 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。
Before a registered or filed new cosmetic ingredient is included in the catalogue of already-used cosmetic ingredients, it shall still be managed as a new cosmetic ingredient.
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。
The catalogue of ingredients prohibited for use in cosmetic production shall be formulated and published by the drug regulatory department of the State Council.
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。
Cosmetics used for hair dyeing, perming, freckle removal and whitening, sun protection, and anti-hair loss, as well as cosmetics claiming new efficacy, are special cosmetics. Cosmetics other than special cosmetics 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 drug regulatory department of the State Council shall, based on factors such as the efficacy claims, application site, product form, and target population of cosmetics, formulate and publish cosmetic classification rules and a classification catalogue.
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。
Special cosmetics may be produced or imported only after registration with the drug regulatory department of the State Council. Domestic ordinary cosmetics shall be filed with the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the filer is located before being sold on the market. Imported ordinary cosmetics shall be filed with the drug regulatory department of the State Council before import.
化妆品注册申请人、备案人应当具备下列条件：
A cosmetic registration applicant or filer shall meet the following conditions:
(一)是依法设立的企业或者其他组织；
(1) It is an enterprise or other organization established in accordance with the 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) It has a quality management system suitable for the products for which registration is applied or filing is made;
(三)有化妆品不良反应监测与评价能力。
(3) It has the capability for monitoring and evaluating adverse reactions to cosmetics.
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：
To apply for registration of a special cosmetic or to file an ordinary cosmetic, the following materials shall be submitted:
(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 registration applicant or filer;
(二)生产企业的名称、地址、联系方式；
(2) The name, address, and contact information of the manufacturer;
(三)产品名称；
(3) The product name;
(四)产品配方或者产品全成分；
(4) The product formula or full ingredient list;
(五)产品执行的标准；
(5) The product implementation standard;
(六)产品标签样稿；
(6) The product label draft;
(七)产品检验报告；
(7) The product inspection report;
(八)产品安全评估资料。
(8) The product safety assessment materials.
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。
If a registration applicant applies for registration of a special cosmetic for the first time, or a filer files an ordinary cosmetic for the first time, it shall submit proof materials that it meets the conditions specified in Article 18 of these Regulations. To apply for registration of an imported special cosmetic or to file an imported ordinary cosmetic, it shall also submit a certificate that the product has been marketed in the country (region) of production and proof materials that the overseas manufacturer complies with the cosmetic production quality management standards; if the product is produced exclusively for export to China and the certificate that the product has been marketed in the country (region) of production cannot be submitted, materials on the relevant research and tests conducted 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 registration applicant or filer shall be responsible for the authenticity and scientific nature of the submitted materials.
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。
The drug regulatory department of the State Council shall review applications for registration of special cosmetics in accordance with the review procedure for new cosmetic ingredient registration specified in the first paragraph of Article 13 of these Regulations. If the requirements are met, registration shall be granted and a special cosmetic registration certificate shall be issued; if the requirements are not met, registration shall be refused and reasons shall be provided in writing. If a registered special cosmetic undergoes substantive changes in production process, efficacy claims, etc., the registrant shall apply to the original registration department for a change of 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。
A filer of an ordinary cosmetic completes the filing upon submitting the filing materials specified in these Regulations through the online government service platform of the drug regulatory department of 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 drug regulatory department at or above the provincial level shall, within 5 working days from the date of granting registration of a special cosmetic or from the date the filer of an ordinary cosmetic submits the filing materials, publish the relevant registration or filing information to the public.
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。
Before registration of a new cosmetic ingredient or a cosmetic, or before filing, the registration applicant or filer shall conduct a safety assessment by itself or entrust a professional institution to do so.
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 professional knowledge related to cosmetic quality and safety and have at least 5 years of relevant professional experience.
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。
Efficacy claims for cosmetics shall have sufficient scientific basis. Cosmetic registrants and filers shall publish on a dedicated website designated by the drug regulatory department of the State Council a summary of the literature, research data, or product efficacy evaluation materials on which the efficacy claims are based, subject to public supervision.
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。
Overseas cosmetic registrants and filers shall designate a domestic enterprise legal person to handle cosmetic registration and filing, assist in carrying out monitoring of adverse reactions to cosmetics, and implement product recalls.
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。
The validity period of a special cosmetic registration certificate is 5 years. If renewal of registration is needed upon expiration, an application for renewal shall be submitted at least 30 working days before the expiration date. Except for the circumstances specified in the second paragraph of this Article, the drug regulatory department of the State Council shall make a decision to grant renewal before the expiration of the special cosmetic registration certificate; if no decision is made within the time limit, renewal shall be deemed granted.
有下列情形之一的，不予延续注册：
Renewal of registration shall not be granted under any of the following circumstances:
(一)注册人未在规定期限内提出延续注册申请；
(1) The registrant fails to submit an application for renewal 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 or technical specifications have been revised, and the cosmetic for which renewal is applied cannot meet the requirements of the revised standards or technical specifications.
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。
The drug regulatory department of the State Council is responsible for the proposal, drafting, solicitation of opinions, and technical review of mandatory national standards for cosmetics. The standardization administrative department of the State Council is responsible for the approval, numbering, and external notification of mandatory national standards for cosmetics.
化妆品国家标准文本应当免费向社会公开。
The texts of national standards for cosmetics shall be disclosed to the 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 comply with mandatory national standards. Enterprises are encouraged to formulate enterprise standards that are stricter than mandatory national standards.
生产经营
Production and Operation
从事化妆品生产活动，应当具备下列条件：
To engage in cosmetic production activities, the following conditions shall be met:
(一)是依法设立的企业；
(1) It is an enterprise established in accordance with the 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) It has production sites, environmental conditions, and production facilities and equipment suitable for the cosmetics produced;
(三)有与生产的化妆品相适应的技术人员；
(3) It has technical personnel suitable for the cosmetics produced;
(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) It has inspection personnel and inspection equipment capable of inspecting the cosmetics produced;
(五)有保证化妆品质量安全的管理制度。
(5) It has a management system to ensure the quality and safety of cosmetics.
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。
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 the applicant is located, along with proof materials that the applicant meets the conditions specified in Article 26 of these Regulations, and the applicant 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 regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall review the application materials, conduct an on-site inspection of the applicant's production site, and make a decision within 30 working days from the date of accepting the application for cosmetic production license. If the conditions are met, the license shall be granted and a cosmetic production license shall be issued; if the conditions are not met, the license shall be refused and reasons shall be provided 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。
The validity period of a cosmetic production license is 5 years. If renewal is needed upon expiration, it shall be handled in accordance with the provisions of the Administrative License Law of the People's Republic of China.
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。
Cosmetic registrants and filers may produce cosmetics themselves 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。
If production is entrusted, the cosmetic registrant or filer shall entrust an enterprise that has obtained the corresponding cosmetic production license, and shall supervise the production activities of the entrusted enterprise (hereinafter referred to as the entrusted manufacturer) to ensure that it produces in accordance with legal requirements. The entrusted manufacturer shall produce in accordance with laws, regulations, mandatory national standards, technical specifications, and the contract, be responsible for the production activities, and accept the supervision of the cosmetic registrant or filer.
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。
Cosmetic registrants, filers, and entrusted manufacturers shall organize production in accordance with the cosmetic production quality management standards formulated by the drug regulatory department of the State Council, establish a cosmetic production quality management system, and establish and implement management systems such as supplier selection, raw material acceptance, production process and quality control, equipment management, product inspection, and sample retention.
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。
Cosmetic registrants, filers, and entrusted manufacturers shall produce cosmetics in accordance with the technical requirements specified in the cosmetic registration or filing materials.
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。
Cosmetic ingredients and packaging materials that directly contact cosmetics shall comply with 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 or cosmetic ingredients that are expired, discarded, or recycled shall not be used to produce cosmetics.
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。
Cosmetic registrants, filers, and entrusted manufacturers shall establish and implement a record system for the inspection of incoming raw materials and packaging materials that directly contact cosmetics, and a record system for product sales. The incoming inspection records and sales records shall be true and complete, ensure traceability, and be kept for a period not less than 1 year after the expiration of the product's use period; if the product's use period is less than 1 year, the retention period shall not be less than 2 years.
化妆品经出厂检验合格后方可上市销售。
Cosmetics may be sold on the market only after passing factory inspection.
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。
Cosmetic registrants, filers, and entrusted manufacturers shall appoint a quality safety officer who shall be responsible for the corresponding product quality 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 quality safety officer shall have professional knowledge related to cosmetic quality and safety and have at least 5 years of experience in cosmetic production or quality safety management.
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。
Cosmetic registrants, filers, and entrusted manufacturers shall establish and implement a health management system for employees. Persons suffering from diseases that may affect the quality and safety of cosmetics as specified by the health administrative department of the State Council shall not directly engage in cosmetic production activities.
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。
Cosmetic registrants, filers, and entrusted manufacturers shall periodically conduct self-inspections on the implementation of the cosmetic production quality management standards; if production conditions change and no longer meet the requirements of the cosmetic production quality management standards, corrective measures shall be taken immediately; if the quality and safety of cosmetics may be affected, production shall be immediately stopped and reported to the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the entity is located.
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。
The smallest sales unit of cosmetics shall have a label. The label shall comply with relevant laws, administrative regulations, and mandatory national standards, and the content 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 may directly use Chinese labels or have Chinese labels affixed; if Chinese labels are affixed, the content of the Chinese labels shall be consistent with the original labels.
化妆品标签应当标注下列内容：
Cosmetic labels shall indicate the following:
(一)产品名称、特殊化妆品注册证编号；
(1) Product name and special cosmetic registration certificate number;
(二)注册人、备案人、受托生产企业的名称、地址；
(2) Name and address of the registrant, filer, and entrusted manufacturer;
(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) Product implementation standard number;
(五)全成分；
(5) Full ingredient list;
(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) Use period, method of use, and 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 that shall be indicated as required by laws, administrative regulations, and mandatory national standards.
化妆品标签禁止标注下列内容：
Cosmetic labels are prohibited from indicating the following:
(一)明示或者暗示具有医疗作用的内容；
(1) Content that explicitly or implicitly suggests medical effects;
(二)虚假或者引人误解的内容；
(2) False or misleading content;
(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 content prohibited by laws and administrative regulations.
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。
Cosmetic operators shall establish and implement a record system for incoming inspection, verify the supplier's market entity registration certificate, the registration or filing status of the cosmetics, and the product factory inspection certificate, and truthfully record and retain relevant vouchers. The retention period of records and vouchers shall comply with the provisions of the first paragraph of Article 31 of these Regulations.
化妆品经营者不得自行配制化妆品。
Cosmetic operators shall not prepare cosmetics by themselves.
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。
Cosmetic producers and operators shall store and transport cosmetics in accordance with the provisions of relevant laws and regulations and the requirements indicated on cosmetic labels, and regularly inspect and promptly dispose of cosmetics that have deteriorated or exceeded their use period.
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。
The organizers of centralized cosmetic trading markets and exhibition venues shall review the market entity registration certificates of cosmetic operators entering the market, assume management responsibility for the cosmetic operators entering the market, and periodically inspect the cosmetic operators entering the market; if they find that a cosmetic operator entering the market has violated the provisions of these Regulations, they shall promptly stop it and report to the local county-level people's government department responsible for drug regulation.
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。
E-commerce platform operators shall conduct real-name registration for cosmetic operators on the platform, assume management responsibility for cosmetic operators on the platform, and if they find that a cosmetic operator on the platform has violated the provisions of these Regulations, they shall promptly stop it and report to the drug regulatory 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 a serious violation is found, they shall immediately stop providing e-commerce platform services to the violating 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。
Cosmetic operators on the platform shall disclose information about the cosmetics they operate comprehensively, truthfully, accurately, and promptly.
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。
Beauty salons, hair salons, hotels, etc., that use cosmetics in their operations or provide cosmetics to consumers shall fulfill the obligations of cosmetic operators as specified in these Regulations.
化妆品广告的内容应当真实、合法。
The content 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 advertisements shall not explicitly or implicitly suggest that the product has medical effects, shall not contain false or misleading content, and shall not deceive or mislead consumers.
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。
If a cosmetic registrant or filer discovers that a cosmetic has quality defects or other problems that may endanger human health, it shall immediately stop production, recall the cosmetics already on the market, notify relevant cosmetic operators and consumers to stop operating and using, and record the recall and notification. The cosmetic registrant or filer shall take measures such as remediation, harmless treatment, or destruction of the recalled cosmetics, and 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 it is 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 an entrusted manufacturer or cosmetic operator discovers that the cosmetics it produces or operate have the circumstances specified in the preceding paragraph, it shall immediately stop production or operation and notify the relevant cosmetic registrant or filer. The cosmetic registrant or filer 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 responsible for drug regulation discovers during supervision and inspection that cosmetics have the circumstances specified in the first paragraph of this Article, it shall notify the cosmetic registrant or filer to implement a recall, and notify the entrusted manufacturer and cosmetic operator to stop production or 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。
If a cosmetic registrant or filer implements a recall, the entrusted manufacturer and 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。
If a cosmetic registrant, filer, entrusted manufacturer, or operator fails to implement a recall or stop production or operation in accordance with this Article, the department responsible for drug regulation shall order it to implement a recall or stop production or operation.
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。
Entry-exit inspection and quarantine authorities shall inspect imported cosmetics in accordance with the provisions of the Law of the People's Republic of China on Import and Export Commodity Inspection; those that fail inspection shall not be imported.
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。
Importers shall verify whether the cosmetics to be imported have been registered or filed and whether they comply with these Regulations and mandatory national standards and technical specifications; those that fail verification shall not be imported. Importers shall truthfully record information on imported cosmetics, and the retention period of records shall comply with the provisions of the first paragraph of Article 31 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。
Exported cosmetics shall meet the standards of the importing country (region) or contractual requirements.
监督管理
Supervision and Administration
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：
When conducting supervision and inspection of cosmetic production and operation, the department responsible for drug regulation has the authority to take the following measures:
(一)进入生产经营场所实施现场检查；
(1) Enter the production and operation site to conduct on-site inspection;
(二)对生产经营的化妆品进行抽样检验；
(2) Conduct sampling inspection of cosmetics being produced or operated;
(三)查阅、复制有关合同、票据、账簿以及其他有关资料；
(3) Review and copy relevant contracts, invoices, account books, and other relevant materials;
(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) Seal up or seize cosmetics and their ingredients, packaging materials that directly contact cosmetics that do not comply with mandatory national standards or technical specifications or for which there is evidence that they may endanger human health, as well as tools and equipment that have evidence of being used for illegal production or operation;
(五)查封违法从事生产经营活动的场所。
(5) Seal up sites where illegal production or operation activities are conducted.
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。
When conducting supervision and inspection of cosmetic production and operation, the department responsible for drug regulation shall have at least 2 inspectors and shall present their law enforcement credentials. Inspectors shall keep confidential the business secrets of the inspected entity that they become aware of during the inspection. The inspected entity shall cooperate with the inspection and shall not conceal 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 responsible for drug regulation shall record the inspection situation and handling results, which shall be signed by the inspectors and the person in charge of the inspected entity; if the person in charge of the inspected entity refuses to sign, it shall be noted.
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。
The drug regulatory department at or above the provincial level shall organize sampling inspection of cosmetics; for cosmetics that are reported or found to have many problems during routine supervision and inspection, the department responsible for drug regulation may conduct special sampling 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。
When conducting sampling inspection, the cost of the samples taken shall be paid, and the required expenses shall be included in the government budget at the same 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 responsible for drug regulation shall promptly publish the results of cosmetic sampling inspections in accordance with regulations.
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。
Cosmetic inspection institutions may engage in cosmetic inspection activities only after obtaining qualification accreditation in accordance with the relevant national regulations on certification and accreditation. The qualification accreditation conditions for cosmetic inspection institutions shall be formulated by the drug regulatory department of the State Council and the market regulatory department of 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。
Cosmetic inspection specifications and regulations on the management of reference standards for cosmetic inspection shall be formulated by the drug regulatory department of the State Council.
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。
For cosmetics that may be adulterated or produced using ingredients prohibited for cosmetic production, if the inspection items and methods specified in the national standards for cosmetics cannot be used for inspection, the drug regulatory department of the State Council may formulate supplementary inspection items and methods for sampling inspection of cosmetics, investigation and handling of cosmetic quality safety cases, and investigation and handling of adverse reactions.
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。
If a cosmetic producer or operator disagrees with the inspection conclusion made in accordance with these Regulations, it may, within 7 working days from the date of receiving the inspection conclusion, submit a re-inspection application to the department that conducted the sampling inspection or the department responsible for drug regulation at the next higher level. The department that accepts the re-inspection application shall randomly determine a re-inspection institution from the list of re-inspection institutions to conduct the re-inspection. The re-inspection conclusion issued by the re-inspection institution shall be 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 of the State Council.
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。
The State establishes a monitoring system for adverse reactions to cosmetics. Cosmetic registrants and filers shall monitor adverse reactions to the cosmetics they have on the market, conduct timely evaluations, and report to the adverse reaction monitoring institution for cosmetics in accordance with the provisions of the drug regulatory department of the State Council. Entrusted manufacturers, cosmetic operators, and medical institutions that discover adverse reactions that may be related to the use of cosmetics shall report to the adverse reaction monitoring institution for cosmetics. Other units and individuals are encouraged to report to the adverse reaction monitoring institution for cosmetics or the department responsible for drug regulation any adverse reactions that may be related to the use of cosmetics.
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 adverse reaction monitoring institution for cosmetics is responsible for collecting, analyzing, and evaluating information on adverse reactions to cosmetics, and providing handling suggestions to the department responsible for drug regulation.
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。
Cosmetic producers and operators shall cooperate with the adverse reaction monitoring institution for cosmetics and the department responsible for drug regulation in conducting investigations into adverse reactions to cosmetics.
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。
Adverse reactions to cosmetics refer to pathological changes in the skin and its appendages, as well as local or systemic damage to the human body, caused by the normal use of cosmetics.
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。
The State establishes a monitoring and evaluation system for cosmetic safety risks to monitor and evaluate risk factors affecting the quality and safety of cosmetics, providing a scientific basis for formulating measures and standards for controlling cosmetic quality safety risks and conducting 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, published, and organized for implementation by the drug regulatory department of the State Council. The national cosmetic safety risk monitoring plan shall specify the varieties, items, and regions to be monitored as a priority.
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 drug regulatory department of the State Council shall establish a mechanism for the exchange of information on cosmetic quality safety risks, organizing cosmetic producers and operators, inspection institutions, industry associations, consumer associations, and news media to exchange and communicate information on cosmetic quality safety risks.
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。
For cosmetics that cause human injury or for which there is evidence that they may endanger human health, the department responsible for drug regulation may take emergency control measures such as ordering a suspension of production or operation, and issue safety warning information; if they are imported cosmetics, the national entry-exit inspection and quarantine department may suspend import.
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。
If, based on the development of scientific research, there is a change in understanding of the safety of cosmetics or cosmetic ingredients, or if there is evidence that cosmetics or cosmetic ingredients may have defects, the drug regulatory department at or above the provincial level may order the registrant or filer of the cosmetic or new cosmetic ingredient to conduct a safety re-evaluation, or directly organize a safety re-evaluation. If the re-evaluation results show that the cosmetic or cosmetic ingredient cannot ensure safety, the original registration department shall revoke the registration, the filing department shall cancel the filing, and the drug regulatory department of the State Council shall include the cosmetic ingredient in the catalogue of ingredients prohibited for use in cosmetic production and publish it to the public.
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。
The department responsible for drug regulation shall promptly publish information on cosmetic administrative licensing, filing, routine inspection results, and investigation and punishment of illegal acts in accordance with the law. When publishing supervision and administration information, it shall keep the business secrets of the parties confidential.
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 responsible for drug regulation shall establish credit files for cosmetic producers and operators. For cosmetic producers and operators with adverse credit records, the frequency of supervision and inspection shall be increased; for producers and operators with serious adverse credit records, joint disciplinary actions shall be implemented in accordance with regulations.
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。
If there are safety hazards in the production or operation of cosmetics that have not been promptly eliminated, the department responsible for drug regulation may conduct a responsibility interview with the legal representative or principal person in charge of the cosmetic producer or operator. The cosmetic producer or operator shall immediately take measures to rectify and eliminate the hazards. The responsibility interview and rectification shall be included in the credit file of the cosmetic producer or operator.
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。
The department responsible for drug regulation shall publish its website address, email address, or telephone number to receive inquiries, complaints, and reports, and shall promptly respond or handle them. For verified reports, the reporter shall be rewarded in accordance with relevant national regulations.
法律责任
Legal Liability
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：
Under any of the following circumstances, the department responsible for drug regulation shall confiscate the illegal gains, the illegally produced or operated cosmetics, and the ingredients, packaging materials, tools, equipment, and other items specially used for illegal production or operation; if the value of the illegally produced or operated cosmetics is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 150,000 yuan shall also be imposed; if the value is 10,000 yuan or more, a fine of not less than 15 times but not more than 30 times the value shall also be imposed; if the circumstances are serious, the production or operation shall be ordered to suspend for rectification, the filing shall be cancelled by the filing department, or the cosmetic license shall be revoked by the original issuing department, and the cosmetic filing application or cosmetic administrative license application submitted by the violator shall not be accepted for 10 years; the legal representative or principal person in charge, the directly responsible supervisor, and other directly responsible personnel of the violator 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 they shall be permanently prohibited from engaging in cosmetic production or operation activities; if a crime is constituted, criminal liability shall be pursued in accordance with the 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) Engaging in cosmetic production activities without a license, or a cosmetic registrant or filer entrusting an enterprise that has not obtained the corresponding cosmetic production license to produce cosmetics;
(二)生产经营或者进口未经注册的特殊化妆品；
(2) Producing, operating, or importing special cosmetics that have not been registered;
(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) Using ingredients prohibited for cosmetic production, or new ingredients that should be registered but have not been registered, to produce cosmetics, illegally adding substances that may endanger human health to cosmetics, or using expired, discarded, or recycled cosmetics or ingredients to produce cosmetics.
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：
Under any of the following circumstances, the department responsible for drug regulation shall confiscate the illegal gains, the illegally produced or operated cosmetics, and the ingredients, packaging materials, tools, equipment, and other items specially used for illegal production or operation; if the value of the illegally produced or operated cosmetics is less than 10,000 yuan, a fine of not less than 10,000 yuan but not more than 50,000 yuan shall also be imposed; if the value is 10,000 yuan or more, a fine of not less than 5 times but not more than 20 times the value shall also be imposed; if the circumstances are serious, the production or operation shall be ordered to suspend for rectification, the filing shall be cancelled by the filing department, or the cosmetic license shall be revoked by the original issuing department; the legal representative or principal person in charge, the directly responsible supervisor, and other directly responsible personnel of the violator shall be fined not less than 1 time but not more than 3 times the income they received from the unit in the previous year, and they shall be prohibited from engaging in cosmetic production or operation activities for 10 years; if a crime is constituted, criminal liability shall be pursued in accordance with the 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) Using ingredients or packaging materials that directly contact cosmetics that do not comply with mandatory national standards or technical specifications, or new ingredients that should be filed but have not been filed, to produce cosmetics, or using ingredients not in accordance with 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) Producing or operating cosmetics that do not comply with mandatory national standards or technical specifications, or that do not comply with the technical requirements specified in the cosmetic registration or filing materials;
(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 cosmetic production quality management standards;
(四)更改化妆品使用期限；
(4) Altering the use period 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) A cosmetic operator preparing cosmetics without authorization, or operating deteriorated or expired cosmetics;
(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 implement a recall after being ordered by the department responsible for drug regulation to do so, or refusing to stop or suspend production or operation after being ordered by the department responsible for drug regulation to do so.
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：
Under any of the following circumstances, the department responsible for drug regulation shall confiscate the illegal gains and the illegally produced or operated cosmetics, and may also confiscate the ingredients, packaging materials, tools, equipment, and other items specially used for illegal production or operation; if the value of the illegally produced or operated cosmetics is less than 10,000 yuan, a fine of not less than 10,000 yuan but not more than 30,000 yuan shall also be imposed; if the value is 10,000 yuan or more, a fine of not less than 3 times but not more than 10 times the value shall also be imposed; if the circumstances are serious, the production or operation shall be ordered to suspend for rectification, the filing shall be cancelled by the filing department, or the cosmetic license shall be revoked by the original issuing department; the legal representative or principal person in charge, the directly responsible supervisor, and other directly responsible personnel of the violator shall be fined not less than 1 time but not more than 2 times the income they received from the unit in the previous year, and they shall be prohibited from engaging in cosmetic production or operation activities for 5 years:
(一)上市销售、经营或者进口未备案的普通化妆品；
(1) Selling, operating, or importing ordinary cosmetics that have not been filed;
(二)未依照本条例规定设质量安全负责人；
(2) Failing to appoint a quality safety officer in accordance with 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) A cosmetic registrant or filer failing to supervise the production activities of the entrusted manufacturer;
(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 these Regulations;
(五)生产经营标签不符合本条例规定的化妆品。
(5) Producing or operating cosmetics whose labels do not comply with 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 a cosmetic being produced or operated has defects but does not affect quality and safety and will not mislead consumers, the department responsible for drug regulation shall order correction; if correction is refused, a fine of not more than 2,000 yuan shall be imposed.
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：
Under any of the following circumstances, the department responsible for drug regulation 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, production or operation shall be ordered to suspend for rectification, and a fine of not less than 30,000 yuan but not more than 50,000 yuan shall be imposed, and the legal representative or principal person in charge, the directly responsible supervisor, and other directly responsible personnel of the violator shall be fined not less than 10,000 yuan but not more than 30,000 yuan:
(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 cosmetic efficacy claims in accordance with 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 a record system for incoming inspection and a record system for product sales in accordance with 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-inspections on the implementation of the cosmetic production quality management standards in accordance with these Regulations;
(四)未依照本条例规定贮存、运输化妆品；
(4) Failing to store or transport cosmetics in accordance with 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) Failing to monitor or report adverse reactions to cosmetics in accordance with these Regulations, or failing to cooperate with the adverse reaction monitoring institution for cosmetics or the department responsible for drug regulation in conducting investigations into adverse reactions to cosmetics.
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 an importer fails to record or retain information on imported cosmetics in accordance with these Regulations, the entry-exit inspection and quarantine authority shall impose a penalty in accordance with the preceding paragraph.
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。
If a registrant or filer of a new cosmetic ingredient fails to report the use and safety of the new cosmetic ingredient in accordance with these Regulations, the drug regulatory department of 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 for the new cosmetic ingredient shall be revoked or the filing of the new cosmetic ingredient shall be cancelled, and a fine of not less than 200,000 yuan but not more than 500,000 yuan shall be imposed.
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。
If false materials are provided or other deceptive means are used in applying for cosmetic administrative licensing, the administrative license shall not be granted; if the administrative license has already been granted, the department that made the licensing decision shall revoke the administrative license, and shall not accept any cosmetic-related license application submitted by the applicant for 5 years, and shall confiscate the illegal gains and the cosmetics that have been produced or imported; if the value of the cosmetics that have been 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 also be imposed; if the value is 10,000 yuan or more, a fine of not less than 15 times but not more than 30 times the value shall also be imposed; the legal representative or principal person in charge, the directly responsible supervisor, and other directly responsible personnel of the violator 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 they shall be permanently prohibited from engaging in cosmetic production or operation activities.
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。
If a cosmetic license is forged, altered, leased, lent, or transferred, the department responsible for drug regulation or the original issuing department shall confiscate or revoke it, and confiscate the illegal gains; if the illegal gains are less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall also be imposed; if the illegal gains are 10,000 yuan or more, a fine of not less than 10 times but not more than 20 times the illegal gains shall also be imposed; if the act constitutes a violation of public security administration, the public security organ shall impose a public security administration penalty in accordance with the law; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
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。
If false materials are provided during filing, the filing department shall cancel the filing, and shall not handle the filing submitted by the applicant for 3 years, and shall confiscate the illegal gains and the cosmetics that have been produced or imported; if the value of the cosmetics that have been 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 also be imposed; if the value is 10,000 yuan or more, a fine of not less than 3 times but not more than 10 times the value shall also be imposed; if the circumstances are serious, production or operation shall be ordered to suspend for rectification until the cosmetic production license is revoked by the original issuing department; the legal representative or principal person in charge, the directly responsible supervisor, and other directly responsible personnel of the violator shall be fined not less than 1 time but not more than 2 times the income they received from the unit in the previous year, and they shall be prohibited from engaging in cosmetic production or operation activities for 5 years.
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。
If the filed materials do not meet the requirements, the filing department shall order correction within a specified period; if the filing materials related to the safety of cosmetics or new cosmetic ingredients do not meet the requirements, the filing department may also order a suspension of sales or use; if correction is not made 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。
If, after the filing is cancelled, the new cosmetic ingredient is still used to produce cosmetics, or the ordinary cosmetic is still sold on the market or imported, penalties shall be imposed in accordance with Articles 60 and 61 of these Regulations, respectively.
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。
If the organizer of a centralized cosmetic trading market or exhibition venue fails to fulfill its management obligations such as review, inspection, stopping, and reporting in accordance with these Regulations, the department responsible for drug regulation shall impose a fine of not less than 20,000 yuan but not more than 100,000 yuan; if the circumstances are serious, it shall order a suspension of business and impose a fine of not less than 100,000 yuan but not more than 500,000 yuan.
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。
If an e-commerce platform operator fails to fulfill its management obligations such as real-name registration, stopping, reporting, and stopping the provision of e-commerce platform services in accordance with these Regulations, the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall impose a penalty in accordance with the provisions of the E-Commerce Law of the People's Republic of China.
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。
If a cosmetic operator has fulfilled its obligations such as incoming inspection records as specified in these Regulations, and there is evidence that it did not know that the cosmetics it purchased did not comply with mandatory national standards or technical specifications or the technical requirements specified in the cosmetic registration or filing materials, the cosmetics it operates that do not comply with mandatory national standards or technical specifications or the technical requirements specified in the cosmetic registration or filing materials shall be confiscated, and administrative penalties may be exempted.
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。
If a cosmetic advertisement violates the provisions of these Regulations, penalties shall be imposed in accordance with the provisions of the Advertising Law of the People's Republic of China; if other methods are used to make false or misleading publicity about cosmetics, penalties shall be imposed in accordance with the provisions of relevant laws; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
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。
If the domestic enterprise legal person designated by an overseas cosmetic registrant or filer fails to assist in carrying out monitoring of adverse reactions to cosmetics or implementing product recalls, the drug regulatory department of the people's government of the 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 the legal representative or principal person in charge, the directly responsible supervisor, and other directly responsible personnel shall be prohibited from engaging in cosmetic production or operation activities for 5 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。
If an overseas cosmetic registrant or filer refuses to comply with an administrative penalty decision made in accordance with these Regulations, the import of its cosmetics shall be prohibited for 10 years.
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。
If a cosmetic inspection institution issues a false inspection report, the certification and accreditation regulatory department shall revoke the inspection institution's qualification certificate, shall not accept its qualification accreditation application for 10 years, confiscate the inspection fees collected, and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan; the legal representative or principal person in charge, the directly responsible supervisor, and other directly responsible personnel shall be fined not less than 1 time but not more than 3 times the income they received from the unit in the previous year, and shall be given or ordered to be given a demotion, removal from office, or expulsion; if expelled, they shall be prohibited from engaging in cosmetic inspection work for 10 years; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
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。
If a cosmetic technical review institution, adverse reaction monitoring institution for cosmetics, or institution responsible for cosmetic safety risk monitoring fails to perform its duties in accordance with these Regulations, resulting in major errors in technical review, adverse reaction monitoring, or safety risk monitoring, the department responsible for drug regulation shall order correction, give a warning, and circulate a notice of criticism; if serious consequences are caused, the legal representative or principal person in charge, the directly responsible supervisor, and other directly responsible personnel shall be given or ordered to be given a demotion, removal from office, or expulsion in accordance with the law.
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。
If a cosmetics producer, operator, or inspection institution hires or employs a person who is not allowed to engage in cosmetics production, operation, or inspection to engage in cosmetics production, operation, or inspection, the drug regulatory department or other relevant department shall order correction and give a warning; if correction is refused, the department shall order suspension of production or business operation until the cosmetics license or inspection institution qualification certificate is revoked.
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：
Under any of the following circumstances, if it constitutes a violation of public security administration, the public security organ shall impose a public security administration penalty according to law; if it constitutes a crime, criminal liability shall be pursued 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 staff of the drug regulatory department 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, or concealing evidence, or hiding, transferring, selling off, or damaging items that have been sealed up or seized according to law.
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。
If a staff member of the drug regulatory department violates these Regulations by abusing power, neglecting duties, or engaging in malpractice for personal gain, a warning, demerit, or serious demerit shall be given according to law; if serious consequences are caused, demotion, removal from office, or expulsion shall be given according to law; if a crime is constituted, criminal liability shall be pursued according to law.
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。
If these Regulations are violated, causing personal, property, or other damages, compensation liability shall be borne according to law.
附则
Supplementary Provisions
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。
Toothpaste shall be managed by reference to the provisions of these Regulations on ordinary cosmetics. After a toothpaste filer conducts efficacy evaluation in accordance with national standards or industry standards, it may claim that the toothpaste has effects such as anti-caries, anti-dental plaque, anti-dentin hypersensitivity, and alleviation of gum problems. The specific management measures for toothpaste shall be formulated by the drug regulatory department of the State Council and submitted to the market supervision and administration department of the State Council for review and issuance.
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。
Soap is not subject to these Regulations, but if it claims to have the efficacy of special cosmetics, these Regulations shall apply.
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。
For cosmetics that have been registered before the implementation of these Regulations and are used for hair growth promotion, hair removal, breast enhancement, body shaping, or deodorization, a transition period of 5 years shall be set from the date of implementation of these Regulations. During the transition period, such cosmetics may continue to be produced, imported, and sold; after the transition period expires, such cosmetics shall not be produced, imported, or sold.
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。
The term 'technical specifications' as used in these Regulations refers to supplementary technical requirements for cosmetics quality and safety that are formulated by the drug regulatory department of the State Council based on the needs of supervision and management when mandatory national standards have not been established.
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。
These Regulations shall come into force on January 1, 2021. The 'Regulations on the Hygiene Supervision of Cosmetics' shall be repealed simultaneously.