中國化妝品登記法規問題集

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HLF-TW-10

請問中國對於化妝品的歸類方式為何？它的正式名稱為何？不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？

What are the categories of cosmetics in China? What is its official name?
What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?

Evershine RD：

在中國，化妝品是指以塗擦、噴灑或者其他類似方法，施用於皮膚、毛髮、指甲、口唇等人體表面，以清潔、保護、美化、修飾為目的的日用化學工業產品。由國務院藥品監督管理部門(NMPA)負責全國化妝品監督管理工作，國務院有關部門在各自職責範圍內負責與化妝品有關的監督管理工作，縣級以上地方人民政府負責藥品監督管理的部門負責本行政區域的化妝品監督管理工作，縣級以上地方人民政府有關部門在各自職責範圍內負責與化妝品有關的監督管理工作。

化妝品、化妝品原料實行分類管理。化妝品分為特殊化妝品和普通化妝品，中國對特殊化妝品實行註冊管理，對普通化妝品實行備案管理。化妝品原料分為新原料和已使用的原料，風險程度較高的化妝品新原料實行註冊管理，其他化妝品新原料實行備案管理。

化妝品分類

用於染髮、燙髮、祛斑美白、防曬、防脫髮的化妝品以及宣稱新功效的化妝品為特殊化妝品，特殊化妝品以外的化妝品為普通化妝品。

In China, cosmetics refer to daily chemical industrial products that are applied to the surface of the human body such as skin, hair, nails, lips, etc. by rubbing, spraying or other similar methods for the purpose of cleaning, protecting, beautifying and modifying.
The National Medical Products Administration (NMPA) is responsible for the supervision and administration of cosmetics nationwide, the relevant departments of the State Council are responsible for the supervision and administration of cosmetics within the scope of their respective responsibilities, and the departments responsible for drug supervision and administration of the local people’s governments at or above the county level are responsible for the supervision and administration of cosmetics within their respective administrative regions. For the supervision and management of cosmetics, the relevant departments of the local people’s governments at or above the county level shall be responsible for the supervision and management of cosmetics within their respective scope of responsibilities.

Cosmetics and cosmetic raw materials shall be managed by classification. Cosmetics are divided into special cosmetics and ordinary cosmetics. China implements registration management for special cosmetics, and records management for ordinary cosmetics.
Cosmetic raw materials are divided into new raw materials and used raw materials.
The new cosmetic raw materials with higher risk are subject to registration management, and other new cosmetic raw materials are subject to record management.

Cosmetics Category

Cosmetics used for hair dyeing, perming, freckle whitening, sun protection, and anti-hair loss, as well as cosmetics that claim new effects, are special cosmetics, and cosmetics other than special cosmetics are ordinary cosmetics.

【參考連結】

https://www.nmpa.gov.cn/directory/web/nmpa/index.html

http://www.gov.cn/zhengce/2020-12/27/content_5573797.htm

HLF-TW-20

外國公司要到中國銷售化妝品，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

If a foreign company wants to sell cosmetics in China, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?

Evershine RD：

無須申請營業特許證。但須通過進口化妝品備案許可批件，且經國家商檢部門檢驗的化妝品方可進口、銷售。化妝品經營需遵守相關經營規範。

化妝品經營

化妝品經營者應建立並執行進貨查驗記錄制度，查驗直接供貨者的市場主體登記證明、特殊化妝品註冊證或者普通化妝品備案信息、化妝品的產品質量檢驗合格證明並保存相關憑證，如實記錄化妝品名稱、特殊化妝品註冊證編號或者普通化妝品備案編號、使用期限、淨含量、購進數量、供貨者名稱、地址、聯繫方式、購進日期等內容。
實行統一配送的化妝品經營者，可以由經營者總部統一建立並執行進貨查驗記錄制度，統一進行查驗記錄並保存相關憑證。經營者總部應保證所屬分店能提供所經營化妝品的相關記錄和憑證。
美容美髮機構、賓館等在經營服務中使用化妝品或者為消費者提供化妝品的，應依法履行化妝品經營者義務。
美容美髮機構經營中使用的化妝品以及賓館等為消費者提供的化妝品應符合最小銷售單元標籤的規定。
美容美髮機構應在其服務場所內顯著位置展示其經營使用的化妝品的銷售包裝，方便消費者查閱化妝品標籤的全部信息，並按照化妝品標籤或者說明書的要求，正確使用或者引導消費者正確使用化妝品。
化妝品集中交易市場開辦者、展銷會舉辦者應建立保證化妝品質量安全的管理制度並有效實施，承擔入場化妝品經營者管理責任，督促入場化妝品經營者依法履行義務，每年或者展銷會期間至少組織開展一次化妝品質量安全知識培訓。
化妝品集中交易市場開辦者、展銷會舉辦者應建立入場化妝品經營者檔案，審查入場化妝品經營者的市場主體登記證明，如實記錄經營者名稱或者姓名、聯繫方式、住所等信息。入場化妝品經營者檔案信息應及時核驗更新，保證真實、準確、完整，保存期限不少於經營者在場內停止經營後2年。
化妝品展銷會舉辦者應在展銷會舉辦前向所在地縣級負責藥品監督管理的部門報告展銷會的時間、地點等基本信息。
化妝品集中交易市場開辦者、展銷會舉辦者應建立化妝品檢查制度，對經營者的經營條件以及化妝品質量安全狀況進行檢查。發現入場化妝品經營者有違反規定行為的，應及時制止，依照集中交易市場管理規定或者與經營者簽訂的協議進行處理，並向所在地縣級負責藥品監督管理的部門報告。
化妝品集中交易市場開辦者、展銷會舉辦者鼓勵建立化妝品抽樣檢驗、統一銷售憑證格式等制度。
電子商務平台內化妝品經營者以及通過自建網站、其他網絡服務經營化妝品的電子商務經營者應在其經營活動主頁面全面、真實、準確披露與化妝品註冊或者備案資料一致的化妝品標籤等信息。
化妝品電子商務平台經營者應對申請入駐的平台內化妝品經營者進行實名登記，要求其提交身份、地址、聯繫方式等真實信息，進行核驗、登記，建立登記檔案，並至少每6個月核驗更新一次。化妝品電子商務平台經營者對平台內化妝品經營者身份信息的保存時間自其退出平台之日起不少於3年。
化妝品電子商務平台經營者應設置化妝品質量管理機構或者配備專兼職管理人員，建立平台內化妝品日常檢查、違法行為製止及報告、投訴舉報處理等化妝品質量安全管理制度並有效實施，加強對平台內化妝品經營者相關法規知識宣傳。鼓勵化妝品電子商務平台經營者開展抽樣檢驗。
化妝品電子商務平台經營者應依法承擔平台內化妝品經營者管理責任，對平台內化妝品經營者的經營行為進行日常檢查，督促平台內化妝品經營者履行規定的義務。發現違法經營化妝品行為的，應依法或者依據平台服務協議和交易規則採取刪除、屏蔽、斷開鏈接等必要措施及時制止，並報告所在地省、自治區、直轄市藥品監督管理部門。
化妝品電子商務平台經營者收到化妝品不良反應信息、投訴舉報信息的，應記錄並及時轉交平台內化妝品經營者處理；涉及產品質量安全的重大信息，應及時報告所在地省、自治區、直轄市藥品監督管理部門。
負責藥品監督管理的部門因監督檢查、案件調查等工作需要，要求化妝品電子商務平台經營者依法提供相關信息的，化妝品電子商務平台經營者應予以協助、配合。
化妝品電子商務平台經營者發現有下列嚴重違法行為的，應立即停止向平台內化妝品經營者提供電子商務平台服務：

．化妝品質量安全相關犯罪被人民法院判處刑罰

．因化妝品質量安全違法行為被公安機關拘留或者給予其他治安管理處罰

．被藥品監督管理部門依法作出吊銷許可證、責令停產停業等處罰

．其他嚴重違法行為

18.因涉嫌化妝品質量安全犯罪被立案偵查或者提起公訴，且有證據證明可能危害人體健康的，化妝品電子商務平台經營者可以依法或者依據平台服務協議和交易規則暫停向平台內化妝品經營者提供電子商務平台服務。

19.化妝品電子商務平台經營者知道或者應知道平台內化妝品經營者被依法禁止從事化妝品生產經營活動的，不得向其提供電子商務平台服務。

20.以免費試用、贈予、兌換等形式向消費者提供化妝品的，應依法履行規定的化妝品經營者義務。

No business license is required. Cosmetics that have passed the registration permit for imported cosmetics and have been inspected by the national commodity inspection department can be imported and sold, but the cosmetics business must comply with relevant business regulations.

Cosmetics operators should establish and implement a purchase inspection record system, inspect the market entity registration certificate of direct suppliers, special cosmetics registration certificate or general cosmetics filing information, cosmetics product quality inspection certificate and keep relevant certificates, and truthfully record cosmetics. Name, registration certificate number of special cosmetics or record number of ordinary cosmetics, use period, net content, purchase quantity, supplier name, address, contact information, purchase date, etc.
Cosmetics operators who implement unified distribution can establish and implement a purchase inspection record system uniformly by the operator’s headquarters, conduct inspection records and keep relevant certificates. The operator’s headquarters shall ensure that its branches can provide relevant records and vouchers for the cosmetics it operates.
Beauty salons, hotels, etc. that use cosmetics in business services or provide cosmetics to consumers shall perform their obligations as cosmetics operators according to law.
Cosmetics used in the operation of beauty salons and cosmetics provided to consumers by hotels, etc., shall comply with the minimum sales unit label requirements.
Beauty salons should display the sales packaging of the cosmetics they use in a prominent position in their service places, so that consumers can easily check all the information on the cosmetics labels, and use them correctly or guide consumers to use them correctly according to the requirements of the cosmetics labels or instructions. cosmetic.
The organizers of the centralized cosmetics trading market and the organizers of the exhibitions should establish and effectively implement the management system to ensure the quality and safety of cosmetics, assume the management responsibility of the operators of the cosmetics, and urge the operators of the cosmetics to perform their obligations according to the law. Every year or during the exhibition, organize at least Carry out a cosmetic quality and safety knowledge training.
The organizer of the centralized cosmetics trading market and the organizer of the exhibition shall establish a file of the operators of the cosmetics entering the venue, review the registration certificate of the market entity of the operators who enter the cosmetics market, and truthfully record the operator’s name or name, contact information, address and other information. The file information of cosmetic operators entering the venue shall be verified and updated in time to ensure authenticity, accuracy and completeness, and the storage period shall not be less than 2 years after the operator ceases operation in the venue.
The organizer of the cosmetics fair should report the time, location and other basic information of the fair to the local county-level department in charge of drug supervision and administration before the fair is held.
The organizers of the centralized cosmetics trading market and the organizers of the exhibitions shall establish a cosmetics inspection system to inspect the operating conditions of the operators and the quality and safety of the cosmetics. If it is found that the operators of cosmetics entering the market have violated the regulations, they should be stopped in time, dealt with in accordance with the centralized trading market management regulations or the agreements signed with the operators, and reported to the local county-level department responsible for drug supervision and management.
The organizers of the centralized cosmetics trading market and the organizers of exhibitions are encouraged to establish a system of sampling inspection of cosmetics and a unified format of sales vouchers.
Cosmetics operators on the e-commerce platform and e-commerce operators operating cosmetics through self-built websites and other online services should fully, truthfully and accurately disclose information such as cosmetics labels that are consistent with cosmetics registration or filing materials on the main page of their business activities .
Cosmetics e-commerce platform operators should register real-name cosmetics operators on the platform, and require them to submit real information such as identity, address, and contact information, conduct verification and registration, establish registration files, and verify at least every 6 months. Update once. Cosmetics e-commerce platform operators shall keep the identity information of cosmetic operators on the platform for not less than 3 years from the date they exit the platform.
Cosmetics e-commerce platform operators should set up cosmetic quality management agencies or assign full-time and part-time management personnel to establish and effectively implement cosmetic quality and safety management systems such as daily inspections of cosmetic products on the platform, suppression and reporting of illegal acts, and handling of complaints and reports, and strengthen the management of cosmetic products. Publicity of relevant laws and regulations for cosmetics operators on the platform. Operators of cosmetic e-commerce platforms are encouraged to carry out sampling inspections.
Cosmetics e-commerce platform operators shall undertake the management responsibilities of cosmetic operators on the platform in accordance with the law, conduct daily inspections of the business behaviors of cosmetic operators on the platform, and urge cosmetic operators on the platform to fulfill their obligations. If the illegal operation of cosmetics is found, it shall take necessary measures such as deletion, blocking, and disconnection in accordance with the law or in accordance with the platform service agreement and transaction rules to stop it in a timely manner, and report to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where it is located.
If the operator of the cosmetics e-commerce platform receives the information on adverse reactions of cosmetics, complaints and reports, it should record and transfer it to the cosmetics operators on the platform in a timely manner; major information involving product quality and safety should be reported to the drug in the province, autonomous region, or municipality directly under the Central Government. Supervision and management department.
If the department in charge of drug supervision and administration requires the operator of the cosmetics e-commerce platform to provide relevant information in accordance with the law due to the needs of supervision and inspection, case investigation, etc., the operator of the cosmetics e-commerce platform shall assist and cooperate.
If the operator of the cosmetics e-commerce platform discovers the following serious violations, it shall immediately stop providing e-commerce platform services to the cosmetics operators on the platform:

．Cosmetics quality and safety related crimes were sentenced by people’s court

．Detained by public security organs or given other public security management penalties due to illegal acts of cosmetic quality and safety

．Punishments such as revocation of licenses and orders to suspend production and business by the drug regulatory authority according to law

．Other serious violations

If a case is placed on file for investigation or a public prosecution for suspected cosmetics quality and safety crime, and there is evidence to prove that it may endanger human health, the cosmetics e-commerce platform operator may suspend the provision of electronic products to cosmetics operators on the platform in accordance with the law or in accordance with the platform service agreement and trading rules. Business platform services.
Cosmetics e-commerce platform operators who know or should know that cosmetics operators on the platform are prohibited from engaging in cosmetics production and business activities in accordance with the law shall not provide them with e-commerce platform services.
If cosmetics are provided to consumers in the form of free trial, gift, exchange, etc., they shall perform the prescribed obligations of cosmetic operators according to law.

【參考連結】

https://gkml.samr.gov.cn/nsjg/fgs/202108/t20210806_333443.html

HLF-TW-25

假如需要辦理，請問中國有專業服務公司可以協助辦理化妝品公司營業許可證？

Evershine RD：

無營業特許證。

HLF-TW-30

外國公司要到中國銷售化妝品，可以指派中國公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？
所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？

If a foreign company wants to sell cosmetics in China, can it assign a China company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?

Evershine RD：

可以，營業代理人須為在中國依法設立的企業或組織作為在華申報責任單位，向中國國務院藥品監督管理部門(NMPA)辦理進口化妝品備案許可批件方可進口化妝品。

在華申報責任單位備案註冊

具備條件

．依法設立的企業或者其他組織。

．有與申請註冊、進行備案的產品相適應的質量管理體系。

．有化妝品不良反應監測與評價能力。

註冊網頁：http://cprp.nmpa.gov.cn/enterprise/zcqy_jk.jsp?from=true
註冊內容

．在華申報責任企業中文名稱、英文名稱、英文地址

．企業所在國家

．郵政編碼

．聯繫人、電話、傳真

產品責任

1.化妝品註冊人、備案人應依法建立化妝品生產質量管理體系，履行產品不良反應監測、風險控制、產品召回等義務，對化妝品的質量安全和功效宣稱負責。化妝品生產經營者應依照法律、法規、規章、強制性國家標準、技術規範從事生產經營活動，加強管理，誠信自律，保證化妝品質量安全。

2.化妝品註冊人、備案人應通過產品標籤、官方網站等方便消費者獲知的方式向社會公佈電話、電子郵箱等有效聯繫方式，主動收集來自受託生產企業、化妝品經營者、醫療機構、消費者等報告的其上市銷售化妝品的不良反應。

3.化妝品註冊人、備案人在發現或者獲知化妝品不良反應後應通過國家化妝品不良反應監測信息系統報告。受託生產企業、化妝品經營者、醫療機構在發現或者獲知化妝品不良反應後，應通過國家化妝品不良反應監測信息系統報告，鼓勵其告知化妝品註冊人、備案人。暫不具備線上報告條件的化妝品經營者和醫療機構，應通過紙質報表向所在地市縣級監測機構報告，由其代為在線提交報告。

網頁：https://caers.adrs.org.cn/adrcos/

化妝品電子商務平台經營者獲知化妝品不良反應的，應記錄報告者信息、發生不良反應者信息、不良反應信息、所使用的化妝品信息等內容，並於7日內轉交平台內化妝品經營者處理。涉及產品質量安全的重大信息，化妝品電子商務平台經營者應自獲知上述信息後，將發生不良反應者信息、症狀或者體徵、不良反應嚴重程度、不良反應發生日期、所使用化妝品名稱、銷售所使用化妝品的平台內經營者等信息於15日內書面報告電子商務平台經營者所在地省級藥監部門。

5.其他單位和個人可以向化妝品註冊人、備案人、境內責任人報告化妝品不良反應，也可以向所在地市縣級監測機構或者市縣級監管部門報告，由上述企業或者單位代為線上提交報告。

6.各級負責藥品監督管理的部門應公佈本部門和同級監測機構的電話、通訊地址等聯繫方式。

Yes, the business agent must be an enterprise or organization legally established in China as the responsible entity for reporting in China, and apply for the import cosmetics record license from the National Medical Products Administration (NMPA) of the State Council of China before importing cosmetics.

Filing and registration of responsible units in China

Conditional

．A legally established enterprise or other organization.

．There is a quality management system suitable for the products applying for registration and filing.

．Ability to monitor and evaluate adverse reactions of cosmetics.

Registration: http://cprp.nmpa.gov.cn/enterprise/zcqy_jk.jsp?from=true
Content

．Declare the Chinese name, English name, and English address of a responsible enterprise in China

．Country where the company is located

．Postal Code

．Contact, Phone, Fax

Product Liability

Cosmetics registrants and filers should establish a cosmetic production quality management system in accordance with the law, perform obligations such as product adverse reaction monitoring, risk control, product recall, etc., and be responsible for the quality, safety and efficacy claims of cosmetics. Cosmetics producers and operators shall engage in production and business activities in accordance with laws, regulations, rules, mandatory national standards and technical specifications, strengthen management, be honest and self-disciplined, and ensure the quality and safety of cosmetics.
Cosmetics registrants and filers should publish effective contact information such as telephone numbers and e-mails to the public through product labels, official websites and other means that are convenient for consumers to know, and take the initiative to collect information from entrusted manufacturers, cosmetics operators, medical institutions, and consumers. and other adverse reactions reported by its marketed cosmetics.
Cosmetics registrants and filers shall report through the National Cosmetic Adverse Reaction Monitoring Information System after discovering or learning about cosmetic adverse reactions. Entrusted manufacturers, cosmetics operators, and medical institutions should report through the National Cosmetic Adverse Reaction Monitoring Information System after discovering or learning about the adverse reactions of cosmetics, and encourage them to inform the cosmetics registrants and filers. Cosmetics operators and medical institutions that do not have the conditions for online reporting for the time being should report to the local city and county-level monitoring agencies through paper statements, and they will submit the reports online on their behalf.

URL: https://caers.adrs.org.cn/adrcos/

If the operator of the cosmetics e-commerce platform is informed of the adverse reactions of cosmetics, it should record the information of the reporter, the information of the adverse reaction person, the information of the adverse reaction, and the information of the cosmetics used, and transfer it to the cosmetics operators on the platform for processing within 7 days. For major information related to product quality and safety, the operator of the cosmetics e-commerce platform shall, after obtaining the above information, report the information, symptoms or signs of adverse reactions, the severity of adverse reactions, the date of occurrence of adverse reactions, the name of the cosmetic used, the name of the cosmetic used for sales The information on the operators of cosmetics on the platform shall be reported in writing to the provincial drug regulatory department where the operator of the e-commerce platform is located within 15 days.
Other units and individuals can report adverse reactions of cosmetics to the cosmetics registrant, filer, and domestic responsible person, or report to the local city or county-level monitoring agency or city- or county-level regulatory department, and the above-mentioned enterprises or units submit reports online on their behalf.
The departments in charge of drug supervision and administration at all levels shall announce the contact information such as telephone numbers and mailing addresses of the departments and monitoring institutions at the same level.

URL: https://gkml.samr.gov.cn/nsjg/fgs/202108/t20210806_333443.html

【參考連結】

https://gkml.samr.gov.cn/nsjg/fgs/202108/t20210806_333443.html

HLF-TW-35

假如需要辦理指派中國公司擔任營業代理人，請問中國有專業服務公司可以協助？

Evershine RD：

MARCIA

http://www.maxiyash.com/

OCI

https://www.chinaoci.com/sy

HLF-TW-40

外國公司銷售到中國化妝品本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？
化妝品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

Do foreign companies need to apply for an approval before importing cosmetics sold to China? If yes, which authority is in charge? What documents are required? What is the application process?
Do cosmetics packaging and labeling require prior approval? Which languages are allowed? Website?

Evershine RD：

需要，化妝品進口須取得中國國務院藥品監督管理部門(NMPA) 的備案許可批件，國外生產企業應委託在中國依法設立的企業或組織作為在華申報責任單位，辦理進口化妝品備案許可。

在華申報責任單位備案註冊

具備條件

．依法設立的企業或者其他組織。

．有與申請註冊、進行備案的產品相適應的質量管理體系。

．有化妝品不良反應監測與評價能力。

註冊網頁：http://cprp.nmpa.gov.cn/enterprise/zcqy_jk.jsp?from=true
註冊內容

．在華申報責任企業中文名稱、英文名稱、英文地址

．企業所在國家

．郵政編碼

．聯繫人、電話、傳真

化妝品備案許可批件

進口憑證

．普通化妝品：進口非特殊用途化妝品備案。

．特殊化妝品：進口特殊用途化妝品行政許可。

受理條件：申請人應是進口化妝品生產企業。進口化妝品新原料行政許可申請人應是進口化妝品新原料生產企業或化妝品生產企業。同一申請人應委託一個在中國境內依法登記註冊，並具有獨立法人資格的單位作為在華申報責任單位，負責代理申報有關事宜。申請人可以變更在華申報責任單位。
申請途徑

．實體申辦：北京市西城區宣武門西大街28號大成廣場3門1層

．線上申辦()

https://zwfw.nmpa.gov.cn/web/user/login?backUrl=/web/ssologin/PTHZPBAXXGLXT?returnUrl=https://hzpba.nmpa.gov.cn/PTHZPBA/&type=againwhy

流程：申請→受理→技術審評→行政許可決定→送達。
普通化妝品申請文件

．進口非特殊用途化妝品行政許可申請表

．產品中文名稱命名依據

．產品配方

．產品質量安全控制要求

．產品原包裝(含產品標籤、產品說明書)；擬專為中國市場設計包裝的，需同時提交產品設計包裝（含產品標籤、產品說明書）

．經國家食品藥品監督管理局認定的許可檢驗機構出具的檢驗報告及相關資料

．產品中可能存在安全性風險物質的有關安全性評估料

．已經備案的行政許可在華申報責任單位授權書複印件及行政許可在華申報責任單位營業執照複印件並加蓋公章

．化妝品使用原料及原料來源符合瘋牛病疫區高風險物質禁限用要求的承諾書

．產品在生產國（地區）或原產國（地區）生產和銷售的證明文件

．可能有助於備案的其他資料

．許可檢驗機構封樣並未啟封的市售樣品1件(進口產品在提交許可申請時，需提交市售包裝。這裡的市售包裝有兩種含義，首次申請許可產品提交的市售包裝，是指國外上市銷售的包裝；進口延續申請時提交的市售包裝，是指在中國市場銷售的包裝。)

特殊化妝品申請文件

．進口特殊用途化妝品行政許可申請表

．產品中文名稱命名依據

．產品配方

．生產工藝簡述和簡圖

．產品質量安全控制要求

．產品原包裝(含產品標籤、產品說明書)；擬專為中國市場設計包裝的，需同時提交產品設計包裝（含產品標籤、產品說明書）

．國家藥品監督管理局註冊和備案檢驗信息管理系統公佈的具備相應能力的檢驗機構出具的檢驗報告及相關資料

．產品中可能存在安全性風險物質的有關安全性評估資料

．申請育發、健美、美乳類產品的，應提交功效成份及其使用依據的科學文獻資料

．已經備案的行政許可在華申報責任單位授權書複印件及行政許可在華申報責任單位營業執照複印件並加蓋公章

．化妝品使用原料及原料來源符合瘋牛病疫區高風險物質禁限用要求的承諾書

．產品在生產國（地區）或原產國（地區）生產和銷售的證明文件

．可能有助於行政許可的其他資料

．許可檢驗機構封樣並未啟封的市售樣品1件(進口產品在提交許可申請時，需提交市售包裝。
這裡的市售包裝有兩種含義，首次申請許可產品提交的市售包裝，是指國外上市銷售的包裝；進口延續申請時提交的市售包裝，是指在中國市場銷售的包裝。)

．產品技術要求

其他

．專為向中國出口生產、無法提交在生產國(地區)已上市銷售的證明文件的，應提交向中國消費者開展的相關研究和試驗的資料。

．註冊申請人、備案人應對所提交資料的真實性、科學性負責。

備註：備案申請不收費。
效期

．普通化妝品為長期有效，備案人應每年向承擔備案管理工作的藥品監督管理部門報告生產、進口情況，以及符合法規、強制性國家標準、技術規範的情況。

．特殊化妝品註冊證有效期為5年，效期屆滿需要延續註冊的，應在有效期屆滿30個工作日前提出延續註冊的申請。

標籤

1.化妝品的最小銷售單元應有標籤，必須符合相關法律、行政法規、強制性國家標準，內容真實、完整、準確。

2.進口化妝品可以直接使用中文標籤，也可以加貼中文標籤；加貼中文標籤的，中文標籤內容應與原標籤內容一致。

3.化妝品標籤應標註下列內容：

．產品名稱、特殊化妝品註冊證編號

．註冊人、備案人、受託生產企業的名稱、地址

．化妝品生產許可證編號

．產品執行的標準編號

．全成分

．淨含量

．使用期限、使用方法以及必要的安全警示

．法律、行政法規和強制性國家標準規定應標註的其他內容。

．生產日期和保質期

4.化妝品標籤禁止標註下列內容：

．明示或者暗示具有醫療作用的內容。

．虛假或者引人誤解的內容。

．違反社會公序良俗的內容。

．法律、行政法規禁止標註的其他內容。

5.網頁：http://www.gov.cn/zhengce/2020-12/27/content_5573797.htm

Mandatory, the import of cosmetics must be filed/licensed by the National Medical Products Administration (NMPA) of the State Council of China, and foreign manufacturers should entrust an enterprise legally established in China as the responsible entity for reporting in China to handle the filing permit for imported cosmetics.

Filing and registration of responsible units in China

Conditional

．A legally established enterprise or other organization.

．Have a quality management system suitable for the products applying for registration and filing.

．Possess the ability to monitor and evaluate adverse reactions of cosmetics.

URL: http://cprp.nmpa.gov.cn/enterprise/zcqy_jk.jsp?from=true
Content

．Declare the Chinese name, English name, and English address of a responsible enterprise in China

．The country in which the company is located

．Postal Code

．Contact, Phone, Fax

Cosmetics import license

Import certificate

．Ordinary cosmetics: import non-special use cosmetics for record.

．Special cosmetics: Administrative license for import of special-purpose cosmetics.

Acceptance conditions: The applicant should be a manufacturer of imported cosmetics. The applicant for the administrative license for imported cosmetic new raw materials should be a manufacturer of imported cosmetic new raw materials or a cosmetic manufacturer. The same applicant should entrust a unit that is legally registered in China and has the status of an independent legal person as the unit responsible for reporting in China, and is responsible for reporting relevant matters as an agent. The applicant can change the entity responsible for reporting in China.
Application

．Physical application: 1st Floor, Gate 3, Dacheng Plaza, No. 28, Xuanwumen West Street, Xicheng District, Beijing

．Online application

https://zwfw.nmpa.gov.cn/web/user/login?backUrl=/web/ssologin/PTHZPBAXXGLXT?returnUrl=https://hzpba.nmpa.gov.cn/PTHZPBA/&type=againwhy

Process: Application → Acceptance → Technical Review → Administrative License Decision → Delivery.
General cosmetic application documents

．Application Form for Administrative License for Import of Cosmetics for Non-Special Purposes

．The Chinese name of the product is named according to

．Product formula

Product Quality Safety Control Requirements

．The original packaging of the product (including product labels and product manuals); if the packaging is to be designed for the Chinese market, the product design packaging (including product labels and product manuals) must be submitted at the same time.

．The inspection report and relevant information issued by the licensed inspection agency recognized by the State Food and Drug Administration

．Relevant safety assessment materials for substances that may exist in products with safety risks

．A copy of the power of attorney of the entity responsible for reporting the administrative license in China and a copy of the business license of the entity responsible for reporting the administrative license in China with official seal

．Letter of Commitment on the Use of Raw Materials and Sources of Raw Materials for Cosmetics to Meet the Requirements for Banning and Restricting High-Risk Substances in Mad Cow Disease-Epidemic Areas

．Documents proving that the product is produced and sold in the country (region) or country (region) of origin

．Other information that may be helpful for the record

．1 commercial sample that has not been unsealed by the licensing inspection agency (imported products need to submit commercial packaging when submitting the license application. The commercial packaging here has two meanings. The commercial packaging submitted for the first application for a licensed product is the Refers to the packaging sold abroad; the commercially available packaging submitted in the application for import extension refers to the packaging sold in the Chinese market.)

Application documents for special cosmetic products

．Application Form for Administrative License for Import of Special Purpose Cosmetics

．Product Chinese name naming basis

．Product Formulation

．Production process brief and sketch

．Product quality and safety control requirements

．Inspection reports and related materials issued by inspection institutions with corresponding capabilities published by the State Drug Administration’s registration and filing inspection information management system.

．Information on safety assessment of substances that may exist in products with safety risks

．Those applying for hair growth, bodybuilding, and breast beauty products should submit scientific literature on the efficacy ingredients and their use basis

．Documents proving that the product is produced and sold in the country (region) or country (region) of origin

．Additional information that may assist administrative clearance

．1 commercial sample that has not been unsealed by the licensing inspection agency (when submitting the license application for imported products, the commercial packaging must be submitted. The commercial packaging here has two meanings. The commercial packaging submitted for the first application for a license is the Refers to the packaging sold abroad; the commercially available packaging submitted in the application for import extension refers to the packaging sold in the Chinese market.)

．Product technical requirements

Others

．If it is specially produced for export to China, and it is impossible to submit the certification documents that it has been marketed in the producing country (region), it should submit the relevant research and test materials for Chinese consumers.

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

Remarks: No charge.
Validity period

．Ordinary cosmetics are valid for a long time, and the filer shall report the production, import, and compliance with laws and regulations, mandatory national standards, and technical specifications to the drug supervision and administration department responsible for the recordation management every year.

．The special cosmetic registration certificate is valid for 5 years. If the registration needs to be renewed after the validity period expires, an application for registration renewal should be submitted 30 working days before the validity period expires.

Label

The minimum sales unit of cosmetics should have a label, which must comply with relevant laws, administrative regulations, and mandatory national standards, and the content is true, complete and accurate.
Imported cosmetics can use Chinese labels directly or affix Chinese labels; if Chinese labels are affixed, the Chinese label content should be consistent with the original label content.
Cosmetic labels should indicate the following:

．Product name, special cosmetic registration certificate number.

．Name and address of the registrant, filing person, and entrusted production enterprise.

．Cosmetics production license number.

．Product implementation standard number.

．Full ingredients.

．Net weight.

．Period of use, method of use and necessary safety warnings

．Other content that should be marked by laws, administrative regulations and mandatory national standards.

．Manufacturing date and shelf life.

Cosmetic labels are prohibited from labeling the following:

．Content that expresses or implies medical effects.

．False or misleading content.

．Content that violates social order and good morals.

．Other content prohibited by laws and administrative regulations.

URL: http://www.gov.cn/zhengce/2020-12/27/content_5573797.htm

【參考連結】

https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100207202200001

https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017204600101\

https://gkml.samr.gov.cn/nsjg/fgs/202101/t20210112_325127.html

HLF-TW-45

請問在中國有哪些專業服務機構，可以協助辦理化妝品產品許可證？

Evershine RD：

匯佳

https://interareapsp.com/

北京佳顏科技有限公司

http://www.jiayankeji.com/

HLF-TW-50

外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？
化妝品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process?
Do cosmetics packaging and labeling require prior approval? Which languages are allowed?Website?

Evershine RD：

化妝品進口須取得中國國務院藥品監督管理部門(NMPA) 的備案許可批件，國外生產企業應委託在中國依法設立的企業或組織作為在華申報責任單位，辦理進口化妝品備案許可。

在華申報責任單位備案註冊

具備條件

．依法設立的企業或者其他組織。

．有與申請註冊、進行備案的產品相適應的質量管理體系。

．有化妝品不良反應監測與評價能力。

註冊網頁：http://cprp.nmpa.gov.cn/enterprise/zcqy_jk.jsp?from=true
註冊內容

．在華申報責任企業中文名稱、英文名稱、英文地址

．企業所在國家

．郵政編碼

．聯繫人、電話、傳真

化妝品備案許可批件

進口憑證

．普通化妝品：進口非特殊用途化妝品備案。

．特殊化妝品：進口特殊用途化妝品行政許可。

受理條件：申請人應是進口化妝品生產企業。進口化妝品新原料行政許可申請人應是進口化妝品新原料生產企業或化妝品生產企業。同一申請人應委託一個在中國境內依法登記註冊，並具有獨立法人資格的單位作為在華申報責任單位，負責代理申報有關事宜。申請人可以變更在華申報責任單位。
申請途徑

．實體申辦：北京市西城區宣武門西大街28號大成廣場3門1層

．線上申辦

https://zwfw.nmpa.gov.cn/web/user/login?backUrl=/web/ssologin/PTHZPBAXXGLXT?returnUrl=https://hzpba.nmpa.gov.cn/PTHZPBA/&type=againwhy

流程：申請→受理→技術審評→行政許可決定→送達。
普通化妝品申請文件

．進口非特殊用途化妝品行政許可申請表

．產品中文名稱命名依據

．產品配方

．產品質量安全控制要求

．產品原包裝(含產品標籤、產品說明書)；擬專為中國市場設計包裝的，需同時提交產品設計包裝（含產品標籤、產品說明書）

．經國家食品藥品監督管理局認定的許可檢驗機構出具的檢驗報告及相關資料

．產品中可能存在安全性風險物質的有關安全性評估料

．已經備案的行政許可在華申報責任單位授權書複印件及行政許可在華申報責任單位營業執照複印件並加蓋公章

．化妝品使用原料及原料來源符合瘋牛病疫區高風險物質禁限用要求的承諾書

．產品在生產國（地區）或原產國（地區）生產和銷售的證明文件

．可能有助於備案的其他資料

特殊化妝品申請文件

．進口特殊用途化妝品行政許可申請表

．產品中文名稱命名依據

．產品配方

．生產工藝簡述和簡圖

．產品質量安全控制要求

．產品原包裝(含產品標籤、產品說明書)；擬專為中國市場設計包裝的，需同時提交產品設計包裝（含產品標籤、產品說明書）

．國家藥品監督管理局註冊和備案檢驗信息管理系統公佈的具備相應能力的檢驗機構出具的檢驗報告及相關資料

．產品中可能存在安全性風險物質的有關安全性評估資料

．申請育發、健美、美乳類產品的，應提交功效成份及其使用依據的科學文獻資料

．已經備案的行政許可在華申報責任單位授權書複印件及行政許可在華申報責任單位營業執照複印件並加蓋公章

．化妝品使用原料及原料來源符合瘋牛病疫區高風險物質禁限用要求的承諾書

．產品在生產國（地區）或原產國（地區）生產和銷售的證明文件

．可能有助於行政許可的其他資料

．許可檢驗機構封樣並未啟封的市售樣品1件(進口產品在提交許可申請時，需提交市售包裝。
這裡的市售包裝有兩種含義，首次申請許可產品提交的市售包裝，是指國外上市銷售的包裝；進口延續申請時提交的市售包裝，是指在中國市場銷售的包裝。)

．產品技術要求

其他

．專為向中國出口生產、無法提交在生產國(地區)已上市銷售的證明文件的，應提交向中國消費者開展的相關研究和試驗的資料。

．註冊申請人、備案人應對所提交資料的真實性、科學性負責。

備註：備案申請不收費。
效期

．特殊化妝品註冊證有效期為5年，效期屆滿需要延續註冊的，應在有效期屆滿30個工作日前提出延續註冊的申請。

標籤

1.化妝品的最小銷售單元應有標籤，必須符合相關法律、行政法規、強制性國家標準，內容真實、完整、準確。

2.進口化妝品可以直接使用中文標籤，也可以加貼中文標籤；加貼中文標籤的，中文標籤內容應與原標籤內容一致。

3.化妝品標籤應標註下列內容：

．產品名稱、特殊化妝品註冊證編號

．註冊人、備案人、受託生產企業的名稱、地址

．化妝品生產許可證編號

．產品執行的標準編號

．全成分

．淨含量

．使用期限、使用方法以及必要的安全警示

．法律、行政法規和強制性國家標準規定應標註的其他內容。

．生產日期和保質期

4.化妝品標籤禁止標註下列內容：

．明示或者暗示具有醫療作用的內容。

．虛假或者引人誤解的內容。

．違反社會公序良俗的內容。

．法律、行政法規禁止標註的其他內容。

5.網頁：http://www.gov.cn/zhengce/2020-12/27/content_5573797.htm

Filing and registration of responsible units in China

Conditional

．A legally established enterprise or other organization.

．Have a quality management system suitable for the products applying for registration and filing.

．Possess the ability to monitor and evaluate adverse reactions of cosmetics.

URL: http://cprp.nmpa.gov.cn/enterprise/zcqy_jk.jsp?from=true
Content

．Declare the Chinese name, English name, and English address of a responsible enterprise in China

．The country in which the company is located

．Postal Code

．Contact, Phone, Fax

Cosmetics import license

Import certificate

．Ordinary cosmetics: import non-special use cosmetics for record.

．Special cosmetics: Administrative license for import of special-purpose cosmetics.

Acceptance conditions: The applicant should be a manufacturer of imported cosmetics. The applicant for the administrative license for imported cosmetic new raw materials should be a manufacturer of imported cosmetic new raw materials or a cosmetic manufacturer. The same applicant should entrust a unit that is legally registered in China and has the status of an independent legal person as the unit responsible for reporting in China, and is responsible for reporting relevant matters as an agent. The applicant can change the entity responsible for reporting in China.
Application

．Physical application: 1st Floor, Gate 3, Dacheng Plaza, No. 28, Xuanwumen West Street, Xicheng District, Beijing

．Online application

https://zwfw.nmpa.gov.cn/web/user/login?backUrl=/web/ssologin/PTHZPBAXXGLXT?returnUrl=https://hzpba.nmpa.gov.cn/PTHZPBA/&type=againwhy

Process: Application → Acceptance → Technical Review → Administrative License Decision → Delivery.
General cosmetic application documents

．Application Form for Administrative License for Import of Cosmetics for Non-Special Purposes

．The Chinese name of the product is named according to

．Product formula

Product Quality Safety Control Requirements

．The inspection report and relevant information issued by the licensed inspection agency recognized by the State Food and Drug Administration

．Relevant safety assessment materials for substances that may exist in products with safety risks

．Documents proving that the product is produced and sold in the country (region) or country (region) of origin

．Other information that may be helpful for the record

Application documents for special cosmetic products

．Application Form for Administrative License for Import of Special Purpose Cosmetics

．Product Chinese name naming basis

．Product Formulation

．Production process brief and sketch

．Product quality and safety control requirements

．Information on safety assessment of substances that may exist in products with safety risks

．Those applying for hair growth, bodybuilding, and breast beauty products should submit scientific literature on the efficacy ingredients and their use basis

．Documents proving that the product is produced and sold in the country (region) or country (region) of origin

．Additional information that may assist administrative clearance

．Product technical requirements

Others

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

Remarks: No charge.
Validity period

Label

The minimum sales unit of cosmetics should have a label, which must comply with relevant laws, administrative regulations, and mandatory national standards, and the content is true, complete and accurate.
Imported cosmetics can use Chinese labels directly or affix Chinese labels; if Chinese labels are affixed, the Chinese label content should be consistent with the original label content.
Cosmetic labels should indicate the following:

．Product name, special cosmetic registration certificate number.

．Name and address of the registrant, filing person, and entrusted production enterprise.

．Cosmetics production license number.

．Product implementation standard number.

．Full ingredients.

．Net weight.

．Period of use, method of use and necessary safety warnings

．Other content that should be marked by laws, administrative regulations and mandatory national standards.

．Manufacturing date and shelf life.

Cosmetic labels are prohibited from labeling the following:

．Content that expresses or implies medical effects.

．False or misleading content.

．Content that violates social order and good morals.

．Other content prohibited by laws and administrative regulations.

URL: http://www.gov.cn/zhengce/2020-12/27/content_5573797.htm

【參考連結】

https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100207202200001

https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100017204600101\

https://gkml.samr.gov.cn/nsjg/fgs/202101/t20210112_325127.html

HLF-TW-55

請問在中國有哪些專業服務機構，可以協助以外國公司名義辦理化妝品產品許可證？

Evershine RD：

匯佳

https://interareapsp.com/

北京佳顏科技有限公司

http://www.jiayankeji.com/

HLF-TW-60

經過核准登記的化妝品，進口到中國要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

What documents are required when importing approved cosmetics into China? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

化妝品進口須取得中國國務院藥品監督管理部門(NMPA) 的備案許可批件(國外生產企業應委託在中國依法設立的企業或組織作為在華申報責任單位申請)，進口前向擬入境口岸檢驗檢疫機構提出備案申請，取得國內收貨人備案資格使得進口化妝品，無銷售許可證。

進口化妝品檢驗檢疫流程

1.獲取產品衛生許可

進口化妝品需事先獲得國家食品藥品監督管理部門頒發的進口化妝品備案許可批件（國家沒有實施衛生許可或者備案的化妝品除外）。

國內收貨人備案

首次進口化妝品的國內收貨人應在產品進口前向擬入境口岸檢驗檢疫機構提出備案申請，取得進口化妝品國內收貨人備案資格。免稅化妝品的收貨人在向所在地直屬檢驗檢疫機構申請備案。

3.報檢

進口化妝品的收貨人或者其代理人應按照國家質檢總局相關規定報檢，應提供入境貨物報檢單、合約、發票、裝箱單、提（運）單等相關外貿單據，同時提供收貨人備案號、進口化妝品備案許可批件、標籤樣張等資料。

首次報檢應提供的資料：

．符合國家相關規定、正常使用不會對人體健康產生危害聲明。

．產品配方。

．國家實施衛生許可或者備案的化妝品，應提交國家相關主管部門批准的進口化妝品衛生許可批件或者備案憑證。

．國家沒有實施衛生許可或者備案的化妝品（牙膏、口腔牙齒清潔劑、盥洗用皂等），應提供下列材料：具有相關資質的機構出具的可能存在安全性風險物質的有關安全性評估資料、在生產國家（地區）允許生產、銷售的證明文件或者原產地證明。

．銷售包裝化妝品成品除前項外，應提交中文標籤樣張和外文標籤及翻譯件（離境免稅化妝品除外）。

．非銷售包裝的化妝品成品應提供包括產品的名稱、數/重量、規格、產地、生產批號和限期使用日期（生產日期和保質期）、加施包裝的目的地名稱、加施包裝的工廠名稱、位址、聯繫方式。

．出入境檢驗檢疫局要求的其他文件。

．上述檔提供影本的應同時交驗正本。

4.檢驗檢疫

檢驗檢疫機構受理報檢後，將根據國家要求對進口化妝品進行檢驗檢疫，包括現場查驗、抽樣留樣、實驗室檢驗、出證等。

．經檢驗檢疫合格的，發放入境貨物檢驗檢疫證明。

．經檢驗檢疫不合格的，根據不合格項目，分別作出技術整改、退運或銷毀等處理。
進口化妝品經檢驗檢疫不合格，涉及安全、健康、環境保護項目的，由海關責令當事人銷毀，或者出具退貨處理通知單，由當事人辦理退運手續。其他項目不合格的，可以在海關的監督下進行技術處理，經重新檢驗檢疫合格後，方可銷售、使用。

5.注意事項

．進口化妝品在取得檢驗檢疫合格證明之前，應存放在海關指定或者認可的場所，未經海關許可，任何單位和個人不得擅自調離、銷售、使用。

．進口化妝品成品的標籤標註應符合規範。海關對化妝品標籤內容是否符合法律、行政法規規定要求進行審核，對與質量有關的內容的真實性和準確性進行檢驗。

．樣品應按照相關規定進行管理，合格樣品保存至抽樣後4個月，特殊用途化妝品合格樣品保存至證書籤發後一年，不合格樣品應保存至保質期結束。涉及案件調查的樣品，應保存至案件結束。

．需要進行實驗室檢驗的，海關應確定檢驗項目和檢驗要求，並將樣品送具有相關資質的檢驗機構。檢驗機構應按照要求實施檢驗，並在規定時間內出具檢驗報告。

所需文件

．進口合約、發票、箱單

．運單/提單

．國外官方原產地證與衛生許可證

．國家藥監局進口化妝品備案憑證或衛生許可批件

．進口化妝品收發貨人的備案號

．進口化妝品中文標籤樣張和外文標籤及翻譯件

．進口化妝品的名稱、規格、數重量、產地的詳細清單

．企業進出口權

．其他進口清關資料

中國海關註冊登記和備案資料

．企業註冊登記或者備案信息以及企業相關人員基本信息

．企業進出口以及與進出口相關的經營信息

．業行政許可信息

．企業及其相關人員行政處罰和刑事處罰信息

．海關與國家有關部門實施聯合激勵和聯合懲戒信息

．AEO互認信息

．其他反映企業信用狀況的相關信息

Cosmetics must be imported with the approval of the National Medical Products Administration (NMPA) of the State Council (foreign manufacturers should entrust a legally established enterprise or organization in China to apply as the responsible entity for declaration in China), and submit the application to the inspection and quarantine agency at the port of entry before importing. Filing an application for filing and obtaining the domestic consignee filing qualification makes imported cosmetics without a sales license.

Imported Cosmetics Inspection and Quarantine Process

Obtain product sanitation license

Imported cosmetics need to obtain the approval document of the import cosmetics filing license issued by the State Food and Drug Administration in advance (except for the cosmetics that have not been implemented by the state for hygiene licenses or filing).

Record of domestic consignee

The domestic consignee who imports cosmetics for the first time should file a filing application with the inspection and quarantine agency at the intended port of entry before the product is imported, and obtain the domestic consignee filing qualification for imported cosmetics. The consignee of duty-free cosmetics is applying to the local inspection and quarantine agency for filing.

Inspection application

The consignee or its agent of imported cosmetics shall apply for inspection in accordance with the relevant regulations of the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China, and shall provide relevant foreign trade documents such as the inspection declaration form, contract, invoice, packing list, and bill of lading (shipping) for inbound goods, as well as the receipt of The record number of the consignor, the approval document for the registration and approval of imported cosmetics, and the label proofs, etc.

Information to be provided in the first inspection application:

．It complies with the relevant national regulations and will not cause harm to human health in normal use.

．Product formula.

．Cosmetics that are subject to hygiene licensing or filing by the state shall submit the hygiene licensing approval document or filing certificate for imported cosmetics approved by the relevant competent state departments.

．For cosmetics (toothpaste, oral and dental cleaners, toilet soaps, etc.) that have not been implemented by the state for sanitary licensing or filing, the following materials should be provided: The relevant safety assessment materials of substances that may have safety risks issued by relevant qualified institutions, and the production The country (region) permitting production and sales documents or origin certificate.

．In addition to the above-mentioned items, the sales package of finished cosmetic products should submit proofs of Chinese labels and labels in foreign languages and translations (except for departure duty-free cosmetics).

．Cosmetics finished products that are not packaged for sale should provide the product name, quantity/weight, specification, place of origin, production batch number and expiry date (production date and shelf life), destination name for packaging, name of factory for packaging, location address and contact information.

．Other documents required by the Entry-Exit Inspection and Quarantine Administration.

．Photocopies of the above-mentioned documents should be submitted for verification at the same time.

Inspection & Quarantine

After the inspection and quarantine agency accepts the inspection application, it will conduct inspection and quarantine on imported cosmetics according to national requirements, including on-site inspection, sampling and retention, laboratory inspection, and issuance of certificates.

．Those who pass the inspection and quarantine will be issued an inspection and quarantine certificate for entry goods.

．If the inspection and quarantine are unqualified, according to the unqualified items, technical rectification, return or destruction will be made respectively. If the imported cosmetics fail to pass inspection and quarantine and involve safety, health, and environmental protection items, the customs shall order the parties to destroy them, or issue a return handling notice, and the parties shall handle the return procedures. If other items are unqualified, they can be technically processed under the supervision of the customs, and can only be sold and used after passing the re-inspection and quarantine.

Notes

．Before obtaining the inspection and quarantine certificate, imported cosmetics should be stored in a place designated or recognized by the customs. Without the permission of the customs, no unit or individual may transfer, sell or use it.

．The labeling of imported cosmetic products should comply with the specifications. The customs examines whether the contents of cosmetic labels comply with the requirements of laws and administrative regulations, and checks the authenticity and accuracy of the contents related to quality.

．Samples shall be managed in accordance with relevant regulations. Qualified samples shall be kept for 4 months after sampling, qualified samples of special-purpose cosmetics shall be kept until one year after the issuance of the certificate, and unqualified samples shall be kept until the end of the shelf life. The samples involved in the case investigation shall be kept until the case is over.

．Where laboratory inspection is required, the customs shall determine the inspection items and inspection requirements, and send the samples to the inspection agency with relevant qualifications. The inspection agency shall carry out inspections as required and issue inspection reports within the specified time.

Documents Required

．Import Contract, Invoice, Packing List

．Waybill / Bill of Lading

．Foreign Official Certificate of Origin and Sanitation License

．State Food and Drug Administration Imported Cosmetics Record Certificate or Sanitation License Approval

．The record number of the consignee and consignor of imported cosmetic products

．Imported cosmetics Chinese label sample and foreign language label and translation

．A detailed list of the name, specification, weight and origin of imported cosmetic products

．Import and export rights of enterprises

．Other import customs clearance materials

China Customs Registration and Filing Information

．Enterprise registration or recordation information and basic information of relevant personnel of the enterprise

．Import and export of enterprises and business information related to import and export

．Industry administrative license information

．Information on administrative punishments and criminal punishments of enterprises and their related personnel

．Information on the implementation of joint incentives and joint punishments by customs and relevant state departments

．Mutual AEO Recognition Information

．Other relevant information reflecting the enterprise’s credit status

【參考連結】

http://www.customs.gov.cn/customs/syx/index.html

https://zwfw.nmpa.gov.cn/web/index

HLF-TW-70

中國化妝品審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

化妝品生產質量規範

機構與人員

．化妝品生產企業應建立化妝品質量安全責任制，明確企業法定代表人（或主要負責人）、質量安全負責人、質量管理部門負責人、生產部門負責人以及其他相關崗位的職責。

質量保證與控制

．應建立化妝品生產質量管理體系文件，包括質量方針、質量目標、質量管理制度、質量標準、產品配方、生產工藝規程、操作規程，以及法規要求的其他文件，並執行文件管理制度，保證化妝品生產質量管理體系文件的製定、審核、批准、發放、銷毀等得到有效控制。

．記錄應標示清晰、存放有序，便於查閱。與產品追溯相關的記錄，其保存期限不得少於產品使用期限屆滿後1年；產品使用期限不足1年的，記錄保存期限不得少於2年。與產品追溯不相關的記錄，其保存期限不得少於2年。

廠房設施與設備管理

．應具備與生產的品種、數量和生產許可項目等相適應的生產場地和設施設備。生產場地應不受有毒、有害場所以及其他污染源的影響，建築結構、生產車間和設施設備便於清潔、操作和維護。按照要求設置生產車間，且不得有污染源，物料、產品和人員流向合理，避免產生污染與交叉污染。

．製水、水貯存及輸送系統的設計、安裝、運行、維護應確保工藝用水達質量標準要求。並執行水處理系統定期清潔、消毒、監測、維護制度。空氣淨化系統的設計、安裝、運行、維護應確保達到環境要求，並執行空氣淨化系統定期清潔、消毒、監測、維護制度。

物料與產品管理

．建立、執行物料供應商遴選制度，對物料供應商進行審核和評價，與物料供應商簽訂採購合同，並在合同中明確物料驗收標準和雙方質量責任。應根據審核評價的結果建立合格物料供應商名錄，明確關鍵原料供應商，並對關鍵原料供應商進行重點審核，必要時應進行現場審核。

．建立並執行物料審查制度，建立原料、外購的半成品以及內包材清單，明確原料、外購的半成品成分，留存必要的原料、外購的半成品、內包材質量安全相關信息。

．在物料採購前對原料、外購的半成品、內包材實施審查，不得使用禁用原料、未經註冊或者備案的新原料，不得超出使用範圍、限制條件使用限用原料，確保原料、外購的半成品、內包材符合法規。

．建立並執行物料進貨查驗記錄制度，建立並執行物料驗收規程，明確物料驗收標準和驗收方法。對關鍵原料留樣本，並保存記錄。樣本的原料應有標籤，至少包括原料中文名稱或者原料代碼、生產企業名稱、原料規格、貯存條件、使用期限等信息，保證可追溯。樣本應滿足原料質量檢驗的要求。

．生產用水的水質和水量應滿足生產要求，水質至少達到生活飲用水衛生標準。生產用水為小型集中式供水或者分散式供水的，應由取得資質認定的檢驗檢測機構進行檢測，每年至少一次，建立並執行工藝用水質量標準、工藝用水管理規程，對工藝用水水質定期監測，確保符合質量要求。

．建立並執行標籤管理制度，對產品標籤進行審核，確保產品的標籤符合法規、強制性國家標準、技術規範的要求。內包材上標註標籤的生產工序在完成最後一道接觸化妝品內容物生產工序的生產企業內完成。

生產過程管理

．建立並執行與生產的化妝品品種、數量和生產許可項目等相適應的生產管理制度。照化妝品註冊、備案資料載明的技術要求建立並執行產品生產工藝規程和崗位操作規程，確保按照化妝品註冊、備案資料載明的技術要求生產產品。明確生產工藝參數及工藝過程的關鍵控制點，主要生產工藝應經過驗證，確保能夠持續穩定地生產出合格的產品。

．根據生產計劃下達生產指令，包括產品名稱、生產批號（或者與生產批號可關聯的唯一標識符號）、產品配方、生產總量、生產時間等內容。對生產過程使用的物料以及半成品全程清晰標識，標明名稱或者代碼、生產日期或者批號、數量，並可追溯。

．建立並執行產品放行管理制度，確保產品經檢驗合格且相關生產和質量活動記錄經審核批准後，方可放行。上市銷售的化妝品應附有出廠檢驗報告或者合格標記等形式的產品質量檢驗合格證明。

產品銷售管理

．建立並執行產品銷售記錄制度，確保所銷售產品的出貨單據、銷售記錄與貨品實物一致。銷售記錄至少包括產品名稱、特殊化妝品註冊證編號或普通化妝品備案編號、使用期限、淨含量、數量、銷售日期、價格，以及購買者名稱、地址和聯繫方式等內容。

．建立並執行產品貯存和運輸管理制度。依照有關法規的規定和產品標籤標示的要求貯存、運輸，定期檢查並及時處理變質或者超過使用期限等質量異常的產品。

．建立並執行退貨記錄制度。退貨記錄內容應包括退貨單位、產品名稱、淨含量、使用期限、數量、退貨原因以及處理結果等內容。

．應建立並執行產品質量投訴管理制度，指定人員負責處理產品質量投訴、記錄，質量管理部門應對投訴內容進行分析評估、提升產品質量。

．建立、實施化妝品不良反應監測和評價，配備相適應的機構和人員，按規定開展不良反應監測工作，並形成監測記錄。

．建立並執行產品召回管理制度，依法實施召回工作。發現產品存在質量缺陷或其他問題，可能危害人體健康的，應立即停止生產，召回已上市銷售的產品，通知相關化妝品經營者和消費者停止經營、使用，記錄召回和通知情況。
對召回的產品，應清晰標識、單獨存放，視情況採取補救、無害化處理、銷毀等措施。召回記錄內容至少包括產品名稱、淨含量、使用期限、召回數量、實際召回數量、召回原因、召回時間、處理結果、向監管部門報告情況等。

化妝品檢驗

理化檢驗：pH 值、汞、鉛砷、鎘、鋰等 37 種元素、二噁烷、甲醇、石棉等。
禁用原料檢驗：氟康唑等 9 種原料、米諾地爾和坎利酮、甲基香豆素、甲氧基補骨脂素等 4 種原料、補骨脂素等 4 種原料、氨基偶氮苯和聯苯胺、氨基聯苯及其鹽、酸性黃 36 等 5 種原料、氯甲苯、氨基己酸、斑蝥素和氮芥、苯並[а]芘、丙烯酰胺、地氯雷他定等 15 種原料、二甘醇、環氧乙烷和甲基環氧乙烷、普魯卡因胺等 7 種原料、馬來酸二乙酯、維甲酸等 8 種原料、維生素 D2 和維生素 D3、鄰苯二甲酸二甲酯等 10 種原料、鄰苯二甲酸二丁酯等 8 種原料、二氯甲烷等 15 種原料、乙醇等 37 種原料、曲安西龍等 63 種原料、甲硝唑等 36 種原料、西咪替丁、甲醛、硼酸和硼酸鹽等。
限用原料檢驗：葡醣醛酸等 10 種原料、二硫化硒、過氧化氫、間苯二酚、可溶性鋅鹽6、奎寧、羥基喹啉、巰基乙酸、酮麝香、游離氫氧化物、總硒等。
防腐劑檢驗：甲基異噻唑啉酮等 23 種原料、吡硫鎓鋅等 18 種原料、己脒定二（羥乙基磺酸）鹽等 7 種原料、聚氨丙基雙胍、海克替啶、甲酸等 9 種原料、游離甲醛等。
防曬劑檢驗：二苯酮-2、二氧化鈦、氧化鋅、亞芐基樟腦等 22 種原料等。
著色劑檢驗：鹼性橙 31 等 7 種原料、著色劑 CI 59040 等 10 種原料等。
染髮劑檢驗：對苯二胺等 32 種原料等。
其他檢驗：乙醇胺等 5 種原料、抗 UVA 能力、熒光增白劑 85 等 5 種原料、α-熊果苷、β-熊果苷、氫醌和苯酚等。
微生物檢驗：菌落總數、耐熱大腸菌群、銅綠假單胞菌、金黃色葡萄球菌、黴菌和酵母菌計數等。
毒理學試驗：急性經口、急性經皮、皮膚刺激性/腐蝕性、皮膚腐蝕性大鼠經皮電阻、眼刺激性/腐蝕性、體外兔角膜上皮細胞短時暴露、皮膚變態局部淋巴結、直接多肽反應、皮膚光、體外 3T3 中性紅攝取光、皮膚光變態反應、細菌突變試驗、體外哺乳動物細胞染色體畸變試驗、體外哺乳動物細胞基因突變試驗、哺乳動物骨髓細胞染色體畸變試驗、微核試驗、哺乳動物紅細胞微核試驗、體外哺乳類細胞微核試驗、睾丸生殖細胞染色體畸變試驗、亞慢性經口毒性試驗、亞慢性經皮毒性試驗、生殖發育毒性試驗、致畸試驗、慢性毒性/致癌性結合試驗等。
人體安全性試驗：檢驗人體皮膚斑貼試驗、人體安全性試用試驗等。
人體功效評價檢驗：防曬化妝品防曬指數（SPF 值）測試、防曬化妝品防水性能測試、防曬化妝品長波紫外線防護指數（PFA 值）測試、祛斑美白功效測試、防脫髮功效測試等。

Cosmetics Production Quality Specification

Institutions and personnel

．Cosmetics production enterprises should establish a cosmetics quality and safety responsibility system, and clarify the responsibilities of the legal representative (or main person in charge), quality and safety person in charge, quality management department, production department, and other relevant positions.

Quality Assurance and Control

．Cosmetics production quality management system documents should be established, including quality policy, quality objectives, quality management systems, quality standards, product formulations, production process regulations, operating procedures, and other documents required by laws and regulations, and the document management system should be implemented to ensure the quality of cosmetic production. The formulation, review, approval, distribution, and destruction of management system documents are effectively controlled.

．Records should be clearly marked, stored in an orderly manner, and easy to refer to. The records related to product traceability shall be kept for a period of not less than 1 year after the expiration of the product use period; if the product service period is less than 1 year, the record keeping period shall not be less than 2 years. For records not related to product traceability, the retention period shall not be less than 2 years.

Plant facilities and equipment management

．There should be production sites, facilities and equipment suitable for the variety, quantity and production license items to be produced. The production site should not be affected by toxic and harmful places and other sources of pollution, and the building structure, production workshop and facility equipment are easy to clean, operate and maintain. Set up production workshops according to the requirements, and there must be no pollution sources. The flow of materials, products and personnel is reasonable to avoid pollution and cross-contamination.

．The design, installation, operation and maintenance of water production, water storage and conveying systems shall ensure that the process water meets the requirements of quality standards. And implement the regular cleaning, disinfection, monitoring and maintenance system of the water treatment system. The design, installation, operation, and maintenance of the air purification system should ensure that the environmental requirements are met, and the air purification system should be regularly cleaned, disinfected, monitored, and maintained.

Materials and product management

．Establish and implement material supplier selection system, review and evaluate material suppliers, sign procurement contracts with material suppliers, and specify material acceptance criteria and quality responsibilities of both parties in the contract. A list of qualified material suppliers should be established based on the results of the audit and evaluation, key raw material suppliers should be identified, and key raw material suppliers should be reviewed with emphasis, and on-site audits should be conducted when necessary.

．Establish and implement a material review system, establish a list of raw materials, purchased semi-finished products and internal packaging materials, clarify the ingredients of raw materials and externally purchased semi-finished products, and retain necessary raw materials, purchased semi-finished products, and internal packaging materials.

．Review raw materials, purchased semi-finished products, and internal packaging materials before purchasing materials. Prohibited raw materials, new raw materials that have not been registered or filed shall not be used, and restricted raw materials shall not be used beyond the scope of use and restricted conditions to ensure that raw materials, purchased materials Semi-finished products and inner packaging materials are in compliance with laws and regulations.

．Establish and implement material purchase inspection record system, establish and implement material acceptance procedures, and clarify material acceptance standards and acceptance methods. Keep samples of key raw materials and keep records. The raw materials of the samples should have labels, including at least the Chinese name of the raw material or the raw material code, the name of the manufacturer, the specifications of the raw material, the storage conditions, the use period and other information to ensure traceability. The samples should meet the requirements of raw material quality inspection.

．The water quality and quantity of production water shall meet production requirements, and the water quality shall at least meet the sanitary standards for drinking water. If the production water is small centralized water supply or decentralized water supply, it shall be tested by a qualified inspection and testing institution at least once a year, establish and implement process water quality standards and process water management regulations, and regularly monitor the quality of process water to ensure that Meet the quality requirements.

．Establish and implement a label management system, review product labels, and ensure that product labels meet the requirements of regulations, mandatory national standards, and technical specifications. The production process of labeling on the inner packaging material is completed in the production enterprise that completes the last production process of contacting the cosmetic contents.

Production process management

．Establish and implement a production management system commensurate with the variety, quantity and production license items of the cosmetics produced. Establish and implement product production process regulations and post operation regulations according to the technical requirements stated in the cosmetic registration and filing materials to ensure that products are produced in accordance with the technical requirements stated in the cosmetic registration and filing materials. Specify the production process parameters and key control points of the process, and the main production process should be verified to ensure that qualified products can be produced continuously and stably.

．The production order is issued according to the production plan, including the product name, production batch number (or a unique identifier that can be associated with the production batch number), product formula, total production volume, production time, etc. The materials and semi-finished products used in the production process shall be clearly identified throughout the entire process, with the name or code, production date or batch number, and quantity, and can be traced back.

．Establish and implement a product release management system to ensure that the product can be released only after it has passed the inspection and the relevant production and quality activity records have been reviewed and approved. Cosmetics sold on the market should be accompanied by a product quality inspection certificate in the form of a factory inspection report or a qualified mark.

Product sales management

．Establish and implement a product sales record system to ensure that the shipping documents and sales records of the products sold are consistent with the physical goods. The sales records at least include the product name, registration certificate number for special cosmetics or record number for ordinary cosmetics, expiry date, net content, quantity, date of sale, price, as well as the name, address and contact information of the purchaser.

．Establish and implement product storage and transportation management systems. Store and transport products in accordance with the provisions of relevant laws and regulations and the requirements of product labels, and regularly inspect and promptly deal with products with abnormal quality such as deterioration or exceeding the expiration date.

．Establish and implement a return record system. The content of the return record shall include the return unit, product name, net content, use period, quantity, reason for return, and processing results.

．A product quality complaint management system should be established and implemented, with designated personnel responsible for handling product quality complaints and records, and the quality management department should analyze and evaluate the content of complaints to improve product quality.

．Establish and implement the monitoring and evaluation of adverse reactions of cosmetics, allocate appropriate institutions and personnel, carry out monitoring of adverse reactions according to regulations, and form monitoring records.

．Establish and implement a product recall management system, and implement recall work in accordance with the law. If it is found that the product has quality defects or other problems that may endanger human health, production should be stopped immediately, the products that have been sold on the market should be recalled, the relevant cosmetics operators and consumers should be notified to stop operation and use, and the recall and notification should be recorded. The recalled products should be clearly marked and stored separately, and measures such as remediation, harmless treatment, and destruction should be taken as appropriate. The contents of the recall record shall include at least the product name, net content, expiry date, recalled quantity, actual recalled quantity, recalled reason, recalled time, processing result, and report to the supervisory authority, etc.

Cosmetic Inspection

Physical and chemical tests: pH value, mercury, lead, arsenic, cadmium, lithium and other 37 elements, dioxane, methanol, asbestos, etc.
Inspection of prohibited raw materials: 9 raw materials such as fluconazole, 4 raw materials such as minoxidil and canrenone, 4 raw materials such as methyl coumarin and methoxypsoralen, 4 kinds of raw materials such as psoralen, Five raw materials including aminoazobenzene and benzidine, aminobiphenyl and its salts, acid yellow 36, chlorotoluene, aminocaproic acid, cantharidin and nitrogen mustard, benzo[a]pyrene, acrylamide, deslorata 15 kinds of raw materials, 7 kinds of raw materials such as diethylene glycol, ethylene oxide and methyl ethylene oxide, procainamide, 8 kinds of raw materials such as diethyl maleate, retinoic acid, vitamin D2 and vitamin D3, 10 kinds of raw materials such as dimethyl phthalate, 8 kinds of raw materials such as dibutyl phthalate, 15 kinds of raw materials such as dichloromethane, 37 kinds of raw materials such as ethanol, 63 kinds of raw materials such as triamcinolone, etc. 36 kinds of raw materials such as azole, cimetidine, formaldehyde, boric acid and borate, etc.
Inspection of restricted raw materials: 10 raw materials such as glucuronic acid, selenium disulfide, hydrogen peroxide, resorcinol, soluble zinc salt 6, quinine, hydroxyquinoline, thioglycolic acid, ketone musk, free hydroxide substances, total selenium, etc.
Preservative inspection: 23 kinds of raw materials such as methylisothiazolinone, 18 kinds of raw materials such as pyrithione zinc, 7 kinds of raw materials such as hexamidine bis(isethionate) salt, polyaminopropyl biguanide, 9 kinds of raw materials such as ketidine, formic acid, free formaldehyde, etc.
Sunscreen inspection: 22 kinds of raw materials such as benzophenone-2, titanium dioxide, zinc oxide, benzylidene camphor, etc.
Colorant inspection: 7 kinds of raw materials such as basic orange 31, 10 kinds of raw materials such as colorant CI 59040, etc.
Hair dye inspection: 32 kinds of raw materials such as p-phenylenediamine.
Other inspections: 5 kinds of raw materials such as ethanolamine, anti-UVA ability, 5 kinds of raw materials such as fluorescent whitening agent 85, α-arbutin, β-arbutin, hydroquinone and phenol, etc.
Microbial inspection: total number of colonies, heat-resistant coliforms, Pseudomonas aeruginosa, Staphylococcus aureus, mold and yeast counts, etc.
Toxicology test: acute oral, acute percutaneous, skin irritation/corrosion, skin corrosion rat transdermal resistance, eye irritation/corrosion, short-term exposure to rabbit corneal epithelial cells in vitro, local skin metamorphosis Lymph node, direct peptide reaction, skin light, in vitro 3T3 neutral red uptake light, skin photoallergy, bacterial mutation test, in vitro mammalian cell chromosome aberration test, in vitro mammalian cell gene mutation test, mammalian bone marrow cell chromosome aberration test, Micronucleus test, mammalian red blood cell micronucleus test, in vitro mammalian cell micronucleus test, testicular germ cell chromosome aberration test, subchronic oral toxicity test, subchronic transdermal toxicity test, reproductive developmental toxicity test, teratogenicity test, chronic toxicity /Carcinogenicity binding test, etc.
Human safety test: test human skin patch test, human safety trial test, etc.
Human body efficacy evaluation test: sunscreen cosmetics sun protection index (SPF value) test, sunscreen cosmetics waterproof performance test, sunscreen cosmetics long-wave ultraviolet protection index (PFA value) test, freckle whitening efficacy test, anti-hair loss efficacy test, etc.

【參考連結】

https://www.nmpa.gov.cn/hzhp/hzhpfgwj/hzhpgzwj/20220107101645162.html?type=pc&m=

https://www.nmpa.gov.cn/hzhp/hzhpfgwj/index.html

HLF-TW-75

中國化妝品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？

Evershine RD：

否，需為中國國家食品藥品監督管理局認定的許可檢驗機構出具的檢驗報告。

HLF-TW-77

請問在中國有哪些化妝品檢驗機構可以提供化妝品檢驗服務？網頁？

Evershine RD：

上海天祥質量技術服務有限公司

https://www.intertek.com.cn/

譜尼測試集團上海有限公司

http://www.ponytest.com/

HLF-TW-80

外國子公司進口化妝品後，如果委託中國的經銷商銷售，經銷商需要化妝品營業許可證嗎？
假如化妝品有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？

After a foreign subsidiary imports cosmetics and entrusts a distributor in China to sell it, does the distributor need a cosmetics business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?

Evershine RD：

無營業特許證。須通過進口化妝品備案許可，且經國家商檢部門檢驗的化妝品方可進口、銷售。化妝品經營需遵守相關經營規範。

化妝品經營

1.化妝品經營者應建立並執行進貨查驗記錄制度，查驗直接供貨者的市場主體登記證明、特殊化妝品註冊證或者普通化妝品備案信息、化妝品的產品質量檢驗合格證明並保存相關憑證，如實記錄化妝品名稱、特殊化妝品註冊證編號或者普通化妝品備案編號、使用期限、淨含量、購進數量、供貨者名稱、地址、聯繫方式、購進日期等內容。

2.實行統一配送的化妝品經營者，可以由經營者總部統一建立並執行進貨查驗記錄制度，統一進行查驗記錄並保存相關憑證。經營者總部應保證所屬分店能提供所經營化妝品的相關記錄和憑證。

3.美容美髮機構、賓館等在經營服務中使用化妝品或者為消費者提供化妝品的，應依法履行化妝品經營者義務。

4.美容美髮機構經營中使用的化妝品以及賓館等為消費者提供的化妝品應符合最小銷售單元標籤的規定。

5.美容美髮機構應在其服務場所內顯著位置展示其經營使用的化妝品的銷售包裝，方便消費者查閱化妝品標籤的全部信息，並按照化妝品標籤或者說明書的要求，正確使用或者引導消費者正確使用化妝品。

6.化妝品集中交易市場開辦者、展銷會舉辦者應建立保證化妝品質量安全的管理制度並有效實施，承擔入場化妝品經營者管理責任，督促入場化妝品經營者依法履行義務，每年或者展銷會期間至少組織開展一次化妝品質量安全知識培訓。

7.化妝品集中交易市場開辦者、展銷會舉辦者應建立入場化妝品經營者檔案，審查入場化妝品經營者的市場主體登記證明，如實記錄經營者名稱或者姓名、聯繫方式、住所等信息。入場化妝品經營者檔案信息應及時核驗更新，保證真實、準確、完整，保存期限不少於經營者在場內停止經營後2年。

8.化妝品展銷會舉辦者應在展銷會舉辦前向所在地縣級負責藥品監督管理的部門報告展銷會的時間、地點等基本信息。

化妝品集中交易市場開辦者、展銷會舉辦者應建立化妝品檢查制度，對經營者的經營條件以及化妝品質量安全狀況進行檢查。發現入場化妝品經營者有違反規定行為的，應及時制止，依照集中交易市場管理規定或者與經營者簽訂的協議進行處理，並向所在地縣級負責藥品監督管理的部門報告。

10.化妝品集中交易市場開辦者、展銷會舉辦者鼓勵建立化妝品抽樣檢驗、統一銷售憑證格式等制度。

11.電子商務平台內化妝品經營者以及通過自建網站、其他網絡服務經營化妝品的電子商務經營者應在其經營活動主頁面全面、真實、準確披露與化妝品註冊或者備案資料一致的化妝品標籤等信息。

12.化妝品電子商務平台經營者應對申請入駐的平台內化妝品經營者進行實名登記，要求其提交身份、地址、聯繫方式等真實信息，進行核驗、登記，建立登記檔案，並至少每6個月核驗更新一次。化妝品電子商務平台經營者對平台內化妝品經營者身份信息的保存時間自其退出平台之日起不少於3年。

13.化妝品電子商務平台經營者應設置化妝品質量管理機構或者配備專兼職管理人員，建立平台內化妝品日常檢查、違法行為製止及報告、投訴舉報處理等化妝品質量安全管理制度並有效實施，加強對平台內化妝品經營者相關法規知識宣傳。鼓勵化妝品電子商務平台經營者開展抽樣檢驗。

14.化妝品電子商務平台經營者應依法承擔平台內化妝品經營者管理責任，對平台內化妝品經營者的經營行為進行日常檢查，督促平台內化妝品經營者履行規定的義務。發現違法經營化妝品行為的，應依法或者依據平台服務協議和交易規則採取刪除、屏蔽、斷開鏈接等必要措施及時制止，並報告所在地省、自治區、直轄市藥品監督管理部門。

15.化妝品電子商務平台經營者收到化妝品不良反應信息、投訴舉報信息的，應記錄並及時轉交平台內化妝品經營者處理；涉及產品質量安全的重大信息，應及時報告所在地省、自治區、直轄市藥品監督管理部門。

16.負責藥品監督管理的部門因監督檢查、案件調查等工作需要，要求化妝品電子商務平台經營者依法提供相關信息的，化妝品電子商務平台經營者應予以協助、配合。

17.化妝品電子商務平台經營者發現有下列嚴重違法行為的，應立即停止向平台內化妝品經營者提供電子商務平台服務：

．化妝品質量安全相關犯罪被人民法院判處刑罰

．因化妝品質量安全違法行為被公安機關拘留或者給予其他治安管理處罰

．被藥品監督管理部門依法作出吊銷許可證、責令停產停業等處罰

．其他嚴重違法行為

19.化妝品電子商務平台經營者知道或者應知道平台內化妝品經營者被依法禁止從事化妝品生產經營活動的，不得向其提供電子商務平台服務。

20.以免費試用、贈予、兌換等形式向消費者提供化妝品的，應依法履行規定的化妝品經營者義務。

產品責任

化妝品電子商務平台經營者獲知化妝品不良反應的，應記錄報告者信息、發生不良反應者信息、不良反應信息、所使用的化妝品信息等內容，並於7日內轉交平台內化妝品經營者處理。涉及產品質量安全的重大信息，化妝品電子商務平台經營者應自獲知上述信息後，將發生不良反應者信息、症狀或者體徵、不良反應嚴重程度、不良反應發生日期、所使用化妝品名稱、銷售所使用化妝品的平台內經營者等信息於15日內書面報告電子商務平台經營者所在地省級藥監部門。

6.各級負責藥品監督管理的部門應公佈本部門和同級監測機構的電話、通訊地址等聯繫方式。

Cosmetics operators should establish and implement a purchase inspection record system, inspect the market entity registration certificate of direct suppliers, special cosmetics registration certificate or general cosmetics filing information, cosmetics product quality inspection certificate and keep relevant certificates, and truthfully record cosmetics. Name, registration certificate number of special cosmetics or record number of ordinary cosmetics, use period, net content, purchase quantity, supplier name, address, contact information, purchase date, etc.
Cosmetics operators who implement unified distribution can establish and implement a purchase inspection record system uniformly by the operator’s headquarters, conduct inspection records and keep relevant certificates. The operator’s headquarters shall ensure that its branches can provide relevant records and vouchers for the cosmetics it operates.
Beauty salons, hotels, etc. that use cosmetics in business services or provide cosmetics to consumers shall perform their obligations as cosmetics operators according to law.
Cosmetics used in the operation of beauty salons and cosmetics provided to consumers by hotels, etc., shall comply with the minimum sales unit label requirements.
Beauty salons should display the sales packaging of the cosmetics they use in a prominent position in their service places, so that consumers can easily check all the information on the cosmetics labels, and use them correctly or guide consumers to use them correctly according to the requirements of the cosmetics labels or instructions. cosmetic.
The organizers of the centralized cosmetics trading market and the organizers of the exhibitions should establish and effectively implement the management system to ensure the quality and safety of cosmetics, assume the management responsibility of the operators of the cosmetics, and urge the operators of the cosmetics to perform their obligations according to the law. Every year or during the exhibition, organize at least Carry out a cosmetic quality and safety knowledge training.
The organizer of the centralized cosmetics trading market and the organizer of the exhibition shall establish a file of the operators of the cosmetics entering the venue, review the registration certificate of the market entity of the operators who enter the cosmetics market, and truthfully record the operator’s name or name, contact information, address and other information. The file information of cosmetic operators entering the venue shall be verified and updated in time to ensure authenticity, accuracy and completeness, and the storage period shall not be less than 2 years after the operator ceases operation in the venue.
The organizer of the cosmetics fair should report the time, location and other basic information of the fair to the local county-level department in charge of drug supervision and administration before the fair is held.
The organizers of the centralized cosmetics trading market and the organizers of the exhibitions shall establish a cosmetics inspection system to inspect the operating conditions of the operators and the quality and safety of the cosmetics. If it is found that the operators of cosmetics entering the market have violated the regulations, they should be stopped in time, dealt with in accordance with the centralized trading market management regulations or the agreements signed with the operators, and reported to the local county-level department responsible for drug supervision and management.
The organizers of the centralized cosmetics trading market and the organizers of exhibitions are encouraged to establish a system of sampling inspection of cosmetics and a unified format of sales vouchers.
Cosmetics operators on the e-commerce platform and e-commerce operators operating cosmetics through self-built websites and other online services should fully, truthfully and accurately disclose information such as cosmetics labels that are consistent with cosmetics registration or filing materials on the main page of their business activities .
Cosmetics e-commerce platform operators should register real-name cosmetics operators on the platform, and require them to submit real information such as identity, address, and contact information, conduct verification and registration, establish registration files, and verify at least every 6 months. Update once. Cosmetics e-commerce platform operators shall keep the identity information of cosmetic operators on the platform for not less than 3 years from the date they exit the platform.
Cosmetics e-commerce platform operators should set up cosmetic quality management agencies or assign full-time and part-time management personnel to establish and effectively implement cosmetic quality and safety management systems such as daily inspections of cosmetic products on the platform, suppression and reporting of illegal acts, and handling of complaints and reports, and strengthen the management of cosmetic products. Publicity of relevant laws and regulations for cosmetics operators on the platform. Operators of cosmetic e-commerce platforms are encouraged to carry out sampling inspections.
Cosmetics e-commerce platform operators shall undertake the management responsibilities of cosmetic operators on the platform in accordance with the law, conduct daily inspections of the business behaviors of cosmetic operators on the platform, and urge cosmetic operators on the platform to fulfill their obligations. If the illegal operation of cosmetics is found, it shall take necessary measures such as deletion, blocking, and disconnection in accordance with the law or in accordance with the platform service agreement and transaction rules to stop it in a timely manner, and report to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where it is located.
If the operator of the cosmetics e-commerce platform receives the information on adverse reactions of cosmetics, complaints and reports, it should record and transfer it to the cosmetics operators on the platform in a timely manner; major information involving product quality and safety should be reported to the drug in the province, autonomous region, or municipality directly under the Central Government. Supervision and management department.
If the department in charge of drug supervision and administration requires the operator of the cosmetics e-commerce platform to provide relevant information in accordance with the law due to the needs of supervision and inspection, case investigation, etc., the operator of the cosmetics e-commerce platform shall assist and cooperate.
If the operator of the cosmetics e-commerce platform discovers the following serious violations, it shall immediately stop providing e-commerce platform services to the cosmetics operators on the platform:

．Cosmetics quality and safety related crimes were sentenced by people’s court

．Detained by public security organs or given other public security management penalties due to illegal acts of cosmetic quality and safety

．Punishments such as revocation of licenses and orders to suspend production and business by the drug regulatory authority according to law

．Other serious violations

If a case is placed on file for investigation or a public prosecution for suspected cosmetics quality and safety crime, and there is evidence to prove that it may endanger human health, the cosmetics e-commerce platform operator may suspend the provision of electronic products to cosmetics operators on the platform in accordance with the law or in accordance with the platform service agreement and trading rules. Business platform services.
Cosmetics e-commerce platform operators who know or should know that cosmetics operators on the platform are prohibited from engaging in cosmetics production and business activities in accordance with the law shall not provide them with e-commerce platform services.
If cosmetics are provided to consumers in the form of free trial, gift, exchange, etc., they shall perform the prescribed obligations of cosmetic operators according to law.

Product Liability

Cosmetics registrants and filers should establish a cosmetic production quality management system in accordance with the law, perform obligations such as product adverse reaction monitoring, risk control, product recall, etc., and be responsible for the quality, safety and efficacy claims of cosmetics. Cosmetics producers and operators shall engage in production and business activities in accordance with laws, regulations, rules, mandatory national standards and technical specifications, strengthen management, be honest and self-disciplined, and ensure the quality and safety of cosmetics.
Cosmetics registrants and filers should publish effective contact information such as telephone numbers and e-mails to the public through product labels, official websites and other means that are convenient for consumers to know, and take the initiative to collect information from entrusted manufacturers, cosmetics operators, medical institutions, and consumers. and other adverse reactions reported by its marketed cosmetics.
Cosmetics registrants and filers shall report through the National Cosmetic Adverse Reaction Monitoring Information System after discovering or learning about cosmetic adverse reactions. Entrusted manufacturers, cosmetics operators, and medical institutions should report through the National Cosmetic Adverse Reaction Monitoring Information System after discovering or learning about the adverse reactions of cosmetics, and encourage them to inform the cosmetics registrants and filers. Cosmetics operators and medical institutions that do not have the conditions for online reporting for the time being should report to the local city and county-level monitoring agencies through paper statements, and they will submit the reports online on their behalf.
If the operator of the cosmetics e-commerce platform is informed of the adverse reactions of cosmetics, it should record the information of the reporter, the information of the adverse reaction person, the information of the adverse reaction, and the information of the cosmetics used, and transfer it to the cosmetics operators on the platform for processing within 7 days. For major information related to product quality and safety, the operator of the cosmetics e-commerce platform shall, after obtaining the above information, report the information, symptoms or signs of adverse reactions, the severity of adverse reactions, the date of occurrence of adverse reactions, the name of the cosmetic used, the name of the cosmetic used for sales The information on the operators of cosmetics on the platform shall be reported in writing to the provincial drug regulatory department where the operator of the e-commerce platform is located within 15 days.
Other units and individuals can report adverse reactions of cosmetics to the cosmetics registrant, filer, and domestic responsible person, or report to the local city or county-level monitoring agency or city- or county-level regulatory department, and the above-mentioned enterprises or units submit reports online on their behalf.
The departments in charge of drug supervision and administration at all levels shall announce the contact information such as telephone numbers and mailing addresses of the departments and monitoring institutions at the same level.

URL: https://gkml.samr.gov.cn/nsjg/fgs/202108/t20210806_333443.html

【參考連結】

https://gkml.samr.gov.cn/nsjg/fgs/202108/t20210806_333443.html

https://caers.adrs.org.cn/adrcos/

HLF-TW-85

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