China Cosmetic Regulation QA

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HLF-TW-10

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：

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, 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

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：

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

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：

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

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：

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

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：

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

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：

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

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

Evershine RD：

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

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：

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

請問在中國有哪些專精於化妝品銷售與消費權益相關法律服務的業者？

Evershine RD：

競天公誠律師事務所

https://www.jingtian.com/

大江橋法律事務所

https://www.ohebashi.com/gb/

Contact Us

Xiamen Evershine BPO Service Corp.
Room 724 No. 76 Hubin South Rd., Siming Dist., Xiamen City, PRC
Email: xmn4ww@evershinecpa.com

Discuss with our representative in Xiamen for further information:
Manager Bing Weng, UK Graduate School Alumni and a well-English speaker
Mobile: +86-180-5008-2372
Tel No.: +86-592-573-4710

Additional Information

Evershine has 100% affiliates in the following cities:
Headquarter,Taipei, Xiamen,Beijing,
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San Francisco,Houston, Phoenix,
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New Delhi,Mumbai,Dhaka,Jakarta,Frankfurt,
Paris,London,Amsterdam,Milan,Barcelona,
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Other cities with existent clients:
Miami, Atlanta, Oklahoma, Michigan, Seattle, Delaware;
Berlin, Stuttgart; Prague; Czech Republic; Bangalore; Surabaya;
Kaohsiung, Hong Kong, Shenzhen, Donguan, Guangzhou, Qingyuan, Yongkang, Hangzhou, Suzhou, Kunshan, Nanjing, Chongqing, Xuchang, Qingdao, Tianjin.

Evershine Potential Serviceable City (2 months preparatory period):
Evershine CPAs Firm is an IAPA member firm headquartered in London, with 300 member offices worldwide and approximately 10,000 employees.
Evershine CPAs Firm is a LEA member headquartered in Chicago, USA, it has 600 member offices worldwide and employs approximately 28,000 people.
Besides, Evershine is Taiwan local Partner of ADP Streamline ®.
(version: 2024/07)

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