Decree of the State Council of the People’s Republic of China

No. 727

The “Cosmetic Supervision and Administration Regulation” was passed at the 77th Executive
Meeting of the State Council on January 3, 2020 and is hereby promulgated, which will come
into force on January 1, 2021.

Premier: Li Keqiang

June 16, 2020

Cosmetic Supervision and Administration Regulation

Chapter I General Provisions

Article 1 This Regulation is formulated for the purpose of regulating cosmetics production and
operation activities, strengthening cosmetics supervision and administration, ensuring
cosmetics quality and safety and consumers’ health, and promoting healthy development of
cosmetics industry.

Article 2 Engaging in cosmetics production and operation activities in the territory of the
People’s Republic of China and supervision and administration thereof shall comply with this
Regulation.

Article 3 “Cosmetics” herein refers to daily chemical products intended to be applied on

external part of human body, e.g. skin, hair, nails, lips, mouth, etc., by spreading, spraying or
other similar ways for cleansing, protecting, beautifying or grooming purposes.

Article 4 The state shall implement classified management of cosmetics and cosmetics
ingredients based on the degree of risk.

Cosmetics are classified into special cosmetics and notification cosmetics. The state shall
implement registration management for special cosmetics and notification management for
notification cosmetics.

Cosmetics ingredients are divided into new ingredients and existing ingredients. The state
shall implement registration management for new cosmetics ingredients with a higher degree
of risk, and notification management for other new cosmetic ingredients.
Article 5 The National Medical Products Administration (NMPA) of the State Council is
responsible for the supervision and administration of cosmetics nationwide. The relevant
departments of the State Council are responsible for the supervision and administration of
cosmetics within their respective scopes of responsibility.

The medical products administration departments 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 areas. The relevant departments of the local people’s
governments at or above the county level are responsible for the supervision and
administration of cosmetics within their respective scopes of responsibility.

Article 6 Cosmetics registration applicants and notification applicants are responsible for the
quality, safety and efficacy claims of cosmetics.

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

Article 7 Cosmetics industry associations shall strengthen industry self-discipline, urge and
guide cosmetics producers and operators to engage in production and operation activities in
accordance with laws to promote the development of credibility of the industry.

Article 8 Consumer associations and other consumer organizations shall conduct public
supervision in accordance with laws on violations of the provisions herein that damage the
legal rights and interests of consumers.

Article 9 The state shall encourage and support the research and innovation of cosmetics to
meet consumer needs, promote the building of cosmetics brands, and give play to the leading
role of cosmetics brands. The state shall protect the legal rights and interests of units and
individuals in carrying out cosmetics research and innovation.

The state shall encourage and support cosmetics producers and operators to adopt advanced
technologies and management standards to improve the quality and safety of cosmetics, use
of modern science and technology and combination with the national traditional superior
projects and special plant resources to research and develop cosmetics.

Article 10 The state shall strengthen the IT construction of cosmetics supervision and
administration, improve the online service of government affairs, facilitate the handling of
cosmetics administrative registration and notification, and promote the sharing of supervision
and administration information.
 Chapter II Ingredients and Products

Article 11 The natural or artificial ingredients used in cosmetics for the first time in the territory
of China belong to new cosmetics ingredients. New cosmetics ingredients with functions of
preservative, sun protection, coloring, hair dyeing, freckle removal and whitening can be used
only after being registered by the NMPA of the State Council. Other new cosmetics ingredients
shall be notified with the NMPA of the State Council before use. The NMPA of the State Council
may adjust the scope of new cosmetics ingredients subject to registration management in
accordance with the development of scientific research, which shall be implemented after
approved by the State Council.

Article 12 Application for registration or notification of new cosmetics ingredients shall submit
the following materials:

(I) The name, address and contact information of the registration applicant and notification
applicant;

(II) The R&D report on new ingredients;

(III) The research documents such as the preparation process, stability and quality control
specification of new ingredients;

(IV) The safety assessment information of new ingredients.

Registration applicants and notification applicants shall be responsible for the authenticity and
scientificity of the documents submitted.

Article 13 The NMPA of the State Council shall transfer the application documents to the
technical review agency within 3 working days upon accepting the application for registration
of new cosmetics ingredients. The technical review agency shall complete the technical review
within 90 working days upon receiving the application documents, and submit the review
comments to the NMPA of the State Council. Then the NMPA of the State Council shall make
a decision within 20 working days upon receiving the review comments. For those that meet
the requirements, the registration shall be approved and a new cosmetic ingredient registration
certificate shall be issued; for those that do not meet the requirements, the registration shall
not be approved and a written explanation shall be given.

Notification applicants of new cosmetic ingredients shall submit the notification documents as
prescribed herein through the online government affairs service portal of the NMPA of the
State Council, after which the notification will be deemed to be completed.
The NMPA of the State Council shall disclose the registration and notification information to
the public within 5 working days upon approving the registration of new cosmetics ingredients
and upon the submission of notification documents by notification applicants.

Article 14 Within 3 years after the registered and notified new cosmetics ingredients are put
into use, the registration applicants and notification applicants shall report the use and safety
of the new ingredients to the NMPA of the State Council annually. For new cosmetics
ingredients with any safety issues, the NMPA of the State Council shall cancel the registration
or the notification. New cosmetics ingredients that do not have any safety issues within the 3
years will be included in the “Inventory of Existing Cosmetic Ingredients in China (IECIC)”
formulated by the NMPA of the State Council.

Before the registered and notified new cosmetics ingredients are included in the IECIC, they
shall be still managed as new cosmetics ingredients.

Article 15 The inventory of ingredients prohibited for production of cosmetics shall be

formulated and announced by the NMPA of the State Council.

Article 16 Cosmetics used for hair coloring, perming, freckle removal and whitening, sun
protection, anti-hair loss and cosmetics claiming new efficacy belong to special cosmetics.
Cosmetics other than special cosmetics are general cosmetics.

The NMPA of the State Council shall formulate and announce cosmetic classification rules
and classification catalog based on factors such as the efficacy claims of cosmetics,
application parts, product dosage forms, and applicable people, etc.

Article 17 Special cosmetics can be produced and imported only after they are registered with
the NMPA of the State Council. Domestic general cosmetics shall be notified with the medical
products administration departments of the people’s government of the province, autonomous
region, or municipality directly under the central government where the notification applicant
is located prior to sale in the market. Imported general cosmetics shall be notified with the
NMPA of the State Council prior to import.

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

(I) It is an enterprise or other organization set up in accordance with law;

(II) It has a quality management system suitable for the products to be registered and notified;

(III) It possesses the ability to monitor and assess the adverse reactions of cosmetics.
Article 19 The following documents shall be submitted for registration of special cosmetics or
notification of general cosmetics:

(I) The name, address and contact information of the registration applicant and notification
applicant;

(II) The name, address and contact information of the production enterprise;

(III) The product name;

(IV) The formula or full ingredient list of the product;

(V) The standard that the product complies with;

(VI) The sample manuscript of the product label;

(VII) The product testing report;

(VIII) The product safety assessment documents.

The registration applicants who apply for registration of special cosmetics for the first time or
the notification applicants who apply for notification of general cosmetics for the first time shall
submit the documents proving its compliance with the conditions prescribed in Article 18 herein.
Whoever applying for registration of imported special cosmetics or notification of imported
general cosmetics shall also submit the certification documents that the product has been sold
in the market in the producing country (region) and the certification documents proving that
the overseas production enterprise comply with the cosmetics production quality management
standard. For products designed specifically for exports to China and failing to submit the
certification documents that the product has been sold in the market in the producing country
(region), relevant documents of research and testing carried out based on Chinese consumers
shall be submitted.

Registration applicants and notification applicants shall be responsible for the authenticity and
scientificity of the materials submitted.

Article 20 The NMPA of the State Council shall review the application for registration of special
cosmetics in accordance with the new cosmetics ingredients registration procedures
prescribed in the first paragraph of Article 13 herein. For those who meet the requirements,
the registration shall be approved and a special cosmetics registration certificate shall be
issued; for those who do not meet the requirements, the registration shall not be approved and
a written explanation shall be given. Where the registered special cosmetics have undergone
substantial changes in production process and efficacy claims, etc., the registration applicant
shall apply to the original registration department for registration changes.
General cosmetics notification applicants shall submit the notification documents as
prescribed herein through the online government affairs service platform of the NMPA of the
State Council, after which the notification will be deemed to be completed.

The medical products administration departments of the people’s government at or above the
provincial level shall disclose the registration and notification information to the society within
5 working days upon approving the registration of the special cosmetics and receiving the
notification documents of the general cosmetics submitted by the notification applicant.

Article 21 Before registering and notification new cosmetics ingredients and cosmetics,
registration applicants and notification applicants shall conduct safety assessment by
themselves or by entrusting a professional institution.

Personnel engaged in safety assessment shall possess professional knowledge related to

cosmetics quality and safety, and have more than 5 years of relevant professional work
experience.

Article 22 Efficacy claims of cosmetics shall be supported by sufficient scientific basis.

Cosmetics registration applicants and notification applicants shall disclose the summary of the
document literature, research data or product efficacy evaluation document on which the
efficacy claims are based on the special website prescribed by the NMPA of the State Council,
and accept social supervision.

Article 23 Overseas cosmetics registration applicants and notification applicants shall

designate an enterprise legal person in the territory of China to handle cosmetics registration
and notification, and assist in monitoring of cosmetics adverse reactions and implementation
of product recalls.

Article 24 Special cosmetics registration certificates are valid for 5 years. If the registration
needs to be renewed after the expiry of the validity period, an application for the renewal shall
be submitted 30 working days before the expiry of the validity period. Except for the
circumstances prescribed in the second paragraph of this article, the NMPA of the State
Council shall make a decision to approve the renewal before the expiry of the validity period
of the special cosmetics registration certificate; where no decision has been made within the
time limit, the renewal will be deemed to be approved.

In one of the following circumstances, the renewal of registration will not be approved:

(I) The registration applicant fails to submit an application for registration renewal within the
prescribed time limit;
(II) The mandatory national standards and technical standards have been revised, and
cosmetics subject to application for registration renewal do not meet the requirements of the
revised standards and technical standards.

Article 25 The NMPA of the State Council is responsible for the project proposal, drafting
organization, opinion solicitation and technical review of the mandatory national standards for
cosmetics. The standardization administration department of the State Council is responsible
for the establishment, numbering and external notification of the mandatory national standards
for cosmetics.

The texts of the national standards for cosmetics shall be freely disclosed to the public.

Cosmetics shall meet the mandatory national standards. Enterprises are encouraged to
formulate the enterprise standards that are stricter than the mandatory national standards.

Chapter III Production and Operation

Article 26 Engaging in cosmetics production activities shall meet the following requirements:

(I) It is an enterprise established in accordance with law;

(II) It has a production site, environmental conditions, production facilities and equipment
suitable for the cosmetics produced;

(III) It is equipped with the technical personnel suitable for the cosmetics produced;

(IV) It possesses the inspection personnel and inspection equipment capable of conducting
inspection of the cosmetics produced;

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

Article 27 Whoever engaged in cosmetics production activities shall file an application to the
medical products administration departments of the local people’s government of the province,
autonomous region or municipality directly under the Central Government, submit documents
proving its compliance with the provisions prescribed in Article 26 herein, and it shall be
responsible for the authenticity of the documents submitted.

The medical products administration departments of the people’s government of the province,
autonomous region, or municipality directly under the Central Government shall review the
application materials, conduct on-site verification of the applicant’s production site, and make
a decision within 30 working days upon accepting the application for cosmetics production
license. For those who meet the prescribed conditions, the license shall be granted and a
cosmetics production license shall be issued; for those who do not meet the prescribed
conditions, the license shall not be granted and a written explanation shall be given.

The cosmetics production license is valid for 5 years. If a renewal is needed after the expiry of
the validity period, it shall be handled in accordance with the provisions of the “Administrative
License Law of the People’s Republic of China”.

Article 28 Cosmetic registration applicants and notification applicants may produce cosmetics
by themselves or by entrusting other enterprises.

In case of entrusted cosmetics production, cosmetic registration applicants and notification

applicants shall entrust an enterprise that has obtained the corresponding cosmetics
production license and supervise the production activities of the entrusted enterprise
(hereinafter referred to as the “entrusted production enterprise”) to ensure that it carries out
production in accordance with legal requirements. The entrusted production enterprise shall
conduct production in accordance with laws, regulations, mandatory national standards,
technical standards and contractual arrangements, be responsible for the production activities,
and accept the supervision from cosmetics registration applicants and notification applicants.

Article 29 Cosmetic registration applicants and notification applicants and entrusted

production enterprises shall organize the production of cosmetics in accordance with the
requirements of the cosmetics production quality management standard formulated by the
NMPA of the State Council, establish a cosmetics production quality management system,
and build and implement management systems such as suppliers selection, ingredients
acceptance, production process and quality control, equipment management, product
inspection and sample retention, etc.

Cosmetics registration applicants and notification applicants and entrusted production

enterprises shall produce cosmetics in accordance with the technical requirements specified
in the cosmetics registration or notification documents.

Article 30 Cosmetics raw materials and packaging materials in direct contact with cosmetics
shall comply with the mandatory national standards and technical standards.

Use of expired, discarded or recycled cosmetics or cosmetics raw materials for production of
cosmetics is prohibited.

Article 31 Cosmetics registration applicants and notification applicants and entrusted

manufacturing enterprises shall establish and implement an incoming inspection and recording
system for raw materials and packaging materials in direct contact with cosmetics and a
product sales recording system. The incoming inspection records and product sales records
shall be true, complete and traceable, and shall be kept for not less than 1 year after product
expiry date; for products with the shelf life of less than 1 year, the records shall be kept for not
less than 2 years.

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

Article 32 Cosmetics registration applicants and notification applicants and entrusted

manufacturing enterprises shall be equipped with the quality and safety responsible person to
undertake corresponding product quality and safety management and product release duties.

The person in charge of quality and safety shall have professional knowledge related to the
quality and safety of cosmetics and more than 5 years of work experience in cosmetic
production or quality and safety management.

Article 33 Cosmetics registration applicants and notification applicants and entrusted

manufacturing enterprises shall establish and implement a health management system for
employees. Personnel suffering from diseases against the quality and safety of cosmetics as
prescribed by the health authority of the State Council shall not directly engage in cosmetic
production activities.

Article 34 Cosmetics registration applicants and notification applicants and entrusted

manufacturing enterprises shall regularly conduct self-inspection on the implementation of
cosmetics production quality management standard; where the production conditions
encounter any changes and are no longer meet the requirements of the cosmetics production
quality management standard, rectification measures shall be taken immediately; where the
quality and safety of cosmetics may be affected, production shall be stopped immediately and
it shall be reported to the medical products administration departments of the local people’s
government of the province, autonomous region, or municipality directly under the Central
Government.

Article 35 The minimum sales unit of cosmetics shall have a label, which shall comply with
relevant laws, administrative regulations and mandatory national standards, the contents
therein shall be true, complete and correct.

Imported cosmetics can use a Chinese label directly, or they can be affixed with a Chinese
label; where a Chinese label is affixed, the contents therein shall be consistent with that of the
original label.

Article 36 Cosmetics labels shall be indicated with the following contents:

(I) The product name and registration license number of special cosmetics;
(II) The name and address of registration applicants and notification applicants and the
entrusted manufacturing enterprise;

(III) The cosmetic production license number;

(IV) The product standard number;

(V) Full ingredients;

(VI) The net content;

(VII) The shelf life, usage instructions, and necessary safety warnings;

(VIII) Other contents that shall be indicated in accordance with laws, administrative regulations
and mandatory national standards.

Article 37 Cosmetics labels are prohibited from being indicated with the following contents:

(I) The expressed or implied contents related to medical effects;

(II) The false or misleading contents;

(III) The contents that violate social public order and good customs;

(IV) Other contents prohibited by laws and administrative regulations.

Article 38 Cosmetics operators shall establish and implement an incoming inspection and
recording system to check the supplier’s market subject registration certificate, cosmetics
registration or notification license, and the product’s factory inspection qualification certificate,
and shall faithfully record and save the relevant credentials. The retention period of records
and credentials shall comply with the provisions of the first paragraph of Article 31 herein.

Cosmetics operators are not allowed to make cosmetics by themselves.

Article 39 Cosmetics producers and operators shall store and transport cosmetics in
accordance with the provisions of relevant laws and regulations and the labeling requirements
of cosmetics, regularly inspect and promptly dispose of deteriorated and expired cosmetics.

Article 40 Organizers of centralized cosmetics trading markets and hosts of trade fairs shall
review the market subject registration certificate of the admissive cosmetics operators, assume
the management responsibilities of the admissive cosmetics operators, and regularly inspect
the admissive cosmetics operators; in case of finding any admissive cosmetics operators who
violate the provisions herein, they shall promptly stop them and report to the medical products
administration departments of the local people’s government at the county level.
Article 41 Operators of e-commerce platforms shall register the real-name of the cosmetics
operators on the platform, and assume the management responsibilities of such cosmetics
operators. In case of finding any cosmetics operators on the platform who violate the
provisions herein, the e-commerce platform operator shall promptly stop them and report to
the medical products administration departments of the local people’s government of the
province, autonomous region, or municipality directly under the Central Government; in case
of serious violations, it shall immediately stop providing e-commerce platform services to the
illegal cosmetics operators.

The cosmetics operators on the platform shall disclose the information of the cosmetics they
operate in a comprehensive, truthful, accurate and timely manner.

Article 42 Where beauty and hairdressing institutions, hotels, etc. use cosmetics in their
operations or provide consumers with cosmetics, they shall fulfill the obligations of cosmetics
operators as prescribed herein.

Article 43 The contents of cosmetics advertisements shall be true and legal.

Cosmetics advertisements shall not express or imply that the product has a medical effect, or
contain any false or misleading contents, or deceive or mislead consumers.

Article 44 Where cosmetics registration applicants and notification applicants find that a
cosmetic has quality defects or other issues that may endanger human health, they shall
immediately stop production, recall the cosmetics that have been marketed, and notify the
relevant cosmetics operators and consumers to stop operation and use, and shall record the
recall and notification. The cosmetics registration applicants and notification applicants
involved shall take measures such as remediation, harmless disposal or destruction of the
recalled cosmetics, and report the recall and disposal to the local medical products
administration department of the people’s government of the province, autonomous region, or
municipality directly under the Central Government.

Where entrusted manufacturing enterprise or cosmetics operators find that the cosmetics they
produce or sell are in the circumstances specified in the preceding paragraph, they shall
immediately stop production and operation, and notify the relevant registration applicants and
notification applicants who shall immediately implement the recall.

Where the responsible medical products administration departments find that a cosmetic is in
the circumstances specified in the first paragraph of this article during the supervision and
inspection, they shall notify the cosmetics registrants or filers to implement the recall, and notify
the entrusted manufacturing enterprise and the cosmetics operators to stop their production
and operation.

Where cosmetics registration applicants and notification applicants implement the recall, the
entrusted manufacturing enterprises and the cosmetics operators shall cooperate with their
work.

Where cosmetics registrants or filers, entrusted manufacturing enterprises or operators fail to

implement the recall or stop production or operation in accordance with the provisions in this
article, the responsible medical products administration departments shall order them to
implement the recall or stop their production or operation.

Article 45 Entry-exit inspection and quarantine institutions shall conduct inspections on

imported cosmetics in accordance with the provisions of the “Law of the People's Republic of
China on Import and Export Commodity Inspection”; the products failing to pass the inspection
shall not be imported.

Importers shall examine whether the cosmetics to be imported have been registered or notified
and whether they comply with this Regulation, mandatory national standards and technical
standards; those failing to pass the examination shall not be imported. Importers shall faithfully
record the information of imported cosmetics and keep the records in accordance with the
provisions of the first paragraph of Article 31 herein.

Exported cosmetics shall meet the standards of the importing country (region) or the contract
requirements.

Chapter IV Supervision and Administration

Article 46 When performing supervision and inspection on cosmetics production and

operation, the medical products administration departments have the rights to take the
following measures:

(I) Entering the production and operation sites to conduct on-site inspection;

(II) Conducting sampling inspection of the cosmetics produced and operated;

(III) Checking and copying relevant contracts, invoices, account books and other relevant
documents;

(IV) Sealing up and detaining cosmetics, raw materials and packaging materials in direct
contact with cosmetics that do not comply with the mandatory national standards, technical
standards, or that are proved to possibly endanger human health, and tools & equipment that
are proved to be used in illegal production and operation;
(V) Sealing up sites that are engaged in illegal production and operation activities.

Article 47 When medical products administration departments perform supervision and

inspection on cosmetics production and operation, two or more supervision and inspection
personnel shall present and show their law enforcement certificates. The supervision and
inspection personnel shall keep the confidentiality of business secrets disclosed by the
inspected units involved in the supervision and inspection in accordance with law. The units
under inspection shall cooperate with the supervision and inspection work, and shall not
conceal relevant information.

Medical products administration departments shall keep records of the supervision and
inspection status and the handling results, which shall be signed by the supervision and
inspection personnel and the responsible person of the inspected unit; if the responsible
person of the inspected unit refuses to sign, an indication shall be marked.

Article 48 The medical products administration departments of the people’s government at or

above the provincial level shall organize sampling inspection of cosmetics. For cosmetics
reported or found to have more issues in daily supervision and inspection, the medical
products administration departments could carry out special sampling inspection.

When performing sampling inspection, the supervision and inspection personnel shall pay the
cost of selected samples, and the charged cost shall be included in the budget plan of people’s
government at the same level.

Medical products administration departments shall promptly disclose sampling inspection

results of cosmetics as prescribed.

Article 49 Cosmetic testing institutions shall be engaged in cosmetics testing activities only
after obtaining qualification accreditation in accordance with relevant national certification and
accreditation provisions. The qualification accreditation criteria for cosmetics testing
institutions shall be formulated by the NMPA and the State Administration of Market Regulation
of the State Council.

The cosmetics testing standards and the administrative provisions of standard samples used
in cosmetics testing shall be formulated by the NMPA of the State Council.

Article 50 For cosmetics that may be adulterated or produced with prohibited raw materials
and that cannot be tested in accordance with the testing items and test methods as prescribed
in the cosmetic national standards, the NMPA of the State Council can formulate
supplementary testing items and test methods for sampling inspection of cosmetics,
investigation and handling of cosmetics quality & safety cases and adverse reaction cases.
Article 51 In case of any objections to the conclusion of the testing carried out as prescribed
herein, cosmetics producers and operators could file a re-testing application to the department
performing the sampling inspection or its one-layer-up medical products administration
department within 7 working days upon receiving the testing conclusion, and the re-testing
institution shall be randomly determined by the department accepting the re-testing application
from the list of re-testing institutions. The re-testing conclusion issued by the re-testing
institution shall be deemed as the final testing conclusion. The re-testing institution shall not
be the initial testing institution. The list of re-testing institutions shall be published by the NMPA
of the State Council.

Article 52 The NMPA shall establish a monitoring system for adverse reactions of cosmetics.
Cosmetics registrants and filers shall monitor the adverse reactions of their cosmetics on the
market, promptly carry out evaluations, and report to the cosmetics adverse reaction
monitoring agency in accordance with the provisions of the NMPA of the State Council. If
entrusted production enterprises, cosmetics operators and medical institutions find any
adverse reactions that may be related to the use of cosmetics, they shall report to the
cosmetics adverse reaction monitoring agency. Other units and individuals are encouraged to
report adverse reactions that may be related to the use of cosmetics to the cosmetics adverse
reaction monitoring agency or the medical products administration department.

Cosmetics adverse reaction monitoring agencies are responsible for the collection, analysis
and evaluation of cosmetics adverse reaction information, and providing handling proposal to
the medical products administration department.

Cosmetics producers and operators shall cooperate with cosmetics adverse reaction
monitoring agencies and medical products administration departments in cosmetics adverse
reaction investigations.

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

Article 53 The NMPA shall establish a cosmetics safety risk monitoring and evaluation system
to monitor and evaluate the risk factors that affect the quality and safety of cosmetics, and
provide a scientific basis for formulating cosmetics quality and safety risk control measures &
standards and conducting cosmetics sampling inspections.

The NMPA of the State Council shall formulate, issue and implement a national cosmetics
safety risk monitoring plan, in which the varieties, projects and regions to be focused in
monitoring shall be specified.
The NMPA of the State Council shall establish a communication mechanism for cosmetics
quality and safety risk information, and organize cosmetics producers and operators, testing
institutions, industry associations, consumer associations, and news media to communicate
cosmetics quality and safety risk information.

Article 54 For cosmetics that cause damages to human or are proved to possibly endanger
human health, the medical products administration departments could take emergency control
measures to suspend of production and operation, and issue safety warning information. For
imported cosmetics, the national entry-exit inspection and quarantine department could
suspend the imports.

Article 55 Where there is a change occurring in the understanding of the safety of cosmetics
and cosmetics raw materials with the development of scientific research, or there is evidence
showing that the cosmetics and cosmetics raw materials may be defective, the medical
products administration departments of people’s government at or above the provincial level
could order the registrants and filers of cosmetics and new cosmetics ingredients to carry out
safety re-assessment or directly organize the safety re-assessment. If the re-evaluation results
show that the safety of cosmetics and cosmetics raw materials cannot be guaranteed, the
registration shall be revoked by the original registration department and the notification shall
be canceled by the notification department. In addition, such cosmetic raw materials shall be
included in the list of ingredients prohibited in production of cosmetics by the NMPA of the
State Council and an announcement shall be made to the public.

Article 56 Medical products administration departments shall promptly disclose the

supervision and administration information such as cosmetics administrative licenses,
notification, daily supervision and inspection results, and investigation and handling of
violations in accordance with law. In the announcement of supervision and administration
information, the enterprises’ business secrets shall be kept.

Medical products administration departments shall establish credit files for cosmetics
producers and operators. For those with poor credit records, the frequency of supervision and
inspection shall be increased; for those with extremely poor credit records, joint punishment
shall be imposed as prescribed.

Article 57 Where there are hidden safety hazards in the manufacturing and marketing of
cosmetics, and no timely measure have been taken to get eliminated, the department in charge
of drug supervision may conduct a responsibility interview with the legal representative or the
main responsible person of cosmetics manufacturer and marketer. Cosmetics manufacturer
and marketer shall immediately take measures to rectify, and eliminate the hidden dangers.
The responsibility interview and rectification results shall be included in the credit files of
cosmetics manufacturer and marketer.

Article 58 the department in charge of drug supervision shall publish its website address, e-
mail address or telephone number to accept inquiries, complaints and reports, and promptly
reply or deal with them. For reports that are verified, the whistleblowers shall be rewarded in
accordance with relevant national provisions.

Chapter V Legal Liability

Article 59 If any of the following circumstances occurs, the medical products administration
departments shall confiscate the illegal income, illegally produced and operated cosmetics,
and the ingredients, packaging materials, tools, equipment and other items specifically used
for illegal production and operation; if the illegally produced and operated cosmetics have a
value of less than 10,000 yuan, a fine of more than 50,000 yuan and less than 150,000 yuan
shall be imposed; if the illegally produced and operated cosmetics have a value of more than
10,000 yuan, a fine of more than 15 times and less than 30 times the value shall be imposed;
in serious circumstances, it shall be ordered to suspend the production and operation, and the
filing shall be canceled by the filing department or the cosmetics license shall be revoked by
the original license-issuing department, and the cosmetics filings or applications for cosmetics
administrative licenses submitted by them shall not be accepted within 10 years. In addition,
the legal representative or the main responsible person, person who is directly in charge and
other directly responsible persons of the illegal unit shall be fined more than 3 times and less
than 5 times the income they obtained from the unit in the previous year, and shall be
prohibited from engaging in cosmetics production and operation activities for life; where a
crime is constituted, the criminal responsibility shall be investigated in accordance with law:

(I) Engaging in cosmetics production activities without licenses, or cosmetics registrants and
filers entrust an enterprise that has not obtained the corresponding cosmetics production
license for cosmetics production;

(II) Production and operation or import of unregistered special cosmetics;

(III) Production of cosmetics using ingredients prohibited in production of cosmetics and new
ingredients that shall be registered but not registered, illegal addition of substances that may
harm human health to cosmetics, or production of cosmetics using expired, discarded and
recycled cosmetics or ingredients.

Article 60 If any of the following circumstances occurs, the medical products administration
departments shall confiscate the illegal income, illegally produced and operated cosmetics,
and the ingredients, packaging materials, tools, equipment and other items specifically used
for illegal production and operation; if the illegally produced and operated cosmetics have a
value of less than 10,000 yuan, a fine of more than 10,000 yuan and less than 50,000 yuan
shall be imposed; if the illegally produced and operated cosmetics have a value of more than
10,000 yuan, a fine of more than 5 times and less than 20 times the value shall be imposed;
in serious circumstances, it shall be ordered to suspend the production and operation, and the
filing shall be canceled by the filing department or the cosmetics license shall be revoked by
the original license-issuing department, and the legal representative or the main responsible
person, person who is directly in charge and other directly responsible persons of the illegal
unit shall be fined more than 1 time and less than 3 times the income they obtained from the
unit in the previous year, and shall be prohibited from engaging in cosmetics production and
operation activities in 10 years; where a crime is constituted, the criminal responsibility shall
be investigated in accordance with law:

(I) Use of ingredients and the packaging materials in direct contact with cosmetics that do not
comply with the mandatory national standards and technical standards, and new ingredients
that shall be filed but not filed in cosmetics production, or failure to use ingredients in
accordance with the mandatory national standards or technical standards;

(II) Production and operation of cosmetics that do not comply with the mandatory national
standards, technical standards, or the technical requirements specified in the cosmetics
registration and filing documents;

(III) Failure to organize production in accordance with the requirements of the cosmetics
production quality management standard;

(IV) Making an alteration to the shelf life of cosmetics;

(V) Cosmetics operators formulating cosmetics without authorization, or operating deteriorated

and expired cosmetics;

(VI) Refusing to recall products, or stop or suspend the production and operation after the
medical products administration departments have ordered.

Article 61 If any of the following circumstances occurs, the medical products administration
departments shall confiscate the illegal income, illegally produced and operated cosmetics,
and the ingredients, packaging materials, tools, equipment and other items specifically used
for illegal production and operation; if the illegally produced and operated cosmetics have a
value of less than 10,000 yuan, a fine of more than 10,000 yuan and less than 30,000 yuan
shall be imposed; if the illegally produced and operated cosmetics have a value of more than
10,000 yuan, a fine of more than 3 times and less than 10 times the value shall be imposed;
in serious circumstances, it shall be ordered to suspend the production and operation, and the
filing shall be canceled by the filing department or the cosmetics license shall be revoked by
the original license-issuing department, and the legal representative or the main responsible
person, person who is directly in charge and other directly responsible persons of the illegal
unit shall be fined more than 1 time and less than 2 times the income they obtained from the
unit in the previous year, and shall be prohibited from engaging in cosmetics production and
operation activities in 5 years:

(I) Marketing, operation or import of unfiled general cosmetics;

(II) Failure to assign a person in charge of quality and safety as prescribed herein;

(III) Cosmetics registrants and filers not supervising the production activities of the entrusted
production enterprise;

(IV) Failure to establish and implement a health management system for employees as
prescribed herein;

(V) Production and operation of cosmetics whose labels do not comply with the provisions
herein.

Where the labels of the cosmetics produced and operated have defects that do not affect the
quality and safety and will not cause any misleading to consumers, the medical products
administration departments shall order it to correct; those who refuse to make corrections shall
be fined not more than 2,000 yuan.

Article 62 If any of the following circumstances occurs, the medical products administration
departments shall order it to make corrections and give a warning and a fine of more than
10,000 yuan and less than 30,000 yuan; in serious circumstances, it shall be ordered to
suspend the production or operation, and a fine of more than 30,000 yuan and less than 50,000
yuan shall be imposed, and the legal representative or the main responsible person, person
who is directly in charge and other directly responsible persons of the illegal unit shall be fined
more than 10,000 yuan and less than 30,000 yuan:

(I) Failure to publish the summary of the basis for cosmetic efficacy claims as prescribed herein;

(II) Failure to establish and implement a purchase inspection and recording system and a
product sales recording system as prescribed herein;

(III) Failure to conduct self-inspection of the implementation of the cosmetics production quality
management standard as prescribed herein;
(IV) Failure to store and transport cosmetics as prescribed herein;

(V) Failure to monitor and report cosmetic adverse reactions as prescribed herein, or to
cooperate with investigations on cosmetic adverse reactions conducted by cosmetics adverse
reaction monitoring agencies and medical products administration departments.

Where an importer fails to record and keep imported cosmetics information as prescribed
herein, a punishment shall be imposed by the entry-exit inspection and quarantine institutions
in accordance with the preceding paragraph.

Article 63 Where new cosmetics ingredients registrants and filers fail to report the use and
safety of new cosmetics ingredients as prescribed herein, the NMPA of the State Council shall
order it to make corrections and impose on a fine of more than 50,000 yuan and less than
200,000 yuan; in serious circumstances, the registration certificate of new cosmetics
ingredients shall be revoked or the filing of new cosmetics ingredients shall be canceled, and
a fine of more than 200,000 yuan and less than 500,000 yuan shall be imposed.

Article 64 Whoever providing false documents or using other deceptive means when applying
for an administrative license for cosmetics shall not be granted an administrative license; if an
administrative license has already been obtained, the administrative license shall be revoked
by the administrative license decision-making department; the cosmetics-related license
application shall be not be accepted in 5 years and the illegal income and produced and
imported cosmetics shall be confiscated; if the produced and imported cosmetics have a value
of less than 10,000 yuan, a fine of more than 50,000 yuan and less than 150,000 yuan shall
be imposed; if the produced and imported cosmetics have a value of more than 10,000 yuan,
a fine of more than 15 times and less than 30 times the value shall be imposed; the legal
representative or the main responsible person, person who is directly in charge and other
directly responsible persons of the illegal unit shall be fined more than 3 times and less than 5
times the income they obtained from the unit in the previous year, and shall be prohibited from
engaging in cosmetics production and operation activities for life.

Whoever forges, alters, leases, lends, or transfers cosmetics licenses, the medical products
administration departments or original license-issuing departments shall confiscate or revoke
the licenses and confiscate the illegal income; if the illegal income is less than 10,000 yuan, a
fine of more than 50,000 yuan and less than 100,000 yuan shall be imposed; if the illegal
income is more than 10,000 yuan, a fine of more than 10 times and less than 20 times the
illegal income shall be imposed; if a violation of security administration is constituted, the public
security organ shall impose on a security administration punishment in accordance with law;
where a crime is constituted, the criminal responsibility shall be investigated in accordance
with law.

Article 65 Whoever provides false documents at the time of filing, the filing shall be canceled
by the filing department and filing submitted by it shall not be accepted in 3 years, also, the
illegal income and the produced and imported cosmetics shall be confiscated; if the produced
and imported cosmetics have a value of less than 10,000 yuan, a fine of more than 10,000
yuan and less than 30,000 yuan shall be imposed; if the produced and imported cosmetics
have a value of more than 10,000 yuan, a fine of more than 3 times and less than 10 times the
value shall be imposed; in serious circumstances, it shall be ordered to suspend production
and operation until the original license-issuing department revokes the cosmetics production
license, and the legal representative or the main responsible person, person who is directly in
charge and other directly responsible persons of the illegal unit shall be fined more than 1 time
and less than 2 times the income they obtained from the unit in the previous year, and shall
be prohibited from engaging in cosmetics production and operation activities in 5 years.

Where the filed documents does not meet the requirements, the filing department shall order
it to make corrections within a time limit. Among them, if the filed documents related to the
safety of cosmetics and new cosmetics ingredients does not meet the requirements, the filing
department may order it to suspend sales and use simultaneously; those who do not make the
corrections within the time limit, the filing shall be canceled by the filing department.

After the filing department cancels the filing, if it still uses such new cosmetics ingredients in
cosmetics production, or it still markets and imports such general cosmetics, it shall be
punished in accordance with the provisions of Article 60 and Article 61 herein.

Article 66 Where the organizers of centralized cosmetics trading markets or the hosts of trade
fairs fail to perform the management obligations such as review, inspection, suppression and
reporting as prescribed herein, the medical products administration departments shall impose
a fine of more than 20,000 yuan and less than 100,000 yuan; in serious circumstances, it shall
be ordered to suspend business and fined more than 100,000 yuan and less than 500,000
yuan.

Article 67 Where the operators of e-commerce platforms fail to perform the management
obligations such as real-name registration, suppression, reporting and cessation of providing
e-commerce platform services as prescribed herein, the medical products administration
departments of the people’s government of the province, autonomous region, or municipality
directly under the Central Government shall give a punishment in accordance with the
provisions of the “E-commerce Law of the People’s Republic of China”.
Article 68 Where cosmetics operators have fulfilled their obligations as prescribed herein such
as purchase inspection and recording, and there is evidence showing that they do not know
that the purchased cosmetics do not comply with the mandatory national standards, technical
standards or the technical requirements specified in cosmetics registration and filing
documents, the cosmetics not meeting the mandatory national standards, technical standards
or the technical requirements specified in the cosmetics registration and filing documents shall
be confiscated, and they may be exempted from administrative punishments.

Article 69 Whoever having cosmetics advertisements violating the provisions herein shall be
punished as prescribed in the “Advertising Law of the People’s Republic of China”; whoever
using other means to make false or misleading publicity on cosmetics, it shall be punished in
accordance with the relevant laws; where a crime is constituted, the criminal responsibility
shall be investigated in accordance with law.

Article 70 Where an enterprise’s legal person in the territory of China that is designated by
the overseas cosmetics registrants and filers fails to assist in the monitoring of cosmetic
adverse reactions and implementing product recalls, the medical products administration
departments of the people’s government of the province, autonomous region, or municipality
directly under the Central Government shall order it to make corrections, give a warning, and
impose a fine of more than 20,000 yuan and less than 100,000 yuan; in serious circumstances,
a fine of more than 100,000 yuan and less than 500,000 yuan shall be imposed, and its legal
representative or the main responsible person, person who is directly in charge and other
directly responsible persons shall be prohibited from engaging in cosmetics production and
operation activities in 5 years.

Where the overseas cosmetics registrants and filers refuse to comply with the administrative
punishment decisions made in accordance with this Regulation, they shall be prohibited from
importing cosmetics in 10 years.

Article 71 For any cosmetic inspection institution issuing a false inspection report, the
certification and accreditation administration departments shall revoke its qualification
certificate, not accept its application for qualification accreditation in 10 years, confiscate the
inspection fees collected, and impose a fine of more than 50,000 yuan and less than 100,000
yuan; the legal representative or the main responsible person, person who is directly in charge
and other directly responsible persons of the illegal unit shall be fined more than 1 time and
less than 3 times the income they obtained from the unit in the previous year, and shall be
given or ordered a demotion, dismissal or discharge in accordance with law; those given a
discharge shall be prohibited from engaging in cosmetics inspection in 10 years; where a crime
is constituted, the criminal responsibility shall be investigated in accordance with law.

Article 72 Where the cosmetics technical review agencies, cosmetics adverse reaction
monitoring agencies and the cosmetics safety risk monitoring agencies fail to perform their
duties as prescribed herein, resulting in major errors in the technical review, adverse reaction
monitoring and safety risk monitoring, the medical products administration departments shall
order them to make corrections, give a warning, and report the criticisms; if they causes serious
consequences, their legal representative or the main responsible person, person who is
directly in charge and other directly responsible persons of the illegal unit shall be given or
ordered a demotion, dismissal or discharge in accordance with law.

Article 73 Where cosmetics producers and operators and inspection agencies recruit or
employ personnel who are not allowed to engage in cosmetics production and operation
activities or who are not allowed to engage in cosmetics inspection work to engage in
cosmetics production and operation or inspection, the medical products administration
departments shall order them to make corrections and give a warning; whoever refusing to
make the corrections shall be ordered to stop production and operation until their cosmetics
licenses and inspection agency qualification certificates are revoked.

Article 74 Whoever has any of the following circumstances and constitutes a violation of
security administration, it shall be given a security administration punishment by the public
security organ in accordance with law; where a crime is constituted, the criminal responsibility
shall be investigated in accordance with law:

(I) Obstructing the staff of medical products administration departments to perform their duties
in accordance with law;

(II) Forging, destroying, hiding evidence, or concealing, transferring, selling, or damaging items
that have been sealed up and detained in accordance with law.

Article 75 Where the staff of medical products administration departments violate the
provisions herein, abuse their powers, neglect their duties, play favouritism and commit
irregularities, they shall be given warnings, a demerit or serious demerit; if they causes serious
consequences, they shall be given a demotion, dismissal or discharge in accordance with law;
where a crime is constituted, the criminal responsibility shall be investigated in accordance
with law.

Article 76 Whoever violating this Regulation and causing personal, property or other damages
shall be liable for compensation in accordance with law.
 Chapter VI Supplementary Provisions

Article 77 Toothpaste shall be managed with reference to the provisions on normal cosmetics
herein. After toothpaste filing person conduct the efficacy evaluation in accordance with
national standards and industry standards, they can claim that the toothpaste has efficacy
such as anti-caries, plaque inhibition, anti-dentine hypersensitivity, and relieve gingiva
problems, etc. The specific administrative measures for toothpaste shall be drafted by the
NMPA of the State Council, and then submitted to the State Administration for Market
Regulation of the State Council for review and promulgation.

This Regulation does not apply to soaps, excluding those claimed to have special cosmetics
efficacy.

Article 78 For the cosmetic products used for hair growth, hair removal, breast beauty,
slimming and deodorization which have already been registered before the implementation of
this Regulation, a transition period of 5 years shall be granted from the implementation date of
this Regulation, during which the production, imports and sales can be continued. However,
after the transition period, the production, imports and sales of such cosmetics are prohibited.

Article 79 The technical standards indicated in this Regulation refer to the supplementary
technical requirements on cosmetic quality and safety which the mandatory national standards
are not available, and set by the NMPA of the State Council in combination with the supervision
and administration needs.

Article 80 This Regulation will come into force on January 1, 2021. The “Regulations
concerning the Hygiene Supervision over Cosmetics” will be repealed simultaneously.