Provisions for the Acceptan ce of Application for  
Administrative Licence for Cosmetics  
 
Article 1 
These Provisions are formulated for th e purposes of regulating acceptance of 
applications for the administrative licence for cosmetics and ensuring acceptance of applications for the administrative licence for cosmetics in an open, fair and just procedure.  
 
Article 2 
Administrative licence for cosmetics re fers to approval for the use of new 
cosmetic ingredients, manufacturing of domestic special-purpose cosmetics and initial import of cosmetics.  
 
Article 3 
These regulations shall apply to th e acceptance of applications for the 
administrative licence for cosmetics set out in The Regulations Concerning the 
Hygiene Supervision over Cosmetics  and their implementation rules.  
 
Article 4 
The State Food and Drug Ad ministration (SFDA) shall be responsible for 
administering acceptance of applications for the administrative licence for cosmetics.  
 
Article 5 
The applicant for the administrative licence of domestic cosmetics shall be the 
manufacturer of cosmetics. The applicant fo r the administrative licence of domestic 
cosmetics in respect of the use of new ingredients shall be the manufacturer of 
cosmetic ingredients or the manufacturer of cosmetics. 
The applicant for the administrative licence of imported cosmetics shall be the 
manufacturer of imported cosmetics. The applicant for the administrative licence of 
imported cosmetics in respect of the use of  new ingredients sha ll be the manufacturer 
of the new ingredients of imported cosmetics or the manufacturer of cosmetics. The applicant shall designate an entity lawfu lly incorporated in China and having an 
independent corporate status (Chinese Agent)  to act as its agent to handle application 
matters on behalf thereof. The applicant may replace its Chinese Agent.  
 
Article 6 
The applicant and the Chinese Agent sha ll apply for the administrative licence for 
cosmetics in accordance with relevant laws , regulations, standards and specifications 
of the State, and be responsible and legally  liable for application materials submitted.   
 
Article 7 The applicant shall file with SFDA its ap plication for the administrative licence 
for cosmetics and submit relevant material s in accordance with these Provisions.  
 
Article 8 
Prior to initial app lication, the original of the power of atto rney appointing the 
Chinese Agent shall be registered with the administrative acceptance body of SFDA 
(the Acceptance Authority).  
The applicant for the administrative licence for cosmetics shall complete the 
application form through the online a pplication system on the SFDA website. 
 
Article 9 
The approval document (registration certificat e) for the administrative licence for 
cosmetics shall remain valid for four years.  
The applicant for extension of the validity  of the approval document (registration 
certificate) for the administrati ve licence for cosmetics shall file its application four 
months prior to expiration thereof.  
Where such application for extension is not filed within the specified time limit 
due to re-issuance of the approval docum ent (registration certificate) for the 
administrative licence for cosmetics, the ap plicant shall file the application for 
extension fifteen days following re-issuan ce of the approval doc ument (registration 
certificate) for the administrative licence fo r cosmetics, provided that the application 
for re-issuance is filed four months prio r to expiration of the approval document 
(registration certificate) for the admi nistrative licence for cosmetics.  
 
Article 10 
The applicant for change approval within  the validity of th e approval document 
(registration certificate) for the administrative licence for cosmetics shall file the application pursuant to relevant requiremen ts and submit relevant materials. In the 
case of any formula change or any other cha nge that may involve safety of cosmetics, 
an application shall be filed in such a way as is required for a new product. Where the original name remains in use after such changes, an appropriate indication thereof shall be provided on the external packaging of product to distinguish from the pre-change product.  
 
Article 11 
Where the approval document (registration certificate) for the administrative 
licence for cosmetics is damaged or lost, an application for re-issuance thereof shall be filed on a timely basis without any concurre nt application for extension or change.  
 
Article 12 
After receipt of the approval documen t (registration certificate) for the 
administrative licence for cosmetics issued  by SFDA, an application for correction 
shall be filed in a single  package in the case of:  
(1) any printing error of the approval doc ument (registration certificate) for the administrative licence for cosmetics; 
(2) any numbering error of the approval doc ument (registration certificate) for the 
administrative licence for cosmetics; and/or 
(3) any other error in the approval docu ment (registration certificate) for the 
administrative licence for cosmetics.  
The scope of correction under this Article 12 shall exclude  any error on the part of 
the applicant.  
 
Article 13 
The applicant may file a re-application under the original name of the product if it:  
(1) fails to apply for extension of the approval document (regi stration certificate) 
for the administrative licence for cosmetics within the specified time limit; 
(2) files such re-application afte r termination of application;  
(3) has applied for deregistration of the original approval docu ment (registration 
certificate) for the administrative licence for cosmetics; or  
(4) files such re-application after the application for administrative licence is 
rejected.  
Re-application shall not be filed if the product is disa pproved due to the presence 
of any prohibited substance, any restricted s ubstance in excess of an applicable limit, 
unacceptable results of the hygienic safety te st and any other reasons in relation to 
product safety.  
 
Article 14 
For the purposes of application hereunde r, where the manuf acturer delegates 
manufacturing (including sub-packaging) of  cosmetics to a contract manufacturer 
beyond the territory of China, such cosmetics shall be deemed domestic if the last 
operation of exposed content is conducted wi thin the territory of  China, or deemed 
imported if the last operation of exposed content is conducted beyond the territory of 
China.  
In the case of any change in the cross- border contract manufacturing relationship 
that occurs after the approval document (regi stration certificate) for the administrative 
licence for cosmetics is issued, a re-application shall be filed in accordance with provisions regarding change  of manufacturing site.  
 
Article 15 
Two or more dosage forms that must be us ed together shall be  deemed as a single 
product for the purpose of application hereunder. Where parts of a product are manufactured by different manu facturers across borders, app lication materials shall be 
provided as are separately required for domestic product and imported product. Upon 
application, an indication sh all be provided to identify the product as domestic or 
imported. The names, manufacturers and pl aces of manufacture of the domestic 
dosage form and the imported dosage form respectively shall be indicated in the 
“Remarks” section of the approval document (registration certificate) for the administrative licence for cosmetics.   
Article 16 
The Acceptance Authority shall, when r eceiving application materials for the 
administrative licence for cosmetics, issue th e Receipt of Application Materials to the 
applicant, conduct a formality examination of  the application materials and decide to 
accept or request further information or correction within five working days.  
The Acceptance Authority shall make a decision of acceptance and issue the 
Notice of Acceptance if a pplication materials are complete and compliant. The 
Acceptance Authority shall issue the No tice of Request for Addition and/or 
Correction that notifies the applicant of all additions and/or corrections requested if 
the application materials are non-compliant . The Acceptance Authority failing to 
issue such notices shall be deemed to have  accepted application as from the date of 
receiving the application materials. Where the application materials remain non-compliant after incorporating additions  and/or corrections, the Acceptance 
Authority may request further a dditions and/or corrections.  
 
Article 17 
The Acceptance Authority shall make a deci sion of rejection and issue the Notice 
of Rejection to the applicant if:  
(1) the subject matter of the application is  not subject to administrative license;  
(2) the subject matter of the application is beyond the scope of the administrative 
license function of SFDA;   
(3) the application for extension is filed beyond the specified limit, unless in the 
circumstances set out in Article 9 of these Provisions; or 
(4) the application is otherwise beyond the scope of acceptance.  
 
Article 18 
The Notice of Acceptance, the Notice of Request for Addition and/or Correction 
and the Notice of Rejection issued by the A cceptance Authority shall indicate the date 
of issue and bear the administrative licence s eal of SFDA. Such notices shall be made 
in duplicate, one being given to the app licant and the other being kept on file.  
 
Article 19 
After the application materials are accepted, any addition or modification to the 
application materials made by the applicant pursuant to the revi ew opinion shall be 
directly submitted to the review body of SF DA. In the case of application through an 
agent, the copy of the power  of attorney of the registered Chinese Agent for 
administrative license purposes shall be at tached. All additional information shall be 
provided in a single package pursuant to the review opinion, and indicate the date of 
addition and the entity, and bear its comm on seal. Additional information shall not 
include any alteration of any part of the a pplication materials that is not covered by 
review opinion.  
 
Article 20 The applicant may, after submitting application materials for administrative 
license to SFDA and before SFDA makes the decision of acceptance,  apply in writing 
for termination of the application and return  of all application materials. Where the 
application is accepted, the applicant may, before the technical  review opinion is 
given, request withdrawal of the application for administrative license and return of 
all application materials. The applicant may file a written request for return of the following materials within six months of r eceiving the “Rejection of Application for 
Administrative License” or the “Rejection of Application for Extension/Change”: 
(1) documentary evidence for the permission of product manufacturing and sale in 
the country (or region) of origin, a nd the GMP certificate of the cosmetics 
manufacturer and their notarial deed, unless more than one product is included in a single application under the original  of a single document or certificate;  
(2) the valid original ap proval document (registration certificate) for the 
administrative licence for cosmetics; and  
(3) application materials for extension.  
 
Article 21 
SFDA shall, within sixty days of acceptance,  review the applicant-furnished safety 
assessment data relating to substances c ontained in the subject product that may pose 
any safety risk.  
 
Article 22 
Where the applicant or the Chinese Agent provides any false a pplication data or 
samples, SFDA will reject its application or  refuse to license, give a disciplinary 
warning against the applicant or the Chinese Agent and refuses to accept such application for administrative license within  one year pursuant to Article 78 of the 
Administrative License Law of th e People's Republic of China .  
 
Article 23 
These Provisions shall be subject to interpretation by SFDA.   
Article 24 
These Provisions shall enter into force on 1st April 2010. In the case of any 
discrepancy between these Provisions and the previously issued provisions for 
acceptance for applications for the hygienic  administrative licence for cosmetics, 
these Provisions shall prevail.     Appendix:  
Requirements on Application Materials  
for Administrative Licence for Cosmetics 
Article 1 Any applicant for the administrative licence for cosmetics shall provide relevant 
materials in accordance with the Provisions for Acceptance of Applications for 
Administrative License for Cosmetics . Application materials shall meet the following 
general requirements: 
(1) with regard to initial applica tion for the administrative licence of 
special-purpose cosmetics, application materials shall be submitted in one original and four copies, which copies sh all be legible and consistent with the 
original;  
(2) with regard to applica tion for registration, extensi on, alteration or re-issuance 
approval, application materials shal l be submitted in one original;  
(3) except for test reports, documents of not arization and official certificates and 
third-party certificates, the original of application material shall be under the 
common seal or paging seal of the ap plicant on a page-by-page basis;  
(4) application materials shall be printed on A4 paper with distinct identification 
marks, arranged in the required order of sequence and bound up;  
(5) China’s legal units of measurement shall be used;  (6) the content of applicatio n shall be complete and clear, and the same items shall 
be maintained consistently;  
(7) all texts in a foreign name (excludi ng foreign address, website, registered 
trademark, patent name, SPF, PFA or PA, UVA and UVB where the foreign 
name must be used) shall be  correctly translated into Chinese that shall be put 
before the original foreign name version; 
(8) the product formula shall be submitted in both paper and electronic forms; and (9) the contents of paper and electr onic documents shall be consistent.  
 
Article 2 
Any applicant for the administrative licence of domestic special-purpose 
cosmetics shall submit:  
(1) the application form for the administra tive licence of domestic special-purpose 
cosmetics;  
(2) the basis of nomenclature of the product;  (3) requirements on product quality and safety control; (4) the product packaging design (i ncluding product label and product 
specification); 
(5) test reports and relevant data i ssued by SFDA-approved testing agencies;  
(6) safety assessment data relating to su bstances contained in the product that may 
pose any safety risk; 
(7) the review opinion on hygienic conditi ons of manufacturing issued by the 
provincial food and drug administration authority;  
(8) active ingredients and unde rlying scientific literature in the case of application 
regarding hair growth, fitne ss or breast enhancement; and 
(9) other data that may help in a pplication for administrative license.  
In addition, one piece of sample sealed, and remaining sealed, by the provincial 
food and drug administration authority shall be provided.   
Article 3 
Any applicant for the administrative licence of imported special-purpose 
cosmetics shall submit:  
(1) the application form for the administ rative licence of imported special-purpose 
cosmetics;  
(2) the basis of nomenclature for the Chinese name of the product;  (3) the product formula;  (4) a brief description and illustrati on of the manufacturing process;  
(5) requirements on product quality and safety control; (6) the original packaging of the produc t (including the product label and product 
specification); where a package is exclus ively designed for the Chinese market, 
such packaging of product (incl uding the product label and product 
specification) shall be provided; 
(7) test reports and relevant data i ssued by SFDA-approved testing agencies;  
(8) safety assessment data relating to su bstances contained in the product that may 
pose any safety risk; 
(9) active ingredients and unde rlying scientific literature in the case of application 
regarding hair growth, fitne ss or breast enhancement; and 
(10) a copy of the registered  power of attorney and a copy of the business licence 
of the Chinese Agent, both under common seal; 
(11) the letter of undertaking evidencing  compliance of the cosmetic ingredients 
and their sources with requirements on re striction or prohibition of high-risk 
substances in BSE-affected regions; 
(12) documentary evidence of product manu facturing and sale in the country (or 
region) of origin; and 
(13) other data that may help in a pplication for administrative license.  
One sample of commercially available produ ct that is and remains sealed by the 
testing agency shall also be provided.  
 
Article 4 
Any applicant for registration of imported general-purpose cosmetics shall submit:  
(1) the application form for the administrative licence of imported 
general-purpose cosmetics;  
(2) the basis of nomenclature for the Chinese name of the product;  (3) the product formula;  (4) requirements on product quality and safety control; (5) the original packaging of the produc t (including the product label and product 
specification); where a package is exclus ively designed for the Chinese market, 
such packaging of product (incl uding the product label and product 
specification) shall be provided; 
(6) test reports and relevant data i ssued by SFDA-approved testing agencies;  
(7) safety assessment data relating to su bstances contained in the product that may 
pose any safety risk; (8) a copy of the registered  power of attorney and a copy of the business licence 
of the Chinese Agent, both under common seal; 
(9) the letter of undertaking evidencing compliance of the cosmetic ingredients 
and their sources with requirements on re striction or prohibition of high-risk 
substances in BSE-affected regions; 
(10) documentary evidence of product manu facturing and sale in the country (or 
region) of origin; and 
(11) other data that may help in registration.  
One sample of commercially available produ ct that is and remains sealed by the 
testing agency shall also be provided.  
 
Article 5 
Any applicant for the administrative licence of new cosmetic ingredients shall 
submit:  
(1) the application form for the administrative licence of new cosmetic 
ingredients; 
(2) the development report:  
(i) background and process of ingredient research and development, and 
relevant technical data;  
(ii) source, physical and chemical prop erties, chemical structure, molecular 
formula and molecular weight of ingredients; and 
(iii)purpose, basis, scope and limit of ingredients in cosmetics.  
(3) a brief description and illustrati on of the manufacturing process;  
(4) requirements on ingredient quality and safety control, including specifications, 
testing methods, and substances that may pose any safety risk and their 
control;  
(5) toxicological safety evaluation data, including safety assessment data relating 
to substances contained in the ingred ients that may pose any safety risk; 
(6) in the case of application through a Chinese Agent, a copy of the registered 
power of attorney and a copy of the bus iness licence of th e Chinese Agent, 
both under common seal; and 
(7) other data that may help in a pplication for administrative license.  
One piece of sample submitted for review shall also be provided.   
Article 6 
The following materials shall be provided in  either of the following circumstances, 
in addition to the materials set out above: 
(1) if the product is manufact ured on a contract basis: 
(i) the contract manufacturing agreement made with the contract manufacturer; 
(ii) in the case of imported product, th e quality management system certificate 
or GMP certificate of the contract  manufacturer or the qualification 
certificate for cosmetics manufacturi ng that complies with legal and 
regulatory requirements of the country (o r region) where the manufacturer is 
located;  (iii) in the case of domestic produc t manufactured on a contract basis by 
domestic enterprise for an overseas manufacturer, the power of attorney 
appointing the Chinese Agent; 
(iv) in the case of imported product manuf actured on a contract  basis by overseas 
enterprise for a domestic manufacturer , the product packaging design; the 
power of attorney appoi nting the Chinese Agen t, certificates of 
manufacturing and sale and original packaging of the product may not be 
submitted;  
(2) in the case that the actual manufactur er and the manufacturer (applicant) of the 
cosmetics are under the same control of a parent company, the certificate that 
demonstrates their same control by the parent company and the product 
quality assurance cer tificate issued by the parent company.   
 
Article 7 
Multiple actual manufacturers of a singl e product may file a single application, 
and one of such actual manufacturers sha ll submit all the foregoing materials for its 
product. In addition, the following mate rials shall also be submitted:   
(1) in the case of contract manufactur ing, the contract manufacturing agreement; 
in the case of imported product, the qua lity management system certificate or 
GMP certificate of the contract manufactur er or the qualification certificate for 
cosmetics manufacturing that complies with the legal and regulatory requirements of the country (or region) where the manufacturer is located; 
(2) in the case of a manufacturer under co mmon control by a parent company, the 
certificate of such common control and the product quality assurance 
document issued by the parent company; 
(3) original packaging of the product ma nufactured by other act ual manufacturers; 
the packaging design may be submitted in the case of domestic product;  
(4) the hygienic (microbiological and h ygienic chemical) test report for product 
manufactured by other actual manufacturers;  
(5) in the case of domestic product, th e review opinion on ma nufacturing hygiene 
conditions issued by the provincial f ood and drug administration authorities 
where the other actual manufacturers are located;  
(6) in the case of imported product,  the letter of undertaking evidencing 
compliance of the cosmetic ingredie nts of other manufacturers and their 
sources with the requirements on rest riction or prohibition of high-risk 
substances in BSE-affected regions.  
 
Article 8 
The applicant desiring a second applic ation after the application for the 
administrative licence is terminated or rej ected shall file a re application accompanied 
by relevant materials. Where the reapplica tion follows termination of application, 
reasons for such termination and reapplic ation shall also be provided; where the 
reapplication follows a rejection of applica tion, a copy of the decision of the rejection 
of application for the administrative licence (or change/extension thereof) shall also be submitted.   
Where such rejection does not involve pr oduct safety, a copy of  the initial test 
report or, in the case of domestic special -purpose cosmetics, a copy of the initial 
review opinion on manufacturi ng hygiene conditions may be  used for reapplication, 
unless the initial application materials ha ve been returned to the applicant.  
 
Article 9 
The applicant for extension of the validity of the administrative licence (or 
registration) shall submit:  
(1) the application form for the extens ion of the administrative licence for 
cosmetics; 
(2) the original of the approval document (registration certificate) for the 
administrative licence for cosmetics 
(3) the basis of nomenclature for the Ch inese name of the product (unless it has 
been provided during the in itial application and the name remains unchanged);  
(4) the product formula;  (5) requirements on product quality and safety control; (6) the packaging of the commercially  available product (including the product 
label and product specification); in  the case of domestic product not 
commercially available, the designed  product packaging (including the 
product label and produc t specification) may be provided;  
(7) in the case of domestic product, the opinion on manufacturing, commercial 
availability and supervision of product, or the review opinion on the commercial unavailability of product issu ed by the provinci al food and drug 
administration authority where the applicant is located;  
(8) in the case of application through a Chinese Agent, a copy of the registered 
power of attorney and a copy of the bus iness licence of th e Chinese Agent, 
both under common seal; and 
(9) other data that may help in a pplication for administrative license.  
A sealed sample of commercially availa ble product shall also be provided.   
 
Article 10 
The applicant for change in the administrative licence shall submit:  
(1) the application form for change in the administrative licence for cosmetics; 
(2) the original of the approval document (registration certificate) for the 
administrative licence for cosmetics 
(3) in the case of application through a Chinese Agent, a copy of the registered 
power of attorney and a copy of the bus iness licence of th e Chinese Agent, 
both under common seal; and 
(4) the following materials, as the case may be: 
(i) for change of product name: 
(a) for change of the Chinese name of  the product, reasons for such change 
shall be stated in the change a pplication form, and the basis of 
nomenclature for the proposed new name and the proposed new packaging design (including the produc t label and product spec ification) shall be 
provided; the foreign name of the im ported product shall not be changed; 
or 
(b) for change in SPF, PFA or PA of sun protection product, the relevant SPF, 
PFA or PA test report shall be prov ided together with the proposed new 
packaging design (including the pro duct label and product specification). 
(ii) for change in the name or addr ess of the manufacturer (including such 
change at its own discretion as a result of acquisition or merger): 
(a) for change in the name or address of  the manufacturer of domestic product, 
the original or a notarized copy of th e certificate evidencing such change 
issued by the local administration fo r industry and commerce, and a copy 
of the hygiene licence of the manufacturer;  
(b) for change in the name or address of  the manufacturer of imported product, 
the relevant certificate evidencing such change issued by a competent authority or agency in the country of origin; if such  change is lawfully due 
to a business acquisition or merger, a copy of the acquisition or merger 
agreement signed by both parties may be provided, with the certificate correctly translated into Chinese text notarized by a notary office in China;  
(c) for adjustment within a domestic parent company, a relevant certificate 
issued by the local administration for industry and commerce shall be 
provided; if any investment by Taiw an, Hong Kong or Macao or foreign 
investors is involved, a notarized copy of the Certificate of Approval for 
Establishment of Enterprises with Foreign Investment in the People’s Republic of China  or the Certificate of Approval for Establishment of 
Enterprises with Investment by Taiwan, Hong Kong and Overseas Chinese 
in the People’s Republic of China ; or 
(d) for change in manufacturing site , the hygienic (microbiological and 
hygienic chemical) test report for product manufactured by the proposed 
new manufacturer shall be provided; in  the case of domestic product, the  
review opinion on manufacturing hygi ene conditions issued by the 
provincial food and drug administrati on authorities where the proposed 
new manufacturer is loca ted shall be provided.  
(iii) for change in the Chinese name of the manufacturer of imported product 
(with the foreign name remaining unchanged):  
(a) the reasons for change in the Ch inese name of the manufacturer; and 
(b) the proposed new packaging design of the product (including the product 
label and product specification). 
(iv) for replacement of the Chinese Agent:  
(a) the original of the power of attorn ey appointing the proposed substitute 
Chinese Agent shall be submitted first for registration;  
(b) a copy of the power of attorney a ppointing the proposed substitute Chinese 
Agent shall be submitted first for registration;  
(c) in the case of change in the name  or address of the Chinese Agent, the 
original or a notarized copy of the certificate ev idencing such change issued by the local administration for industry and commerce shall be 
provided;  
(d) a notarized statement terminatin g the Chinese Agent issued by the 
manufacturer shall be provided.  
(v) for replacement of th e actual manufacturer:  
(a) in the case of contract manuf acturing, the contr act manufacturing 
agreement; in the case of importe d product, the quality management 
system certificate or GMP certificate of  the contract manufacturer, or the 
qualification certificate for cosmetics manufacturing that complies with legal and regulatory requirements of the country (or region) where the manufacturer is located; 
(b) in the case of a manufacturer unde r common control by a parent company, 
the certificate of such common cont rol and the product quality assurance 
document issued by the parent company; 
(c) the original packaging of the product manufactured by the proposed 
substitute manufacturer;  
(d) the hygienic (microbiological and hygi enic chemical) test report for the 
product manufactured by the proposed  substitute manufacturer;  
(e) in the case of domestic product,  the review opinion on manufacturing 
hygiene conditions issued by the prov incial food and drug administration 
authorities where the proposed substitute manufacturer is located;  
(f) in the case of imported product, th e letter of undertaking evidencing the 
compliance of the cosmetic ingredients of the substitute manufacturer and their sources with the requirement s on restriction or  prohibition of 
high-risk substances in BSE-affected regions.  
(vi) for change in the type of special -purpose cosmetics, appropriate materials 
shall be provided in accordance with re quirements applicable to the relevant 
type; or 
(vii) for any other change, the reasons sh all be stated in detail and relevant 
documentary evidence shall be provided.  
 
Article 11 
The applicant for re-issuance of the a pproval document (registration certificate) 
for the administrative licence shall submit:  
(1) the application form for re-issuance of the approval document (registration 
certificate) for the administrative licence for cosmetics; 
(2) the original of the approval document (registration certificate) for the 
administrative licence for cosmetics if it is damaged;  
(3) the original of the declaration of loss  published in newspapers of provincial or 
larger circulation if the approval doc ument (registration certificate) for 
administrative license is lost; the applic ation for re-issuance due to loss shall 
be filed at least twenty days after pu blication of the declaration of loss;  
(4) in the case of application through a Chinese Agent, a copy of the registered 
power of attorney issued to the Chin ese Agent and a copy of the business licence of the Chinese Agent under common seal.  
 
Article 12 
The applicant for correction of errors in the approval document (registration 
certificate) for the administrative licence shall :  
(1) submit the application form for the correction of errors in the approval 
document (registration certificate) for th e administrative licence for cosmetics;  
(2) submit a copy of the approval document (registration certificate) for the 
administrative licence for cosmetics signed by the applicant; and  
(3) surrender the original of the approval document (registration certificate) for 
the administrative licence for cosme tics upon receiving the new approval 
document (registration certificate).  
 
Article 13 
The following materials shall be provided when additional materials are submitted 
to the review body of SFDA:  
(1) the notice of review opinion; and (2) additional materials in the same seque nce as the questions are listed in the 
review opinion.  
 
Article 14 
The product formula data shall meet the following requirements:  
(1) the formula shall be provided in the fo rm of a single table that contains the 
serial numbers, INCI names (except fo r domestic product), standard Chinese 
names, percentage contents and purposes of ingredients, in Song Ti font sized 
sub-five;   
(2) names of ingredients shall be provi ded, contents shall be presented in 
percentage, and the content of the active ingredient shall be indicated (absence 
of such indication will be deemed to be a 100% content of active ingredient); 
composite ingredients shall be stated in composite form, with the content of each component thereof indicated in percentage; any special circumstances shall be stated, such as the presence of crystal water and different molecular or 
structural formula of ingr edients; all ingredients shall be listed in descending 
order by content;  
(3) the Chinese name of each ingredient  (including each component of composite 
ingredients) shall be the standa rd Chinese name defined in the Catalogue of 
Standard Chinese Names of International Cosmetic Ingredients ; if the INCI 
name is unavailable or the standard Chinese name is not defined in the 
Catalogue of Standard Chinese Names of International Cosmetic Ingredients , 
the name provided in the Chinese Pharmacopoeia or the chemical or Latin name of the plant shall a pply; the trade name or co lloquial name shall not be 
used, except for composite ingredients;  
(4) for any colorant, the colorant index (C I) defined in the Hygienic Standard for 
Cosmetics shall be provided, unless such CI is not defined;  (5) where any animal organ or tissue or blood extract is contained, the source of 
the ingredient, quality specifications and the certificate ev idencing permit of 
its use in the country of or igin shall be provided;  
(6) where the product formula contains any hydrocarbon derived from petroleum 
or coal tar (except for any single component), the Chemical Abstract Service index numbers (CAS numbers) of the releva nt ingredients shall be stated in the 
product formula;  
(7) where the Hygienic Standard for Cosmetics imposes any specification 
requirements on any ingredient falli ng under the category of restricted 
substance, the quality specification certifi cate of such ingredient issued by the 
ingredient manufacturer shall be provided;  
(8) for any sub-packaged or assembled product that comprises multiple dosage 
forms (such as hair dye and perm products ) or any product that is included in 
an integral packaging and comprises differently formulated contents, each 
formula shall be provided;  
(9) with regard to the ve rification certificate for the formula of imported product 
issued by the testing agency, the date of  verification shall be consistent with 
the date of acceptance of the tested sample;   
(10) with regard to any product clai ming to be designed for pregnant women, 
lactating women or infants, the formula design principle based on safety considerations (including th e overall analysis report on formula), principles of 
and requirements on ingredient selecti on, and the manufacturing process and 
quality control process shall be provided.  
 
Article 15 
The safety assessment data relating to substances contained in the product that 
may pose any safety risk shall be provided in line with the ingr edients and product 
characteristics of the cosmetics and include the following:  
(1) the name of the substance contained in the product that may pose any safety 
risk (including any substa nce introduced by ingredie nts or generated in the 
manufacturing process), relevant testing methods and test data;  
(2) the safety risk assessment report on the substance contained in the product that 
may pose any safety risk; 
(3) technical data on any te chnology that is currently av ailable and able to reduce 
the content of the substance contained in the product that may pose any safety 
risk and, where necessary, process improvement measures;  
(4) where any ingredient is of a plant or igin, any possible contaminants such as 
residual pesticide or any impurities intr oduced in the extraction process shall 
be disclosed.  
 
Article 16 
Requirements on product quality and safety control shall include the following:  
(1) sensory indicators, such as  colour, odour or appearance; 
(2) microbial indicators (unless not requi red for testing), hygienic chemical indicators;  
(3) the pH value (excluding  water-in-oil - oily prod uct, powdered, puff-cake and 
wax-based products) and its testing method of any hair perm, hair removal or 
freckle product, or any product claiming to contain α-hydroxy acid or any 
product that does claim to contain α-hydroxy acid but w hose content of 
α-hydroxy is ≥3% (w/w); 
(4) in the case of imported product, the requirements on product quality and safety 
control applied in the country of origin (both foreign text and Chinese translation) shall be provided; where the requirements on product quality and 
safety control applied in the country of  origin do not include requirements set 
out in Item (1), (2) or  (3) of this Article 16,  the requirements on product 
quality and safety control containing re levant indicators shall be also be 
provided; and 
(5) the applicant shall provide a letter of undertaking evidencing compliance with 
the Hygienic Standard for Cosmetics .  
 
Article 17 
The review opinion on hygienic condi tions of manufacturing of domestic 
special-purpose cosmetics shall include:  
(1) the application form for the review of  hygienic conditions of manufacturing of 
cosmetics;  
(2) the review form for hygienic conditi ons of manufacturing of cosmetics; 
(3) the product formula;  (4) a description and illustration of the manufacturing process;  
(5) a list of manufacturing equipment; and  (6) a copy of the hygiene licen ce of the manufacturer.  
 
Article 18 
Test reports and relevant data issued  by SFDA-approved testing agencies shall 
meet the following requirements:  
(1) The test reports for cosmetic license shall include hygienic safety test reports 
(microbial, hygienic chemical and toxico logical) and human safety test reports; 
the tested samples shall be manufactured in the same batch or on the same date 
and in the same name of product;  
(2) The following materials shall be provid ed if sun protection indices (SPF, PFA 
or PA) or the new ingredient test repor t issued by an overseas laboratory is 
used:  
(i) where the laboratory issuing such repor ts has been certified, the certification 
document shall be provided;  
(ii) where the laboratory issuing such  reports has not been certified, the 
certificate evidencing its compliance w ith the Good Clinical Practice (GCP) 
or the Good Laboratory Practice (GLP) shall be provided; and 
(iii) other data that may help demonstr ate the qualification of the laboratory.  
With regard to each and every initial submission of overseas test reports, the original of the foregoing documents or a copy (including tran slation) thereof 
accredited by the guild, Chinese embassy (or co nsulate) or notary office in the country 
(or region) of the issuing laboratory shall be provided; if such copy is approved by 
SFDA, only such copy is re quired for reapplication.  
Where the original of the test report i ssued by an overseas laboratory is required 
and the product series meets random inspectio n requirements, the original shall be 
provided for at least one product and copi es may be provided for other products 
together with a reference to the name of the product for which the original is provided.  
Where the test report issued by an overseas  laboratory is used, the documentary 
evidence that matches the tested sample and the test report and is issued by the 
relevant laboratory shall also be provided.  
(3) The test report issued by an a pproved testing agency shall include:  
(i) the application form for testing; (ii) the letter of acceptance for testing; (iii) the product specifications; (iv) the hygienic safety test report  (microbial, hygienic chemical and 
toxicological); and 
(v) the following documents, if applicable: 
(a) human safety test report (pat ch test or human usage test); 
(b) test report on sun protecti on indices (SPF, PFA or PA); 
(c) other additional test reports (tes t report on asbestos contained in 
cosmetics).  
 
Article 19 
The letter of undertaking evidencing the compliance of the cosmetic ingredients 
and their sources with the requirements on restriction or prohibition of high-risk 
substances in BSE-affected regions shall be  issued pursuant to relevant provisions.  
 
Article 20 
The original packaging of the imported product shall be provided for both the 
foreign and Chinese versions together with a Chinese label of the product (including 
specifications of the product) that meets the relevant laws and regulations of China.  
 
Article 21 
Documentary evidence of manufacturing and sale in the country (or region) of 
origin shall meet the following requirements:  
(1) It shall be issued by the competen t government authority or guild in the 
country (or region) of origin of product; a copy accredit ed by the issuing 
organization or Chinese embassy (or consulate) may be provided if the 
original is not available; 
(2) It shall indicate the name of the pr oduct, the name of the manufacturer, the 
name of the issuing organization (includi ng its common seal or signature of its 
legal representative or his pr oxy) and the date of issue;  (3) The name of the product and the name of the manufacturer indicated shall be 
identical to those provided in the application materials; in the case of manufacturing on a contract basis or otherwise and inconsistency of the 
manufacturer indicated between the doc umentary evidence and application 
materials, the applicant shall issu e a supporting document to provide 
reasonable explanations; in the case  of any product comprising multiple 
dosage forms that must be used together, the documentary evidence of manufacturing and sale may be provide d only for the imported part of the 
product; and 
(4) Any documentary evidence of manufact uring and sale made in a foreign 
language shall be correctly translated into Chinese text notarized by a notary 
office in China.  
 
Article 22 
The quality management system certificate or GMP certificate of the contract 
manufacturer or the qualification certificate for cosmetics manufacturing that complies with legal and regulatory requireme nts of the country (or region) where the 
manufacturer is located shall meet the following requirements: 
(1) It shall be issued or certified by a cer tification agency or a third party; a copy 
notarized by a notary office in China or accredited by the Chinese embassy (or consulate) may be provided if th e original is not available; and 
(2) The name and address of the manufactur er indicated shall be identical to those 
provided in the application materials.  
 
Article 23 
The power of attorney appointing the Chinese Agent shall meet the following 
requirements:  
(1) The power of attorney shall be exec uted by the cosmetics manufacturer and the 
Chinese Agent (either signed or seal ed by the head of the cosmetics 
manufacturer, and signed and sealed by th e legal representative of the Chinese 
Agent) and notarized by a notary office; wh ere the power of attorney is made in 
a foreign language, a notarized Chines e translation shall be provided;  
(2) The power of attorney shall include: th e name of the appointing entity, the name 
of the Chinese Agent appointed, the term of authorization (at least four years), 
the scope of the product under authorizati on, and the scope of authorization; the 
scope of authorization shall include aut horizing the Chinese Agent to act as an 
agent for the application and may also in clude authorizing the Chinese Agent to 
affix a seal to application material s on behalf of the manufacturer; and 
(3) The original of the power of attorney (including a Ch inese translation) shall be 
submitted and put on file for future review.  
 
Article 24 
The documentary evidence of manufactur ing and sale, the quality management 
system certificate or GMP certificate, the ce rtificate evidencing that manufacturers in different countries are under common contro l by a parent company and the contract 
manufacturing agreement may include more than one product. Where such products 
are included in a single application, the orig inal shall be provided for one product and 
copies may be used for other products together  with a written reference to the name of 
product for which the original is provided; where such products are not included in a 
single application, the original  shall be provided for one product and notarized copies 
shall be provided for other products together with a written reference to the name of the product for which the original is provided.  
 
Article 25 
The sample submitted for review sealed by a provincial food and drug 
administration authority or testing agency shall be submitted in complete packaging that indicates the same name of product, date of manufacture/ba tch number (or shelf 
life/expiry date) and test acceptance number as  those of the tested sample, and product 
specification. Where the product specificatio n is not provided or printed on the 
product container due to the small size of the product (such as lipstick or pomade), 
relevant explanations shall be containe d in the product packaging part of the 
application materials. External packagi ng of the sample of imported product shall 
carry an additional Chinese name label on  the product without covering any foreign 
identification information. The sample of  imported product manufactured by overseas 
manufacturers on a contract basis for domestic enterprise shall be submitted for review in such as way as if  it were domestic product.  
 
Article 26 
Samples that fall under any of the followi ng categories shall meet the following 
application requirements:  
(1) Where a single sample packaging c ontains two or more separate small 
containers or two or mo re separable samples (such as eye shadow, puff cake 
and blusher) that are in cluded in a single applica tion, their product formula 
and test reports shall be submitted separately; where samples are not separately packaged in small containers  or inseparable, one test report and 
separate product formulae shall be provided.  
(2) Where samples that are different in  physical states an d ingredients are 
contained in an integral composite packaging and submitted for application under the same product, their product formulae and test reports shall be 
provided separately;  
(3) Two or more dosage forms that have to be used together shall be deemed as a 
single product for the purpose of applic ation hereunder. Either a mixed test 
report or separate test reports may be submitted for these dosage forms, 
depending on whether such dosage forms are mixed before use.  
 
Article 27 
Where an application is filed for a toxi cological sample test of general-purpose 
cosmetics available in multiple colours that  are identical in basic formula, such cosmetics in multiple colours may be incl uded as a group of products in a single 
application. The application materials for each product shall include the schedule of 
product series, basic formula, schedule of colorants and list of products sampled and 
tested.  
The sampling rate for a toxicological sample test of general-purpose cosmetics 
available in multiple colours shall be 30 %, subject to a minimum of 10 samples; 
sampling shall give precedence to those cont aining organic colorant and/or having the 
highest content of colorant.  
 
Article 28 
Where an application is filed for a sun protection (SPF, PFA or PA) test of sun 
protection cosmetics available in multiple colours that are identical in basic formula, such cosmetics in multiple colours may be in cluded as a group of products in a single 
application. The application materials for each product shall include the schedule of 
product series, basic formula, schedule of colorants and list of products sampled and 
tested.  
The sampling rate for a sun protection test of sun protection cosmetics available in 
multiple colours shall be 20%, subject to a minimum of 5 samples; sampling shall give precedence to those having the lowest content of colorant (or without a basic 
formula of colorant).  
 
Article 29 
In the case of cosmetics that are under the same name but different in fragrance or 
sun protection indices (SPF, PFA or PA),  one licence approval document shall be 
obtained for each product, with applica tion materials submitted separately.   
 
Annexes: 
1. Application Form for Administrative  Licence of Domestic Special-purpose 
Cosmetics 
2. Application Form for Administrativ e Licence of Imported Special-purpose 
Cosmetics 
3. Application Form for Registration of Imported General-purpose Cosmetics 
4. Application Form for Administrative Licence of New Cosmetic Ingredients 
5. Application Form for Change in Administrative Licence for Cosmetics 
6. Application Form for Extension of  Administrative Licence for Cosmetics 
7. Application Form for Re-issuance of  Approval Document (Registration 
Certificate) for Cosmetic Licence 
8. Application Form for Corre ction of Errors in Approva l Document (Registration 
Certificate) for Administ rative Licence for Cosmetics 
 
   Annex 1:  
 
 
Application Form for Administ rative Licence for Domestic 
Special-purpose Cosmetics  
 
      
Name of Product               
 
State Food and Drug Administration  
 Instructions  
 
1. This application form is downl oadable from the SFDA website at 
http://www.sfda.gov.cn.  
2. This application form and all other a pplication materials shall be printed.  
3. This application form shall be filled  out completely and legibly without any 
alteration.  
4. Please carefully read the relevant laws  and regulations and provisions governing 
the acceptance of applications prior to filling out this application form.   
5. In the “Type of Product” cell, please specify the type of  the special-purpose 
cosmetics, such as sun pr otection or hair growth. 
6. An electronic form containing the same da ta as provided in the paper form shall 
be submitted simultaneously.  
 
  
Name of Product 
  
Type of Product 
  
Product Test 
Acceptance No.  
Name  
  
Address  Postal 
Code  
Phone Number  Contact 
Person  Manufacturer 
Hygiene Licence 
No. of 
Manufacturer  Expired on Date/month/year 
 
  
Letter of Undertaking  
 
We, the undersigned, hereby undertake that  the information contained in and 
attached to this application form is true, lawful and consistent with the original, if 
applicable, and data provided in attachments hereto are de rived from studies and tests 
on the product in compliance with the Hygienic Standard for Cosmetics . We are willing 
to assume any legal liability for and all consequences of any misrepresentation.  
           
                                     
 
M a n u f a c t u r e r  ( S t a m p )               Legal Representative (Signature)  
  
D a t e :                      
  
 
 
 Documents attached (Please mark “ √” in the appropriate box) 
 
□ 1. Application form for the administra tive licence of domest ic special-purpose 
cosmetics 
□ 2. Basis of nomenclature of product 
□ 3. Requirements on product quality and safety control 
□ 4. Product packaging design (including produc t label and produc t specification) 
□ 5. Test reports and relevant data i ssued by SFDA-approved testing agency  
□ 6. Safety assessment data relating to subs tances contained in the product that 
may pose any safety risk 
□ 7. Review opinion on hygienic conditi ons of manufacturing issued by the 
provincial food and drug administration authority  
□ 8. Active ingredients and underlying scie ntific literature,  in the case of 
application regarding hair growth, fitness or breast enhancement. 
□ 9. One piece of sample sealed, and remain ing sealed, by the provincial food and 
drug administration authority, and other data that may help in the application for 
administrative license. 
 
Please provide the following information if  the actual manufactur er is other than 
the above signed or there is more than one manufacturer:    
Name of actual manufacturer:    Address of actual manufacturer:    Hygiene licence number of  actual manufacturer:   
 Relationship between manufactur er and actual manufacturer:  
□ Contract manufacturing  
□ Under common control  
 Others:  
 
     
 Annex 2:  
 
 
Application Form for Administ rative Licence for Imported 
Special-purpose Cosmetics  
 
        
Chinese Name of Product      
 
State Food and Drug Administration  Instructions   
 
1. This application form is downloa dable from the SFDA website at  
http://www.sfda.gov.cn. 
2. This application form and all other application materials shall be printed.  
3. This application form shall be filled out completely and legibly without any 
alteration.  
4. Please carefully read the relevant laws  and regulations and provisions governing 
the acceptance of applications prior to filling out this application form.  
5. In the “Type of Product” section, pleas e specify the type of special-purpose 
cosmetics, such as sun protection or hair growth.  
6. An electronic form containing the same da ta as provided in the paper form shall 
be submitted simultaneously.  
 
         
 
Chinese name 
   
Name of  
Product 
  
Foreign name 
  
 
Type of 
product 
  
 
Product test 
acceptance 
No. 
  
 
 
Chinese name 
  
 
Foreign name 
  
 
Address 
  Country (or 
region) of origin  Manufacturer 
 
Phone number 
  Contact 
person  
 
Name 
  
 
Address 
  
 
Fax number 
  Postal code  Chinese 
Agent 
 
Phone number 
  Contact 
person   
Letter of Undertaking  
 We, the undersigned, hereby undertake th at the information contained in and 
attached to this application form is true, lawful and consistent with the original, if 
applicable, and data provided in attachments hereto are derived from studies and tests 
on the product in compliance with the Hygienic Standard for Cosmetics . We are willing 
to assume any legal liability for and all consequences of any misrepresentation.  
       
              
 M a n u f a c t u r e r  ( S t a m p )                   L e g a l  R e p r e s e n t a t i v e  ( S i g n a t u r e )   
    
Date: 
 
 
       
Letter of Undertaking  
 
 
We, the undersigned, hereby declare that we understand the requirements set forth 
in the Provisions for Acceptance of Applica tions for Administrative Licence for 
Cosmetics concerning application for the admini strative licence for cosmetics in 
accordance with applicable laws, regulations, standards and specifications of the State 
as well as the responsibility and le gal liability for application materials.  We have 
reviewed the content of a pplication and materials att ached and undertake that all 
application materials we submit are true, lawf ul and consistent with the original, if 
applicable, and data provided in attachment s hereto are derived from studies and tests 
on the product in compliance with the Hygienic Standard for Cosmetics . We are 
willing to assume any legal liability for and all consequences of any misrepresentation.  
 
       
             
C h i n e s e  A g e n t  ( S t a m p )                     L e g a l  R e p r e s e n t a t i v e  ( S i g n a t u r e )  
 
  
Date:  
 
 Documents attached (Please mark “ √” in the appropriate box)  
 
□ 1. Application form for administrativ e licence of imported special-purpose 
cosmetics  
□ 2. Basis of nomenclature for the Chinese name of product  
□ 3. Product formula  
□ 4. Brief description and illustra tion of manufacturing process  
□ 5. Requirements on product quality and safety control  
□ 6. Original packaging of product (i ncluding product label and product 
specification); where a package is exclusively designed for the Chinese market, such packaging of product (including pr oduct label and product specification) 
shall be provided 
□ 7. Test reports and relevant data i ssued by SFDA-approved testing agency  
□ 8. Safety assessment data relating to subs tances contained in the product that 
may pose any safety risk  
□ 9. Active ingredients and underlying scie ntific literature,  in the case of 
application regarding hair growt h, fitness or breast enhancement  
□ 10. A copy of the registered power of attorney and a copy of the business 
licence of the Chinese Agent, both under common seal  
□ 11. Letter of undertaking evidencing comp liance of cosmetic ingredients and 
their sources with requirements on re striction or prohib ition of high-risk 
substances in BSE-affected regions 
□ 12. Documentary evidence of product manufacturing and sale in the country (or 
region) of origin 
□ 13. One sample of commercially available product that is and remains sealed by 
the testing agency, and other data that may help in the application for administrative license  
 
     
Please provide the following information if  the above-signed manufacturer is not 
in the country (or region) of origin or ther e is more than one country of manufacturing 
or Chinese Agent:  
Name of actual manufacturer:    Address of actual manufacturer:    Country of actual manufacturer:    Relationship between manufactur er and actual manufacturer:  
□ Contract manufacturing  
□ Under common control  
 
Others:   
     
 Annex 3:  
 
  
Application Form for Registration of Imported 
General-purpose Cosmetics  
 
       
Chinese Name of Product      
State Food and Drug Administration  Instructions  
 
1. This application form is downl oadable from the SFDA website at 
http://www.sfda.gov.cn. 
2. This application form and all other application materials shall be printed.  
3. This application form shall be filled out completely and legibly without any 
alteration.  
4. Please carefully read the relevant laws  and regulations and provisions governing 
the acceptance of applications prior to filling out this application form.   
5. An electronic form containing the same da ta as provided in the paper form shall 
be submitted simultaneously.  
 
 
Chinese name 
   
Name of Product 
   
Foreign name 
  
 
Product test 
acceptance No. 
  
 
 
Chinese name 
  
 
Foreign name 
  
Address 
  Country (or 
region) of origin 
  Manufacturer 
 
Phone number 
  Contact person  
 
Name 
  
 
Address 
  
 
Fax number 
  Postal code   
Chinese Agent 
 
 
Phone number 
  Contact person   
 
Letter of Undertaking  
 
We, the undersigned, hereby undertake that the information contained in and attached 
to this application form is true, lawful and c onsistent with the original, if applicable, and 
data provided in attachments he reto are derived from studies  and tests on the product in 
compliance with the Hygienic Standard for Cosmetics . We are willing to assume any 
legal liability for and all conseque nces of any misrepresentation.   
         
           
M a n u f a c t u r e r  ( S t a m p )                  L e g a l  R e p r e s e n t a t i v e  ( S i g n a t u r e )     
Date:    
 
 
  
Letter of Undertaking  
 
 
We, the undersigned, hereby declare that we  understand requirements set forth in 
the Provisions for Acceptance of Applicat ions for Administrative Licence for 
Cosmetics concerning applic ation for the administrative licence for cosmetics in 
accordance with applicable laws, regulati ons, standards and specifications of the 
State as well as the responsibility and le gal liability for app lication materials. We 
have reviewed the content of the application and materials attached and undertake that 
all application materials we submit are true, la wful and consistent with the original, if 
applicable, and data provided in attachment s hereto are derived from studies and tests 
on the product in compliance with the Hygienic Standard for Cosmetics . We are 
willing to assume any legal liability for and all consequences of any misrepresentation.   
 
            
           
C h i n e s e  A g e n t  ( S t a m p )                 L e g a l  R e p r e s e n t a t i v e  ( S i g n a t u r e )  
 
    
 
Date:  
 
   Documents attached (Please mark “ √” in the appropriate box) 
 
□ 1. Application form for administrative licence of imported general-purpose 
cosmetics 
□ 2. Basis of nomenclature for the Chinese name of product 
□ 3. Product formula 
□ 4. Requirements on product quality and safety control 
□ 5. Original packaging of product (i ncluding product label and product 
specification); where a package is exclusively designed for the Chinese market, such packaging of product (including pr oduct label and product specification) 
shall be provided 
□ 6. Test reports and relevant data i ssued by SFDA-approved testing agency  
□ 7. Safety assessment data relating to subs tances contained in the product that 
may pose any safety risk 
□ 8. A copy of the registered power of a ttorney and a copy of the business licence 
of the Chinese Agent, both under common seal 
□ 9. Letter of undertaking evidencing complian ce of cosmetic ingredients and their 
sources with requirements on restriction or prohibition of high-risk substances in BSE-affected regions 
□ 10. Documentary evidence of product manufacturing and sale in the country (or 
region) of origin 
□ 11. One sample of commercially available product that is and remains sealed by 
the testing agency, and other data th at may help in registration process  
 
       
Please provide the following information if the above-signed manufacturer is not in the 
country (or region) of origin or there is more  than one country of manufacturing or Chinese 
Agent:  
Name of actual manufacturer:    Address of actual manufacturer:    Country of actual manufacturer:    Relationship between manufacturer and actual manufacturer:  
□ Contract manufacturing  
□ □ Under common control  
 
Others:      
 Annex 4:  
 
 
Application Form for Admini strative Licence for New 
Cosmetic Ingredients  
 
       
Chinese Name of Product       
State Food and Drug Administration  Instructions  
 
1. This application form is downloa dable from the SFDA website at  
http://www.sfda.gov.cn. 
2. This application form and all other application materials shall be printed.  
3. This application form shall be filled out completely and legibly without any 
alteration.  
4. Please carefully read the relevant laws  and regulations and provisions governing 
the acceptance of applications prior to filling out this application form.   
5. An electronic form containing the same da ta as provided in the paper form shall 
be submitted simultaneously.  
 
 
Chinese name 
  
Name of new 
ingredient  
Foreign name 
  
Purpose of new 
ingredient  
 
Chinese name 
  
 
Foreign name 
  
Address  Country (or 
region) of origin  Manufacturer 
 
Phone number 
  Contact 
person  
 
Name 
  
 
Address 
  
 
Fax number 
  Postal 
code  Chinese Agent 
 
Phone number 
  Contact 
person  
  
 
Letter of Undertaking  
 
We, the undersigned, hereby undertake that the info rmation contained in and attached to this 
application form is true, lawful and consistent wi th the original, if applicable, and data provided 
in attachments hereto are derived from studies and tests on the product in compliance with the 
Hygienic Standard for Cosmetics . We are willing to assume a ny legal liability for and all 
consequences of any misrepresentation.             
            
M a n u f a c t u r e r  ( S t a m p )                  L e g a l  R e p r e s e n t a t i v e  ( S i g n a t u r e )     
Date:    
  
Letter of Undertaking 
  
We, the undersigned, hereby declare that we understand requirements set forth in the 
Provisions for Acceptance of Applications for Administrative Licence for Cosmetics concerning 
application for the administrati ve licence for cosmetics in a ccordance with applicable laws, 
regulations, standards and specifications of the State as well as the responsibility and legal 
liability for application materials. We have reviewed the content of the application and 
materials attached and undertake that all applic ation materials we submit are true, lawful and 
consistent with the original, if applicable, and data provided in attachments hereto are derived 
from studies and tests on the product in compliance with the Hygienic Standard for Cosmetics . 
We are willing to assume any legal liability for and all consequences of any misrepresentation.  
         
             
C h i n e s e  A g e n t  ( S t a m p )                     L e g a l  R e p r e s e n t a t i v e  ( S i g n a t u r e )       
Date: 
         
Note: In the case of application through a Chinese Agent, the letter of  undertaking of the Chinese Agent 
shall be provided.   
 Documents attached (Please mark “ √” in the appropriate box) 
 
□ 1. Application form for administrative licence of new cosmetic ingredients 
□ 2. Development report 
□ 3. Description and illustration of the manufacturing process  
□ 4. Requirements on product quality and safety control 
□ 5. Toxicological safety evaluation data 
□ 6. In the case of application through a Chinese Agent, a copy of the registered power of 
attorney issued to the Chinese Agent and a copy of the business licence of the Chinese 
Agent under common seal 
□ 7. One piece of sample submitted for review and other data that may help in application 
for administrative license 
  Others 
                               Annex 5:  
 
 
Application Form for Change in  Administrative Licence for 
Cosmetics  
 
        
Chinese Name of Product       
State Food and Drug Administration  Instructions  
1. This application form is downl oadable from the SFDA website at 
http://www.sfda.gov.cn. 
2. This application form and all other application materials shall be printed.  
3. This application form shall be filled out completely and legibly without any 
alteration.  
4. Please carefully read the relevant la ws and regulations and requirements on 
application materials prior to fil ling out this application form.   
5. All items provided in the table are those set forth in the approval document for 
hygiene license issued by the State Food and Drug Admini stration or the 
Ministry of Health.   
6. An electronic form containing the same da ta as provided in the paper form shall 
be submitted simultaneously.   
 
 
 
Name of Product 
  
 
Product Test 
Acceptance No. 
  
 
 
Name 
  
 
Address 
  Manufacturer 
 
Phone 
Number 
  Contact 
Person  
 
Name 
  
 
Address 
  
 
Fax number 
  Postal code  Chinese Agent 
 
Phone 
number 
  Contact 
person  
  
Hygiene Licence 
No. of 
Manufacturer     
Expired on 
  
Date/month/year 
 
Original approval 
document no.     
Expired on 
 Date/month/year  
 
 Documents and certificates attached:   
□ 1. Application form for change in administrative licence for cosmetics 
□ 2. Original of the approval document  (registration certificate) for the 
administrative license for cosmetics 
□ 3.In the case of application through a Ch inese Agent, a copy of the registered 
power of attorney appointing the Chin ese Agent and a copy of the business 
licence of the Chinese Agent, both under common seal 
□ 4. Other data required for change  
 
 
 
 
       
Letter of Undertaking  
 
 
We, the undersigned, hereby undertake th at the information contained in and 
attached to this application form is true, lawful and consistent with the original, if 
applicable, and data provided in attachment s hereto are derived from studies and tests 
on the product in compliance with the Hygienic Standard for Cosmetics . We are 
willing to assume any legal liability for and all consequences of any misrepresentation.   
 
        
           
M a n u f a c t u r e r  ( S t a m p )             Legal Representative (Signature) 
 
  
Date:  
    
 
            
      
Letter of Undertaking  
 
 
We, the undersigned, hereby declare that we understand the requirements set forth 
in the Provisions for Acceptance of Applica tions for Administrative Licence for 
Cosmetics concerning application for the admini strative licence for cosmetics in 
accordance with applicable laws, regulations, standards and specifications of the State 
as well as the responsibility and le gal liability for application materials . We have 
reviewed the content of the application a nd the materials attached and undertake that 
all application materials we submit are true, la wful and consistent with the original, if 
applicable, and data provided in attachment s hereto are derived from studies and tests 
on the product in compliance with the Hygienic Standard for Cosmetics . We are 
willing to assume any legal liability for and all consequences of any misrepresentation.  
 
        
             
C h i n e s e  A g e n t  ( S t a m p )                     L e g a l  R e p r e s e n t a t i v e  ( S i g n a t u r e )  
 
        
  
Date: 
     
 
Note: In the case of application through a Ch inese Agent, the letter of undertaking of the 
Chinese Agent shall be provided.  Itemized changes applied for:    
              
Reasons for changes (please attach additional sheets if necessary):                      Annex 6:  
 
 
Application Form for Extensio n of Administrative Licence 
for Cosmetics  
 
        
Chinese Name of Product      
 
State Food and Drug Administration  Instructions   
1. This application form is downl oadable from the SFDA website at 
http://www.sfda.gov.cn. 
2. This application form and all other application materials shall be printed.  
3. This application form shall be filled out completely and legibly without any 
alteration.  
4. Please carefully read the relevant laws  and regulations and provisions governing 
the acceptance of applications prior to filling out this application form.   
5. In the “Type of Product” section, pleas e specify the type of  the special-purpose 
cosmetics, such as sun protection or hair growth.  
6. All items provided in the table are those set forth in the approval document for 
hygiene license issued by the State Food and Drug Admini stration or the 
Ministry of Health.   
7. An electronic form containing the same da ta as provided in the paper form shall 
be submitted simultaneously.  
 
 
 
Chinese name 
  
Name of 
Product  
Foreign name 
  
 
Type of 
product 
  
 
Chinese name 
  
 
Foreign name 
  
Address  Country (or 
region) of 
origin   Manufacturer 
 
Phone number 
  Contact 
person  
 
Name  
  
 
Address 
  Chinese Agent 
 
Fax number  Postal code   
 
Phone number 
  Contact 
person  
 
Hygiene 
Licence No. of 
Manufacturer 
   Expired on Date/month/year 
 
Original 
approval 
document no. 
   Expired on Date/month/year  
Letter of Undertaking  
  
We, the undersigned, hereby undertake that  the information contained in and 
attached to this application form is true, lawful and consistent with the original, if 
applicable, and data provided in attachment s hereto are derived from studies and tests 
on the product in compliance with the Hygienic Standard for Cosmetics . We are 
willing to assume any legal liability  for and all consequences of any 
misrepresentation.  
    
       
            
M a n u f a c t u r e r  ( S t a m p )                  L e g a l  R e p r e s e n t a t i v e  ( S i g n a t u r e ) :      
Date:   
  
Letter of Undertaking 
  
We, the undersigned, hereby declare that we understand the requirements set forth 
in the Provisions for Acceptance of Applica tions for Administrative Licence for 
Cosmetics concerning application for the admini strative licence for cosmetics in 
accordance with applicable laws, regulations, standards and specifications of the State 
as well as the responsibility and le gal liability for application materials . We have 
reviewed the content of the application a nd the materials attached and undertake that 
all application materials we submit are true, la wful and consistent with the original, if 
applicable, and data provided in attachment s hereto are derived from studies and tests 
on the product in compliance with the Hygienic Standard for Cosmetics . We are 
willing to assume any legal liability for and all consequences of any misrepresentation.           
             
C h i n e s e  A g e n t  ( S t a m p )                     L e g a l  R e p r e s e n t a t i v e  ( S i g n a t u r e )        
Date:   
     
Note: In the case of application through a Ch inese Agent, the letter of undertaking of the 
Chinese Agent shall be provided.  
 
 Documents attached (Please mark “ √” in the appropriate box) 
 
□ 1. Application form for extension of  administrative licence for cosmetics 
□ 2. Original of the approval document (registration certificate) for the 
administrative license for cosmetics 
□ 3. Basis of nomenclature for the Chinese name of the product (unless it has been 
provided during initial application and the name remains unchanged) 
□ 4. Product formula 
□ 5. Requirements on product quality and safety control 
□ 6. Packaging of commercially availabl e product (including  product label and 
product specification); in the case of  domestic product not commercially 
available, the designed product packag ing (including product  label and product 
specification) may be provided 
□ 7. In the case of domestic product, the opinion on manufacturing, commercial 
availability and supervision of produc t or the review opinion on commercial 
unavailability of product issued by the provincial food and drug administration 
authority where the applicant is located 
□ 8. In the case of application through a Chin ese Agent, a copy of the registered 
power of attorney issued to the Chinese Agent and a copy of the business licence of the Chinese Agent under common seal 
□ 9. A sealed sample of commercially av ailable product and other data that may 
help in application for administrative license 
 Others 
                   Annex 7:  
 
 
Application Form for Re-issu ance of Approval Document 
(Registration Certificate) for Cosmetic Licence  
 
   
  
    
Chinese Name of Product       
State Food and Drug Administration  Instructions   
1. This application form is downloa dable from the SFDA website at 
http://www.sfda.gov.cn. 
2. This application form and all other application materials shall be printed.  
3. This application form shall be filled out completely and legibly without any 
alteration.   
4. Please carefully read the relevant la ws and regulations and requirements on 
application materials prior to fil ling out this application form.   
5. All items provided in the table are those set forth in the approval document for 
hygiene license issued by the State Food and Drug Admini stration or the 
Ministry of Health.   
6. An electronic form containing the same da ta as provided in the paper form shall 
be submitted simultaneously.   
 
 
 
Name of Product 
  
 
Reason for re-issuance 
 □ Damaged       □ Lost 
 
Name 
  
 
Address 
  Manufacturer 
 
Phone 
number 
  Contact 
person  
 
Name 
  
 
Address 
  
 
Fax 
number 
  Postal code  Chinese Agent 
 
Phone 
number 
  Contact 
person   
Hygiene Licence No. of 
Manufacturer 
   Expired on Date/month/year 
 
Original approval 
document no. 
   Expired on Date/month/year 
 
 Documents attached  
□ 1. Application form for re-i ssuance of approval document (registration certificate) for 
the administrative licence for cosmetics 
□ 2. Origin of the approval document (registration certificate) for the administrative 
license for cosmetics if it is damaged 
□ 3. Original of the declaration of loss publis hed in newspapers of provincial or larger 
circulation if the approval document (registration certificate) is lost; the application for re-issuance due to loss shall be filed at least twenty days after publication of the declaration of loss 
□ 4. In the case of application through a Chinese Agent, a copy of the registered power of 
attorney issued to the Chinese Agent and a copy of the business licence of the Chinese 
Agent under common seal 
 
 
Letter of Undertaking  
  
We, the undersigned, hereby undertake that the in formation contained in and attached to 
this application form is true, lawful and consis tent with the original, if applicable, and data 
provided in attachments hereto are derived from studies and tests on the product in 
compliance with the Hygienic Standard for Cosmetics . We are willing to assume any legal 
liability for and all consequences  of any misrepresentation.   
         
            
M a n u f a c t u r e r  ( S t a m p )                  L e g a l  R e p r e s e n t a t i v e  ( S i g n a t u r e ) :      
Date: 
  
Letter of Undertaking 
   
We, the undersigned, hereby declare that we understand the requireme nts set forth in the 
Provisions for Acceptance of Applications  for Administrative Licence for Cosmetics 
concerning application for the administrative licence for cosmetics in accordance with 
applicable laws, regulations, standards and sp ecifications of the State as well as the 
responsibility and le gal liability for a pplication materials . We have reviewed the content of 
the application and the materials attached and undertake that all appl ication materials we 
submit are true, lawful and consistent with the original, if applicable , and data provided in 
attachments hereto are derived from studies and tests on the product in compliance with the 
Hygienic Standard for Cosmetics . We are willing to assume any legal liability for and all 
consequences of any misrepresentation.            
             
C h i n e s e  A g e n t  ( S t a m p )                     L e g a l  R e p r e s e n t a t i v e  ( S i g n a t u r e )        
 
      
Date: 
     
 Annex 8:  
 
Application Form for Correcti on of Errors in Approval 
Document (Registration Certificate) for Administrative 
License for Cosmetics  
 
Original acceptance no. 
  
 
Chinese 
  
Name of 
Product  
Foreign 
  
 
Approval (registration) 
no. 
  
Name of manufacturer 
or Chinese Agent  
 
Contact person 
  Telephone  
 
Errors in approval document (registration certificate):   
        
Note: In the case of application th rough a Chinese Agent, the letter of undertaking of the Chinese 
Agent shall be provided.    
Requested changes in approval document (registration certificate):            
 
            
             
C h i n e s e  A g e n t  ( S t a m p )                     L e g a l  R e p r e s e n t a t i v e  ( S i g n a t u r e )      
Date: