1 
 Proposed Draft of Regulations for Issuance of Permit License of Specific Purpose 
Cosmetics  
This Draft has been translated into English according to the 
original Chinese version. If there is any inconsistency or 
ambiguity between these two versions, the Chinese version shall 
prevail.  
 
Chapter 1 General Provisions  
Article 1  This Regulation is prescrib ed pursuant to Paragraph 6 of Article 5 of 
Cosmetics Hygiene and Safety Act (the “Act” ). 
Article 2  Cosmetics, obtaining permit license  of medical or poisonous drugs per 
the predecessor of the Act prior to enforcement of the Act, shall be 
deemed as Specific Purpose Cosmetics within the valid term of such 
permit.  
Article 3  Terms used under this Regulations defined as below:  
1. Specific Purpose Cosmetics: referring to Cosmetics as announced 
by the competent authorities per Paragraph 1 of Articl e 5 of the 
Act used for sun screen , hair dying, permanent wave, 
antiperspirant, deodorant, teeth -whitening or other purposes.  
2. Authorization Letter: referring to certificates of allowing applicant 
to import and  distribution issued by oversea original manufacturer, 
the headquarter, or OEM importing Specific Purpose Cosmetics.  
3. The Manufacture and Free Sale Certificates (“ MFSC ”): referring to 
certificates provided or issued by the country of original for 
manufacturing and free distribution in that country.  
4. Ingredient List: referring to formula table of full ingredients issued 
by t he manufacturer or the headquarter identifying name of 
ingredients and its content.  
5. Certificate of Analysis: referring documentation identifying 
characteristic, active ingredients, identification methods, 
quantitative methods, acceptable range of concentr ation, test 
results and other determination data.  
 
Chapter 2 Manufacture and Importation  
Article 4  Applicants applying for registration of the permit for manufacturing 
Specific Purpose Cosmetics per Paragraph 1 of Article 5 of the Act shall 
file an application, attach below documents, data, and pay fees to the 2 
 competent authorities.  
1. Copy of factory registration certificate.  
2. Copy of license of the pharmacist in charge of manufacturing, or 
employment certificate and qualification of personnel  deploy ed for 
resident supervisory of manufacturing.  
3. Product labels, description and packaging design draft.  
4. Certificate of Analysis.  
5. For OEM, copy of company registration or business registration 
certificate of applicant and the OEM agreement . 
Certificates of GMP lawfully obtained by premises where cosmetics 
manufactured can be substitution of the aforesaid Certifi cate of 
Analysis under Sub -Paragraph 4 of the preceding Paragraph if the 
applied permit of Specific Purpose Cosmetics carrying same dosage 
form as that of the cosmetics on the GMP certificate.  
Article 5  Applicants applying for registration of the permit for importing 
Specific Purpose Cosmetics per Paragraph 1 of Article 5 of the Act shall 
file an application, attach below documents, data, and pay fees to the 
competent authorities.  
1. Copy of company registration or business registration certificate.  
2. Product labels, description and packaging design draft.  
3. Authorization Letter issued within past two years.  
4. MFSC  issued within past two years.  
5. Ingredient List issued within past two years.  
6. Certificate of Analysis.  
7. For OEM, the OEM agreement.  
Article 6  Authorization Letter stipulated under Sub -Paragraph 3 of the 
preceding Article shall include:  
1. The name and address of the assignor of Authorization Letter. If 
not issued by the original manufacturer, to include the name and 
address of the original manufacturer.  
2. Name and address of the assignee.  
3. Name and item of products authorized.  
4. The authorizing intention.  
The information provided per the preceding Paragraph shall be in line 
with what provided in the application. If Authorization Letter is writte n 
in the language other than Chines or English, the Chinese or English 
translation shall be attached.  
If Specific Purpose Cosmetics is not imported by the original 3 
 manufacturer, the headquarter, or the OEM, the shipping voucher or 
other certificates that m ay confirm the source of products issued by 
the original manufacturer, the headquarter, or the OEM may be the 
substitution for Authorization Letter.  
Article 7  MFSC  stipulated under Sub -Paragraph 4 of Article 5 shall include:  
1. The name of the product.  
2. The name and address of the manufacturer.  
MFSC  shall be authenticated by oversea embassies except for that was 
issued by the government of country of original or notarized by the 
local notary public.  
If MFSC  is written in the language other than Chines or English, the 
Chinese or English translation shall be attached.  
The free distribution certificate issued by the country of the assignor 
together with the manufacture certificate issued by the country of 
assig ned manufacturer may be the substitution of MFSC . 
MFSC  may be issued by either the authorities of country of the 
assignor or the authorities of country of assigned manufacturer, if 
Specific Purpose Cosmetics is imported by the OEM. If the applicant is 
the secondary manufacturer, the relationship between the assignor 
and the assigned manufacturer shall be addressed  
If cosmetics is manufactured in Japan and the MFSC  only stipulates the 
vendor information without the information of the manufacturer, the 
copy o f the manufacture certificate carrying the name and the address 
of the manufacturer and the name of the product issued by the health 
authorities of the country where cosmetic manufactured may be 
provided as substitution , while free distribution certificate  shall be 
attached . 
Article 8  Ingredient List stipulated under Sub -Paragraph 5 of Article 5 shall 
include:  
1. Product name.  
2. Name and content of active ingredients, preservative, pigments, or 
other relevant ingredients.  
The name of ingredients provided for th e Sub -Paragraph 2 of the 
preceding Paragraph shall refer to that provided under International 
Nomenclature of Cosmetic Ingredients (“INCI”) or its common English 
chemical name. Its content shall be made by weight or volume 
percentage (i.e. W/W% or W/V%); p rovided that the content may be 
labelled as “appropriate amount” for other ingredients and pigments if 4 
 no limits on usage of same.  
Ingredient List shall be authenticated by oversea embassies except for 
that was issued by the government of country of origi nal or notarized 
by the local notary public.  
Article 9  Certificate of Analysis stipulated under Sub -Paragraph 4 of Article 4 
and Sub -Paragraph 6 of Article 5 shall include:  
1. Characteristic: appearance, color, sharp, and dosage form of 
products.  
2. Active ingredients: specific purpose ingredients included in the 
product.  
3. Method of identifying active ingredients included in the product.  
4. Method of quantifying active ingredients included in the product.  
5. Acceptable range of active ingredients included in the product shall 
be within  90% to 110% of the labelled content.  
6. Test result.  
7. Other determination data.  
If the active ingredients of oxidation hair dye products are contained 
too low or unsteady and theref ore cannot be quantified exactly, the 
freebase (Alkalinity) or free ammonia (limited to active ingredients 
containing ammonia) may be the substitution to be stipulated under 
Sub-Paragraph 4 and 5 of the preceding Paragraph.  
Article 10  Active ingredients of Specific Purpose Cosmetics shall conform to the 
acceptable ranges announced by the competent authorities. If the 
active ingredients are not stipulated but is listed as active ingredients 
per the announcement made by the authorities of countries (areas) 
recognized by the competent authorities, after providing such 
announcement, the permit to be issued per this Regulation may be 
approved after applying for registration per this Regulation.   
Article 11  When applying for Specific Purpose Cosmetics with new active 
ingredients, or active ingredient with new usage  or new maximum  
concentration , its application shall attach relevant information  per the 
appendix . For applications, with active ingredient not in the list  (the 
acceptable ranges ) in the preceding article, in accordance with 
preceding article, this provision shall not apply.  
Article 12  Cosmetics products applied for permit license  of Specific Purpose 
Cosmetics shall not contain any ingredient prohibited from being used 
via the announcement made by the competent authorities per 
Paragraph 1 of Article 6 of the Act.  5 
 Cosmetics products of the preceding Paragraph containing bovine and 
sheep tissue composition shall attach certificates identifying source of 
materials or source of products not from infected countries  or zones of 
Bovine Spongiform Encephalopathy.  
Article 13  The applications of permit license  of Specific Purpose Cosmetics may 
be combined when manufacturing or importing Specific Purpose 
Cosmetics from the same manufacturer, for the same usage, and with 
the same active ingredients and dosage form.  
The combined application in the preceding Paragraph shall attach 
documents and data set forth under Sub -Paragraph of each Article for 
each individual product except for those of Sub -Paragraph 1, 2, and 5 
of Article 4 and Sub -Paragraph 1 of Article 5.  
Article 14  The applicant shall be notified the result of the application reviewed 
by the competent authorities per Article 4 and 5. The applicant after 
being notified the approval of permit  license  and registration shall 
provide approved soft copy of labels, description, and packaging, and 
pay the fees to the competent authorities to obt ain the permit license  
within 3 months upon execution  of the notice.  
Article 15  Registration under the preceding Paragraph shall include:  
1. Product item.  
2. Product name: model number and color code for series products.  
3. Active ingredients  and its concentration in percentage . 
4. Dosage form.  
5. Description, labels, and specifications.  
6. Purpose.  
7. Name of applicant.  
8. Name and address of manufacturer.  
Article 16  The permit under Article 1 4 shall stipulate its valid term and other 
items set forth under Sub -Paragraph of the preceding Article except 
for Sub -Paragraph 5.  
Article 17  If any document or data is missing or the fees is unpaid, the 
competent authorities shall notify the applicant to  cure same within 
the set deadline. The applicant shall cure all at once.  
The applicant who fails to cure same within the set deadline of the 
preceding Paragraph may request for extension to the competent 
authorities with reasons in writing prior to the ex piration of the set 
deadline. The extension is 1 month upon the next day of the expiration 
of aforesaid set deadline and may only be requested once.  6 
 If the applicant fails the cure same per the preceding two Paragraphs, 
the application shall be rendered in admissible.  
Article 18  The application shall be disapproved if one of the following conditions 
occur:  
1. Text of documents or data provided contrary to those of the 
application.  
2. Ingredients prohibited from being used under Paragraph 1 of 
Article 6 of the Act  contained; or violation of limit on usage of 
ingredients set forth under Paragraph 2 of Article 6 of the Act.  
3. Packaging, labels or description not labelled per Article 7 of the 
Act. 
4. Text or graphic design used in the name, packaging or description 
are deceptive, exaggerated, or involving medical efficacy as set 
forth under Paragraph 1 and 2 of Article 10 of the Act.  
5. Any conditions that may be harmful to human health.  
6. Other violation of laws, regulations or announcement made by the 
competent authorities.  
Article 19  If permit license  of Specific Purpose Cosmetics are damaged or lost, 
the applicant may pay fees to the competent authorities for 
replacement or new permit license . If applying for new permit license , 
the original permit shall be attached.  
 
Chap ter 3 Modification of Registration and Transfer and Modification of Permit 
license  
Article 20  If there is any change of the information provided for registration or 
permit license  under Article 1 5 or 1 6, the applicant shall provide 
original permit and relevant supporting documents and pay fees to the 
competent authorities to apply for changes per Paragraph 2 of Article 
5 of the Act. After reviewed by the competent authorities, the original 
permit shall a ddress the changes and date then returned with stamps.  
If the changes of the preceding Paragraph are to increase more items 
or color systems, those products shall be made by the same 
manufacturer, with same active ingredients, same dosage form and 
usage, and conforming to limit on usage of specific purpose 
ingredients as set forth by the competent authorities.  
Article 21  When applying for transfer of permit license  of Specific Purpose 
Cosmetics, the transferor and transferee shall file a joint applicatio n, 
attach original permit and relevant supporting documents, and pay 7 
 fees to the competent authorities to obtain the approval.  
The original permit shall address the name of the assignor and the 
approval date when issuing the approval by the competent autho rities 
per the preceding Paragraph.  
Article 22  When applying for revocation of permit license  of Specific Purpose 
Cosmetics, the application shall be filed attaching the original permit 
together with relevant documents to be submitted to the competent 
authorities.  
 
Chapter 4 Extension of Permit license  
Article 2 3 When applying for extension of the term of permit license  of Specific 
Purpose Cosmetics per Paragraph 5 of Article 5 of the Act, the 
applicant shall file the application, attach below documents and data, 
and pay fees to the competent authorities:  
1. Original permit  license . 
2. Copy of company or business registration  certificates.  
3. Authorization Letter issued within past two years except for 
manufactured domestically.  
Article 2 4 If the extension is not applied prior to the expiration of the term of 
permit license  of Specific Purpose Cosmetics per the preceding Article , 
the application shall re -apply for registration and permit license  per 
Paragraph 1 of Article 5 of the Act. Provided that, if it is within 6 
months after the expiration, the applicant may file the application, 
attach below documents and data, and pay fee s to the competent 
authorities when re -applying for the permit license : 
1. Original permit license . 
2. Copy of company or business registration certificates . 
3. For OEM, the OEM agreement.  
4. For the importer, MFSC , Ingredient List and Authorization Letter 
issued with in past 2 years  
The new registration number will be issued to the permit after being 
approved per the preceding Paragraph.  
 
Chapter 5 Supplementary.  
Article 2 5 This Regulation takes effect starting from the date of promulgation .