1 
 Regulations for Issuance of License of Specific Purpose Cosmetics  
This regulation  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  These Regulations are prescribed pursuant to Paragraph 6 of Article 5 of the Cosmetics 
Hygiene and Safety Act (the “Act”).  
Article 2  Before the enforcement of the Act, cosmetics have obtained the license of medical or 
poisonous drugs per the Statute for Control of Cosmetic Hygiene shall be deemed as 
Specific Purpose Cosmetics within the valid term of such license.  
Article 3  The terms used in these Regulations are defined as follows:  
1. Specific purpose cosmetics: refers to cosmetics designated by public announcement 
of the cen tral competent authority per Paragraph 1 of Article 5 of the Act , and  used 
for sunscreen, hair -dyeing, p erman ent waving, a ntiperspirant, deodorant, 
tooth -whitening or other purposes .  
2. Authorization letter: refers to a certificate issued by the original overseas 
manufacturer, the headquarter, or its contract manufacturer of specific purpose 
cosmetics, allows registration applicant to import and d istribute  such cosmetics.  
3. Manufacture and Free Sale Certificate (“MFSC”): refers to a certificate issued by 
the country of origin proves the approved manufacturing and free sale.  
4. Ingredients list: refers to a formula t able of full ingredients issued by the 
manufacturer or the headquarter identifying names and content of ingredients.  
5. Certificate of analysis: refers to documentation identifying characteristic, active 
ingredients, identification methods, quantitative meth ods, an acceptable range of 
content, test results, and other determination data.  
Chapter 2 Manufacture and Import  
Article 4  An a pplicant applies for the registration of the license for manufacturing specific 
purpose cosmetics per Paragraph 1 of Article 5  of the Act shall submit an application 
with following documents, and pay the fee to the central competent authority:  
1. A copy of the f actory registration certificate.  
2. A copy of the license of the pharmacist in charge of supervision of manufacturing, 
or empl oyment certificate and qualification of personnel who is stationed at the 
factory to supervise the dispensation and manufacturing.  
3. Drafts of product labels, leaflets, and packaging.  
4. The certificate of analysis.  
5. For the contract manufacturer, a copy of comp any registration or business 2 
 registration certificate of the applicant and the OEM agreement . 
A cosmetic manufacturing facility receives the certificate of cosmetic Good 
Manufacturing Practice by law, and applies for specific purpose cosmetics license for 
the same dosage  form stated in such certificate, the certificate of analysis mentioned in 
Sub-paragraph 4 of the preceding Paragraph may be replaced with such certificate.  
Article 5  An a pplicant applies for the registration of the license for importing specific purpose 
cosmetics per Paragraph 1 of Article 5 of the Act shall submit an application with 
following documents, information, and pay the fee to the central competent authority:  
1. A copy of company registration or business registration certificate.  
2. Drafts of product labels, leaflets, and packaging.   
3. The authorization letter issued within the past two years.  
4. The MFSC issued within the past two years.  
5. An ingredient list issued within the past two years.  
6. The certificate of analysis.  
7. For the contract manufacturer, a certificate identifies the relationship between the 
hiring firm and contract manufacturer . 
Article 6  The a uthorization letter stipulated under Sub -paragraph 3 of the preceding Article shall 
state the following information:  
1. The name and ad dress of the authorization letter submitter. If the letter is not issued 
by the original manufacturer, it shall additionally state the name and address of the 
original manufacturer.  
2. The name and address of the agent.  
3. The name and item of authorized products.  
4. The intention of authorization.  
The information mentioned in the preceding Paragraph shall be consistent with the 
application. If the authorization letter is written in the language other than Chinese or 
English, the Chinese or English translation shall be attached.  
Article 7  The MFSC stipulated under Sub -Paragraph 4 of Article 5 shall state the following 
information:  
1. The name of the product.  
2. The name and address of the manufacturer.  
The MFSC shall be authentica ted by the overseas diplomatic mission. The MFSC 
issued by the government of the country of origin, or notarized by the local notary 
public may be exempted from authentication.  
If MFSC is written in the language other than Chines e or English, the Chinese o r 
English translation shall be attached.  
The MFSC may be replaced with the free sale certificate issued by the country of the 
hiring firm and the manufacture certificate issued by the country of the contract 3 
 manufacturer.  
The MFSC may be issued by either t he authorities of the country of the hiring firm or 
contract manufacturer if specific purpose cosmetics is imported by the OEM.  
If the country of origin of cosmetics in  Japan and the MFSC only states the 
information of the vendor rather than the manufacturer, the copy of the manufacturing 
certificate carrying the name and the address of the manufacturer and the name of the 
product issued by the hygiene authority of the c ountry of origin may be provided as 
substitution, while free sale certificate shall be attached.  
Article 8  Ingredient list stipulated under Sub -paragraph 5 of Article 5 shall state the following 
information:  
1. The name of the product.  
2. The name and content o f active ingredients, preservatives, pigments, or other 
ingredients.  
The name of ingredients mentioned in the Sub -paragraph 2 of the preceding Paragraph 
shall refer to the International Nomenclature of Cosmetic Ingredients (“INCI”) or its 
common chemical n ame in English. Its content shall be made by weight or volume 
percentage (i.e., W/W% or W/V%); provided that the content may be labeled as 
“appropriate amount” for other ingredients and pigments with no limits on the usage of 
same.  
Ingredient list shall b e authenticated by an overseas diplomatic mission. The list 
issued by the government of the country of origin, or notarized by the local notary 
public may be exempted from authentication.  
Article 9  The certificate of analysis stipulated under Sub-paragraph 4 of Article 4 and 
Sub-paragraph 6 of Article 5 shall state the following information:  
1. Characteristic: appearance, color, shape, and dosage  form of the product.  
2. Active ingredients: specific purpose ingredients in the product.  
3. Method for ident ifying active ingredients.  
4. Method for quantifying active ingredients.  
5. Acceptable content range of active ingredients, and it shall be within 90% to 110% 
of the content.  
6. The test results.  
7. Other determination data.  
If the active ingredients of oxidativ e hair - dyeing products are too low or unstable and 
therefore cannot be quantified precisely, the active ingredients stipulated under 
Sub-Paragraph 4 and 5 of the preceding Paragraph may be replaced with freebase 
(Alkalinity) or free ammonia (limited to ac tive ingredients containing ammonia)  
Article 10  When central competent authority designates specific purpose cosmetics by the public 
announcement per Para graph 1 of Article 5 of the Act , the content of public 4 
 announcement shall contain the names, scopes, and limitations of active ingredients . 
The a ctive ingredient of cosmetics are not stipulated under preceding Paragraph; 
however, it is identified the characteristic of specific purpose cosmetic by the 
authorities of countries (areas)  or regions  recognize d by the central competent 
authority, the applicant may apply for registration per the Act and attach the 
certificates used by those countries (areas) or regions.   
Article 11  Applying for the license of specific purpose cosmetic  shall attach relevant information 
per th e Appendix if active ingredient  of cosmetic  is new substance , with new purpose 
or new maximum concentration . However, the condition mentioned in Paragraph 2 of 
the preceding Article shall exempt from it.  
Article 12  Cosmetics appl ied for the license of specific purpose cosmetics shall not contain any 
ingredient prohibited from using per the public announcement made pursuant to 
Paragraph 1 of Article 6 of the Act.  
Cosmetics mentioned in the preceding Paragraph contain b ovine and sheep tissue 
composition shall attach certificates of products or raw materials from Bovine 
Spongiform Encephalopathy -free countries, regions, or zones.  
Article 13  The license may be jointly applied if specific purpose cosmetics come from the sa me 
manufacturer, with the same purpose, same active ingredients and dosage  form.  
The joint application stipulated under the preceding Paragraph shall attach documents 
and data mentioned in Paragraph 1 of Article 4 and Article 5 separately in accordance 
with different products, except for those documents or data mentioned in 
Sub-Paragraph 1, 2, and 5 of Paragraph 1 of Article 4 and Sub -Paragraph 1 of Article 
5. 
Article 14  The central competent authority shall notify the applicant the result of the applic ation 
stipulated under Article 4 and 5. The applicant, within three months after the arrival 
date of the notice, shall provide electronic files of approved labels, leaflets, and 
packaging, and pay the fee to the central competent authority to obtain the li cense.  
Article 15  The i tems  of registration stipulated under the preceding Article shall be as follows:  
1. Product item.  
2. Product name; model number and color code for serial products.  
3. Active ingredients and content percentage.  
4. Dosage  form . 
5. Leaflets, labels,  packaging, and specifications.  
6. Purpose.  
7. Name of the applicant.  
8. Name and address of the manufacturer.  
Article 16  The license stipulated under Article 14 shall state validity term and i tems  mentioned in 
Sub-paragraph of the preceding Article except for the  items  of Sub -paragraph 5.  5 
 Article 17  If the document or data attached to the application is deficient, or the fee is unpaid, the 
central competent authority shall request the applicant for the correction within the 
time limit.  
The applicant who fails to correct the deficiency within the time limit under the 
preceding Paragraph may request an extension in writing to the central competent 
authority with reasons before the expiration of the time limit. The extension is one 
month upon the next day of the expi ration of correction.  
If the applicant fails to correct the deficiency per the preceding two Paragraphs, the 
application shall be refused.  
Article 18  The application shall be disapproved if one of the following conditions applies:  
1. Attached document or dat a is inconsistent with the content of the application.  
2. Containing prohibited ingredients per Paragraph 1 of Article 6 of the Act, or the 
ingredients violate the limit on usage of ingredients set forth under Paragraph 2 of 
Article 6 of the Act.  
3. The labeling  of packaging, labels or, leaflets violates Article 7 of the Act.  
4. Text or picture of the product name, packaging, labels or, leaflets has  deception, 
exaggeration, or involving medical efficacy as set forth under Paragraph 1 and 2 of 
Article 10 of the Act.  
5. Any conditions that may harm human health.  
6. Other violation of laws, regulations or public announcement made by the central 
competent authority.  
Article 19  If the license of specific purpose cosmetics is damaged or lost, the applicant may pay 
the fee to the central competent authority and apply for the replacement or reissue. 
The original license shall be attached if applying for the replacement.  
Chapter 3 Modification of Registration, and Transfer and Modification of License  
Article 20  If there is any change of the information of registration or license mentioned in Article 
15 or 16, the applicant shall provide the original license and relevant documents  and 
pay the fee to the central competent authority to apply for the modification per 
Paragraph 2 of Article 5 of the Act. After the central competent authority reviews and 
approves, the original license shall additionally state the modified registration, d ate, 
and returned the license with the stamp.  
If the Modification mentioned in the preceding Paragraph is to increase items or color 
systems, those products shall be made by the same manufacturer, same active 
ingredients, same dosage  form and purpose , and  conforming to the limit on usage of 
specific purpose ingredients as set forth by the central competent authority.  
Article 
21 Applying for transfer of the license of specific purpose cosmetics, the transferor and 
transferee shall file a joint application with the original license and relevant 
certificates, and pay the fee to the central competent authority to apply for the 6 
 approval.  
The original license shall identify the name of the transferee and the approval date 
when the central competent authority mak es an approval mentioned in the preceding 
Paragraph.  
Article 
22 Applying for the revocation of the license of specific purpose cosmetics, the 
application with the original license and relevant documents shall be submitted to the 
central competent authority.  
Chapter 4 Extension of License  
Article 23  Applying for an extension of the term of validity of the license of specific purpose 
cosmetics per Paragraph 5 of Article 5 of the Act, the applicant shall submit an 
application with the following documents, and pay the fee to the central comp etent 
authority:  
1. The original license.  
2. The copy of the company or business registration certificate.  
3. The Authorization letter issued within the past two years except for domestic 
manufacturing.  
Article 24  If the extension is not applied before the expira tion of the term of the license of specific 
purpose cosmetics per the preceding Article, the application shall re -apply for 
registration and license per Paragraph 1 of Article 5 of the Act. However, the applicant 
may submit an application with the followin g documents, and pay the fee to the central 
competent authority if re -apply license within six months after the term expired:  
1. The original license.  
2. The copy of the company or business registration certificate.  
3. For domestic contract manufacturer , the manufactur e agreeme nt. For foreign 
contract manufacturer  and import, the certificate identifies the relationship between 
the hiring firm and contract manufacturer .  
4. For importer, MFSC, ingredient list and authorization letter issued within the past 
two years  
The license with the new license  number will be issued after the approval of the 
application mentioned in the preceding Paragraph.  
Chapter 5 Supplementary.  
Article 25  These Regulations shall take effect on July 1, 2019.  
 
  7 
 Appendix: Required Technical Information for registration of specific purpose 
cosmetics containing new substance, new purpose or new maximum concentration  
item information  New 
substance  New 
purpose  New maximum 
concentration  
(elevating maximum 
concentration ) 
origin of substances, 
research and develop 
history, foreign 
application status  origin of substances, 
research and develop 
history  ○ ○ ○ 
foreign application status  ○ ○ ○ 
Characteristic comparison 
information  ○ ○ ○ 
Characteristics, 
specification of analysis  Chemical structure  ○ ╳ ╳ 
Physical/chemical 
Characteristics  ○ ╳ ╳ 
specification and method 
of analysis  ○ ○ ○ 
Stability test  Long -term test  ○ ○ ○ 
Stress test  ○ ○ ○ 
Acceleration test  ○ ○ ○ 
Safety test report  Acute toxicity test  ○ △ △ 
subacute toxicity test  ○ △ △ 
Chronic toxicity test  ○ △ △ 
Local sensitizing test  ○ △ △ 
Antigenicity test  ○ △ ╳ 
*Mutagenicity test  △ ╳ ╳ 
*Carcinogenicity test  △ ╳ ╳ 
*Reproductive toxicity test  △ ╳ ╳ 
Test report of 
Absorption,  
Distribution,  
Metabolism,  
Excretion  Absorption  △ △ △ 
Distribution  △ △ △ 
Metabolism  △ △ △ 
Excretion  △ △ △ 
Purpose -related 
information  Functionality or efficacy 
data ○ ○ ○ 
Human test data  ○ ○ ○ 
Approval document  
Of other country  △ △ △ 8 
 Notes： 
1. 「○」means that the information under that item shall be provided. 「△」means that 
it depends via a case -by-case basis. 「╳」means that the information under that 
item is not necessary to be provided.  
2. 「Foreign application status 」: No need to provide if developed domestically.  
3. 「Test specifications and results 」: Including materials and preparations.  
4. 「Stability test 」:Including materials and preparations. No need to provide 
preparations for the ones bearing 「*」mark.  
5. Antigenicity tests shall include skin allergen tests and photoallergic  tests; local 
irritation tests shall include skin irritation tests and mucosal stimulation tests.  
6. Operation of stability tests may refer to international guideline or 「Guidelines on 
the Drug Stability Study 」as announced by the central health competent autho rity。 
7. To conduct safety evaluation of cosmetics or cosmetic ingredients , cosmetics 
businesses shall comply with paragraph 4 and paragraph 6 of article 6 of the Act.  
 
 