1 
 Proposed Draft of Regulations  for Cosmetic  Product  Information  File Management  
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.  
 
Article 1  The regulations are prescribed pursuant to  Paragraph 3 of Article 4 of 
the Cosmetic Hygiene and Safety Act (hereinafter referred to as "th e 
Act").  
Article  2 The cosmetics manufacturers or importers of a certain scale  
(hereinafter referred to as " cosmetics manufacturers or importers ")  
mentioned in Paragraph 1 of Article 4 of th e Act shall mean the 
following entities which engage in cosmetics manufacturing or 
importing:  
1. The c ompanies and businesses which shall  apply for  registration  
according  to the Company Act and Business Registration Act.  
2. The factories which shall complete registration a ccording to 
Paragraph 1 of Article 8 of th e Act . 
3. The groups and corporations which engage in cosmetics 
manufacturing or importing , except the handmade soap entities 
which are exempt from industry registration, excluding the entities 
mentioned  in preceding two subparagraphs . 
Article 3  Cosmetic product inf ormation file sh all establish t he following 
information  in Chinese or English:  
1. Basic information  of the product: the name of the product, the 
categor y of the product, dosage form, purpose, the name s and 
address es of manufactur ing facilit ies, information of  product 
manufacturer s or importer s.   
2. Evidentiary  documents of completing product registration . 
3. Full ingredient names and the individual content . 
4. The outer packaging of the product s, container s, label s or leaflet s.  
5. GMP compliance certificate s or self -declaration s which the 
manufacturing facilities comply with cosmetic Good Manufacturing 
Practice Regulations  
6. Manufacturing methods  and procedures . 
7. Usage methods, body parts, dosage, frequencies and the targeted 2 
 population.  
8. Adverse effects of the product application.  
9. Physical and chemical characteristics of the products and individual 
ingredients.  
10. Toxicological data of the ingredients.  
11. The product stability test reports.  
12. The microbiological test reports.  
13. The antimicrobial effectiveness test reports.  
14. Suppor ting information of the functional assessments.  
15. Information about the packaging material s which ha ve contact  
with the products.  
16. Product safety information:  
(1) Safety evaluation conclusion and suggestion which ha s the 
signature  of the signator y for the safety report and the date.  
(2) Qualification certificates which the signator y for the safety 
report  complies with Article 4, 5 and 6.  
Cosmetic products which are manufactured  in separate processes , the 
name s and address es of manufacturing facilities mentioned in the 
Subparagraph 1 of the previous paragraph shall include all of the 
manufacturing facilities in the process es and their operation 
procedures . 
Cosmetic product information file shall be renewed in accordance 
with Paragraph 1 when it changes.  
 
Article 4  A person  who  graduate d from department of medicine,  department  of 
pharmacy, toxicology ,  cosmetic  and other  related departments or 
graduate schools at the  domestic university or the foreign university 
which complies  with Regulations Governing the Assessment and 
Recognition of Foreign Academic Records by Institutions of  Higher 
Education  (hereinafter referred to as " domestic or foreign university "), 
and has taken  cosmetic safety evaluation training course s which are 
provided  by domestic or foreign university , or by central competent 
authority , the person  may serve  as a signatory for the safety report of 
product information file  mentioned in Subparagraph 16 of P aragraph 1 
of the  preceding  article.  
The content  and hours  of cosmetic safety  evaluation  training course s 
mentioned in the preceding  paragraph shall be:  3 
 1. Cosmetic  management regulation s: including cosmetic  hygiene 
management regulations of R.O.C ( Taiwan ), international cosmetic 
hygiene  regulations , and the system  of cosmetic product 
information file in R.O.C. (Taiwan) ; at least 4 hours.  
2. Applications  and risk s of cosmetic ingredients: including the action 
principles and safety of whitening , sunscreen, antiperspirant, 
deodorant, hair -dyeing, permanent wavi ng and other ingredients, 
and common cosmetic adverse effects and violations ; at least 8 
hours.  
3. Methods of cosmetic  safety  evaluation : including skin anatomy and 
physiology , cosmetic percutaneous  absorption  capacity , skin 
irritation , the mechanism and symp tom of photoaging and 
photoallergy, the safety evaluation  of nanomaterial s, the safety 
evaluation  of natural substance  cosmetic , the cosmetic risk 
assessment, toxicological evaluation methods(skin irritation, skin 
sensitization, skin corrosivity, eye irrit ation and  genetic toxicity and 
mutagenicity test ), systemic toxicity and margin of safety,  and 
alternative method s of animal testing ; at least 36 hours.  
4. Concluding the product safety evaluation : at least 6 hours.  
Article 5  The signatory for the safety report of product information file  shall 
take at least eight hours courses yearly which are provided by the 
domestic  or foreign university,  or by central competent authority , and 
the courses shall relate to Paragraph 2 of the preceding  article.  
Article 6  The countr ies (region s) or areas which have signed the cooperation 
agreement s of the signatory for the safety report of product 
information file with R.O.C  (Taiwan) , their  signatories are exempted  
from  the application of  Paragraph1 of A rticle 4 and the pre ceding  
article . 
Article 7  The cosmetic product information file may be stored  by written 
records or the means of electronic data storage media . 
The file stated in the preceding paragraph shall be kept for a t least five  
years from the next day of the date of the product lastly available in 
the market . 
Article 8  The cosmetics manufacturers or importers shall store  the product 
information file at the address mentioned in  Subparagraph 7 of 
Paragraph 1 of Article 7 of th e Act and provid e it for the competent 
authority  inspection .  
The competent authority  shall s end a notification  at least five days 4 
 before it assigns officers to inspect the file  mentioned in the preceding 
paragraph unless  the emergency or  the need of public interests . 
Article 9  The Regulations shall  be effective on the date of promulgation of the 
Act.