G/TBT/N/TPKM/195
16 January 2015 
(15-0291)  Page: 1/2
Committee on Technical Barriers to Trade  Original: English
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: THE SEPARATE CUSTOMS TERRITORY OF TAIWAN, PENGHU, KINMEN 
AND MATSU 
If applicable, name of local government involved (Article 3.2 and 7.2):    
2. Agency responsible: 
Food and Drug Administration 
Ministry of Health and Welfare No.161-2, Kunyang St, Nangang District 
Taipei City 115-61, Taiwan 
Tel.: (886-2) 2787-8000 ext 7564 Fax: (886-2) 2787-7589 E-mail: myrna_li@fda.gov.tw   
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :   
3. Notified under Article 2.9.2 [ X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:  
4. Products covered (HS or CCCN where applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Cosmetics 
5. Title, number of pages and language(s) of the notified document: Proposed 
amendment of the Statute for Control of Co smetic Hygiene (12 pages, in English) 
6. Description of content: In view of the fact that current cosmetic regulations are 
inadequate in the face of practical requirem ents, the proposed amendment of the Statute 
for Control of Cosmetic Hygiene was formulated  to increase the protection of national 
health and international trade liberalization. The main amendments contained in this draft 
are as follows:  
1.  The definition of cosmetics has been revised to expend the cosmetic categories to 
oral care products; 
2. Both of registration and market approval for cosmetics containing medical, 
poisonous or potent drug(s) and pre-market filing for other cosmetics have been replaced by requirements of product no tification and product information files 
creation; 
3. Regulations governing the labelling information have been amended; 
4. Manufacturers for cosmetics have been required to comply with good manufacturing 
practice and be supervised by pharmacists or personnel with professional skills in 
the field of cosmetics; 
5. Pre-approval of advertisements has been  replaced by increase of the legal 
responsibility of businesses, including that cosmetics businesses may be required to 
publish or broadcast corrective advertisements in case of severe violations of 
advertisements regulation and media businesses shall preserve data pertaining to commissioning entities for advertisements to allow an effective tracking of the 
source of violating advertisements; G/TBT/N/TPKM/195 
 
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  6. Cosmetics businesses have been given responsibilities of keeping data on direct 
supply sources and destinations of products and reporting serious adverse effect generated by cosmetics; 
7. The central competent authority is authorized to announce certain cosmetics 
categories or items that may be pose a hazard to hygiene and safety requiring test checks and inspection at the time of importation; 
8. 
 Competent authorities may grant rewards to people who found violations of the 
provisions listed in this Act; 
9. Criminal punishment has been converted into administrative fines with minimum fine 
amounts have been specified and maximum fine amounts have been increased. 
Competent authorities have been authorized to publish information about violations and 
businesses committing violations to protect the rights and interests of consumers, and to appoint or commission other units to conduct legally required inspections, test checks, 
tests or issue production and sales certificates. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Consumer protection 
8. Relevant documents:  Statute for Control of Cosmetic Hygiene 
9. Proposed date of adoption:   To be determined 
Proposed date of entry into force:   To be determined 
10. Final date for comments: 60 days from the date of notification 
11. Texts available from: Nati onal enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
WTO/TBT Enquiry Point 
The Bureau of Standards, Metrology and Inspection 
Ministry of Economic Affairs 
4, Chinan Road, Section 1 Taipei City 100, Taiwan 
Tel.: (886-2) 2343-1801 
Fax: (886-2) 2343-1804 E-mail: tbtenq@bsmi.gov.tw  
https://members.wto.org/crnattachm ents/2015/TBT/CHT/15_0200_00_e.pdf