G/TBT/N/TPKM/457  
28 May 2021  
(21-4431) 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:   
Toxic and Chemical Substances Bureau  
Environmental Protection Administration  
No.1, Aly. 35, Ln. 132, Sec. 2, Da'an Rd.  
Da'an Dist., Taipei City 10667, Taiwan  
Tel: +886 -2-2325-7399 ext.55329  
Fax: +886 -2-2325-3823 
Email: poyen.hsieh@epa.gov.tw  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding th e notification shall be indicated if different from above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [X], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Chemical 
Substances; INORGANIC CHEMICALS; ORGANIC OR INORGANIC COMPOUNDS OF 
PRECIOUS METALS, OF RARE -EARTH METALS, OF RADIOACTIVE ELEMENTS OR OF 
ISOTOPES (HS 28); ORGANIC CHEMICALS (HS 29); MISCELLANEOUS CHEMICAL 
PRODUCTS (HS 38); PLASTICS AND ARTICLES THEREOF (HS 39); CHEMICAL 
TECHNOLOGY (ICS 71)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Amendments to Regulations for New and Existing Chemical Substances Registration (22 
page(s), in E nglish; 58 page(s), in Chinese)  
6. Description of content:  Regulations of New and Existing Chemical Substances 
Registration (hereinafter referred to as the Regulations) were promulgated on 11 
December 2014 and amended on 11 March 2019.  
After reviewing the  practice of annual reporting and standard registration of existing 
chemical substances through collecting stakeholders' opinions, the draft amendments to 
the Regulations is introduced under the consideration of the impacts of the COVID -19 
pandemic, and in  accordance with the Toxic and Concerned Chemical Substances Control 
Act amended on 16 January 2019. The highlights of the amendments are as follows:  
1. The name and the provisions of the Toxic and Concerned Chemical Substances 
Control Act, with which the Regulations are established in accordance, is 
amended.  
2. The controlled chemicals, as prescribed in the Occupational Safety and Health 
Act, as well as the concerned chemical substances, as defined by the Toxic and G/TBT/N/TPKM/457  
 
- 2 - 
 
  Concerned Chemical Substances Control Act, a re not applicable to the 
Regulations.  
3. To reduce the highly overlapping contents of appendixes, the appendixes of the 
Regulations are combined and amended accordingly.  
4. The valid and confidential periods of the registration approval are unified as 5 
years. F urthermore, for a new chemical substance that has been included in the 
inventory of existing chemical substances, the maximum confidential period is 
15 years.  
5. The deadline for standard registration of existing chemical substances is 
extended to 4 years. I n addition, the on -site isolated intermediates of existing 
chemical substances are exempted from standard registration.  
6. Completion numbers for the standard registration of existing chemical 
substances are issued to those who apply and complete information items 
regarding registrants and substances. The registrants shall complete the 
remaining information items proactively or before the appointed due date.  
7. The articles governing the notification of report supplementation and correction 
are also specified.  
8. The review periods and the number of extensions of review periods for 
applications are also amended.  
9. The article stating that registrants must retain all application documents for 
future reference is deleted.  
7. Objective and rationale, including the nature  of urgent problems where 
applicable:  The purpose of the amendments is to reflect the practice of chemical 
substances registration mechanisms and the stakeholders' opinions . 
8. Relevant documents:  Toxic and Concerned Chemical Substances Control Act (TCCSCA)  
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 notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
WTO/TBT Enquiry Point  
Bureau of Standards, Metrology and Inspection  
Ministry of Economic Affairs  
No.4 , Sec. 1, Jinan Rd., Zhongzheng Dist.  
Taipei City 100 , Taiwan  
Tel: +(886 2) 3343 -5140  
Fax: +(886 2) 2343 -1804  
E-mail: tbtenq@bsmi.gov.tw  
https://members.wto.org/crnattachments/202 1/TBT/TPKM/21_3685_00_x.pdf  
https://members.wto.org/crnattachments/2021/TBT/TPKM/21_3685_00_et.pdf