G/TBT/N/TPKM/291/Rev.1  
 
4 April 2018  
(18-2036) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
  
NOTIFICATION  
Revision  
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 (Articles 3.2 and 7.2):   
2. Agency responsible:   
Environmental Protection Administration  
No. 83, Zhonghua Rd. Sec 1  
Zhongzheng Dist, Taipei City 10042, Taiwan  
Tel: (+886 2) 2325 -7399  
Fax: (+886 2) 2325 -3823  
Email: chjin@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 the 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  
5. Title, number of pages and language(s) of the notified document: Amendments to 
Regulations of New and Existing Chemical Substances Registration (Draft) (32 page(s), in 
English; 67 page(s), in Chinese)  
6. Description of content: The Toxic Chemical Substances Control Act (TCSCA) was 
amended and promulgated on 11 December 2013. Pursuant to TCSCA, the subordinate 
implementing law "Regulations of New and Existing Chemical Substances Registration and 
Manageme nt" were enacted on 11 December 2014. This proposal aims to update the 
provisions under the "Regulations of New and Existing Chemical Substances Registration." 
Major amendments include the following:  
1. Clarifying the scope of application of the Regulations. The Regulations shall not apply to 
Toxic Chemical Substances, as defined by TCSCA.  
2. Harmonizing the information requirement between the EPA and the Ministry of Labour 
regarding hazard assessment  and exposure assessment;  
3. Issuing the registration number, instead of the registration document for the 
registration approved;  
4. Clarifying the quantity that triggers the obligation for the existing chemical substance 
phase 1 registration. For an exi sting chemical substance manufactured or imported in the 
annual volume of 100 kilograms or more, the phase 1 registration must be made within 6 G/TBT/N/TPKM/291/Rev.1  
 
- 2 - 
 
  months. Also a voluntary phase 1 registration may be made for the existing chemical 
substance manufactured or im ported in the annual volume less than 100 kilograms.  
5. Designating the first stage of 106 chemical substances subject to the standard 
registration of existing chemical substances.  
6. Clarifying the period of the information confidentiality of chemical s ubstances included in 
the inventory of existing chemical substances, and ensuring consistency in the period of 
the information confidentiality and the validity of registration approval;  
7. Requiring an annual report of the new and existing chemical substa nce registered and 
approved. For the chemical substance registered and approved, an annual report shall be 
completed from April to September each year;  
8. Indicating the calculation of the review period, so that the review period is calculated 
anew upon t he registrant's supplementation or modification of the registration application;  
9. Extending the limit on the time period and the number of times that a supplementation 
and correction may be made for a registration application, by taking into account the  
scientific and technical feasibility assessed by the EPA.  
10. Accepting written appeal with stated reasons for which the registrant may have 
concerns over the review result.  
11. Deleting outdated provisions.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The purpose of these amendments are to reflect the global trends in chemical 
substance registration mechanisms, to meet the essential need of inter -agency 
cooperation, to reasonably reduce the costs incurred from  chemical risk assessment and 
governmental administration, as well as to achieve the goal of environmental and human 
health protection.  
8. Relevant documents: Toxic Chemical Substances Control Act (TCSCA)  
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 or 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  
4, Chinan Road, Section 1  
Taipei City 10051, Taiwan  
Tel: (+886 2) 2343 -1813 
Fax: (+886 2) 2343 -1804 
E-mail: tbtenq@bsmi.gov.tw  
https://members.wto.org/crnattachments/2018/TBT/TPKM/18_1833_00_x.pdf  
https://members.wto.org/crnattachments/2018/TBT/TPKM/18_1833_00_e.pdf