G/TBT/N/TPKM/291  
 
29 September 2017  
(17-5224) 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:  
Environmental Protection Administration  
No. 83, Sec 1, Zhonghua Rd.  
Zhongzheng Dist, Taipei City 10042, Taiwan  
Tel: (+886 2) 2325 -7399  
Fax: (+886 2) 2325 -3823  
Email: chhahsu@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  
5. Title, number of pages and language(s) of the notified document: Amendments to 
Regulation of New and Existing Chemical  Substances Registration (Draft) (21 page(s), in 
English; 59 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, "Regulation of New and Existing Chemical Substances Registration and 
Management ", was enacted on 11 December 2014. This proposal aims to update the 
provisions under the "Regulation of New and Existing Chemical Substances  Registration."  
Major amendments are as follows:  
1. Harmonizing the information requirement between the Environmental Protection 
Administration (EPA) and the Ministry of Labour regarding hazard assessment and 
exposure assessment;  
2. Issuing the registration num ber, instead of the registration document for the 
approved registration;  
3. Clarifying the quantity that triggers the obligation of the existing chemical 
substance phase 1 registration. For an existing chemical substance manufactured 
or imported in the annual  volume of 100 kilograms or more, the phase 1 
registration must be made within 6 months. Also a voluntary phase 1 registration 
may be made for the existing chemical substance manufactured or imported in an 
annual volume of less than 100 kilograms;  G/TBT/N/TPKM/291  
 
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  4. Clarifyi ng the period of confidentiality of information on chemical substances 
included in the inventory of existing chemical substances, and ensuring consistency 
in the period of the information confidentiality and the validity of registration 
approval;  
5. Requiring  an annual report on new and existing chemical substances registered 
and approved;  
6. Indicating the calculation of the review period, that the review period is calculated 
anew upon the registrant 's supplementation or correction to the registration 
applicatio n; 
7. Extending the limit on the time period and the number of times that 
supplementations and corrections may be made for a registration application, by 
the EPA taking into account the scientific and technical feasibility;  
8. Accepting written appeals with stated reasons for which the registrant may have 
concerns over the review results;  
9. Deleting outdated provisions.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: The purpose of this amendment is to align with global tr ends in chemical 
substance registration, to meet the essential needs of inter -agency cooperation, to 
reasonably reduce the costs incurred for chemical risk assessment and governmental 
administration, as well as to achieve the goal of environmental and huma n 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 and fax 
numbers and email and website addresses, if available, of other body:   
TPKM -WTO/TBT Enquiry Point  
Bureau of Standards, Metrology and Inspection  
Ministry of Economic Affairs  
No.4, Sec 1, Jinan Rd.  
Zongzheng Dist, Taipei City 100, Taiwan  
Tel: (+886 2) 2343 -1813 
Fax: (+886 2) 2343 -1804 
E-mail: tbtenq@bsmi.gov.tw  
https://members.wto.org/crnattachments/2017/TBT/TPKM/17_4382_00_e.pdf  
https://members.wto.org/crnattachments/2017/TBT/TPKM/17_4382_00_x.pd f