G/SPS/N/TPKM/342  
 
7 January 2015  
(15-0052)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
1. Notifying Member: THE SEPARATE CUSTOMS TERRITORY OF TAIWAN, PENGHU, 
KINMEN AND MATSU 
If applicable, name of local government involved:   
2. Agency responsible: Ministry of Health and Welfare 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Food for human consumption 
4. Regions or countries likely to be affected , to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document: Act Governing Food Safety and Sanitation  
Language(s): Chinese  Number of pages: 13 
http://members.wto.org/crnattachments/2014/sps/CHT/14_5608_00_x.pdf  
6. Description of content: A Decree was promulgated to amend the Act Governing Food 
Safety and Sanitation on 10 December 2014. The key features of the new amendment 
are: the listed companies, OTC companies and food enterprises under a certain category 
or with a certain scale shall establish laboratories for self-testing, food enterprises subject to the establishment of a traceability  system shall follow the requirements of 
competent authorities to use electronic invoices on stages for accuracy of tracing, the 
factories for food or food additives shall be established independently and the production, processing and preparation of non-food commodities is prohibited, imposing 
comprehensively stricter penalties on non-compliant businesses. 
7. Objective and rationale: [X] food safety, [ ] animal health, [ ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [ ] protect territory from 
other damage from pests.   
8. Is there a relevant international stan dard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None 
Does this proposed regulation conform to the relevant international standard?   
[ ] Yes   [ ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   G/SPS/N/TPKM/342 
 
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  9. Other relevant documents and language (s) in which these are available: Act 
Governing Food Safety and Sanitation (Presidential Decree No. Hua-Zhong-Yi-Yi-Zi-10300184621 dated 10 December 2014) can be found at: http://www.fda.gov.tw
  
(available in Chinese). 
10. Proposed date of adoption (dd/mm/yy) : The law was enacted on 
10 December 2014. 
Proposed date of publication (dd/mm/yy) : Not applicable. 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : The Act Governing Food Safety and Sanitation entered into force 
on 12 December 2014. Subsequent regulations will be developed later to implement different aspects of the statute. 
[ ] Trade facilitating measure   
12. Final date for comments: [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable.  
Agency or authority designated to hand le comments: [X] National Notification 
Authority, [X] National Enquiry Point. Address, fax number and e-mail address 
(if available) of other body:   
13. Text(s) available from: [X] National Notifi cation Authority, [X] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
Food and Drug Administration  
Ministry of Health and Welfare No.161-2, Kunyang St., Nangang District, Taipei City 115-61, Taiwan (R.O.C.) 
Tel: +(886 2) 2787 7313 
Fax: +(886 2) 2653 1062 E-mail: 1587syj@fda.gov.tw