. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/TPKM/185 
26 May 2010  
 (10-2901) 
Committee on Sanitary a nd 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:  Food and Drug Administration, Department of Health, Executive 
Yuan 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Foods produced using recombinant-DNA organisms 
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:  Draft Guideline for Food Safety Assessment of 
Genetically Modified Foods Derive d from Recombinant-DNA Organisms  Language:  
English  Number of pages:  26 
http://members.wto.org/crnattach ments/2010/sps/TPKM/10_2173_00_e.pdf  
http://members.wto.org/crnattach ments/2010/sps/TPKM/10_2173_00_x.pdf  
6. Description of content:  The draft guideline explains the information required for food 
safety assessment of genetically modified foods  (hereafter as GM foods) produced using 
recombinant-DNA organisms. 
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:  
[X] 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)    
[ ] None Does this proposed regulation conform to the relevant international standard?   
 [ ] Yes   [ ] No G/SPS/N/TPKM/185 
Page 2  
 
   If no, describe, whenever possible, how and why it deviates from the 
international standard:  The "Guideline for the Conduct of Food Safety Assessment of 
Foods Derived from Recombinant-DNA Plants" is  the reference.  The full texts may be 
downloaded from the following website:   http://www.codexalimentarius.net/ download/standards/10021/CXG_045e.pdf
 
9. Other relevant documents and language(s) in which these are available:  Draft 
Guideline for Food Safety Assessment of Genetically Modified Foods Derived from 
Recombinant-DNA Organisms available in English from the Food and Drug Administration, Department of Health, Ex ecutive Yuan.  The guideline will be announced 
when adopted.  The full texts may be downloaded from the following website:  http://www.fda.gov.tw/news.aspx?newssn=4714& key_year=2010&keyword=&classifysn=
3   
10. Proposed date of adoption (dd/mm/yy) :  To be determined. 
Proposed date of publication (dd/mm/yy) :    
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  To be determined. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  10 July 2010 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [X] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:   
Food and Drug Administration  
Department of Health, Executive Yuan  No.161-2, Kunyang St, Nangang District, Taipei City 115-61, Taiwan  Tel.:  +(886 2) 2653 1248  Fax: +(886 2) 2653 1062 E-mail:  sarah@fda.gov.tw 
13. Texts available from:  [X] National Notification Authority, [X] National Enquiry 
Point.  Address, fax number and e-mail address (if available) of other body:    
Food and Drug Administration  
Department of Health, Executive Yuan  No.161-2, Kunyang St, Nangang District, Taipei City 115-61, Taiwan  Tel.:  +(886 2) 2653 1248  Fax: +(886 2) 2653 1062 
E-mail:  sarah@fda.gov.tw