G/SPS/N/KOR/506  
 
12 June 2015  
(15-3065)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
1. Notifying Member: REPUBLIC OF KOREA 
If applicable, name of local government involved:   
2. Agency responsible: Ministry of Food and Drug Safety 
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): Testing laboratories (foods, livestock products, drugs, 
traditional Korean medicinal substances, medical devices, cosmetics) 
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: Proposal to Amend Enforcement Regulation of Testing 
and Inspection of Food and Drugs Act  Language(s): Korean  Number of pages: 53 
http://members.wto.org/crnattachments/2015/SPS/KOR/15_2309_00_x.pdf  
6. Description of content: This proposal seeks to: 
a. Impose laboratories to establish appropriate number of testing case considering their 
manpower, facilities, instruments and etc., and comply with it.  
b. Prepare legal base to delist improper laboratories when reviewing for renewal after 
three years from previous designation, by  considering annual testing cases, service 
suspension records, or test capability evaluation results.  
c. Amend the Testing Laboratories Guidelines to install an audit trail for instruments. d. Lengthen the service suspension for th e laboratories which failed to report 
unacceptable results, conduct testing in a standardized method, or receive the 
correct fee.  
e. Widen the standards for medical device testing laboratories to harmonize with the 
international standards.  
f. Shorten administrative process time fo r representative change of laboratories. 
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 st andard? 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)    G/SPS/N/KOR/506 
 
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  [ ] 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:   
9. Other relevant documents and language (s) in which these are available: Testing 
and Inspection of Food and Drugs Act, Regulation of Food and Drugs Testing 
Laboratories Assessment (available in Korean) 
10. Proposed date of adoption (dd/mm/yy) : To be determined. 
Proposed date of publication (dd/mm/yy) : To be determined. 
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: [X] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 11 August 2015 
Agency or authority designated to hand le comments: [ ] National Notification 
Authority, [X] National Enquiry Point. Address, fax number and e-mail address 
(if available) of other body:  
International Cooperation Office 
Ministry of Food and Drug Safety #187 Osongsaengmyeong2-ro, Osong-eup, Heungdoek-gu Cheongju-si, 
Chungcheongbuk-do 
363-700, Korea Tel: +(82 43) 719 1559 
Fax: +(82 43) 719 1550 
E-mail: wtokfda@korea.kr 
13. Text(s) available from: [ ] National Notifi cation Authority, [X] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
Documents are available from the Korea Ministry of Government Legislation website at 
http://www.law.go.kr . Also available from: 
International Cooperation Office 
Ministry of Food and Drug Safety  #187 Osongsaengmyeong2-ro, Osong-eup, Heungdoek-gu Cheongju-si, 
Chungcheongbuk-do 
363-700, Korea Tel: +(82 43) 719 1559 
Fax: +(82 43) 719 1550 
E-mail: wtokfda@korea.kr