G/TBT/N/KOR/686  
 
1 November 2016  
(16-5976) 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 : REPUBLIC OF  KOREA  
If applicable, name of local government involved  (Article 3.2 and 7.2) :  
2. Agency responsible : Ministry of Food and Drug S afety 
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 : 
International Cooperation Of fice, Ministry of Food and Drug Safety  
187 Osongsaengmyeong2 -ro, Osong -eup 
Heungdeok -gu, Cheongju -si 
Chungcheongbuk -do, 28159, Republic of Korea   
Tel: (+82) 43 -719-1564 
Fax: (+82) 43 -719-1550 
Email : wtokfda@korea.kr   
3. Notified under Article 2.9.2 [ X], 2.10.1 [  ], 5.6.2 [  ], 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) : Health functional food 
product s 
5. Title, number of pages  and language(s)  of the notified document : Proposed 
Amendments  for "Regulations for Re -assess ment of Functional Ingredients"(13 pages, 
available in Korean)  
6. Description of content : Main proposed amendment of the "Regulations for Re -
assess ment o f Functional Ingredients" as  follows:  
This regulation is pursuant to Article 15(2) of the "Functional Health Foods  Act" and 
Article  20(3) of the Enforcement Rules of the Act, to establish the requirements for the 
standards, methods, proc edures, etc. of reviewing and assessing the safety and 
functionality of functional ingredients (including final products) that have been previously 
identified, as well as of health functional foods, to the latest scientific level.  
 To set forth conditions a nd methods of re -assessment of functional ingredients  
 To determine matters related to the publishing of re -assessment results  
 Related data of functionality contents, including the human study, cases 
collected through distribution, literature information, etc.  
 Related data of safety, including adverse event, toxicological data, cases 
collected through distribution, literature information, etc.  
 To determine the scope of data of functional ingredients needed to be submitted for 
their re -assessment  
 To determi ne matters needed to be taken into account in examining draft proposals 
for re -assessment  G/TBT/N/KOR/686  
 
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  7. Objective and rationale , including the nature of urgent problems where 
applicable : Provide better information to consumers, promotion of public health  
8 Relevant  documents : Ministry of  Food and Drug Safety Advance Notice No. 2016 -685, 
21 October 2016 (available in Korean)  
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  [ ] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:  
Technical Barriers to Trade(TBT) Division  
Korean Agency for Technology and Standards (KAT S) 
93, Isu -ro, Maengdong -myeon, Eumseong -gun 
Chungcheongbuk -do, 27737  
Republic of Korea  
Tel.: (+82) 43 870 5525   
Fax: (+82) 43 870 5682  
E-mail: tbt@kats.go.kr   
Website : http://www.k nowtbt.kr   
https://members.wto.org/crnattachments/2016/TBT/KOR/16_4545_00_x.pdf