1. Introduce on Imported Foods System in Korea - Under The Food Sanitation Act - Korea Food and Drug Administration

2. History of KFDA  1996. 4. 6 : The Korean Food & Drug Safety Headquarter and six Regional offices were established.  1998. 2. 28 : The Korea Food & Drug Administration 1

3. VISION of KFDA  Promoting the public health by ensuring the safety and efficacy of foods, pharmaceuticals, medical devices and cosmetics, and supporting the development of the food and pharmaceutical Industries. 2

4. Mission Statement  Supervising manufacture, importation, and distribution of foods and health functional foods and their safety  Supervising manufacture and importation of pharmaceuticals and distribution of narcotic drugs and approving importation Pharmaceuticals  Supervising manufacture and importation of medical devices and medical radioactivity  Supervising manufacture of cosmetics and evaluating the safety and efficacy of functional cosmetics  Setting standards and specifications for foods and pharmaceuticals and conducting research related to their safety 3

5. Bodies Responsible in Food safety  Regional Food & Drug Administrations  National Quarantine Station  National Veterinary Research & Quarantine Service  National Plant Quarantine Service  National fisheries Products Quality Inspection Service Ministry of Health and Welfare (MOHW) Ministry of Agriculture and Forestry(MAF) Ministry of Maritime Affairs and Fisheries(MOMAF) 4

6. Principal Food Safety & Quality Legislation  Purpose of the Act To protect the people from health hazards which may be caused by eating or drinking, and to help improve an promote public health Any Foods not complying with the FSA shall not be collected, manufactured, imported, processed, used, prepared, stored, transported or displayed for sale or for other commercial purpose The Food Sanitation Act 5

7.  Enforcement Regulations of the Food Sanitation Act (MOHW) Korea Food Code (KFDA Notification) Korea Food Additives Code (KFDA Notification ) Foods Labeling Standards (KFDA Notification ) The Specification and standards for foods 6

8. Food headquarters  To establish general policy for food safety management systems Food Safety Policy Team Food Management Team Food Import Team Food Safety & HACCP Team Risk Management Planning Team Food Headquarters 7

9.  To supervise overall food hygiene matters including surveillance for illegal and adulterated food  Supervising food importation and exportation, and conducting imported food inspection  Handling works relating to genetically modified foods  Codex-Alimentarius activities 8

10. Government Agencies  6 Regional agencies SEOUL, BUSAN(3 branches), GYEONGIN(3 branches), DAEGU, GWANGJU, AND DAEJEON REGIONAL KFDA Each agency serves as a field operation base conducting food & Drug surveillance and imported food inspections at its local Laboratory  9 National Quarantine Stations 9

11. KFDA Regional Offices Regional Quarantine Offices Gyeong-in Seoul Gwang-ju Busan Dae-jeon Daegu Headquarters Mokpo Yeosu Ulsan Pohang Donghae Jeju Gunsan Masan Tongyeong 10

12. Procedures for Imported Foods  Food Meat, Dairy, Egg Products MAF Fisheries Products MOMAF  Food Additives  Apparatus, Container-Packages  Health Functional foods Products Requiring Import Notifications 11

13. 1. Applicant 15. Violation 16. Notify to the Applicant and Regional Customs Director 17. Returns, Discards or Changes of the product of usages 18. Issue Pre-Certificate For Import Report Flow Charts of Import Procedures 3. Document Inspection 6. Random Sampling Inspection 5. Laboratory Test 4. Organoleptic Inspection Organoleptic Inspection 9. Conformity Assessment 10. Conformity 11. Issue Certificate for Import 12. Customs Clearance 13. Market access 14. Surveillance of Distributed Food Product 2. Files “Entry Report for Foods” 12 7. Field Inspection (Sampling) 8. Laboratory Test (by Food Sanitation Inspection Lab.)

14. Automated Imported Foods Inspection System  KFDA developed an Automated Inspection System for Imported Foods in April 1998  Improvement of efficiency and transparency of the procedures of imported foods inspection 13

15. Regulations related to imported foods ( KFDA Notification)  Inspection Guidelines for Imported Foods etc.  Provisions on the standards, etc. for authorization of foreign official laboratories  Pre/Confirmation based registration system of imported foods 14

16. Authorization of Foreign Official Laboratory  To acceptance of inspection results prepared by official laboratories of exporting countries Objectives  Laboratories which are under the direct control of central or local governments of exporting countries  Private Laboratories approved or designated by central or local governments of exporting countries  43 Organizations in 10 Countries USA(2), Thailand(5), Taiwan(4), Australia(9), Finland(1), Germany(1), Vietnam(6), China(10), India(4), France(1) Requirements for Application for Authorization 15

17. Pre / Conformation Based Registration System of Imported Foods  Overview of the system In the event it is confirmed in advance (prior to import) through on-the-spot investigation that the foods manufactured and processed in the factory of an export country comply with the Food Sanitation Act of Korea, document inspection may suffice for applying importation 16

18. Standard for Genetically Modified Food  To provide correct information to consumers  To ensure "Right-to-Know" & "Right-to-Choose"  Foods using soybeans, corns, and soybean sprout  July 13, 2001 Objectives Labeling 17

19. Exporting Foods Regulations  Notwithstanding the provisions of FSA, standards and specifications of foods for export may be subject to those as required by the importers 18

20. Items EUTotal Account Weight (Ton) Amount (1,000$) Account Weight (Ton) Amount (1,000$) Total33,783274,510863,894196,96811,454,4636,503,834 Agr Forest Products74424,10813,82932,3167,677,8912,497,456 Processed Foods22,718164,624551,810110,967342,4222,703,102 Foods Additives5,14155,663130,24027,613162,957418,248 Apparatus etc.3,79628,864161,76720,256169,722452,194 Health functional foods3841,2516,2485,81611,471432,834 Status of Imported Foods (2004) 19

21. Thank You !!! KFDA Food Import Team Phone : 82-2-380-1733,4 Fax : 82-2-388-6392 http://www.kfda.go.kr Any Questions ?