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

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

VISION of KFDA v Promoting the public health by ensuring the safety and efficacy VISION of KFDA v 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

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

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

Principal Food Safety & Quality Legislation The Food Sanitation Act v Purpose of the Principal Food Safety & Quality Legislation The Food Sanitation Act v Purpose of the Act ü To protect the people from health hazards which may be caused by eating or drinking, and to help improve an promote public health ü 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 5

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

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

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

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

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

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

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

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

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

Authorization of Foreign Official Laboratory Objectives v To acceptance of inspection results prepared by Authorization of Foreign Official Laboratory Objectives v To acceptance of inspection results prepared by official laboratories of exporting countries Requirements for Application for Authorization v Laboratories which are under the direct control of central or local governments of exporting countries v Private Laboratories approved or designated by central or local governments of exporting countries v 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) 15

Pre / Conformation Based Registration System of Imported Foods v Overview of the system Pre / Conformation Based Registration System of Imported Foods v Overview of the system ü 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

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

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

Status of Imported Foods (2004) EU Items Account Total Weight (Ton) Total Amount (1, Status of Imported Foods (2004) EU Items Account Total Weight (Ton) Total Amount (1, 000$) Account Weight (Ton) Amount (1, 000$) 33, 783 274, 510 863, 894 196, 968 11, 454, 463 6, 503, 834 744 24, 108 13, 829 32, 316 7, 677, 891 2, 497, 456 Processed Foods 22, 718 164, 624 551, 810 110, 967 342, 422 2, 703, 102 Foods Additives 5, 141 55, 663 130, 240 27, 613 162, 957 418, 248 Apparatus etc. 3, 796 28, 864 161, 767 20, 256 169, 722 452, 194 384 1, 251 6, 248 5, 816 11, 471 432, 834 Agr • Forest Products Health functional foods 19

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