Prior Safety Management System of Imported Food Korea Food & Drug Administration Prior Safety Management System of Imported Food 2012

CONTENTS 1 2 3 4 Onsite Inspection of Exporter’s Facilities System of Registration for Prior Inspection Completion Good Importer Practice 3 System of Managing Safety of OEM Imported Foods 4

Onsite Inspection of Exporter’s Facilities 1

1. Onsite Inspection of Exporter’s Facilities Secure the safety of imported food in advance as recommendations for improvement after prediction of hazards occurrence possibility by inspecting the state of sanitation in exporters' manufacturing facilities Secure the safety of imported food by explanation of Korea's food import system and food standards and specifications Exchange of information between the countries’ officials on exportation and importation food system to import safe foods

System of Registration for Prior Inspection completion 2

2.1. System of Registration for Prior Inspection Completion This system is to secure safety of food imports by preemptively identifying any food safety hazards in manufacturing and processing facilities either by; conducting onsite inspections or, requiring the exporting country government to administer inspections and report the results. Food imports that are proved safe through this process are exempt from inspections when they are imported Exemption from the initial close inspection and random sampling inspection on imported foods of registered supplier

Application Qualification 2.2. System of Registration for Prior Inspection Completion Application Qualification suppliers manufacturing and processing food to be exported to Korea ※ importers can also apply on behalf of the exporters Registration Subject foods, food additives, utensils, containers, and packages, functional foods ※ agricultural, forestry, and fishery food products and other food products made though simple processing are excluded replace

Registration procedures Applying for registration for prior inspection 2.3. System of Registration for Prior Inspection Completion Registration procedures Applying for registration for prior inspection completion (required documents must be attached) →evaluation of documents → onsite inspection → final evaluation and determination → registration when satisfies ※ exporting country governments' inspection can replace onsite inspection

Costs( benefit principle is applied ) 2.4. System of Registration for Prior Inspection Completion Costs( benefit principle is applied ) - application charge of KRW 28,000 travel expenses for onsite inspectors Checklists whether or not the product should be included in the sales prohibition list with safety hazards whether or not the product meets specifications, and facilities meet standards whether or not there are any false or misleading labels whether or not the product satisfies HACCP standards

Good Importer Practice 3

3.1. Good Importer Practice This system is to make importers, as the first line of responsibility for the safety of food imports, conduct onsite inspection of manufacturing and processing facilities, of which the result can be confirmed, and can be registered as a "good importer" if it is satisfied Incentives on the Registered Product exemption from random sampling inspection, and fast- track administrative procedure when import declaration designated on KFDA homepages as an excellent import business - Allowed to use the " Good Importer" logo

3.2. Good Importer Practice Application Qualification persons who wish to import foods, etc Subjects - foods, food additives, utensils, containers, and packages ※ functional foods, agricultural, forestry, fishery food products and other food products made through simple processing are excluded Registration Procedures Inspect sanitation procedures in the exporter's facilities → apply to register → onsite sanitation inspection by the KFDA → register as a good importer

3.3. Good Importer Practice Required documents documents proving business licenses of the exporting manufacturer inspection report of manufacturers' facilities Application charge of KRW 28,000 Cheklists 85 items in 6 areas of raw materials and their storage, facilities, process management, quality control of finished products and their storage, consumer information, and staff training for conducting sanitation inspections ※ in accordance with the「Sanitation Management Standard for Manufacturers of Exporting Countries」

System of Managing Safety of OEM Imported Foods 4

4.1.System of Managing Safety of OEM Imported Foods This system is to make OEM food importers mandatorily conduct sanitation inspection of the exporter' manufacturing facilities and control the quality of the products ※ OEM(Original Equipment Manufacturing) foods are manufactured by overseas contractors and labeled with the contractee's brand(logo, sign, letter, figure, etc.)

Obligarion 4.2.System of Managing Safety of OEM Imported Foods Mandatory product quality control Imposing on OEM food importers duties of mandatory self-quality control for OEM food products (maintaining 2 years of product quality control records) Mandatory Sanitation Control Imposing on OEM food importers duties of mandatory sanitation control for the manufacturing facilities of the exporting country Mandatory submission of reasons for setting the circulation period applied to first-time batch of imports after Aug.12, 2009 when the regulation came into effect Mandatory labeling of OEM food imports Labeling place of origin and its OEM status in Korean around the main marking area of the product name on the package, in a size larger than 50% of the product name

4.3.System of Managing Safety of OEM Imported Foods Inspection Contents - OEM food importers entrust food safety inspection agencies to conduct the safety inspection of exporters' manufacturing facilities in accordance with the designated inspection cycle Subjects - food, food additives ※ functional foods, agricultural, forestry, and fishery food products, alcohol beverages are excluded Cycle of sanitation inspection for OEM food food determined to be inadequate after inspection & food for special uses : once per year - other foods : more than once every two years

4.4.System of Managing Safety of OEM Imported Foods Sanitation Inspection Checklists 62 items in 6 areas of raw materials and their storage, facilities, process management, quality control of finished products and their storage, consumer information, and staff training for conducting sanitation inspections ※ In accordance with the「Sanitation Management Standard for Manufacturers of Exporting Countries」 For cases where sanitation inspection may be exempt - the product registered as a good importer practice when it is demonstrated that the sanitation level is maintained in accordance with international standards of which the level is equal to, or higher than, the standards of Korea

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