2012

Korea Food & Drug Admin-istration

Onsite Inspection of Exporter’s Facil-ities

System of Registration for Prior Inspec-tion Completion

Good Importer Practice

CONTENTSCONTENTS

System of Managing Safety of OEM Im-ported Foods

Onsite Inspection of Exporter’s Facilities

1. Onsite Inspection of Exporter’s Facili-ties

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’ of-ficials on exportation and importation food system to import safe foods

System of Registra-tion for Prior Inspec-tion completion

2.1. System of Registration for Prior Inspection Completion

This system is to secure safety of food imports by preemp-

tively identifying any food safety hazards in manufacturing

and processing facilities either by; conducting onsite inspec-

tions 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 sup-

plier

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

2.2. 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

2.3. 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

2.4. System of Registration for Prior Inspection Completion

Good Importer Prac-tice

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 satis-fied

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 Im-ported Foods

4.1.System of Managing Safety of OEM Imported Foods

This system is to make OEM food importers mandato-

rily conduct sanitation inspection of the exporter' manu-

facturing facilities and control the quality of the products

※ OEM(Original Equipment Manufacturing) foods are manufactured by overseas contrac-tors and labeled with the contractee's brand(logo, sign, letter, figure, etc.)

ObligarionMandatory Sanitation Control

Imposing on OEM food importers duties of mandatory sanitation control for the manu-facturing facilities of the exporting country

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 submission of rea-sons for setting the circulation periodapplied to first-time batch of imports after Aug.12, 2009 when the regulation came into effect

Mandatory labeling of OEM food importsLabeling 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

4.2.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

4.3.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

4.4.System of Managing Safety of OEM Imported Foods

Thank You