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Korea Food & Drug Administration
CONTENTS
Onsite Inspection of Exporter’s Facilities


System of Registration for Prior Inspection Completion

Good Importer Practice


System of Managing Safety of OEM Imported Foods
Onsite Inspection of
Exporter’s Facilities
1. Onsite Inspection of Exporter’s Facilities


 u 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

 u Secure the safety of imported food by explanation of
 Korea's food import system and food standards and
 specifications

 u Exchange of information between the countries’
 officials on exportation and importation food system to
 import safe foods
System of Registration for
Prior Inspection completion
2.1. System of Registration for Prior Inspection Completion


   u 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
   u Exemption from the initial close inspection and random
   sampling inspection on imported foods of registered supplier
2.2. System of Registration for Prior Inspection Completion



  u Application Qualification
  - suppliers manufacturing and processing food to
    be exported to Korea
   ※ importers can also apply on behalf of the exporters
  u 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
2.3. System of Registration for Prior Inspection Completion



   u 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
2.4. System of Registration for Prior Inspection Completion


  u Costs( benefit principle is applied )
  - application charge of KRW 28,000
  - travel expenses for onsite inspectors
  u 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
3.1. Good Importer Practice

 u 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

  u 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


  u Application Qualification
  - persons who wish to import foods, etc
  u 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
  u 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

  u Required documents
  - documents proving business licenses of the exporting
    manufacturer
  - inspection report of manufacturers' facilities
  u Application charge of KRW 28,000
  u 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
4.1.System of Managing Safety of OEM Imported Foods



  u 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.)
4.2.System of Managing Safety of OEM Imported Foods


             Obligarion
    Mandatory Sanitation Control                             Mandatory product quality
    Imposing on OEM food importers duties of                 control
    mandatory sanitation control for the                     Imposing on OEM food importers duties of
                                                             mandatory self-quality control for OEM food
    manufacturing facilities of the exporting
                                                             products (maintaining 2 years of product quality
    country
                                                             control records)




   Mandatory submission of                                Mandatory labeling of OEM
   reasons for setting the                                food imports
   circulation period                                     Labeling place of origin and its OEM status in Korean
                                                          around the main marking area of the product name on
   applied to first-time batch of imports after Aug.12,
                                                          the package, in a size larger than 50% of the product
   2009 when the regulation came into effect              name
4.3.System of Managing Safety of OEM Imported Foods


  u 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
  u Subjects
  - food, food additives
  ※ functional foods, agricultural, forestry, and fishery food
      products, alcohol beverages are excluded
  u 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


   u 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」
   uFor 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
Thank You

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Prior Safety Management System of Imported Food_2012

  • 1. Korea Food & Drug Administration
  • 2. CONTENTS Onsite Inspection of Exporter’s Facilities System of Registration for Prior Inspection Completion Good Importer Practice System of Managing Safety of OEM Imported Foods
  • 4. 1. Onsite Inspection of Exporter’s Facilities u 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 u Secure the safety of imported food by explanation of Korea's food import system and food standards and specifications u Exchange of information between the countries’ officials on exportation and importation food system to import safe foods
  • 5. System of Registration for Prior Inspection completion
  • 6. 2.1. System of Registration for Prior Inspection Completion u 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 u Exemption from the initial close inspection and random sampling inspection on imported foods of registered supplier
  • 7. 2.2. System of Registration for Prior Inspection Completion u Application Qualification - suppliers manufacturing and processing food to be exported to Korea ※ importers can also apply on behalf of the exporters u 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
  • 8. 2.3. System of Registration for Prior Inspection Completion u 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
  • 9. 2.4. System of Registration for Prior Inspection Completion u Costs( benefit principle is applied ) - application charge of KRW 28,000 - travel expenses for onsite inspectors u 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
  • 11. 3.1. Good Importer Practice u 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 u 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
  • 12. 3.2. Good Importer Practice u Application Qualification - persons who wish to import foods, etc u 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 u Registration Procedures - Inspect sanitation procedures in the exporter's facilities → apply to register → onsite sanitation inspection by the KFDA → register as a good importer
  • 13. 3.3. Good Importer Practice u Required documents - documents proving business licenses of the exporting manufacturer - inspection report of manufacturers' facilities u Application charge of KRW 28,000 u 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」
  • 14. System of Managing Safety of OEM Imported Foods
  • 15. 4.1.System of Managing Safety of OEM Imported Foods u 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.)
  • 16. 4.2.System of Managing Safety of OEM Imported Foods Obligarion Mandatory Sanitation Control Mandatory product quality Imposing on OEM food importers duties of control mandatory sanitation control for the Imposing on OEM food importers duties of mandatory self-quality control for OEM food manufacturing facilities of the exporting products (maintaining 2 years of product quality country control records) Mandatory submission of Mandatory labeling of OEM reasons for setting the food imports circulation period Labeling place of origin and its OEM status in Korean around the main marking area of the product name on applied to first-time batch of imports after Aug.12, the package, in a size larger than 50% of the product 2009 when the regulation came into effect name
  • 17. 4.3.System of Managing Safety of OEM Imported Foods u 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 u Subjects - food, food additives ※ functional foods, agricultural, forestry, and fishery food products, alcohol beverages are excluded u 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
  • 18. 4.4.System of Managing Safety of OEM Imported Foods u 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」 uFor 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