Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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International Risk Information

System of Managing Safety of OEM food imports
  • Registration Date 2011-12-21
  • Hit 3427

Purpose

To secure food safety for the health of the public by delegating to OEM food importers the responsibility to inspect sanitation in his or her suppliers' manufacturing and processing facilities

Legal Basis

mandating OEM food importers to take an on-site inspection and self-quality control for OEM food products
(Article 44, clause 5 of the Food Sanitation Act, enacted on February 6, 2009 and effectuated on August 7, 2009)
Designating agencies or groups to conduct the inspection
(Article 30 of the Enforcement Decree of the Food Sanitation Act )
Drawing up inspection points in manufacturing facilities
(The KFDA's Notification 2009-159, established on October15, 2009)

Outline

Outline
Name of agencies or groups Legal basis Duties of agencies or groups
Expert Inspection Agency of Food Sanitation Art. 24, Clause 2, Item 1, of the Food Sanitation Act The persons who perform sanitation inspection should be qualified as a food sanitation inspector in accordance with art. 16, clause 2 of the Enforcement Decree of the Food Sanitation Act
Korean Institute of Health Industry Promotion Korean Institute of Health Industry Promotion Act
Universities Art.2, clause 1 , 2 of the Higher Education Act
Universities or institutes designated by the KFDA Commissioner Art. 30, Clause 1 of the Food Sanitation Act

Mandatory Sanitation Control-Mandatory product quality control-Mandatory submission of reasons for setting the circulation period-Mandatory labeling of OEM food products

When food and food additives are imported after manufactured by overseas contractor and labeled with the contractee's brand, the contractee must conduct sanitation inspection and product quality inspection in the contractor's facilities
Food for special uses (infant formula, growth formula, cereals, all other food products designated for the infant and child market) > Review once per year
Other food products Review more than once every two years
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 set by the KFDA Notification
When the product is manufactured by an excellent import business
Other food products Review more than once every two years
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 set by the KFDA Notification
Article 30, Clause 1 of the Enforcement Decree of the Food Sanitation Act (prescribing matters including parties to conduct sanitation inspection)
Other food products Review more than once every two years
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 set by the KFDA Notification
When the product is manufactured by an excellent import business
Other food products Review more than once every two years
Other food products Review more than once every two years
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 set by the KFDA Notification
When the product is manufactured by an excellent import business
Other food products Review more than once every two years
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 set by the KFDA Notification
When food and food additives are imported after manufactured by overseas contractor and labeled with the contractee's brand, the contractee must conduct sanitation inspection and product quality inspection in the contractor's facilities
Food for special uses (infant formula, growth formula, cereals, all other food products designated for the infant and child market) > Review once per year
Article 30, Clause 1 of the Enforcement Decree of the Food Sanitation Act (prescribing matters including parties to conduct sanitation inspection)
Other food products Review more than once every two years
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 set by the KFDA Notification
When the product is manufactured by an excellent import business
Other food products Review more than once every two years
Other food products Review more than once every two years
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 set by the KFDA Notification
When the product is manufactured by an excellent import business
Other food products Review more than once every two years
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 set by the KFDA Notification
When food and food additives are imported after manufactured by overseas contractor and labeled with the contractee's brand, the contractee must conduct sanitation inspection and product quality inspection in the contractor's facilities
Food for special uses (infant formula, growth formula, cereals, all other food products designated for the infant and child market) > Review once per year
Article 30, Clause 1 of the Enforcement Decree of the Food Sanitation Act (prescribing matters including parties to conduct sanitation inspection)
Other food products Review more than once every two years
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 set by the KFDA Notification
When the product is manufactured by an excellent import business
Other food products Review more than once every two years
Other food products Review more than once every two years
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 set by the KFDA Notification
When the product is manufactured by an excellent import business
Other food products Review more than once every two years
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 set by the KFDA Notification
Attached File

Division

Written by Kim, Hyun Jin