1.1 Imported Food Act
Special act on imported food safety control, also known as the imported food act, was first released in Feb, 2015, it has been reviewed for several times. This act contributes to the safety of imported food and promoting improvement in quality.
Ministry of Food and Drug Safety (MFDS) issued the latest revised Imported Food Act (Act No. 15940) on 11th, Dec, 2018. A new term of “food subject to special management” along with the relevant importation sanitation assessment and two administrative measures are added. The schedule to conduct an import sanitation assessment on livestock products has also been brought forward. New sanitation education requirements are also detailed.
1.2 Definition of Imported Food
"Imported food, etc. "includes foods, food additives, apparatus, containers and packages, health functional foods, and livestock products imported into South Korea (hereinafter referred to as "imported food")
1.3 People Affected
Any person who intends to import and sell imported food or files an import declaration of imported food by proxy or is involved in the purchase/storage of imported food shall apply to register with the Ministry of Food and Drug Safety(MFDS).
2. Steps Prior to Importation
2.1 Registration of Foreign Food Facilities
Person who intend to import food into South Korea or person who establishes and operates a foreign owned food facility shall register with the Minister of Food and Drug Safety before he/she files an import declaration. It also applies to the registration updating or renewal. The registration can be applied online as well.
When it is deemed as necessary by the MFDS, more evidence material shall be submitted. Otherwise the registration can be cancelled. The term of validity is 2 years after it is registered.
2.2 On-Site Inspection of Foreign Food Facilities
The MFDS may conduct an on-site inspection of a foreign food facility, when the MFDS deems that an on-site inspection is necessary to prevent hazards in the imported food or to confirm facts about safety information on imported food collected at home and abroad.
If the importer refuses to inspection or a hazard is found, the MFDS can suspend the importation of that imported food. However, after the government of an exporting country, or a foreign food facility, or a business entity identifies any cause of a problem in imported food and suggests improvements, or where such imported food is deemed non-hazardous, the MFDS may revoke the suspension of importation. In such cases, where it is necessary to confirm such improvements, the Minister of Food and Drug Safety may conduct an on-site inspection.
2.3 Registration of Good Importers and Good Foreign Food Facilities
Any person who intends to file an import declaration and inspect the status of sanitation control of a foreign food facility to ensure the safety of the relevant imported food may register such facility as a good importer with the MFDS. Furthermore, where one establishes and operates a foreign food facility meets criteria for registration of good foreign food facilities set by the MFDS, he/she may register such facility as a good foreign food facility with the MFDS.
Facility registered as a good importer or a good foreign food facility may enjoy preferential policies of imported food's being removed from the scope of random samples to be inspected, the MFDS' on-line publicity, etc. From a customer perspective, the mark of food importer or good foreign food facility is more trustworthy.
2.4 Import Sanitation Assessment of Livestock Products
As for the imported livestock products that is firstly permitted to be imported to South Korea or under other situations in which it is deemed as necessary to be reexamined by the MFDS, the relevant livestock products may be reassessed.
Any person that establishes and operates a foreign owned food facility dealing with food subject to special management shall register the facility with MFDS as required. However he/she shall register via the government of the exporting country instead of registering directly with the Minister of Food and Drug Safety in line with the revised act.
This regulation on food subject to special management is released on 11th, Dec, 2018 and will be enforce from 6th, Jun, 2019 onward.
However, where the Minister of Agriculture, Food and Rural Affairs determines it is permissible to import livestock products amounting to designated objects subject to quarantine for which there is no risk of animal disease, the MFDS shall then conduct an import sanitation assessment on the livestock products concerned.
In the latest revised version (Act No. 15940), the import sanitation assessment may start after the Minister of Agriculture, Food and Rural Affairs determines to analyze importation risk. The time allotted to prepare for administrative procedure before importation has also been reduced. This regulation on the schedule to conduct the import sanitation assessment will be enforce from 6th, Jun, 2019 onward.
The MFDS may determine and publish the requirements for import sanitation for each exporting country or each livestock product according to the results of import sanitation assessments conducted thereof. People who intend to import livestock products shall import livestock products from countries or regions for which the MFDS has determined and published the import sanitation requirements: Provided, That in case of livestock products amounting to designated objects subject to quarantine under the Act on the Prevention of Contagious Animal Diseases, the importation of livestock products shall be limited to countries or regions from which the Minister of Agriculture, Food and Rural Affairs permits to import livestock products.
The MFDS may conduct an on-site inspection of a foreign establishment in order to examine or verify whether the foreign establishment fulfills requirements for import sanitation of livestock products published by MFDS. And any person who files an import declaration of livestock products shall attach a health certificate for export.
2.5 Registration of Foreign Establishments (livestock products)
Any person who establishes and operates a foreign establishment shall file an application for registration with the MFDS via the government of an exporting country before he/she submits an import declaration on livestock products. The same shall also apply where he/she intends to change registered matters.
3. Control of Importing Business
3.1 Types of Business and Facility Standards
As is mentioned above, any person who intends to import and sell the imported food, to file import declaration of imported food by proxy, to purchase the imported food by proxy online, or to storage the imported food shall apply to register with the MFDS. He or she shall have facilities satisfying the Standards of Facilities by Business Kind prescribed by Ordinance of the Prime Minister.
3.2 Registration of Business
To register the business, files including application of business registration and required files shall be submitted to the Minister of Regional Korea Food & Drug Administration in written or electronic form. The same apply to any person who intends to change his/her place of business. After the applicant has been reviewed, a registration certificate will be issued.
However, where there is a difficulty in identifying the applicant, the Minister of Regional Korea Food & Drug Administration can ask for more supporting certificates. In this situation, the certificates or statements provided by the foreign government or other relevant authorities can be submitted through the local Korea consulate when the applicant is not Korean. The registration certificate of business will be approved after certificating. If the registration certificate of business is lost or damaged or in any situation where needs to be reissued, the application of reissuing the business registration shall be submitted to the Minister of Regional Korea Food & Drug Administration.
When the applicant changes any affairs except the business place, he/she shall submit an applicant of changing affairs of business registration with a registration certificate of business and certificates proving the changes.
Where the registrant closes down his/her business, he/she shall file a report of the closure of business with the Minister of Food and Drug Safety. While any business entity ordered to suspend its business shall not file a report of the closure of business during the period of suspension of business.
Where a business entity has obtained the permission or has made the registration or reporting pursuant to the Food Sanitation Act, the Health Functional Foods Act, or the Livestock Products Sanitary Control Act, imports food as raw materials for manufacturing its own product, it shall be deemed to have obtained registration.
3.3 Succession of Business
Where a business entity transfers its business or is dissolved, or corporations are merged, the transferee or successor of such business, or the corporation surviving the merger or the corporation incorporated according to the merger shall succeed to the status of such business entity.
3.4 Sanitation Education
Any person who intends to conduct the imported food business shall undergo education on the sanitation control, etc. of imported food, etc. in advance. Nevertheless, if he/she is unable to undergo education in advance for unavoidable reasons, the education may be taken after starting business.
Any person who intends to conduct business or business entity may designate the person in charge of management to undergo the education instead, if he/she can not attend the education with unavoidable reason.
3.5 Matters to be Observed by Business Entities
Any business entity shall comply with Matters to be Observed by Business Entities. Any business entity who imports and sells food, etc. has entrusted manufacturing or processing to an exporting country by original equipment manufacturing shall comply with each of the following matters:
1) It shall require an imported food sanitation audit institution to conduct on-site sanitation audits, etc. on an enterprise manufacturing or processing imported food by OEM according to Method and Standard of On-Site Inspection of Foreign Food Facilities and Foreign Establishments prescribed by the MFDS;
2) It shall conduct inspections under regulations of the Food Sanitation Act on Imported Food, etc. by OEM, and keep records thereof for two years.
4. Control of Steps in Customs Clearance
4.1 Import Declaration
Where a business entity intends to import food to sale or to use them for business, he/she shall file an import declaration of the relevant imported food with the MFDS.
Also a person who intends to file an import declaration or has filed an import declaration shall be held responsible for the safety and quality of food he/she imports, and shall not engage in any improper conducts.
Where a business entity files an import declaration of imported food, he/she shall report a statement of reasons for setting the expiration date set according to Establishment Standard of Expiration Dates of Food, Food Additives, Livestock and Health Functional Food.
4.2 Import Inspections
The MFDS shall require a relevant public official or inspection officer, or inspection agency to conduct necessary inspections before customs clearance formalities for imported food, etc., for which an import declaration has been filed are completed. In such cases, he/she may accept the import declaration upon attaching conditions, such as the prohibition of use or sale, before the confirmation of the results of inspection or supplementation on violated matters. Then the MFDS may conduct inspections differentially by classifying imported food according to the history of inspections of imported food, domestic and international food safety information, and other similar matters.
Moreover, the inspection may be omitted by the MFDS fully or partially, if the imported food is imported by a person whose facility has been registered as a good importer or a good foreign food facility, or an inspection report or a certificate of inspection by an inspection agency prescribed by Act on Testing and Inspection in Food and Drug Industry on the imported food is submitted, or the imported food deemed to have no safety issues by MFDS. Thus, as mentioned above, to get a qualification as a good importer or a good foreign food facility may bring advantages.
5. Control of Distribution Steps
5.1 Traceability of Imported Food
The MFDS may require business entities to register traceability by prescribing imported food subject to traceability, if he/she deems it necessary to manage imported food, in which a problem occurs.
The MFDS may also order business entities to undergo education on the safety and quality control, etc. of imported food under particular condition and shall order business entities which fail to comply with the Act to make necessary corrections for the safety control of imported food, such as improving facilities, revocation of registration, suspension or closure of the business, etc.
People who intends to register for a good importer and make changes in registered matters, to register for a good foreign food facility or make changes in registered matters, to obtain designation as an imported food sanitation audit institution, to register his/her business and make changes in registered matters, to undergo inspection, or to obtain the registration of traceability shall pay fees prescribed by Ordinance of the Prime Minister
In addition, any person shall be punished by imprisonment with labor or by a fine, or may be punished by both the aforesaid imprisonment and the aforesaid fine, if he/she fails in compliance with relevant rules and regulations.
The three main steps to import food into South Korea is 1) to register Foreign Food Facilities before the importation, 2) to register the business, and 3) to file the import declaration in the customs declaration. And to be noticed that if one intends to import livestock products, he/she shall undergo the sanitation assessment and register the foreign establishments as well. And for the foreign applicants, more registration certificates may be asked to be approved when applying for registration of business.