, was first released in Feb, 2015. This act is the main and leading act which contributes to the safety of imported and promoting improvement in quality. Itis applicable to all kinds of imported s in Korea. Several regualtions are established to enrich the provisions of imported safety control.
Imported , etc. includes s, additives, apparatus, containers and packages, health functional s, and livestock products imported into South Korea (hereinafter referred to asimported )
Any person who intends to import and sell imported or files an import declaration of imported by proxy or is involved in the purchase/storageof imported shall apply to register with the Ministry of and Drug Safety(MFDS).
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Person who intend to import into South Korea or person who establishes and operates a foreign owned facility shall register with the Minister of and Drug Safetybefore 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 evidencematerial shall be submitted. Otherwise the registration can be cancelled. The term of validity is 2 years after it is registered.
The MFDS may conduct an on-site inspection of a foreign facility, when the MFDS deems that an on-site inspection is necessary to prevent hazards in the imported or to confirm facts about safety information on imported collected at home and abroad.
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If the importer refuses to inspection or a hazard is found, the MFDS can suspend the importation of that imported . However, after the government of an exporting country, or a foreign facility, or a business entity identifies any cause of a problem in imported and suggests improvements, or where such imported 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 and Drug Safety may conduct an on-site inspection.
Any person who intends to file an import declaration and inspect the status of sanitation control of a foreign facility to ensure the safety of the relevant imported may register such facility as a good importer with the MFDS.
Facility registered as a good importer may enjoy preferential policies, such as imported 's being removed from the scope of random inspection during the customs clearance, the MFDS' on-line publicity, etc.
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On April 7, 2020, MFDS replaced the registration mechanism for Good Foreign Facilities with the newly introduced HACCP accreditation for Foreign Facility.When a Foreign Facility is in compliance with theHazard Analysis and Critical Control Point, it can be confirmed as a Foreign Facility applicable for HACCP, the validity period of which is three years. If the government of the exporting country drafts a HACCP standard separately after consulting with MFDS, it can be accepted instead of the Korean accreditation.
Products with high risks specifiedby MFDS can be exported to South Korea only when they are manufactured, processed, packaged, stored, etc. by a Foreign Facility with HACCP accreditation. From this aspect, the designation Foreign Facility applicable for HACCP is similar to a license for managing high-risk products. And soon after, on June 30, 2020, MFDSdesignated the overseas Kimchi factories as the first batch of Foreign Facilitysubject to compulsory HACCP accreditation.
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.
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However, where the Minister of Agriculture, and Rural Affairs (MAFRA) 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.
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, 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.
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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.
As is mentioned above, any person who intends to import and sell the imported , to file import declaration of imported by proxy, to purchase the imported by proxy online, or to storage the imported 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.
To register the business, files including application of business registration and required files shall be submitted to the Minister of Regional Korea &DrugAdministration 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.
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However, where there is a difficulty in identifying the applicant, the Minister of RegionalKorea&DrugAdministration 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 registrationcertificate of business will be approved after certificating. If the registrationcertificate 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 RegionalKorea & 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 registrationcertificate of business and certificates proving the changes.
Where the registrant closes down his/her business, he/she shall file a reportofthe closureof business with the Minister of 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.
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Where a business entity has obtained the permission or has made the registration or reporting pursuant to the Sanitation Act, the Health Functional s Act, or the Livestock Products Sanitary Control Act, imports as raw materials for manufacturing its own product, it shall be deemed to have obtained registration.
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.
Any person who intends to conduct the imported business shall undergo education on the sanitation control, etc. of imported , etc. in advance.Nevertheless, ifhe/she is unable to undergo education in advance for unavoidable reasons, theeducationmay be takenafter starting business. In this case, he/she can also designate the person in charge of management to undergo the educationinstead.
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Any business entity shall comply withMatters to be Observed by Business Entities. Any business entity who imports and sells , 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 sanitation audit institution to conduct on-site sanitation audits, etc. on an enterprise manufacturing or processing imported by OEM according to Method and Standard of On-Site Inspection of Foreign Facilities and Foreign Establishments prescribed by the MFDS;
2)It shall conduct inspections under regulations of the Sanitation Act on Imported , etc. by OEM, and keep records thereof for two years.
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Where a business entity intends to import to sale or to use them for business, he/she shall file an import declaration of the relevant imported 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 he/she imports, and shall not engage in any improper conducts.
Where a business entity files an import declaration of imported , he/she shall report a statement of reasons for setting the expiration date set according to Establishment Standard of Expiration Dates of , Additives, Livestock and Health Functional .
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The MFDS shall require a relevant public official or inspection officer, or inspection agency to conduct necessary inspections before customs clearance formalities
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