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Registration of Foreign Facilities Producing Food and Food Packaging Sold in Korea
Apr 27, 2016
Only a few months remain before the August 3, 2016 deadline for Korean registration of foreign food and food packaging manufacturing facilities. Registration is required for all facilities producing food, food additives, food packaging, functional health foods, and livestock products that are marketed or sold in Korea. The legislative history relating to the new registration system, the data requested from registrants, and the potential penalties for non-compliance are discussed in turn below.
Special Act on Imported Food Safety Management
 was finalized last February and took effect on February 4, 2016. Notably, Article 5 of the Special Act requires that the Korean authorities impose a registration requirement on foreign food and food packaging manufacturers around the world that market their products within Korea. The Korean Ministry of Food and Drug Safety (MFDS), formerly known as "KFDA," has been tasked with overseeing these registrations. The law further authorizes the Ministry to conduct on-site inspections of foreign facilities. Where the government in an exporting country or a foreign food facility refuses an on-site inspection, MFDS may take measures to suspend the importation of imported food, etc. of the foreign food facility concerned.
In this regard, the registration system is intended to provide the necessary information on foreign manufacturers marketing within Korea. Further, the Special Act supplies the legal basis for MFDS to not only oversee the safety of such imported products, but also take corrective action should foreign manufacturers decline audits initiated by the Ministry.
Considering the need to properly implement these mandates, the
did not take effect for 1-year after its publication. Earlier this year, MFDS offered an additional 6-month grace period in the interest of ensuring that industry had a sufficient time to register facilities producing food ingredients, additives, and/or food packaging materials that may be offered for sale in Korea. The Ministry has now indicated that registration of relevant foreign food and food packaging facilities must be completed no later than August 3, 2016. In particular, the Article 2(1) of the Special Act defines “imported food, etc.” to include foods, food additives, as well as “apparatus” and “containers and packages” as defined under Article 2 of the Food Sanitation Act.
Again, the MFDS registration requirement applies not only to producers of food and food additives but also food packaging materials.
Registration Impact, On-Site Inspections and Potential Penalties
As noted above, the deadline for registration of facilities selling product into Korea is August 3, 2016. For facilities not yet in operation (or which have yet to supply product to Korea), the companies must complete their facility registration no less than seven days prior to filing an import declaration for the relevant products. MFDS retains the right to reject the import declarations filed by importers, etc. that have failed to register in accordance with Article 5. Accordingly, companies that fail to properly register their foreign facilities may risk having their product/s held at port and not permitted entry into Korea.
The registration remains effective for two years unless MFDS determines that such registration should be revoked. Generally speaking, this relates to a scenario wherein the Ministry identifies a hazard resulting from the facility in question, or that the registration was secured via fraud. Should MFDS determine that a registration should be revoked, that facility will not be permitted to register again for a period of three years. Given that the lack of a registration can limit the ability to secure port clearance for imported product, this presents a significant risk to companies doing business in Korea.
Companies that register are subject to on-site inspections. As noted above,MFDS may take measures to suspend the importation of imported food, etc. of a foreign food facility if the foreign food facility (or government in the exporting country) refuses an on-site inspection.
Online Platform and Information Required
The MFDS online registration platform is available in both English  and Korean. In this regard, companies located abroad should have no problem accessing the platform from overseas. In addition, no registration fee is required.
The application for registration requires that companies provide the following information:
Location and contact information (address, tel. no., fax. no., email address)
Facility owner/operator in charge
Facility location and contact information (address, tel. no., fax. no., email address)
All of these fields must be entered on the MFDS platform, although certain information may be the same depending upon the corporate structure.
Companies with more than one factory must input information on all production facilities that require registration. We note, however, that the online platform does not permit registrants to cover multiple factories within a single registration. Thus, companies must register each additional facility separately with the same applicant information.
The final section of the registration portal allows companies to upload documents relating to their products. MFDS has indicated that companies should include certification documents relating to the relevant facility. For example, companies may upload hazards analysis and critical control points (HACCP) Certifications or ISO Certificates relating to each facility. Other certifications also can be uploaded as appropriate.
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Should you have any questions concerning the registration process or require assistance in registering your facilities, please contact David Ettinger or Mark Thompson at Keller and Heckman's Shanghai Representative Office, or your regular contact at Keller and Heckman.
 Available in English at
 The registration requirement in Article 5 pertains to "imported food, etc." This term is defined in Article 2 of the Special Act to capture "foods, food additives, apparatus, and containers and packages" as defined under Article 2 of the Food Sanitation Act...imported into the Republic of Korea from abroad, functional health foods under Article 3 of the Functional Health Foods Act, and livestock products under Article 2 of the Livestock Products Sanitary Control Act.
 Article 2 of the Food Sanitation Act defines "apparatus" to capture machines or utensils that come into direct contact with foods or food additives, or other goods (excluding machines, utensils or other goods used for collecting foods in agriculture or fisheries), and fall under any of the following items: (a) goods used for eating foods or packing foods; (b) goods used for collecting, manufacturing, processing, cooking, storing, subdividing, transporting or displaying foods or food additives. Article 2 also defines "containers and packages" to apply to goods used for packing or wrapping foods or food additives, which are delivered with foods and food additives.
 See Article 8(4) and (5).
 See Article 8(6).
 See Article 6(1) and (2).
David J. Ettinger
Senior Regulatory Counselor
Jenny Xin Li
Food & Drug
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