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Registration of Foreign Facilities Producing Food and Food Packaging Sold in Korea

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 as well as components thereof, including 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. 

Legal Background

Korea's Special Act on Imported Food Safety Management [1] 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.[2] 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 Special Act 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.

Again, the MFDS registration requirement applies not only to producers of food and food additives but also food packaging materials. In this regard, the online registration platform only references "apparatus, container, package." [3] Although this language suggests that companies selling finished articles into Korea would be responsible for registering, we understand that MFDS takes the position that the registration requirement applies to producers of starting materials as well as finished articles.Thus, even companies manufacturing plastic resins and other starting substances used in the production of food packaging will be required to register their facilities with MFDS by this August.

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.[4] 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.[5] 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.[6] 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 [7] and Korean.[8] 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:

Company name
Location and contact information (address, tel. no., fax. no., email address)
Facility name
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.


[1] Available in English at www.law.go.kr/eng/engLsSc.domenuId=1&query=import+food&x=0&y=0

[2] 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.

[3] Article 2 of the Food Sanitation Act defines "apparatus" to capture utensils (e.g., tableware, cookware, etc.), and machines, implements and other things used for collecting, manufacturing, processing, preparing, storing, transporting, displaying, delivering or taking food or food additives, which come in contact directly with food or food additives, excluding such machines, implements and other things used for collecting food in agriculture and fishery. Article 2 also defines "containers and packages" to apply to articles which are used for containing or packaging food or food additives, and offered with them at the time of their delivery;

[4] See Article 8(4) and (5).

[5] See Article 8(6).

[6] See Article 6(1) and (2).

[7] https://impfood.mfds.go.kr/#!CFABB01F010

[8] https://impfood.mfds.go.kr/#!CFAAA01F040

© 2019 Keller and Heckman LLP

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About this Author

David J. Ettinger, Keller Heckman, Partner, Food and Drug Corporation, International Trade Lawyer, Attorney, Shanghai, China
Partner

David Ettinger joined Keller and Heckman in 1999. Mr. Ettinger represents domestic and foreign corporations in the area of food and drug law.

Mr. Ettinger relocated to Keller and Heckman's Shanghai office in November 2012 to focus on the Asian market and counsel companies in the Far East on food, drug, and chemical regulatory matters. He has extensive experience counseling clients on product development and product protection of food and drug packaging in the United States, Europe, Asia, Canada, and South America. From 2006-2007, Mr. Ettinger...

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Wilfred Feng, Keller Heckman, registration programs, herbicide development scientist, Consultant, Shanghai, China
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Wilfred Feng joined Keller and Heckman in 2005.

Mr. Feng provides technical assistance to clients on regulatory issues focusing on food and drug regulation and chemical control laws in Asia, including food additives, food labeling, food packaging, dietary supplements, drugs, medical devices, cosmetics, pesticides, bioengineered products, and industry and specialty chemicals.

Mr. Feng has an extensive background in regulatory affairs, government affairs, marketing, and project management and has worked in several capacities in Industry. His experience includes working with government officials and industry groups in developing policy-making for the biotechnology industry, securing necessary approvals, product management and designing and executing field development and registration programs for herbicide development in China.

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Jenny Li, Keller Heckman, China Food, Drug Regulation, Shanghai, International Trade
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Jenny Li joined Keller and Heckman in October 2007.

Ms. Li counsels clients on regulatory issues focusing on food and drug, with an emphasis on regulatory regimes in the Asia-Pacific region. She also counsels clients on food labeling, food claims, food additives, as well as, important issues regarding food imports in Asian countries.

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Mark Thompson, Keller Heckman, EU Regulatory Compliance, Asian markets Lawyer, Attorney, Shanghai, China
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Mark Thompson joined Keller and Heckman in 2008 as an Associate with the firm’s Washington, DC office.  During that time, Mr. Thompson assisted clients in demonstrating compliance with U.S. and EU regulations pertaining to food, food packaging, drugs, as well as applicable environmental requirements.  In October 2009, Mr. Thompson transferred to Keller and Heckman's office in Shanghai, China, after which he expanded upon his practice to capture regulatory compliance matters in various Asian markets.   He currently advises a wide array of businesses and trade associations...

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Chen Hu , Keller Heckman, Scientist, Food Chemistry, Regulatory Compliance, Shanghai
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Chen Hu joined Keller and Heckman in April 2009. He provides technical assistance in the area of food, food packaging, and chemical control, in matters related to regulatory compliance in Asian-Pacific regions.

Mr. Hu works closely with government authorities and trade associations in various phases of regulatory development. Mr. Hu has prepared and submitted hundreds of Chinese applications for registration of food packaging materials, food additives, new food ingredients, and new chemical substances. He is experienced in auditing plant...

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