Korea signed the Cartagena Protocol on Biosafety in 2000 and enacted implementing legislation, the Act on Transboundary Movements of Living Modified Organisms and Other Related Matters (LMO Act), the following year. The LMO Act regulates overall issues concerning genetically modified organisms (GMOs). Importing, cultivating, researching, and developing GMOs are permitted under the LMO Act, as long as applicable procedures are observed. However, even though more and more research on GMOs is being performed, people are still concerned about undiscovered side effects and unanticipated adverse effects on the environment. As yet, there has been no authorized GMO cultivation within Korea.

Restrictions on GMO food include a safety assessment under the Food Sanitation Act in addition to a risk assessment and approval procedure under the LMO Act. Sellers of genetically modified food must follow labeling requirements under the Food Sanitation Act.

I. Introduction

South Korea signed the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (Cartagena Protocol) in 2000 and ratified it in 2007.[1] The Cartagena Protocol became effective for Korea at the beginning of 2008. To implement the Protocol, Korea enacted the Act on Transboundary Movements of Living Modified Organisms and Other Related Matters (LMO Act) in 2001 and it became effective when the Protocol became effective in Korea.[2] The LMO Act aims to improve the living conditions of people by protecting public health and the conservation and sustainable use of biodiversity from any adverse effects posed by genetically modified organisms (GMOs).[3] As of today, while research and development related to GMOs is actively conducted, there has been no authorized GMO cultivation within Korea.[4] There is no social or political consensus regarding the safety of GMOs for cultivation or consumption in Korea. However, stopping the importation of genetically modified (GM) grains, such as soybeans and corn, is nearly impossible because Korea has a low level of self-sufficiency with regard to grains and non-GM grains are becoming less available. As of 2012, for example, GM soybeans occupied 81% of the total soybean cultivation area in the world.[5]

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II. Public and Scholarly Opinion

Public awareness of GMOs has generally been high in South Korea. The Korea Biosafety Clearing House (KBCH) has issued annual statistical analyses on public perception and knowledge levels of GMOs since 2004.[6] The KBCH was established as a legal institute for the management and exchange of information on GMOs and promoting international coordination.[7] According to a statistical analysis conducted in 2013, 80.2% of the general public in Korea is aware of GMOs and they learn and acquire knowledge and information mainly from television, the Internet, newspapers, and friends and acquaintances. However, the level of understanding of the current status of domestic distribution and risk assessment procedures for GMOs, among other issues, is low.[8]

The public sentiment trends against GMOs. Generally, people are more tolerant of the pharmaceutical or medical use of GMOs, but unwilling to accept GMOs in food or livestock, according to the KBCH’s 2012 survey.[9] In terms of the necessity of restricting GMOs, more than 83% of the survey respondents said it was necessary to impose strict regulations on GMO handling, storage, distribution, and labeling.[10]

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III. Structure of Pertinent Legislation

The Biotechnology Support Act, which was enacted to promote biotechnology in 1983,[11] was the first law in Korea that required implementing measures to prevent potential risks involved in the development of biotechnology. In September 2000, Korea signed the Cartagena Protocol and in March 2001 enacted the LMO Act as a general law to establish the legal basis for domestic implementation of the Protocol.[12] However, the LMO Act does not apply to GMOs used as medicines for the human body.[13] The Enforcement Decree of the LMO Act[14] and ministerial ordinances[15] provide detailed provisions for the effective enforcement of the LMO Act. The Unified Enforcement Regulation of the LMO Act (Unified Enforcement Regulation) was prepared in 2007 in order to provide detailed and technical measures to implement the LMO Act.[16] The Unified Enforcement Regulation regulates different areas such as GMO use in food, medicine, agriculture, and intentional introduction of GMOs into the environment.

The LMO Act designates a competent national authority, a national focal point, and relevant central administrative agencies. The Ministry of Trade, Industry and Energy (MOTIE) is the designated competent national authority and is in charge of GMO regulations in the industrial sector. The Ministry of Foreign Affairs (MOFA) is the national focal point.[17] Jurisdictions of the ministries designated as relevant central authorities are as follows:

Ministry	Jurisdictional Area Under the LMO Act
Ministry of Science, Information, Communication, Technology & Future Planning (MSIP)	GMOs used in research and development
Ministry of Health & Welfare (MW)	GMO research facilities related to health, medical sectors
Ministry of Environment (ME)	Environmental issues related to GMOs
Ministry of Agricultural, Food & Rural Affairs (MAFRA)	GMOs in agricultural, forestry, livestock sectors, and in animal health improvement
Ministry of Oceans & Fisheries (MOF)	GMOs in oceans, inland bodies of water
Ministry of Food and Drug Safety (MFDS)	GMOs in food, medicine, medical devices

Source: LMO Act art. 2, para. 5; Enforcement Decree art. 2, para. 1.

MOTIE established the Biosafety Committee based on the LMO Act.[18] The vice-minister of each relevant central authority is a member of the Committee.[19] The Committee deliberates on matters concerning implementation of the Cartagena Protocol, establishment and implementation of risk management plans, reassessment of risks for previously denied GMOs, prevention, and plans for countering any damage caused by GMOs, among other things.[20]

The LMO Act obligates relevant central authorities to establish and enforce risk management plans. The plans include basic policies of safety management concerning the import and export of GMOs, matters on safety management for employees and facilities that deal with GMOs, and matters on GMO technology development and related support measures. Such risk management plans should be approved in advance by the Biosafety Committee.[21]

The LMO Act has a definition of GMOs, which is substantially the same as definitions appearing in other acts:

Living modified organisms means any organism that possesses a novel combination of genetic material obtained through the use of the following modern biotechnology(ies) ;
(1) technologies for artificially recombining genetic materials or directly injecting nucleic acid constituting genetic materials into cells or organelles;
(2) technologies for cell fusion which is beyond the family under taxonomy.[22]

A GM agricultural or marine product is defined in the Agricultural Act as an agricultural or marine product that possesses targeted features made through the artificial separation or recombination of genes.[23] Under the Food Sanitation Act, genetically modified food is any food or food additive produced or processed with raw ingredients that are cultivated with the technologies for recombining genetic materials.[24]

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IV. Restrictions on Research, Production, and Marketing

Research on and the development of GMOs must meet the requirements and permission procedures under the LMO Act and accord with social values, as discussed below.

A. Risk Assessment

A person who intends to import, produce, use, or develop GMOs must follow the risk assessment procedure through the relevant central authority before the person applies for permission to import, produce, or use a GMO.[25] The risk assessment process is designed to identify and evaluate the possible adverse effects of GMOs on the conservation and sustainable use of biodiversity, taking into account risks to human health.[26] The minister of the relevant central authority should establish the criteria for the assessment and publicize it.[27] A minister of the relevant central authority must consult with the Ministry of Health and Welfare (MW) when risks to human health are examined. When the GMOs are to be released into the environment, other ministers are involved in addition to the relevant central authority, as described in Part V, below.[28] The applicant and the general public are notified of the results of the risk assessment.[29] If the risk is too high, the import, production, use, or development of the GMO may be restricted.

B. Prior Approval for Production, Import, or Export of GMOs

A person who intends to import GMOs must obtain the approval of the minister of the related central authority.[30] When the sole purpose of importing GMOs is for experimentation on, research into, or exhibition of GMOs, only reports to the relevant central authorities are required.[31] However, approval is required if the GMOs fall into one of the following categories:

• GMOs obtained using microorganisms for which the human pathogenic capability is unknown and the taxonomic name is not specified
• GMOs with the ability to produce toxins against vertebrates, as determined and published by the Minister of MW
• GMOs intentionally introduced with a drug-resistant gene, excluding ones with drug-resistant genes that the Minister of MW publishes
• GMOs obtained using pathogenic micro-organisms that the Minister of MW publishes because management by the state is necessary in view of public health concerns.[32]

A person who intends to produce GMOs must also obtain approval from the related central authority.[33] As of September 2013, one GM microorganism had been approved for production.[34]

The minister of the relevant central authority may prohibit or restrict the importation or production of GMOs if he or she determines that such GMOs have adverse effects on public health or the preservation of biodiversity and sustainable use, and also if he or she determines that such GMOs have or may have negative effects on social or economic values with regard to domestic biodiversity.[35]

A person who intends to export GMOs must notify the relevant central authority of the items, quantity, importing country, and other required information under Annex II of the Protocol.[36] Anyone who intends to unload and export GMOs via a domestic port or airport must give a transit report to the relevant central authority.[37]

C. Laboratory Permission

A person who intends to establish a laboratory that conducts GMO research or conduct such research at an existing laboratory must acquire an approval for laboratory use from, or report the laboratory use to, the relevant central authorities in accordance with the level of safety of the research.[38] Levels of safety are classified from 1 (safest) to 4 (highest risk).[39] A person who establishes or runs a laboratory that carries out research that falls under levels 3 or 4 must obtain permission from the Minister of Science, Information, Communication, Technology & Future Planning in terms of environmental risk assessment or from the Minister of MW in terms of the risk assessment for the human body.[40] Level 3 research is research or experimentation involving GMOs that may cause serious but curable disease to the human body or serious but curable danger to the environment. Level 4 research is research or experimentation involving GMOs that may cause fatal disease to the human body or irreparable danger to the environment.[41] Laboratories that conduct level 1 and 2 research must only submit a report to the Minister of Science, Information, Communication, Technology & Future Planning.[42] As of July 2013, reported and permitted research facilities numbered 2,608 in total and of that number 1,985 were schools.[43]

D. Laboratory Research Approval

Separate from research laboratory permission, a laboratory must obtain approval to conduct experiments from the relevant central authority if the GMOs that are developed or used in the experiments are considered highly dangerous.[44] Experiments that fall within this category include the following:

• Experiments involving GMOs obtained using microorganisms for which the human pathogenic potential is unknown and the taxonomic name is not specified
• Experiments using GMOs that have the ability to produce toxins against vertebrates, as determined and published by the Minister of MW
• Experiments using GMOs intentionally introduced with a drug-resistant gene, excluding ones with drug-resistant genes that the Minister of MW publishes
• Experiments involving GMOs obtained using pathogenic micro-organisms that the Minister of MW publishes because management by the state is necessary in view of public health concerns
• Experiments related to releasing GMOs into the environment
• Experiments involving, or the development of, GMOs classified as highly dangerous by the minister of the relevant central authority through deliberation of the relevant committee[45]

E. Labeling Requirements for GMOs

The LMO Act imposes labeling obligations upon anyone who develops, imports, exports, or produces GMOs. A person who develops, imports, exports, or produces GMOs must label the GMOs, the package containing GMOs, or the import invoice concerning the GMOs with the following information:

• Name, type, use, and character of the GMOs
• Precautions on the safe handling of the GMOs
• Name, address, and phone number of the GMO developer, producer, exporter, and importer
• The fact that such product is GM
• Whether such GMOs are to be released into the environment[46]

A person who fails to label GMOs according to these guidelines, or who falsely labels or intentionally changes or removes a GMO label is subject to imprisonment not exceeding one year or a fine not exceeding 20,000,000 Korean won (KRW) (about US$20,000).[47]

When there is a special labeling regulation, the labeling regulation under the LMO Act does not apply. For example, there is a special labeling regulation for GMO food. (See Part VI, below, for a discussion of approved GMOs for food and feed.)

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V. Restrictions on Releasing Organisms into the Environment

A person who intends to import GMOs for discharge into the environment must obtain approval from the minister of the relevant central authority through the Minister of MOTIE.[48] The minister of the relevant central authority must consult with the Minister of MW when potential risks to human health are examined. When the GMOs are to be released into the environment, other ministers are involved in addition to the relevant central authority: MAFRA for risks to the cultivation of crops, ME for risks to the ecosystem, and MOF for risks to the marine environment and marine ecosystem.[49] The minister of the relevant central authority considers any potential social and economic effect upon the value of domestic biodiversity resulting from approval.[50] Necessary documentation for applications includes the following:[51]

• A consent form on the import of GMOs for the purpose of intentional release into the environment issued by the Minister of MOTIE upon request from the importer
• AAn importing agreement, handling agreement, or self-handling schedule
• AA safety management policy addressing the handling of, professional manpower for, and facility where the GMO is to be used/processed

Once the minister of the relevant central authority completes the evaluation, he or she notifies the Minister of the MOTIE. The Minister of MOTIE, via the Korea Biosafety Clearing House, announces the results to the exporting nation and to the Biosafety Clearing House under the Protocol.[52]

The cultivation of GM crops in a field is allowable under the LMO Act if it is approved by the relevant central authority.[53] However, there has been no authorized GMO cultivation within Korea thus far.[54]

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VI. Restrictions on GMOs in Foodstuffs

A. Food

The safety of GM food is assessed under the Food Sanitation Act, in addition to the risk assessment and approval procedure under the LMO Act.[55] MFDS established the Safety Assessment Committee to review materials submitted for assessment.[56] The committee performs risk assessments of the effect of GMOs on the human body, upon request. Once the committee reaches a conclusion, MFDS must announce that conclusion via the Internet and gather opinions from the public. If a reasonable opinion with scientific support is received, MFDS may reflect that opinion in its conclusion. MFDS notifies the applicants of the final conclusion and publicizes it via the Internet and the official gazette.[57] As of September 2013, ninety-six GMOs had been approved for food and food additives, including soybean, maize, cotton, canola, potato, alfalfa, sugar beet, and one microorganism.[58]

B. Fodder for Livestock

A person who wants to import or produce GMO feed may apply for the environmental risk assessment separately before he applies for an approval to import.[59] MAFRA is the designated ministry for this risk assessment and approval. MAFRA has established the Environmental Risk Expert Committee, and that Committee has in turn established a risk assessment procedure.[60] Once the Committee issues the results of a risk assessment, the Minister of MAFRA must announce it and gather opinions via the Internet or the official gazette.[61] When making a decision on importing or producing GMO feed, the Minister may, if necessary, consult with an advisory committee that evaluates the socio-economic effects of GMOs.[62] As of September 2013, eighty-eight GMO feeds had been approved, including soybean, maize, cotton, canola, and alfalfa.[63]

C. Labeling

To share information and guarantee the public’s right to know and the right of choice, GM food (including agricultural products and processed foods) and GM feed may have to be labeled in accordance with all the relevant laws: the LMO Act,[64] the Food Sanitation Act,[65] the Agricultural and Marine Products Quality Control Act,[66] and the Control of Livestock and Fish Feed Act.[67] Food is subject to labeling as follows:

	Agricultural Products	Processed Foods
Subject to labeling	Every GM agricultural product approved for importation by MFDS	1. Food containing GM ingredients derived from agricultural products that are subject to labeling 2. Food containing GM ingredient(s) as main ingredient(s)[68] 3. Processed food that tests positive for foreign heterologous proteins
Not subject to labeling	1. Agricultural products separately handled from non-GMOs 2. GMO content of less than 3% (considered as unintentional inclusion)	1. Using agricultural products separately handled from non-GMOs 2. GMO content of less than 3% (considered as unintentional inclusion)

Source: Labeling Guideline for Agricultural Products art. 3, paras. 2 & 3 (agricultural products); Yujeonja Jaejohab Sikpoom Deung-ui Pyoshi Kijoon [Labeling Guideline for Genetically Modified Food by Ministry of Food and Drug Safety (Labeling Guideline for Processed Food)], Enforcement Regulation, No. 2000-43, Aug. 30, 2000, amended by Enforcement Regulation, No. 2013-165, Apr. 5, 2013 (processed foods).

When labeling is required for agricultural products, the label should be one of following:

• “Genetically modified [name of agricultural product]”
• “Partially contains genetically modified organism”
• “Possibly contains genetically modified organisms”[69]

The label for the GM agricultural product should be on the package, the container, or the storage facility of the product. The label must be eye-catching, with a different color from the background color.[70]

When labeling is required for processed food, the label should be one of followings:

• “Genetically modified food”
• “Partially contains genetically modified organism”
• “Possibly contains genetically modified organisms”

The label for processed food should be created with a non-erasable ink in an eye-catching form on the package or container of GM food.[71]

A person who sells, displays, transfers, or imports GM food without a label or with a false label is subject to cancellation of approval, suspension from producing such item, and imprisonment not exceeding three years or a fine not exceeding 30,000,000 KRW (about US$30,000).[72]

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VII. Liability Regime

There is no existing law or regulation that specifically regulates liability issues with regard to damage caused by GMOs. Academics have been actively discussing the necessity of creating a liability scheme through amendments to existing laws or supplemental laws. There have been several attempts to apply other existing legal principles, such as the product liability regime or the no-fault liability regime, or reversing/easing the burden of proof.[73] However, the question of liability with regard to GMOs remains unsettled.

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VIII. Judicial Decisions / Prominent Cases

No court decision that directly deals with GMOs has yet been issued by the Supreme Court or the Constitutional Court.

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Sayuri Umeda
Foreign Law Specialist*
March 2014

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