In China, restrictions on genetically modified organisms (GMOs) are primarily provided by the agricultural GMO regulations enacted by the State Council in 2001 and relevant administrative rules. The agricultural GMO regulations regulate not only crops, but also animals, microorganisms, and products derived from these sources.

The testing, production, and marketing of GMOs in China are subject to government approval. Foreign companies that export GMOs to the PRC, including GMOs as raw materials, must apply to the Ministry of Agriculture and obtain GMO Safety Certificates.

I. Introduction

A. Policy Issues

The agriculture biotech industry is supported by the central government of the People’s Republic of China (PRC or China) as an emerging sector of strategic importance.[1] According to China’s 12th Five-Year Plan on National Economic and Social Developmentfor 2011–2015 (12th Five-year Plan), the country will “speed up the innovation and application of biotechnology breeding in agriculture,” “develop new biological variety with important application value and independent intellectual property rights,” and “foster a large and strong modern seed industry.”[2]

Based on the 12th Five-year Plan and other plans supplementing it, the Ministry of Agriculture (MOA) released the 12th Five-Year Plan for Development of Agricultural Science and Technology (Agricultural S&T Plan), which provides more details on the development of agricultural science and technology. In this Plan, the MOA proposes to strengthen research involving genetically modified organisms (GMOs).[3] Major research projects on breeding new varieties of GMOs will continue to be carried out in the 2011–2015 period, according to the Agricultural S&T Plan.[4] The plans also incorporate biosafety assessment and management as focus areas of biotech industry development.[5]

B. Legislative Purposes

The country’s legislation attempts to balance the promotion of agricultural GMOs with concern for consumers and environmental safety. As early as 2002, the PRC Agriculture Law incorporated safety controls over the research, testing, production, processing, marketing, and other applications of agricultural GMOs.[6]

When formulating the Regulations on Administration of Agricultural Genetically Modified Organisms Safety (GMO Regulations), currently China’s primary legislation on GMOs, the State Council outlined the purposes of the Regulations in article 1, as

• strengthening the safety management of agricultural GMOs;
• safeguarding the health of human bodies and the safety of animals, plants, and microorganisms;
• protecting the ecological environment; and
• promoting research into technologies of agricultural GMOs.[7]

China is a party to the Convention on Biological Diversity, which became effective to China in 1993.[8] China is also a party to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, which entered in force in 2005.[9]

C. Approved GMOs

According to the data published by the MOA on April 27, 2013, China has issued GMO Safety Certificates to seven domestically developed, genetically modified (GM) crops, including a varieties of tomato (1997), cotton (1997), petunia (1999), sweet pepper and chili pepper (1999), papaya (2006), rice (2009), and corn (2009). Among them, the approved cotton has been broadly cultivated in China. As of 2010, China grew 3.3 million hectares of the approved cotton and a few hectares of the papaya, while the other GM crops had not been cultivated broadly, according to the MOA.[10]

An International Service for the Acquisition of Agri-Biotech Applications brief, Global Status of Commercialized Biotech/GM Crops: 2012, indicates that China grew 4.0 million hectares of GM crops, including cotton, papaya, poplar, tomato, and sweet pepper, as of 2012, which constituted the largest biotech crop area among developing countries, and the sixth largest around the world.[11]

Licenses have been granted for the import into China of four foreign GM crops: cotton, soybean, corn, and rape. Among them, only the cotton is permitted to be grown in China; the other crops can only be used as raw materials, according to the MOA.[12] In 2011, imported GM soybeans constituted two-thirds of the soybeans consumed domestically.[13]

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II. Public and Scholarly Opinion

A. Public Opinion

The safety of GMOs is hotly debated in China through traditional media and the emerging online social media, where the public expresses deep concerns about the safety of GMO foodstuffs. A study of a GM grain carried out in China in 2012 caused great concern to the public. In the study, a US researcher and her team were accused of feeding Chinese children a GM grain, golden rice, and measuring the effects without telling their parents. The incident was widely reported in the Chinese media, and the public is reportedly “furious” about the study using children for tests.[14] As a result, the Chinese government rapidly punished three Chinese coauthors of the study by removing them from their jobs. A year later, in September 2013, the home institute of the American researcher, Tufts University, announced that the researcher broke ethical rules while carrying out the study of GM golden rice in China.[15]

Some nonprofit organizations have also alleged that GMOs generate food safety concerns and environmental dangers. Greenpeace China, for example, particularly focuses on GM rice sold in China. It has released multiple reports warning the public about the danger of GMOs and illegal sales of GM rice in China.[16]

B. Scholarly Opinion

Mainstream research institutes in China appear to share the government’s view in promoting GMO research. Major research institutes contribute funds and laboratory facilities to GMO research. Among them, the Chinese Academy of Agricultural Sciences has established a Biotechnology Research Institute. The Institute not only supports GMO safety evaluations, but also carries out projects on GM plant research and production.[17]

Some recent discussions have raised new concerns over GMOs other than threats to human health and the environment, suggesting GMOs may endanger the country’s food security. In September, a conference on “GMOs and National Security” was held in Beijing, where scholars warned that the issues relating to GMOs were not just about science or technology, but also about food security, ecological security, and even national security.[18]

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III. Structure of Pertinent Legislation

A. GMO Regulations and Rules

China has not passed a national law specifically regulating GMOs. Restrictions are primarily on agricultural GMOs, which are provided by the GMO Regulations enacted by the State Council in 2001 and the administrative rules implementing the GMO Regulations. The GMO Regulations are designed to regulate not only crops, but also animals, microorganisms, and their products. [19] AgriculturalGMO research, testing, production, processing, business operations, and import/export activities within the PRC’s territory are subject to the GMO Regulations.[20]

The MOA and the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) have issued the following administrative rules implementing the GMO Regulations, which regulate, respectively, safety evaluations, processing, labeling, import, and entry and exit inspections and quarantine:

• Administrative Measures for Safety Evaluations of Agricultural GMOs (Safety Evaluation Measures)[21]
• Measures for Examination and Approval of the Processing of Agricultural GMOs[22]
• Administrative Measures for Labeling Agricultural GMO Marks (Labeling Measures)[23]
• Administrative Measures for Safety Control for Importing Agricultural GMO Products[24]
• Administrative Measures on the Entry and Exit Agricultural GMO Products Inspection and Quarantine[25]

In addition, the Ministry of Forestry has issued a separate document regulating gene-altered engineering of trees in forests (Forestry Measures).[26]

B. Rules on GMO Foodstuffs

The Ministry of Health (MOH) issued the Administrative Measures for Genetically Modified Food Hygiene in 2002,[27] but those measures were abolished in 2007.[28] GMO foodstuffs are now subject to the Agricultural GMO Safety Regulations. There is no separate legislation specifically regulating GMO foodstuffs today.

C. Other GMO Provisions

Apart from the aforementioned legislation, the PRC Law on Seeds,[29] PRC Law on Fisheries,[30] PRC Law on the Environment,[31] and the Administrative Measures for Safety Control over Genetic Engineering[32] contain provisions relating to GMOs.

D. Local Rules

Zhangye City in China’s Gansu Province recently issued a ban on growing, selling, or using any GM seeds. This is the first local ban on GM seeds in China.[33] In a document released on October 25, 2013, the city government ordered that no organizations or companies may grow, trade, or use any GM seeds in the area.[34]

E. Definition of Agricultural GMO

Under the GMO Regulations, “agricultural GMO” refers to any plant, animal, or microorganism whose genome constitution has been changed by using genetic engineering technology, and their products, which includes

• GM animals, plants (planting seeds, breed livestock, breed fowl, aquatic seedlings), and microorganisms;
• GM animal, plant, and microorganism products;
• products directly processed from GM agricultural products; and
• planting seeds, breed livestock, breed fowl, aquatic seedlings, pesticides, veterinary medicines, fertilizers, and additives that contain GM animal, plant, or microorganism ingredients.[35]

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IV. Restrictions on Research, Production, and Marketing

Under the GMO Regulations, testing, production, and marketing of GMOs in China are subject to government approval. Research involving Class III and IV GMOs must be reported to the MOA.

A. Responsible Agencies

1. MOA

The MOA is the primarily responsible agency for biosafety management of GMOs in China. Agricultural administrative departments of subnational governments above the county level are also responsible for biosafety management in their own jurisdictions.[36]

2. GMO Biosafety Committee

A national agricultural GMO Biosafety Committee was established in accordance with the GMO Regulations to evaluate applications for GMO Safety Certificates.[37] The Committee consists of experts in GMO research, production, processing, inspection, quarantine, health, and environmental protection. The committee members serve three-year terms.[38]

B. Research and Testing

All institutes engaged in agricultural GMO research and testing are required to have facilities and measures commensurate with their GMO safety class to ensure safety.[39] Research into agricultural GMOs classified as Class III and IV need to report to the MOA before the research is carried out.[40]

Under the GMO Regulations, testing is chronologically subdivided into three stages: medium testing (small-scale tests, also referred to as “restricted field tests”), environmental release, and product testing.[41] After completing research in the laboratory, if the testing organization needs to proceed to medium testing, the testing organization must report to the MOA.[42] Moving from one testing stage to the next requires approval from the MOA.[43]

C. Production

Upon the completion of the three testing stages, researchers may apply for a GMO Safety Certificate from the MOA.[44] According to the GMO Regulations, organizations or individuals engaged in the production and processing of agricultural GMOs must obtain approval from the MOA or a provincial agricultural administrative department.[45]

The production of GM planting seed, breed livestock, breed fowl, or aquatic seedlings requires a production license from the MOA.[46]

D. Marketing

1. Licenses and Permits

Marketing GM planting seeds, breed livestock, breed fowl, and aquatic seedlings requires a marketing license from the MOA.[47] Advertising agricultural GMOs requires a permit from the MOA as well.[48]

Any foreign company that exports to the PRC GM planting seeds, breed livestock, breed fowl, and aquatic seedlings, or any of these items plus other products (pesticides, veterinary medicines, fertilizers, or additives) using GMOs or containing GM ingredients must submit an application to the MOA and obtain a GMO Safety Certificate.[49]

Those who export GMOs as raw materials to the PRC must go through a similar process and obtain a GMO Safety Certificate.[50]

2. Labeling

GMO products on the GMO list published by the state must be clearly labeled when sold within the PRC territory; unlabeled products may not be sold.[51] The label should indicate the name of the GM materials and, if there are special restrictions on where it may be sold, the area in which it will be sold.[52]

The list of the first group of GMO products to be included under the labeling system was published along with the Labeling Measures, and it appears that no additional products have been added to the list since the first group was published. The first group of products included soybean seeds, soybeans, soybean powder, soybean oil, and soybean meal; seed corn, corn, corn oil, and corn powder; planting seed of rape, rapeseed, rapeseed oil, rapeseed meal; cotton seed; and tomato seed, fresh tomatoes, and tomato paste.[53]

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V. Restrictions on Releasing Organisms into the Environment

The purposes of regulating GMOs in China, according to the GMO Regulations, include safeguarding the health of human bodies; safeguarding animals, plants, and microorganisms; and protecting the ecological environment. The classification of GMOs is also based on the nature of their potential danger to humans, animals, plants, microorganisms, and the ecological environment.

A. Environmental Release

Environmental release under the GMO Regulations refers to the medium-scale testing conducted under natural conditions with appropriate safety measures—the second testing stage after the restricted field tests and before the product testing.[54]

Upon completion of the restricted field tests, an application must be submitted to the MOA in order to release the tested GMO into the environment. Only after the application passes a safety evaluation conducted by the GMO Biosafety Committee will the MOA approve product testing.[55] When making the application, the applicant must also submit

• a designation of the safety class of the GMO and the justifications for that designation,
• a copy of the inspection report issued by a technical inspection body of agricultural GMOs,
• a list of appropriate safety administration and precautionary measures, and
• a summary report of the previous testing stage.[56]

B. Reporting Requirements

Individuals or organizations engaged in GMO production and processing must arrange their production in accordance with the approved varieties, scope, safety control requirements, and relevant technical standards. They are also required by the GMO Regulations to regularly report their production, processing, safety controls, and the products’ whereabouts to their local agricultural administrative department.[57] Entities engaging in GMO tests and production are required to regularly report to the MOA and local agricultural administrative departments.[58]

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VI. Restrictions on GMOs in Foodstuffs

GMO foodstuffs are regulated by the GMO Regulations as “GMO products.” Therefore, the restrictions mentioned in Part IV, above, apply to GMO foodstuffs. In addition to the MOA, the local governments above the county level are responsible for the safety management of GMO foodstuffs.[59]

Fodder for livestock is also subject to the GMO Regulations.[60]

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VII. Liability Regime

The GMO Regulations provide a chapter with thirteen articles on the penalties to be imposed for violations of those Regulations.[61] Violators are mainly subject to administrative penalties, while civil or criminal penalties may also apply under certain circumstances (discussed below).

A. Administrative Penalties

Importing GMOs without a permit, or producing or processing GMOs without a permit, or with a permit but not in accordance with its terms concerning the permitted varieties, scope, safety control requirements, and technical standards, is punishable with a fine of up to RMB200,000 (about US$33,000), or up to five times the illegal gain if the gain is over RMB100,000.[62]

Researching, testing, storing, or transporting agricultural GMOs without approval may also result in administrative penalties, such as suspension of activities, a demand to correct the problem, confiscation of illegal gains, or fines.[63]

B. Civil Penalties

Any damages caused by GMO accidents in the course of research, testing, production, processing, storage, transportation, sales, or import and export must be compensated, according to the GMO Regulations.[64]

C. Criminal Penalties

Under the GMO Regulations, whoever forges, falsifies, transfers, sells, or purchases GMO certifying documents may be criminally punished if such offense violates the Criminal Law.[65] Government officials may also be criminally punished for issuing GMO certifying documents in violation of the Regulations, or for failing to perform their oversight duties.[66]

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VIII. Judicial Decisions / Prominent Cases

The Chinese courts do not systematically report their judgments, and court decisions do not have precedential effect as in common law jurisdictions. Court decisions that have significantly influenced GMO regulations in China were not located.

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Laney Zhang
Foreign Law Specialist*
March 2014

 

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Last Updated: 12/30/2020