The report discusses the legislation of genetically modified organisms (GMOs) and genetically modified (GM) plants and foods in Argentina, Belgium, Brazil, Canada, China, Egypt, England and Wales, France, Germany, Israel, Italy, Japan, Lebanon, Mexico, the Netherlands, New Zealand, Norway, the Russian Federation, South Africa, South Korea, Sweden, and the United States. The European Union and International Protocols. This report summarizes enacted laws on the cultivation and sale of GMOs, as well as public opinion on GM products.
A bibliography is included.
Full Report (PDF, 1,398KB)
Argentina is the third largest grower of biotech crops in the world, after the United States and Brazil. GMOs are regulated in Argentina under the Law on Seeds and Phytogenetic Creations and the Law on the Promotion of the Development and Production of Modern Biotechnology, and under administrative regulations issued by the Secretary of Agriculture, Livestock, Fisheries and Food. Argentina has not ratified the Cartagena Protocol on Biosafety.
Belgium is considered to have an intermediate level of restrictions on GMOs, although public opinion tends to generally be hostile to GMOs. Most of Belgium’s regulation of GMOs is directly or indirectly derived from European regulations. Overall, regulation of GMOs in Belgium is mostly focused on authorization requirements prior to their production, use, or distribution; on mandatory technical requirements to limit the potential release of GMOs into non-GMO fields; and on information and transparency measures.
In Brazil, GMOs are governed by a law that defines the concept of a GMO and sets rules for the laboratories that work with them. Additionally, it establishes authorization procedures for GMO research, and establishes rules for the production and marketing of GMOs, restrictions on their release into the environment, regimes for their cultivation, requirements for reporting their release, inspections and monitoring of GMO research activities and their commercial release, implementing authorities and authorizing procedures for their release, and restrictions on GMOs in foodstuffs. Finally, it provides for the punishment of administrative violations and criminal offenses.
Canada regulates products derived from biotechnology processes as part of its existing regulatory framework for “novel products.” The focus is on the traits expressed in the products and not on the method used to introduce those traits. The Canadian Food Inspection Agency is responsible for regulating GM plants and approving GM feed for animals. Health Canada is mandated to assess the safety of foods for human consumption, including GMOs in foodstuff, and for authorizing them to be sold in Canada. Advertising or labeling the presence of GMOs in particular food is voluntary unless there is a health or safety concern.
In China, restrictions on 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.
Egypt takes a permissive approach to GMOs, and its public policy does not oppose growing, importing, and exporting genetically modified crops. Egyptian activists have voiced their rejection of this policy. Egyptian laws do not contain restrictions on researching, producing, or marketing genetically modified crops and food products. The country also has no restrictions on releasing genetically modified organisms into the environment. A draft law on biosafety was not approved by the Egyptian Parliament.
England and Wales
The growth and sale of GMOs are permitted in England and Wales, subject to an intensive authorization process that occurs primarily at the European Union level. Most legislation in England and Wales that applies to GMOs is implementing legislation for EU law. The general attitude in England is averse to GM products; however, a slight shift in attitude towards GM products has recently been reported, and the UK government’s policy indicates a more receptive attitude towards these products.
The production and sale of certain GMOs are legal in France, but are subject to very restrictive rules. French legislation supplements the broader framework of European regulation with national rules that provide additional restrictions, particularly focused on the potential release of GMOs in the environment, and on labeling requirements for GM products. As a result of both public hostility to GMOs and these legal restrictions, there are currently no GM crops grown in France, even though France imports substantial amounts of GMOs from abroad.
This country report was updated June 2014.
Germany discourages the cultivation of GM crops to the extent possible within the already stringent European Union legislation on GMOs. Germany imposes strict liability for accidental contamination with GMOs, and has tough and methodically enforced controls over the release of GMOs.
Israeli law permits the development and growth of GMOs for research purposes in accordance with requirements established by subsidiary legislation. Although GMO growth is not permitted for commercial purposes, GMO products may be imported, sold, and used in the production of food and pharmaceuticals in Israel. Israel’s religious kashrut authority has determined that the use of GMO ingredients in food does not affect its kosher status because GMOs are only used in “microscopic” proportions. To date, legislation specifically regulating the labeling of GMO components in food does not appear to have been passed.
As a member of the European Union, Italy has been implementing European directives concerning GMOs over the last two decades, but at a rather reluctant pace. In fact, as reflected by GMO legislation in Italy, Italian public opinion has shifted from a decidedly general opposition to the introduction of GMOs into a more recent open acceptance of them. The Italian Constitutional Court has ruled that the national government is constrained from encroaching on the power of regional governments to establish their own regimes on GMOs. As a consequence, some regions have enacted slightly more permissive regimes than others.
Japan enacted the Cartagena Act in 2003 to implement the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. Although it is legal to plant GM crops in Japan if certain procedures are followed, no commercial planting of GM crops (aside from ornamental flowers) is occurring in Japan at this time, mainly because the general public is skeptical about the safety of GM crops. Nevertheless, Japan is one of largest importers of GMO foods, though labeling is required if GM crops are used in food in certain cases.
Although Lebanon ratified the Convention on Biological Diversity in 1994 and the Cartagena Protocol in 2008, it has not yet adopted policies dealing with GMOs. While there are some existing laws that are indirectly relevant to this subject matter it is fair to say that no comprehensive legal regime on this issue exists at this time.
Mexico’s Law on Biosecurity of Genetically Modified Organisms is a federal law that provides rules concerning GMOs, and is aimed at preventing, avoiding, or reducing the risks that these activities may cause. The GMO Law provides that violations of its provisions or its regulations are punishable with civil penalties. Mexico’s Federal Criminal Code provides that an individual who, in contravention of applicable law, commercializes, transports, stores, or releases into the environment a GMO that negatively alters or may alter the components, structure, or functioning of natural ecosystems is punishable with imprisonment of one to nine years and a fine.
Although the Netherlands was the first European Union Member State to have legal coexistence guidelines on genetically engineered (GE) crops, commercial production of GM crops has not yet taken place. While the government and the agriculture sector take a pragmatic approach toward the import and use of GM products, public opinion is divided as to whether GM foods pose health risks. Activities involving GMOs are for research purposes in laboratories or field trials, and are tightly regulated, in particular through EU Directives made applicable in the Netherlands. Prior risk assessment and subsequent monitoring and reporting are necessary for all GMO-related activities. Criminal penalties and administrative sanctions may be applied to violations of licensing requirements.
The importation, development, testing, and release of GMOs are strictly regulated in New Zealand. Such activities must be approved by the Environmental Protection Authority, which is required to take into account environmental, economic, social, cultural, and public health considerations. GM techniques have been approved for use in research involving both plants and animals, subject to various controls. There are currently no GM commercial crops, though imported food and ingredients derived from GMOs must be approved by a food safety authority and clearly labeled on packaging before sale. Criminal and civil penalties may be applied in relation to breaches of the legislation, and offenders may be ordered to mitigate or remedy any adverse effect on people or the environment.
Norway is one of the most restrictive importers of GM products and does not produce GMOs. As Norway is only part of the European Economic Area and not a full European Union Member it is not bound by EU Directives but generally implements EU Directives nonetheless. There are several EU-approved GMOs that are specifically illegal in Norway. Following a recent regime shift in Norway it is yet unclear whether Norway’s position on GMOs might change.
Cultivation of transgenic plants for commercial use is not allowed in the Russian Federation. However, several types of GM food and feed lines that have passed the procedure of state registration and control are allowed to be imported, processed, and used for food or feed production. Research on genetically engineered animals is not supported by the government. Russia recently adopted an approval procedure for release of GMOs into the environment, which brings the country closer to possible cultivation of GM plants. Currently, eighteen GM food lines and fourteen GM feed lines are approved and registered in Russia.
The primary legislation in South Africa dealing with GMOs, including their contained use, trial release, commercial release, and import and export is the Genetically Modified Organisms Act of 1997 (GMO Act) and its subsidiary legislation. The GMO Act places various restrictions on the research, production, and marketing of GMOs, including requiring permits, risk assessments, notification to the public, registration, and demonstrated safety to the environment. The GMO Act imposes civil liability on people who conduct GMO-related activities for damage they cause and criminalizes various acts, including violations of its provisions or refusing to cooperate with the regulatory bodies.
Korea signed the Cartagena Protocol on Biosafety in 2000 and enacted implementing legislation the following year. Importing, cultivating, researching, and developing GMOs are permitted, as long as applicable procedures are observed. Even though more and more research on GMOs is being performed, people are still concerned. As yet, there has been no authorized GMO cultivation within Korea. Restrictions on GMO food include a safety assessment in addition to a risk assessment and approval procedure. Sellers of GM food must follow labeling requirements.
Swedes, both consumers and producers, are very conscious of GMOs. GMO use is limited and almost exclusively used in animal fodder products. The use of GMOs in food is a sensitive topic that generates strong public opinion. A majority of Swedes consider it important that their milk is GMO free, and dairy farmers therefore avoid GMOs in their fodder. Sweden, as a European Union Member, has adopted a case-by-case analysis for each GMO. One GM potato for industrial use has been approved for cultivation in Sweden, but currently no GMOs are being produced.
GMOs are regulated in the United States under the Coordinated Framework for Regulation of Biotechnology, published in 1986, pursuant to previously existing statutory authority regulating conventional products, with a focus on the nature of the products rather than the process in which they are produced. The form of regulation varies depending on the type of GMO involved.
Plant GMOs are regulated by the US Department of Agriculture’s Animal and Plant Health Inspection Service under the Plant Protection Act. GMOs in food, drugs, and biological products are regulated by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. GMO pesticides and microorganisms are regulated by the Environmental Protection Agency pursuant to the Federal Insecticide, Fungicide and Rodenticide Act and the Toxic Substances Control Act.
There are two major international protocols that address genetically modified organisms, the Cartagena Protocol of 2000 and the Nagoya-Kuala Lumpur Supplementary Protocol of 2010. They are attached to the Convention on Biological Diversity of 1993. They apply only to transboundary actions; they do not apply to use or transit of GMOs within countries.
The European Union (EU) has in place a comprehensive and strict legal regime for GMOs, food and feed made from GMOs, and food/feed consisting or containing GMOs. The EU’s legislation and policy on GMOs is designed to prevent any adverse effects on the environment and the health and safety of humans and animals, and it reflects concerns expressed by skeptical consumers, farmers, and environmentalists.
GMOs and food or feed made from GMOs can be marketed in or imported into the EU, provided that they are authorized after passing strict evaluation and safety assessment requirements that are imposed on a case-by-case basis. Since 2001 the EU has had a de facto moratorium on GMO approvals, but a September 2013 decision of the General Court of the EU may put an end to the moratorium. While marketing and importing GMOs and food and feed produced with GMOs are regulated at the EU level, the cultivation of GMOs is an area left to the EU Members. Liability issues and compensation schemes for individuals fall primarily within the domain of the EU Member States. In general, the EU espouses the principle that the polluter pays.
This bibliography lists selected, recent English-language works on restrictions on GMOs. The first section contains discussions of aspects of the topic in general and in international law. The second section has materials discussing the issue in particular jurisdictions and is divided into sections on Africa, the Americas, Asia, and Europe.
Last Updated: 06/09/2015