As the first country in Africa, Nigeria authorized guidelines on genome editing in December 2020 through its National Biosafety Management Agency (NBMA). Decisions are made on a case-by-case basis: when edited lines do not contain a new combination of genetic material, they can be classified as conventional varieties or products (https://doi.org). On February 10, 2022, the NBMA distributed printed copies of the guidelines to the public in Abuja to ensure that all genome edited product in Nigeria are properly regulated (https://www.isaaa.org).

The "National guidelines for the regulation of gen editing” can be found here.

Kenya implemented regulations for genome-edited crops in March 2022, becoming the second African country, after Nigeria, to publish such guidelines (https://www.isaaa.org/). The National Biosafety Authority (NBA) released these guidelines to clarify which genome-edited organisms and products fall under Kenya’s Biosafety Act and which are considered conventional varieties or breeds (https://africenter.isaaa.org). A key feature of the guidelines is the provision for early consultation to determine the appropriate regulatory pathway based on the outcomes of genome editing procedures (https://allianceforscience.org).

The “Guidelines for determining the regulatory process of genome edited organisms and products in Kenya” can be found here.

In February 2022 the Ministry of Natural Resources and Climate Change published the Guidelines for Determining the Regulatory Process of Genome Edited Plant and their Products in Malawi. The guidelines exempt genome edited products from the current Biosafety Act if the processed products are free of inserted foreign DNA and similar to products that could occur in nature or through use of conventional breeding techniques (https://africenter.isaaa.org/) Further the guidelines state that any products containing novel combination of DNA will still be regulated as GMOs (https://www.isaaa.org/).

In October 2023 Ghana’s National Biosafety Authority (NBA) has published the guidelines on Genome Editing and Gene Stacks with regards Genetically Modified Organisms (GMOs). Products of genome editing will be regulated on a case-by-case basis. Any products generated with SDN-1 methods that do not contain inserted nucleic acids or its replicated product will exempted from the current Biosafety Act (https://bch.cbd.int/en/database/).

The “Guidelines for genome editing applications in Ghana” can be found here.

Canada adapted its existing biotechnology laws in 2016 to incorporate new regulations for genome edited crops, with a focus on the product characteristics of the genetic changes rather than the method used (Schmidt et al., 2020). Therefore, the Canadian government specified that genome edited crops, such as those modified with CRISPR-Cas9, would be assessed on a case-by-case basis. The Canadian Food Inspection Agency (CFIA) and Health Canada decided that if the editing did not introduce new genetic material (e.g., foreign DNA), then the crop would not be subject to the same regulatory process as GMOs (https://www.canada.ca). This was a pivotal moment in distinguishing between traditional GMOs and genome-edited crops in Canada. In 2019-2020 Canada published its Genome Editing Framework to further clarify its stance. Under this framework, certain types of genome edited crops (without the introduction of foreign genes) are treated as “non-regulated” or as conventional crops, as long as they do not present new risks to human health or the environment. In contrast, crops that involve the addition of foreign DNA are still regulated under existing GMO laws (https://canadagrainscouncil.ca).

In the United States, genome editing is regulated under the Coordinated Framework for the Regulation of Biotechnology, focusing on the final product’s characteristics rather than the editing method. The USDA reviews genome-edited plants for agricultural safety, exempting those that mimic natural mutations or lack foreign DNA under the SECURE Rule (https://www.aphis.usda.gov). The FDA ensures food and animal safety, treating genome-edited animals as new animal drugs, which requires premarket approval, while genome-edited foods are reviewed like conventional foods. The EPA regulates environmental risks, especially for genome-edited plants with pesticidal properties or pest resistance traits. Overall, the U.S. takes a case-by-case, product-based approach, making it more permissive than the EU, particularly for non-transgenic genome edits.

Already in 2019, as part of the Central America Customs Union initiative, Guatemala and Honduras signed a resolution that exempted new genetic combinations without stable integration of exogenous DNA from their existing GMO regulations. This resolution, approved by the Ministry of Agriculture, Livestock and Food (MAGA), lays the groundwork for treating edited plants similar to conventional breeds (Gatica-Arias, 2020; Kuiken and Kuzma, 2021). However, despite the implementation of a scientifically substantiated regulatory framework that permits the approval of biotechnology seeds for cultivation in 2019, the government of Guatemala has maintained a de facto ban on the cultivation of genome edited crops since March 2022 (https://apps.fas.usda.gov/).

Together with Guatemala and El Salvador, Honduras approved a technical regulation on March 19, 2019 which aimed at the commercial exchange and safe use of agricultural biotechnology and took effect October 1, 2019. Shortly before, the Honduras National Service of Health and Food Safety (SENASA) implemented a streamlined procedure for approving certain genome-edited products that are not classified as “Living Modified Organisms” (https://apps.fas.usda.gov/). This new process significantly reduces approval times. According to the regulations, the committee will evaluate each request on a case-by-case basis to determine whether it qualifies for the simplified approval process. Since then Honduras has not made any modifications to its established regulatory framework regarding genetically engineered crops (https://apps.fas.usda.gov/).

On October 1, 2019, El Salvador, Guatemala, and Honduras agreed to harmonize biosafety regulations for agricultural biotechnology, with the aim of facilitating trade and ensuring the safe utilization of modified organisms in farming across Central America. El Salvador delegated the responsibility for approving and maintaining records of biotechnology-related activities to the Ministry of Agriculture. In 2023, national and international trade organizations and the Ministry of Agriculture to revise the country's Plant Health Law, with the aim of incorporating emerging technologies such as gene editing and aligning El Salvador with the biotech agreement between Guatemala and Honduras (https://apps.fas.usda.gov/).

Argentina has been a global leader in establishing regulatory frameworks for genome editing, particularly in agriculture. In May 2015, the Ministry of Agriculture, Livestock, and Fisheries (MAGyP) introduced a “prior consultation procedure” under Decision 173/15, specifically addressing crops developed through new breeding techniques (NBTs), including genome editing (Schmidt et al., 2020). If a genome-edited product does not retain foreign genes in the final product, it is typically not classified as a genetically modified organism (GMO) and is regulated similarly to conventional new varieties. This approach emphasizes the characteristics of the final product rather than the techniques used in its development (Lema, 2019). Upon receiving a prior consultation request, the National Advisory Commission on Agricultural Biotechnology (CONABIA) evaluates the product to determine the regulatory status (Goberna, et al., 2022, ). Argentina’s regulatory approach has been adopted by neighboring countries such as Brazil, Chile, Paraguay, and Colombia, promoting a harmonized framework within the region.

Brazil has established a comprehensive regulatory framework for genome editing, particularly in agriculture and biotechnology. The National Technical Commission on Biosafety (CTNBio) is the primary body responsible for overseeing activities involving products derived from genome editing (Entine, et al. 2020). Issued by CTNBio in 2018, the Normative Resolution No. 16 (RN16/2018) addresses also products developed through genome editing. It evaluates, on a case-by-case basis whether a product is free from foreign DNA or recombinant material and has no significant unintended effects and then exempts it from GMO regulations (Schmidt et al., 2020). As of 2022, Brazil had approved 27 genome-edited products, including modified crops, fish, and cattle with enhanced traits (Hallerman, et al., 2023). Overall, Brazil’s regulatory framework balances biosafety with innovation, making it one of the most progressive countries in genome editing.

In 2017, the Agricultural and Livestock Service (SAG) in Chile implemented a case-by-case evaluation process to determine whether products developed through genome editing, are classified as GMOs (Schmidt et al., 2020). Chile’s regulatory approach aligns with the Cartagena Protocol’s definition of GMOs but makes a key distinction: plants modified via NBTs without exogenous DNA are not classified as GMOs. This means that genome-edited plants lacking foreign genetic material are treated as conventional products, exempting them from GMO regulations (Sánchez, 2024). The consultation process requires applicants to provide detailed information about the phenotype, biotechnological techniques used, and evidence of the absence of foreign DNA. As of November 2024, SAG had reviewed 57 applications, with 52 classified as non-GMOs due to the absence of foreign genetic material (https://www.seedworld.com). By adopting a clear and efficient regulatory process, Chile fosters innovation in agricultural biotechnology while maintaining biosafety standards. This approach not only benefits domestic agricultural development but also positions Chile as a significant player in the global advancement of genome-edited crops.

In Colombia, the regulatory framework for genome-edited crops is evolving to accommodate advancements in agricultural biotechnology. In 2022, the Government of Colombia issued Resolution 29291 (Suspended the previous Resolution 29299/2018), which provides criteria to determine whether crops developed through innovative technologies, such as genome editing, should be regulated under existing genetically engineered (GE) crop regulations or as conventional crops (https://www.ica.gov.co/).

Colombia evaluates genome-edited crops on a case-by-case basis, considering the specific modifications and their implications. If a genome-edited crop does not contain foreign DNA and exhibits traits achievable through traditional breeding methods, it may be regulated as a conventional crop. However, if the modifications involve transgenic elements or present novel characteristics, the crop would be subject to the more stringent GE regulations (https://apps.fas.usda.gov/).

Ecuador has developed a regulatory framework for genome editing in 2019 and was among the first countries to specify that only organisms containing foreign DNA should be classified as GMO (Entine et al., 2021). The Seed Technical Committee (CTS), established by Ministerial Agreement 163/2020, serves as the consulting body to assess and determine if a seed or crop obtained through precision breeding techniques can be registered as a conventional organism (https://www.fontagro.org). Overall, Ecuador’s regulatory framework for genome editing in agriculture is designed to promote sustainable agricultural practices and address challenges such as disease resistance and crop yield improvement. The country continues to develop its policies to keep pace with advancements in biotechnology (Buchholzer, et al., 2023).

In 2019, the Paraguayan government established a regulatory framework that allows exemption of genome edited products from their specific GMO regulations after consultation with the National Biosafety Commission. These regulations require applicants to provide detailed documentation on potential off-target effects and validation of the absence of foreign DNA (Gatica-Arias, 2020). This approach aligns with Paraguay’s commitment to international standards and its efforts to promote agricultural innovation while maintaining biosafety (Buchholzer, et al., 2023).

Although Uruguay and other countries already issued a joint statement to the World Trade Organization in 2018 with the intention to relaxed regulations for gene editing, it has only recently established a regulatory framework for genome-edited crops. In March 2024, the Ministries of Environment and Livestock, Agriculture, and Fisheries introduced a decree outlining procedures for evaluating products derived from new genome editing. A Technical Working Group (GTT) comprising experts from various institutions, such as the National Institute of Agricultural Research (INIA), the National Seed Institute (INASE), and the University of the Republic (UdelaR) is tasked with assessing whether specific products or organisms and their derived products, should be classified as GMOs (https://www.isaaa.org). By adopting this approach, Uruguay aims to enhance its competitiveness in the global market and support sustainable agricultural practices.

Japan has a well-defined regulatory framework for genome-edited crops, established in 2019 by the Ministry of the Environment (MOE) and the Ministry of Health, Labour and Welfare (MHLW). Japan does not regulate genome edited plant varieties in a different manner than conventionally bred varieties, if they do not contain new DNA (SDN‐1 and SDN‐2). Developers of genome edited crops must notify the MOE and MHLW before releasing them but do not need full risk assessments like with GMOs (Schmidt et al., 2020).

In January 2022, the Ministry of Agriculture and Rural Affairs (MARA) issued the “Guidelines for Safety Evaluation of Gene-Edited Plants for Agricultural Use”, for a safety evaluation of genome edited plants that do not contain exogenous DNA (Mallapaty, 2022). In the application process, the Chinese government focuses on a safety evaluation regarding the risk of genome-edited plants on the environment and divides the risk into 4 categories. The draft rules stipulate that once gene edited plants have completed pilot trials, a production certificate can be obtained, eliminating the need for further time-consuming field trials. Key information requested includes a detailed description of the trait, risks and benefits, how it was generated, evidence for the absence of vector sequences, and validation of the stability of the trait over three generations (USDA Report Number CH2022-0015). By December 2024, China had approved five gene-edited crops to enhance high-yield crop production and ensure food security (https://www.reuters.com). In February 2025, China released guidelines to promote biotechnological advancements in agriculture, focusing on gene editing tools and developing new varieties (https://www.reuters.com)

On March 30, 2022, the Indian Government signed the Office Memorandum ‘Exemption of the Genome Edited plants falling under the categories of SDN1 and SDN2 from the provisions of the Rules, 1989’ (indianexpress.com). The memorandum states that work with genome edited plants must be carried out under strict safety precautions until it can be ensured that exogenous introduced DNA is no longer present. The guidelines cover genome-edited plants produced by SDN-1 and SDN-2. If validated to be free of exogenous DNA, they are exempted from the current GMO regulations and can be released as a new variety and used for further development and evaluation. In May 2022, the Department of Biotechnology, Government of India, released the ‘Guidelines for the Safety Assessment of Genome Edited Plants, 2022’, which provides detailed guidance on the regulatory requirements. Notably, Bangladesh, Nepal, Sri Lanka and Cambodia have ‘Seeds without borders' agreements in place that will likely lead to harmonization of genome editing guidelines (Gauchan & Joshi, 2019).

In December 2023, the Ministry of Agriculture published the “Standard Operating Procedures for Research and Release of Genome Edited Plants of Categories SDN-1 and SDN-2 in Bangladesh.” This SOP provides guidelines for the research and release of genome-edited crops, aiming to facilitate innovation while ensuring safety and compliance. Therefore, the government has exempted crops derived through specific gene-editing techniques, such as SDN-1 and SDN-2, from the stringent regulatory processes required for GMO’s. This move is intended to streamline the development and commercialization of genome-edited crops that do not contain foreign DNA (https://www.dhakatribune.com/).

In May 2022, the Philippine Department of Agriculture issued the Memorandum Circular No. 8, Series of 2022 (MC8) 1 which provides the regulatory background for the use of genome edited plants (https://gain.fas.usda.gov).The circular excludes plants from the existing GMO regulations that do not contain a novel combination of genetic material obtained through biotechnology. Developers must submit an application detailing the genome-editing techniques used and the genetic changes introduced. The application is reviewed to assess whether the resulting plant falls under existing GE regulations or is exempt. After a crop was determined non-GMO, a certificate will be issued to the developer (USDA Report Number CH2022-0026). The government states that the regulations aim at accelerating the development of plant varieties and reducing costs for farmers and possible impact on the environment.

Already in March 2017, the Israeli National Committee for Transgenic Plants (NCTP) determined that SDN‐1‐ and SDN‐2‐derived plant products are regulated as conventional plants if no foreign DNA is present. The applicant must, however, submit data showing that they meet the determined criteria to ensure that foreign DNA sequences were not incorporated into a plant genome (https://apps.fas.usda.gov). Overall, Israel’s regulatory approach to genome editing is characterized by a supportive stance towards agricultural innovation, particularly for gene-edited crops without foreign DNA, while maintaining stringent ethical standards in human genetic research.

In 2016, Russia enacted Federal Law No. 358-FZ, which prohibits the cultivation and breeding of genetically modified (GM) plants and animals, except for research purposes. This law defines GMOs as organisms with genetic modifications “that cannot result from natural processes” (Korobko, et al.2016). Although, genome edits could potentially be excluded from this definition, there is no regulatory process in place yet. In 2019, a decree of the President of Russia (Resolution of April 22, 2019 No. 479) established funding for genome editing, and classified transgene-free edited crops as equivalent to those generated by conventional breeding (Dobrovidova, 2019). In summary, while Russia maintains stringent regulations against the cultivation of GM and genome editing organisms, it actively invests in genome editing research and development, particularly in agriculture. 

Vietnamese institutions are collaborating with international organizations to study and apply genome editing in plant breeding. Efforts are underway to develop appropriate regulations that align with global standards and address the unique aspects of genome-edited products (https://apps.fas.usda.gov/).

A European Court of Justice (ECJ) decision in 2018 ruled that organisms obtained through genome editing are subject to existing GMO regulations. In 2021, the European Union (EU) began to reevaluate its position and performed a study examining the implementation of EU legislation on genome editing (europarl.europa.eu). After the Commission collected feedback in 2021 and hold a public consultation in 2022 (ec.europa.eu) the European Parliament’s Environment Committee proposed new legislation for plants produced by targeted mutagenesis and cisgenesis in 2023. The measure must still be agreed to in negotiations with the European Union’s member states. However, as of now, this proposal has not been adopted, and genome-edited crops remain regulated under traditional GMO laws (https://www.robert-schuman.eu/).

The Norwegian government established a public committee on genome technology in 2020 with the task of publishing a comprehensive overview of gene technology by June 2022 (Kjeldaas et al., 2021). A public consultation on proposed revisions to Norway’s Gene Technology Act has led to a recommendation to ease regulations on edited crops which are comparable to natural bred varieties. However, as of now, Norway’s regulatory framework for genome editing is still primarily governed by the Gene Technology Act of 1993.

Switzerland maintains a cautious approach toward genome editing, particularly in agriculture. The regulatory framework is primarily defined by the Gene Technology Act. In 2005, the Swiss voters approved an initiative in favor of a Moratorium on GMOs in agriculture which is currently extended until 2027. In March 2022, the Swiss parliament decided to allow exemptions for genome editing in plant breeding, under the condition that there is a clear benefit for farmers, consumers, and the environment over conventional breeding (https://www.sciena.ch/). Under the new rules, transgene-free edited lines would not fall under the genetic engineering law and would not be treated or declared as GMO. However, detailed regulations have still to be developed and are not in place yet.

The UK regulates genome editing in agriculture under the Genetic Technology (Precision Breeding) Act 2023, which distinguishes precision-bred organisms from traditional GMOs and allows gene editing in crops. Researchers and developers must notify authorities about precision-bred organisms, ensuring transparency. Notably, the statutory instrument that would enable field trials defines ‘qualifying higher plants’ (QHPs) as genome edited plants that could have been produced by traditional breeding techniques or could have arisen through natural processes (https://www.gov.uk/). While England is advancing with gene editing, Scotland and Wales have not adopted the new regulations. The UK government faces delays in implementing secondary legislation, partly due to concerns about conflicts with EU regulations. Despite this, policymakers emphasize the potential benefits of gene editing for food security and climate resilience.

Australia regulates genome editing in agriculture under a product-based framework, focusing on the characteristics of the final organism rather than the modification process. In 2019, regulatory amendments allowed certain gene-editing techniques, such as SDN-1 (which does not introduce foreign DNA), to be exempt from GMO laws. The Gene Technology Regulator oversees approvals, ensuring safety for health and the environment (https://www.nature.com/).

Historically, New Zealand maintained stringent regulations on gene technologies, effectively limiting research and commercialization. However, in August 2024, the government introduced the Gene Technology Bill 2024, aiming to modernize the regulatory framework. The legislation aims to exempt “low-risk” gene editing techniques from their regulations, provided the changes are indistinguishable from conventional breeding. Additionally, it proposes the establishment of a dedicated regulator to oversee gene technologies. The government plans to enact this legislation and operationalize the regulatory body by the end of 2025 (https://www.reuters.com/).