Burkina Faso is one of six African countries to have published genome editing-specific guidelines, following the SDN classification framework promoted by AUDA-NEPAD. Under the oversight of the Agence Nationale de Biosécurité (ANB), products developed via SDN-1 and SDN-2 methods that do not contain foreign DNA are exempt from GMO regulation and classified as conventional varieties. Regulatory decisions are made on a case-by-case basis. In July 2024, the ANB issued Decision No. 2023-000122/MESRI/SG/ANB/DG, formally authorizing the use of genome-edited rice lines targeting bacterial blight resistance (pmc.ncbi.nlm.nih.gov), making Burkina Faso the first African country to approve a genome-edited crop for field evaluation.

Ethiopia is among the six African countries that have published genome editing-specific guidelines, joining Nigeria, Kenya, Ghana, Malawi, and Burkina Faso as regulatory frontrunners on the continent (ghanabusinessnews.com). The guidelines follow the SDN classification framework, with SDN-1 and SDN-2 products free of foreign DNA classified as conventional plant varieties. Regulatory decisions are made on a case-by-case basis. Ethiopia's framework is being developed with active support from AUDA-NEPAD's communication and advocacy program, which targets eight African countries.

In October 2023, Ghana's National Biosafety Authority (NBA) published the Guidelines on Genome Editing and Gene Stacks with regard to Genetically Modified Organisms (GMOs), joining Nigeria, Kenya, and Malawi as the fourth African country with validated genome editing guidelines (bch.cbd.int). Products of genome editing are regulated on a case-by-case basis under the Biosafety Act, 2011 (Act 831). Any products generated with SDN-1 methods that do not contain inserted nucleic acids or their replicated product are exempted from the current Biosafety Act. Products that do contain foreign genetic material continue to be regulated as GMOs.

It is important to note that under Ghana's current regulatory framework, genome-edited products exempt from the Biosafety Act may be imported for use as food or feed following regulatory review; however, the cultivation and export of genome-edited organisms are not currently permitted (nature.com). In July 2024, the NBA approved a research application from the Biotechnology and Nuclear Agriculture Research Institute (BNARI) to commence genome editing of rice, targeting disease resistance against the yellow mottle virus and improved drought tolerance (apps.fas.usda.gov).

The "Guidelines for genome editing applications in Ghana" 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.

Madagascar is one of only three countries worldwide that explicitly prohibit the cultivation, import, and export of genome-edited organisms. This ban has been in force since 2018 and treats all genome-edited plants as equivalent to conventional GMOs, barring their commercial use entirely (npj Science of Plants). The country's highly biodiversity-oriented environmental policy drives this restrictive stance. As of mid-2026, there are no indications that the ban is under review.

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/).

The “Guidelines for Determining the Regulatory Process of Genome Edited Plant and their Products in Malawi” can be found here.

Mozambique has developed draft genome editing guidelines, aligned with the broader African regulatory framework promoted by AUDA-NEPAD and modeled on guidelines from Nigeria, Kenya, Malawi, and Ghana. As of early 2026, these guidelines are still undergoing a validation and publication process (npj Science of Plants). Once adopted, they are expected to exclude genome-edited products free of foreign DNA from GMO regulation on a case-by-case basis. The lead institutions are the National Institute of Biotechnology (INBI) and the Centro Nacional de Biotecnologia e Biociencias (CNBB), which participates in the AUDA-NEPAD Africa Genome Editing Policy Landscape review (pmc.ncbi.nlm.nih.gov).

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.

Rwanda became the fourth African country to formally adopt a genome editing regulatory framework in 2024, following Nigeria (2021), Kenya (2022), and Malawi (2022) (npj Science of Plants). Rwanda's biosafety framework was developed as part of the country's Vision 2050 development agenda. The Rwanda Environment Management Authority (REMA) oversees biosafety regulation and the National Biosafety Committee reviews applications. Genome-edited products that do not contain foreign DNA are assessed on a case-by-case basis to determine whether they qualify as Living Modified Organisms (LMOs); transgene-free products may be classified as conventional varieties (africenter.isaaa.org).

South Africa is the largest GMO crop producer in Africa and has one of the continent's most established biotechnology regulatory frameworks, governed by the Genetically Modified Organisms (GMO) Act of 1997. Despite this advanced GMO regulatory capacity, South Africa has adopted one of the most restrictive positions on genome editing in Africa. In October 2021, the Executive Council of the GMO Act formally decided that all genome-edited products would be treated the same as GE products under the GMO Act, regardless of the presence of foreign DNA. This means that SDN-1 and SDN-2 derived crops without foreign DNA are subject to the full GMO risk assessment process, unlike in neighboring Kenya, Nigeria, or Malawi. Nature

The agricultural industry, represented by the Agricultural Business Chamber of South Africa (AGBIZ), the South African National Seed Organisation (SANSOR), and CropLife, launched a formal appeal against this decision. An independent Appeal Board was appointed and sided with the industry, recommending a more differentiated approach. However, in early 2024, the Minister of Agriculture formally upheld the October 2021 Executive Council decision, rejecting both the industry challenge and the Appeal Board's findings, and confirming that the GMO risk assessment framework applies to all new breeding techniques. South Africa's regulatory framework under the GMO Act therefore remains firmly process-based, and genome editing continues to be regulated as GMO technology. As of mid-2026, no amendment to the regulatory framework is expected in the near term (biosafety.org.za).

Canada regulates agricultural biotechnology under a product-based framework, focusing on the characteristics of the final organism rather than the method used to develop it. The Canadian Food Inspection Agency (CFIA) and Health Canada are the primary regulatory bodies, overseeing environmental safety under the Seeds Regulations and food safety under the Food and Drug Regulations respectively. Plants that introduce traits that are both new to cultivated populations in Canada and have the potential to negatively impact the environment are classified as "Plants with Novel Traits" (PNTs) and require pre-market assessment. Critically, this classification applies regardless of the breeding method used, meaning conventionally bred, genome-edited, and transgenic crops are all assessed by the same product-based criteria (inspection.canada.ca).

Between 2022 and 2024, Canada completed a three-stage update to its regulatory guidance for genome-edited crops. Health Canada updated its novel food guidelines in May 2022, clarifying that gene-edited products without foreign DNA generally do not require pre-market food safety assessment. The CFIA followed with an environmental safety guidance update in May 2023. On May 3, 2024, the CFIA published the third and final policy update, completing the regulatory pathway for gene-edited crops and establishing that they can be considered non-novel or non-genetically modified by Canadian standards, with approvals based on their traits or characteristics, not on the breeding techniques or how they were developed. As a result, gene-edited crops that do not introduce foreign DNA and do not present novel traits can enter the Canadian market without pre-market regulatory assessment or mandatory government notification. Products that do introduce novel traits continue to require standard PNT review. As of October 2024, Canada has approved 147 PNTs across nine crop species, including alfalfa, apple, canola, corn, flax, maize, potato, soybean, and sugar beet. No labeling is required for genome-edited food products in Canada.

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's Animal and Plant Health Inspection Service (APHIS), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA) share oversight responsibilities. In May 2020, APHIS finalized the SECURE (Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient) Rule, which updated biotechnology regulations to focus on product characteristics, exempting genome-edited plants that mimic natural mutations or lack foreign DNA from pre-market review. However, on 2 December 2024, the United States District Court for the Northern District of California prospectively vacated the SECURE Rule, finding that APHIS had not adequately justified certain aspects of the regulation. As a result, APHIS reverted to the pre-2020 biotechnology regulations (7 CFR Part 340, 2019) (aphis.usda.gov). Regulatory Status Review responses, Confirmation Request responses, and active permits issued prior to 2 December 2024, remain valid and continue to be legally marketed. APHIS has announced plans to develop a new interim final rule titled "Regaining Lost Efficiencies for Products of Biotechnology" to address the regulatory gap (congress.gov). The FDA ensures food and animal safety through a voluntary consultation process for foods derived from gene-edited plants, reaffirmed in updated guidance issued in February 2024, applying a risk-based approach focused on objective characteristics of the food irrespective of the development method (congress.gov). Genome-edited animals continue to be treated as new animal drugs, requiring premarket approval. 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.

In November 2023, Costa Rica updated its national biotechnology regulatory framework, becoming one of the first Central American countries to explicitly address genome editing. The revised framework, published on November 11, 2023, introduces a clear distinction between “organisms containing a novel combination of genetic material” and “organisms equivalent to those obtained through conventional improvement techniques”. A novel combination of genetic material is defined as a stable genomic insertion of DNA that could not have been achieved through conventional breeding methods (USDA GAIN Report CS2024-0014).

Under the new rules, products derived from New Genomic Techniques (NGTs) that do not introduce a novel combination of genetic material are treated as conventional products and are exempt from GMO regulations. Applications are evaluated on a case-by-case basis. The National Technical Biosafety Committee (NTBC) advises the agricultural sector on regulatory procedures, while the State Phytosanitary Service (SFE) of the Ministry of Agriculture and Livestock (MAG) handles individual product assessments. This approach is broadly aligned with the regulatory frameworks of other Central and South American countries (USDA FAS – Costa Rica Opens Door to Innovative Biotechnologies).

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/).

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) via Ministerial Agreement No. 271, creates a simplified process for evaluation and registration of seeds that have been approved by countries with commercial ties with Guatemala, and exempts plants that do not have added DNA or a new combination of DNA from regulation, after the government verifies that they meet those conditions (Gatica-Arias, 2020; Kuiken and Kuzma, 2021). MAGA is the lead authority responsible for receiving and reviewing petitions for the domestic production of genome-edited plants, and once a plant is verified as non-GE, it is treated as a conventional variety. nih

Despite this framework, Guatemala has not translated its regulatory provisions into practice. The country maintains a de facto ban on the cultivation of genetically engineered crops considered sensitive, particularly corn and beans, which remain Guatemala's principal staple foods. No approvals or authorizations for GE live plants, seeds, or propagative materials exist. Regulatory decisions in this area have been driven by political considerations rather than scientific evidence, limiting the use of innovative biotechnologies as tools for productivity, food safety, or agricultural competitiveness. As of December 2025, the most recent USDA GAIN report confirms that this de facto ban remains in place and no changes to the regulatory position have been announced (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/).

Mexico currently lacks a dedicated regulatory framework for genome-edited crops. All genome-edited organisms fall under the country's existing, highly restrictive biosafety law for GMOs, administered by SADER, SENASICA, and SEMARNAT. The country has been discussing a regulatory pathway since 2016 but no specific framework has been enacted. In October 2025, a coalition of 28 Mexican scientists petitioned the government to establish clear, evidence-based regulations that distinguish modern genome editing technologies such as CRISPR from conventional GMOs (isaaa.org). The broader GMO environment is highly restrictive: an injunction has banned the cultivation of genetically modified corn since 2013, and several states have declared themselves GMO-free zones. Mexico risks falling behind its Latin American neighbors, which have largely established permissive NGT frameworks.

Nicaragua currently regulates all genome-edited plants as conventional GMOs, without any specific regulatory framework distinguishing NGT crops from transgenic organisms (npj Science of Plants). This places Nicaragua in contrast to its Central American neighbors Honduras, El Salvador, and Guatemala, which have established frameworks that partially exempt transgene-free genome-edited crops from their GMO laws. No public consultation or legislative review process addressing NGT-specific regulation has been announced as of mid-2026.

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://apps.fas.usda.gov). 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).

Peru maintains a moratorium on the cultivation and importation of Living Modified Organisms (LMOs) under Law No. 29811, extended in 2021 until December 2035. The moratorium includes three exceptions: laboratory research, pharmaceutical and veterinary products, and food/feed processing (frontiersin.org). The Ministry of the Environment (MINAM) is the lead regulatory authority. In March 2026, MINAM enacted Ministerial Resolution No. D000068-2026-MINAM-DM, introducing a case-by-case scientific assessment framework to determine whether a genome-edited organism qualifies as an LMO under existing biosafety law (isaaa.org). This measure does not lift the moratorium but creates a potential pathway for transgene-free genome-edited organisms to be classified as non-LMOs and therefore fall outside its scope.

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.

In December 2023, the Ministry of Agriculture published 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/).

The “Standard Operating Procedures for Research and Release of Genome Edited Plants of Categories SDN-1 and SDN-2 in Bangladesh” can be found here.

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 guidelines on the assessment of genome edited plants,  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).

The “Guidelines for the Safety Assessment of Genome Edited Plants 2022” can be found here.

Indonesia has been in the process of adapting its existing biotechnology legislation to address genome-edited crops since 2020 (npj Science of Plants). No specific regulatory framework formally distinguishing NGT crops from GMOs has yet been enacted. Regulatory responsibility is shared between the Ministry of Agriculture, the National Biosafety Commission, and BPOM (the National Agency for Food and Drug Control). Private sector entities and research institutions are actively developing genome-edited varieties but await regulatory clarity before commercialization. As of mid-2026, Indonesia's regulatory position remains that of ongoing legislative adaptation.

Already in March 2017, the Israeli National Committee for Transgenic Plants (NCTP) determined that SDN-1 derived plant products are regulated as conventional plants if no foreign DNA is present. Plants modified solely through the deletion of nucleotides, without the insertion of foreign DNA, are not classified as transgenic and are therefore exempt from GE seed regulations. In March 2019, the NCTP reaffirmed that plants resulting from targeted mutagenesis using genome editing techniques that delete nucleotides and do not incorporate foreign DNA are not classified as transgenic plants. frontiersin

However, Israel's regulatory framework does not constitute a general approval of genome-edited crops, and its correct classification is case-by-case. Applicants must provide supporting data to demonstrate that no foreign DNA sequences were incorporated into the plant genome. The NCTP reviews each submission individually before granting an exemption, meaning no genome-edited crop is automatically cleared without regulatory scrutiny. Gene-edited crops are assessed on a case-by-case basis based on the characteristics of the product, and a dossier must be submitted to determine whether they qualify for exemption from GMO regulations. Furthermore, the Ministry of Health requires that all new food products, including conventional crops and gene-edited ones, undergo a risk assessment before approval. Plants incorporating foreign DNA, as well as their progeny, remain fully subject to the GE Seed Regulations. In August 2024, Israel adopted over 40 new EU food standards under the Protection of Public Health Law (Food) – 2015, which entered into force on 1 January 2025, introducing updated food labeling requirements, though these do not alter the existing regulatory pathway for genome-edited products (apps.fas.usda.gov).

Japan has a well-defined regulatory framework for genome-edited crops, established in 2019. The Ministry of the Environment (MOE) and the Ministry of Agriculture, Forestry and Fisheries (MAFF) oversee environmental and agricultural safety under the Cartagena Act, while food safety is governed by the Consumer Affairs Agency (CAA), which took over from the Ministry of Health, Labour and Welfare (MHLW) on 1 April 2024 (apps.fas.usda.gov).

Under the Cartagena Act, SDN-1 organisms are not subject to regulation, whereas those created using SDN-2 and SDN-3, which involve templates and the insertion of genes, remain regulated. SDN-2 products therefore require a case-by-case LMO assessment by the MOE for environmental release, even though the CAA has deregulated SDN-2 food products on the food safety side. Japan's framework is correctly classified as case-by-case rather than general approval: developers are expected to complete a mandatory notification process with the CAA before distribution, even when a product is not subject to formal regulation, and must separately notify MAFF regarding biodiversity impacts, with MAFF confirming non-LMO status on a product-by-product basis. Developers must notify the MOE, MAFF, and the CAA before release, but full GMO risk assessments are not required for SDN-1 and qualifying SDN-2 products (Schmidt et al., 2020).

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.

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. 

Singapore's Food Agency (SFA) implemented the "Regulatory Framework for the Use of Genome Edited Crops in Food and/or Animal Feed" on 1 August 2024, following a public consultation that closed in February 2024 (apps.fas.usda.gov). The framework creates two regulatory pathways. Pathway A applies to genome-edited crops without foreign DNA, which are considered equivalent to conventionally bred crops and require only a notification process of 60–90 days. If SFA confirms the absence of foreign DNA, the crop is exempt from GMO pre-market safety assessment and a public list of confirmed crops is maintained on SFA's website. Pathway B applies to crops containing foreign DNA, which undergo the full GMO pre-market assessment (sfa.gov.sg).

South Korea is in the process of adapting its Living Modified Organism (LMO) Act to accommodate genome-edited crops. In 2024, draft legislation was introduced to define organisms derived from genome editing that do not use or contain foreign genes as a new regulatory category, distinct from LMOs, providing a lighter regulatory pathway for such products (apps.fas.usda.gov). On 2 December 2025, the National Assembly passed revisions to the Food Sanitation Act expanding mandatory labeling requirements to include genome-edited products containing no detectable foreign DNA. As of mid-2026, no formal exemption from GMO regulation for genome-edited crops has been enacted. Active R&D is ongoing: the Rural Development Administration (RDA) approved 87 field trial research projects in October 2025.

Thailand became the 25th country globally to formally approve genome editing in agriculture when the Minister of Agriculture and Cooperatives signed the "Certification of Organisms Developed from Genome Editing Technology for Agricultural Use, B.E. 2567 (2024)" on 11 July 2024. The regulation was published in the Royal Gazette on 16 July 2024 and came into force 30 days later, on 16 August 2024 (fas.usda.gov). Genome-edited plants that meet the certification criteria are not classified as GMOs and may be imported, cultivated, and exported. The Department of Agriculture (DoA) manages a case-by-case certification process, expected to take approximately 2–3 months per application. The framework was extended to livestock on 19 November 2024, with the Department of Livestock Development publishing parallel rules for genome-edited animals (apps.fas.usda.gov).

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 Commission published a legislative proposal on 5 July 2023, aiming to create a dedicated legal framework for NGT plants. In February 2024, the European Parliament approved a first-reading position, broadly supporting a two-tier classification of NGT plants while calling for a full ban on patents for all NGT varieties.

Following months of political discussions, on 14 March 2025, EU Member States agreed in the European Council on a common position, allowing formal negotiations with the European Parliament to begin (mofo.com). On 4 December 2025, the European Council and the European Parliament reached a provisional agreement on a comprehensive new regulatory framework for NGTs (lawbc.com). On 21 April 2026, the EU Council formally adopted the new rules (consilium.europa.eu).

The regulations exclude plants whose genetic changes could have occurred naturally or through conventional breeding. These are no longer considered GMOs and are subject only to a verification procedure rather than a full risk assessment. The so-called NGT-1 seeds must be labelled, but food and feed derived from them need not carry a GMO label.

All NGT plants must be listed in a public database, and NGT plants are excluded from organic production. Herbicide-tolerant plants and plants with known insecticidal effects are placed in Category 2 and therefore require full authorization. The regulation is expected to be published in the Official Journal of the EU in the course of 2026 and to start applying approximately two years after publication, around mid-2028. Existing GMO legislation remains unchanged for plants that do not fall under the NGT-1 or NGT-2 criteria (consilium.europa.eu).

Georgia is one of three countries worldwide that explicitly ban the cultivation, import, and export of genome-edited plants, a position in force since 2017 (npj Science of Plants). This places Georgia alongside Madagascar (since 2018) as the two countries with the most restrictive regulatory environment for genome-edited crops globally. Georgia's ban aligns with its broader precautionary approach to biotechnology. As of mid-2026, no review of this policy has been announced.

Moldova currently regulates all genome-edited crops as conventional GMOs, without a specific legal framework distinguishing NGT crops from transgenic organisms. Moldova is among seven countries globally that explicitly classify genome-edited plants as transgenic organisms subject to full GMO regulation (npj Science of Plants). As of mid-2026, no public discussion or legislative process addressing NGT-specific regulation has been reported in Moldova.

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). In June 2023, the Norwegian Gene Technology Committee published a comprehensive proposal recommending a shift from the current process-based regulatory approach to a case-by-case, product-risk-based assessment for gene-edited crops. The committee concluded that gene technology could play a significant role in meeting future challenges related to food production, climate change, and health, and proposed aligning upcoming Norwegian regulations with any changes introduced by the EU, in order to support cooperation and socially beneficial innovation (geneticliteracyproject.org). A public consultation on proposed revisions to Norway's Gene Technology Act has led to a recommendation to ease regulations for edited crops that are comparable to naturally bred varieties. As of mid-2026, Norway's regulatory framework for genome editing is still primarily governed by the Gene Technology Act of 1993, and no formal update to the law has been adopted.

Switzerland maintains a cautious approach toward genome editing, particularly in agriculture. The regulatory framework is primarily defined by the Gene Technology Act. In 2005, Swiss voters approved an initiative in favor of a moratorium on GMOs in agriculture, which has since been extended and currently runs 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 (sciena.ch). Under these provisions, transgene-free edited plant lines would not fall under the genetic engineering law and would not be treated or declared as GMOs.
In April 2025, Switzerland's Federal Council took a further step by releasing a formal proposal for the Breeding Technologies Act (Züchtungstechnologiegesetz, BTA). This Bill provides a concrete legal framework for NGT plants, including CRISPR-edited varieties, and is intended to establish Switzerland's own distinct regulatory path, separate from both EU and UK frameworks, while maintaining the country's precautionary principles for agricultural policy (isaaa.org). Detailed implementing regulations for the BTA have not yet been finalized.
 

The United Kingdom's approach to genome editing in agriculture is characterized by a deliberate distinction between the regulations of its four constituent nations. Following Brexit, the UK Parliament passed the Genetic Technology (Precision Breeding) Act 2023, establishing that genome-edited plants and animals whose changes could have been produced by traditional breeding or natural processes are classified as "precision-bred organisms" (PBOs), not GMOs. However, the devolved administrations of Scotland, Wales, and Northern Ireland have not adopted this legislation, creating a regulatory divergence within the UK. The implementing secondary legislation, the Genetic Technology (Precision Breeding) Regulations 2025, came into force on 13 November 2025 in England only.

England is the only part of the United Kingdom that has fully implemented the Genetic Technology (Precision Breeding) Act 2023. The implementing secondary legislation came into force on 13 November 2025. The regulatory process works in two stages: developers first apply to the Department for Environment, Food and Rural Affairs (Defra) for a marketing notice confirming the crop qualifies as a "qualifying higher plant" (QHP), followed by a food and feed marketing authorisation from the Food Standards Agency (FSA). Crops that meet the QHP definition do not require a full GMO risk assessment. On the same date, the ACRE Guidance on Producing Precision Bred Plants was published. England is the first major European economy to have fully implemented a science-based regulatory framework for gene-edited crops (isaaa.org).

Scotland and Wales have not adopted the Genetic Technology (Precision Breeding) Act 2023 or its implementing regulations, as the regulation of genetic technologies in agriculture is a devolved competence. Both nations continue to apply the legacy EU-derived GMO regulatory framework, under which all genome-edited organisms are subject to the same requirements as conventional GMOs. Precision-bred crops approved in England may therefore not be grown or commercially marketed in Scotland or Wales.

Northern Ireland has a distinct legal basis: under the Windsor Framework governing its relationship with the EU single market, Northern Ireland aligns with EU food and agriculture regulations. Since the EU's new NGT Regulation will not apply until around 2028, Northern Ireland currently treats genome-edited organisms as GMOs under EU GMO legislation (npj Science of Plants). All three nations effectively prohibit the commercial cultivation of genome-edited crops under the Precision Breeding framework.

Australia is one of the few countries globally where genome-edited crops receive general approval rather than case-by-case review, making it a regulatory pioneer in this field. In October 2019, the Australian Government amended the Gene Technology Regulations 2001, formally adding SDN-1 organisms to Schedule 1 of the Regulations as excluded organisms, clarifying that they fall outside the legal definition of a GMO under the Gene Technology Act 2000. This statutory exclusion means that developers of SDN-1 crops do not need to notify, apply to, or consult any regulatory authority under GMO law before cultivating or commercializing their product. The exclusion applies to organisms modified through unguided repair of site-directed nuclease activity, meaning no nucleic acid template was added to cells to guide genome repair following SDN application. Site-directed nucleases covered include CRISPR/Cas9, zinc finger nucleases, meganucleases, and TALENs. GeneticliteracyprojectPubMed Central

This distinguishes Australia clearly from case-by-case countries such as Japan or Israel, where developers must actively notify or submit dossiers to regulatory agencies before release, even if no full risk assessment is ultimately required. SDN-2 and SDN-3 techniques, where a nucleic acid template is added to guide homology-directed repair, continue to be regulated as GMOs and require authorization under the Act. The Gene Technology Regulator (OGTR) oversees compliance with these boundaries, publishing updated guidance on the regulatory status of gene editing techniques, most recently in February 2025 (ogtr.gov.au).

Historically, New Zealand maintained stringent regulations on gene technologies under the Hazardous Substances and New Organisms (HSNO) Act 1996, effectively limiting research and commercialization. In August 2024, the government introduced the Gene Technology Bill 2024, aiming to modernize the regulatory framework by replacing the HSNO Act with a standalone, risk-based system. The legislation proposes the exemption of low-risk gene editing techniques from regulation, provided the resulting changes are indistinguishable from conventional breeding (reuters.com).

The Bill passed its first reading in Parliament on 17 December 2024 and was referred to the Health Select Committee. The Committee received approximately 14,500 written submissions and heard oral evidence from approximately 287 submitters before releasing its revised draft report in October 2025. The Bill proposes the establishment of a dedicated gene technology regulator within the Environmental Protection Authority (EPA) and a Māori Advisory Committee. As of mid-2026, the Bill has not yet been enacted. Political negotiations between coalition parties and the approaching general election have delayed its second reading, meaning the original target of full implementation by the end of 2025 has not been met (nzherald.co.nz).