Global Differences in Regulation of Genetically Modified Crops: The History and Where We Are Going

A Tale of Two Fields

Imagine two farmers growing the same drought-tolerant maize variety developed using modern biotechnology. One farmer plants it without hesitation. The crop is approved, seeds are commercially available, and national policies actively support agricultural innovation. The other farmer cannot grow that same variety legally, even though the country permits the import of identical grain for animal feed.

The science is the same. The seeds are the same. The regulation is not.

Now imagine the plant scientists behind that variety. The molecular change is identical, a small, targeted mutation indistinguishable from a naturally occurring variant. In one country, the variety advances towards commercialization with minimum regulatory hurdles. In another, the same edits trigger years of environmental risk assessment because the method falls under GMO legislation. In both cases, the path from laboratory discovery to field deployment depends not on the biology of the trait, but on the structure and philosophy of the regulatory system governing it.

Nearly three decades after genetically modified (GM) crops first entered global agriculture in 1996, the world remains divided over how they should be governed. Ironically, the real difference lies not in the science, but in how societies define acceptable risk and balance innovation with precaution. Across regulatory systems, the safety of food, animal feed, and the environment remains the core benchmark against which agricultural technologies are evaluated (Huesing et al. 2016).

Today, more than 209 million hectares of genetically modified crops are cultivated globally (AgbioInvestor GM monitor, 2024), concentrated primarily in soybean (105.1 million hectares ~ 50%), maize (68.4 million hectares ~ 32.5%), cotton (24.2 million hectares ~11.8%), and canola (10.4 million hectares ~ 5%), and largely in countries such as the United States (75.4 Mha; 35.9%), Brazil (67.9 Mha; 32.4%), and Argentina (23.8 Mha; 11.4%). Yet in other regions, most notably Europe, cultivation remains extremely limited despite substantial imports of the same commodities for feed and food use.

 

What is a GMO and why the definition matters

Genetically Modified Organism (GMO) is defined as an organism whose genetic material has been altered using modern biotechnology in a way that does not occur naturally through mating or natural recombination. Article 3 of the Cartagena Protocol on Biosafety defines a “Living Modified Organism (LMO)” as any living organism possessing a novel combination of genetic material obtained through modern biotechnology, including recombinant DNA techniques. This definition is consistent with those of the World Health Organization and the Food and Agriculture Organization, which similarly emphasize genetic alteration beyond natural reproductive processes. When these definitions were drafted in the 1990s, genetic engineering primarily referred to transgenic approaches i.e. inserting the DNA sequence from one organism into another. Since then the landscape of modern technology for the genetic engineering of crops for better traits evolved faster than the legal frameworks designed to define them. Policymakers now face a deceptively simple question: when does innovation become “genetic modification?”

 

Genome Editing and SDN Distinction

New Breeding Technologies (NBTs), particularly the genome editing technology, rely on tools known as site-directed nucleases (SDNs) such as CRISPR-Cas systems, TALENs, Zinc-finger nucleases (ZFNs), meganucleases and Oligonucleotide Directed Mutagenesis to introduce precise changes at specific genomic locations (Puchta, 2017; Metje-Sprink et al. 2019). Unlike earlier transgenic approaches, many genome edits do not involve inserting foreign DNA and can generate mutations indistinguishable from those arising naturally or through conventional mutagenesis. From a regulatory perspective, genome editing outcomes are often categorized into three types (Lussar et al. 2012):

• SDN-1: A targeted DNA break repaired by the plant’s natural mechanisms, typically resulting in small insertions or deletions without introducing foreign DNA.
• SDN-2: A targeted change guided by a short repair template, enabling a specific nucleotide substitution.
• SDN-3: The insertion of a longer DNA sequence at a defined site, producing outcomes more similar to traditional recombinant DNA techniques.

This technical distinction has become central to regulatory debates. Some countries exempt SDN-1 (and sometimes SDN-2) plants from GMO legislation if no foreign DNA remains in the final product. Others regulate all genome-edited organisms under existing GMO frameworks, regardless of the nature of the modification.The policy question that follows is deceptively simple: when a genetic change is indistinguishable from a natural mutation, should regulation hinge on how the change was made — or on the characteristics of the final plant?

This blog explores how different regions regulate genetically modified and gene-edited crops, why these approaches diverged historically, and how emerging technologies are prompting reconsideration of long-standing regulatory boundaries — with direct implications for plant science research and innovation worldwide.

How Different Regions Regulate GM Crops

In the international regulatory landscape, GMO frameworks are commonly described as either product-based or process-based. The product-based approach evaluates the characteristics and risks of the final organism, regardless of the breeding technique used. By contrast, the process-based approach regulates organisms developed through specific biotechnological tools, such as genetic engineering or genome editing, which automatically trigger regulatory requirements. This model is often linked to a stricter application of the precautionary principle (McHughen, 2016).

 

In practice, countries fall at different points along a spectrum between these two approaches.

The American Continent: From Product-Based, Science-Driven Assessments to Precautionary Blocking Policies

Since their introduction in the mid-1990s, GM crops have been rapidly adopted across the continent, but frameworks and political attitudes toward GMO technology vary widely among countries.

On one hand, the continent hosts the largest genetically modified crop areas, with 75.4 million hectares in the United States, 67.9 in Brazil, 23.8 in Argentina, and 11.7 in Canada (AgbioInvestor GM monitor, 2024). These countries feature large-scale, commodity-exporting economies, technology-intensive agricultural systems, and clearly supportive biotechnology policies, with GM crops playing a central role in maintaining competitiveness through yield, scale, and cost efficiency. Regulatory systems in these countries tend to be product-based or hybrid, assessing risk primarily by the final product while including process-based triggers when genetic engineering is involved (see Table 1).

Canada follows a strictly product-based regulatory approach (Marchant & Stevens, 2016). The Canadian Food Inspection Agency (CFIA) initiates risk assessment when a specific trait is expressed at least 20–30% above or below the levels observed in conventional varieties. In such cases, the plant is classified as a “Plant with Novel Traits” (PNT), regardless of whether it was produced via transgenesis, conventional breeding, or gene editing (Turnbull et al, 2021).

The United States does not have a specific law dedicated exclusively to GMOs. Instead, the Coordinated Framework for the Regulation of Biotechnology (1986) recognized the similarity between the risks posed by GMOs and those obtained with earlier technologies and assigned the risk assessment and management of GMOs to existing agencies. However, certain process-based elements remain. For instance, APHIS, which evaluates phytosanitary risks to determine whether a plant could act as a pest or affect other crops and ecosystems, requires notification for any plant developed through genetic engineering, and EPA automatically regulates crops expressing pesticidal traits (Marchant & Stevens, 2016). Additionally, the FDA is responsible for ensuring food safety by assessing toxicity, allergenicity, and nutritional composition, and the USDA coordinates broader agricultural, commercial, and import aspects of regulation (McHughen & Smyth, 2008).

Argentina established one of the first Latin American formal regulatory frameworks for GMOs, with the creation of the National Advisory Commission on Agricultural Biotechnology (CONABIA) in 1991, which served as a model for other countries (Fernández Ríos et al, 2024). Argentina was the second country worldwide to commercially cultivate a transgenic crop (herbicide-resistant soybean) in 1996, and the first to publish specific regulations for NBTs. These regulations clarify that gene-edited crops may be considered non-GMO if the final product contains no transgenic DNA and does not present a “new combination of genetic material” (Whelan & Lema, 2015). For all these milestones, Argentina is considered a referent in agricultural biotechnology regulation (Lewi et al, 2025). The Argentine regulatory system is mostly product-based, with biosafety assessments focusing on the risks of the final product, though process-based elements exist in the initial determination of whether an organism falls under the regulatory regime. Assessment occurs in three stages: CONABIA evaluates environmental risks, the National Service for Agrifood Safety and Quality (SENASA) assess food and feed safety, and a governmental office evaluates commercial impacts (Segretin et al, 2024). CONABIA also offers a prior consultation procedure, allowing developers, including academic groups and small companies, to determine early whether a development will be regulated as a GMO, reducing time and costs (Lewi et al, 2025).

Brazil began GMO regulation with Biosafety Law No. 8,974 (1995), governing the first commercial GMOs in 1998, and later replaced by Biosafety Law No. 11,105 (2005), establishing safety standards, monitoring, and the National Biosafety Policy (PNB). The PNB creates a hierarchical regulatory system: the National Biosafety Council (CNBS) defines strategic and socioeconomic guidelines; the National Technical Biosafety Commission (CTNBio) assesses environmental and health risks and issues biosafety opinions; Internal Biosafety Committees (CIBio) oversee institutional GMO handling; and Registration and Inspection Bodies (OERFs) enforce regulations across sectors. For organisms developed with NBTs, CTNBio’s 2018 Resolution No. 16 allows case-by-case classification as GMO or non-GMO, treating certain edited organisms (SDN-1 and SDN-2) similarly to classical mutants (da Cunha et al, 2025).

Chile represents a distinctive case in the region, as it applies an intermediate regulation characterized by pragmatic differentiation. GM crops can be planted only for seed production and export, not for commercial grain production, under the Agricultural and Livestock Service (SAG) oversight. However, there are no restrictions on importing GM food or feed, with Brazil being the main supplier of soybean and maize. This configuration allows Chile to participate in international biotechnology markets while maintaining a differentiated approach to domestic agricultural production. Besides, the country has adopted an early case-by-case approach for NBT plants: GMO status is mainly determined by  the presence of foreign DNA (Turnbull et al, 2021).

Conversely, other countries of the region have restricted or prohibited the commercial cultivation of GMOs, reflecting political, cultural, and social concerns about food sovereignty, biodiversity conservation, and more traditional agricultural models. Their policies prioritize the protection of local genetic resources and native crop heritage, arguing that transgenic crops may threaten traditional varieties, increase dependence on patented seeds controlled by multinational corporations, promote monocultures with greater agrochemical use, and undermine diversified local systems. These concerns are reflected in both regulatory frameworks and public debates favouring precautionary approaches.

Ecuador incorporated into its Constitution that the country is “free of transgenic crops and seeds” in 2008, blocking GMOs introduction for commercial use, although research is permitted under certain conditions. This prohibition is linked to the defense of food sovereignty and the control of traditional seeds. Despite this declaration, the country has recently joined other nations seeking to harmonize policies to incorporate NBTs through the Ministerial Agreement No. 063/2023, which excludes organisms that do not contain foreign or recombinant DNA from risk analysis (Gatica-Arias, 2020).

Peru has transitioned towards a more restrictive policy on GMOs. Initially, Law No. 27104 governed their confined use and release, as well as their introduction, commercialization, research, transportation, and storage under controlled conditions. However, Law No. 29811 (2011) banned GMO production and imports for ten years to strengthen biosecurity capacities, assess potential risks to biodiversity, and prepare a regulatory framework before wider release of GMOs. Law No. 31111 (2021) extended moratorium until 2035, reflecting continued emphasis on the protection of the country’s biodiversity and a precautionary approach (Rozas et al, 2022).

Venezuela promulgated a law in 2015 that explicitly bans the production, use, commercialization and research of GMOs throughout its territory, considering that their release could affect biodiversity, agroecological systems and community control of seeds (Camacaro et al, 2016). However, it imports GM soybean and maize for food and feed from Brazil, Argentina, and the United States (Turnbull et al, 2021).

In Bolivia, the use of GMOs is not explicitly prohibited. A regulatory framework, established under Supreme Decree No. 24,676 (1997), governs and monitors all activities involving GMOs. Nevertheless, the country has faced significant political and social debates over the adoption of transgenic crops, with soy being the only major transgenic crop commercially cultivated (Gonzalez, 2025).

In Mexico, transgenic corn used to be cultivated mainly for research or experimental trials under the Biosafety Law for GMOs (2005). However, a constitutional reform banned its planting in 2025 (Reuters, 2025). As the country is the center of origin and diversity for maize, concerns about gene flow to native varieties and the protection of biodiversity and food sovereignty have led to strong social and political pressure to restrict commercial cultivation (Garcia Ruiz et al, 2018). Currently, gene-edited crops are not specifically regulated and are generally covered under existing GMO legislation (ISAAA, 2025).

 

GMOs regulation in Europe

In the 1990s, while the United States accelerated the adoption of transgenic crops, Europe responded with caution. This led to a regulatory system founded on Directive 2001/18/EC, which ensures that no GMO is released or sold without a strict safety review. Under this directive, every GMO must undergo a case-by-case environmental risk assessment by the European Food Safety Authority (EFSA) and receive political approval from Member States. To ensure transparency, the directive also introduced two other rules: traceability, to track GMOs through the entire food chain, and labelling for any product containing more than 0.9% GMOs. Following these rules, Europe operates under a regulatory paradox: while GMO cultivation is extremely limited, with the insect-resistant maize MON810 being the only significant crop grown, the EU remains one of the world’s largest importers of GMO soy and maize for animal feed.

With the rise of New Genomic Techniques (NGTs), such as CRISPR-Cas9, scientists argue that the current directive is outdated. While conventional mutagenesis, using radiation or chemicals, alters genomes extensively, it is exempt from the Directive due to a “long history of safety.” In contrast, NGT products are heavily restricted and a 2018 ruling by the European Court of Justice classified them as GMOs, subjecting them to the strict requirements of Directive 2001/18/EC. As NGTs represent a significant advancement in plant breeding, offering potential benefits such as disease reduction and decreased reliance on chemical inputs, there is a push to reform the regulations to reflect current scientific reality.

In July 2023, the European Commission proposed a new framework to exempt certain NGT plants from Directive 2001/18/EC. By December 2025, the European Parliament and Council reached an agreement on this proposal. The core of this new regulation divides NGT plants into two categories: NGT1 and NGT2. NGT1 plants are considered equivalent to conventional plants and will be exempt from the strict GMO directive. For these plants, seeds will be labeled, but the final products will not. A plant is considered NGT1 if it differs from the parent plant by no more than 20 genetic modifications. These modifications must fall into specific types: substitutions or insertions of no more than 20 nucleotides, deletions of any number of nucleotides or targeted insertion of DNA sequences that already exist within the breeders’ gene pool (targeted cisgenesis). NGT2 plants, involving more complex modifications, will remain subject to the Directive 2001/18/EC, though with some simplified procedures.

As many countries in the Americas, Asia and Africa, as well as the UK, have already adopted regulations that facilitate the use of NGTs, the approval of this new European regulation is seen as a necessary step to end an unjustified and unsustainable delay in European agriculture.

 

Asia-Pacific: Adaptive Diversification Under Precaution

The Asia-Pacific region combines substantial biotechnology adoption with persistent regulatory caution, illustrating adaptive diversification rather than policy convergence (see Table 1). According to  ISAAA Brief 57  and AgbioInvestor (2023–2024), the region accounts for a significant share of global GM crop cultivation, concentrated primarily in insect-resistant cotton and maize. India, China, and Pakistan anchor regional adoption, while Australia and Southeast Asian countries contribute through maize and canola systems. Yet beneath these cultivation figures lies considerable heterogeneity in regulatory philosophy.

India remains the region’s largest adopter, cultivating approximately 11–12 million hectares of Bt cotton annually, representing more than 95% of its national cotton area (ISAAA, 2023). This places India among the world’s leading biotech cotton producers. However, high adoption in fiber crops contrasts with continued political resistance to GM food crops, including the long-standing moratorium on Bt brinjal despite scientific approval by the Genetic Engineering Appraisal Committee (GEAC). India’s biosafety framework, established under the Environment (Protection) Act (1986) and the 1989 Rules on Genetically Engineered Organisms, remains process-based. Nevertheless, regulatory recalibration is evident: a 2022 Office Memorandum from the Ministry of Environment, Forest and Climate Change exempted SDN-1 and SDN-2 genome-edited plants without foreign DNA from certain provisions of the GMO rules, introducing outcome-based differentiation while maintaining oversight of SDN-3 events (MoEFCC, 2022).

China, the region’s second-largest adopter, cultivates approximately 3 million hectares of Bt cotton and maintains stable production of virus-resistant papaya (ISAAA, 2023). In 2023–2024, China expanded commercialization of GM maize and soybean varieties following biosafety certification, reflecting strategic diversification aligned with food security objectives. Oversight by the Ministry of Agriculture and Rural Affairs (MARA) requires staged field trials, environmental release testing, and pre-production evaluation before commercial approval. In parallel, China issued Guidelines for the Safety Evaluation of Gene-Edited Plants (2022), introducing a streamlined pathway for low-risk edits. Rather than deregulation, this represents acceleration within a centralized and state-directed governance architecture.

Pakistan cultivates approximately 2–3 million hectares of Bt cotton (ISAAA, 2023), making it another major regional contributor. Regulatory oversight remains process-based, though evolving guidance has signaled openness toward SDN-1 gene-editing approaches. Across Southeast Asia, adoption is more crop-specific. The Philippines and Vietnam together cultivate over 1 million hectares of GM maize annually, while Indonesia maintains smaller but growing areas of biotech maize and sugarcane (AgbioInvestor, 2024). Bangladesh continues commercial cultivation of Bt brinjal, representing one of the few public-sector GM food crop deployments in the region. In several of these countries, regulatory clarity for genome editing is still emerging, often influenced by trade alignment and regional policy statements.

Australia presents a different profile, cultivating approximately 0.7–0.8 million hectares of GM canola alongside significant GM cotton production (ISAAA, 2023). Its 2019 amendment to the Gene Technology Regulations excluded SDN-1 organisms from GMO classification, aligning regulatory triggers more closely with molecular outcome than breeding method. Japan has taken a similar SDN-differentiated approach: SDN-1 edits without foreign DNA are not regulated as GMOs, enabling limited commercialization of genome-edited products such as high-GABA tomato, though large-scale GM field crop cultivation remains minimal (MAFF, 2019 guidance).

New Zealand remains comparatively precautionary under the Hazardous Substances and New Organisms (HSNO) Act, regulating gene-edited organisms as GMOs regardless of foreign DNA presence. However, proposed reform through the Gene Technology Bill (2024) signals movement toward a more risk-tiered model, potentially aligning more closely with Australia’s framework while retaining strong environmental safeguards.

 

Africa: Structured Leadership and Strategic Expansion

Africa’s biotechnology landscape is transitioning from cautious expansion to strategically structured growth, with several countries emerging as regulatory leaders while others consolidate biosafety capacity (see Table 1). South Africa remains the continent’s dominant adopter, cultivating approximately 2.7–3.0 million hectares of GM maize, soybean, and cotton annually (ISAAA, 2023). Its regulatory framework under the GMO Act remains firmly process-based, and genome editing continues to be regulated as GMO technology. Notably, in 2024, severe drought conditions required South Africa to import over $100 million in GM maize and soybean from the United States to stabilize domestic supply, highlighting both the country’s integration into global biotech markets and the climate vulnerability shaping agricultural policy.

Ethiopia has recently emerged as a significant new player. In 2025, it granted commercial approval for TELA maize hybrids and Bt-GT cotton, marking its first transition to a genetically engineered food crop intended for direct consumption. This approval signals not only technological adoption but also regulatory maturation under its GMO Proclamation framework, aligning biosafety governance with national food security objectives.

West Africa has reached important food-crop milestones. Nigeria has integrated TELA maize (SAMMAZ 72T–75T) and pod-borer-resistant cowpea into its commercial landscape under the National Biosafety Management Agency (NBMA), demonstrating institutional continuity from confined trials to market deployment. Ghana achieved a landmark decision in 2024 by approving its first GM crop, the insect-resistant Songotra-T cowpea. Field evaluations reported average yields of approximately 2,500 kg/ha, substantially higher than conventional varieties, underscoring the agronomic relevance of locally developed biotech solutions (ISAAA, 2024). These approvals represent rare examples globally of regionally prioritized staple food crops advancing through national regulatory systems.

A quieter but equally significant transformation is unfolding in genome-editing governance. Between 2022 and 2026, several African countries began publishing formal guidelines that differentiate gene-edited products from traditional transgenic GMOs, particularly where no foreign DNA is present. As of early 2026, Nigeria, Kenya, Ghana, Malawi, Ethiopia, and Burkina Faso have issued genome-editing guidance documents, and at least 57 genome-editing projects are underway across 16 African countries. These projects focus on climate resilience, pest resistance, and yield improvement in crops such as cassava, maize, sorghum, and rice. Kenya currently leads in project activity, with over a dozen genome-editing initiatives spanning both crops and livestock, although commercial rollout of certain GM crops remains subject to judicial review.

 

Regulation, Social Perception, and Production

The core of regulatory systems lies in the assessment of environmental and health risks, but they are closely intertwined with social perceptions. In fact, several countries formally adopt product-based frameworks, but in practice, regulatory oversight is often triggered by the use of genetic engineering. This “process trigger” reflects the historical context in which GMOs regulation emerged, when scientific uncertainty was higher and the precautionary principle prevailed.

In the beginning, this principle aimed to manage scientific uncertainty and to provide confidence and predictability in a context of social debate surrounding an emerging technology. But today, the premise that any GM organism requires special regulations persists, despite large scientific evidence indicating that GM crops are not inherently riskier than conventionally bred crops. This framing reinforces the idea that GMOs remain “threatening”. Then, rather than being neutral instruments, regulatory systems construct social understandings of technological risk.

Besides, public debates surrounding GM crops are still being shaped by narratives promoted by environmental organizations that have historically linked GMOs to monocultures, intensive agrochemical use, the concentration of seed markets, and potential impacts on biodiversity (Tagliabue, 2018). Also, the widespread myth that transferring genes from one species to another is “unnatural” and therefore dangerous has fueled fear and misinformation, despite scientific evidence accumulated through decades. Likewise, “natural” is not synonymous with safe, as the natural venoms of some vipers can be lethal.

The prevailing message has left out the fact that all domesticated crops are the result of human manipulation, whether through traditional breeding or modern biotechnology, and that transgenic plants do not break biological laws: the biology of GMO plants remains consistent with genetics and physiology, as evidenced by the fact that the plants remain fully functional and viable. Furthermore, it fails to mention that gene transfer between species occurs spontaneously and functionally in nature, as in the classic example of Agrobacterium tumefaciens, a plant pathogen that injects part of its DNA into plant cells, integrating it into the plant genome, a naturally occurring process that, in fact, inspired modern plant genetic engineering.

Regulation and adoption of GM crops may also be influenced by agricultural productive models. For example, GM crops are consistent with efficiency, cost reduction and productivity goals in countries focused on large-scale commodity exports, but at the same time, their commercial success also depends on approval in importing countries, which ultimately determine market access. In contrast, the productive advantages of GM crops may be relative in countries with land-constrained or more diversified agricultural systems, or their introduction may interact with consumer preferences in models that emphasize product tradition and differentiation.

 

Regulation, Trade, and Research

The lack of international harmonization in regulatory standards means that developers must produce extensive evidence to access global markets, involving confined trials, regulated field studies, large data requirements, and complex administrative procedures. These demands increase  times and costs, acting as a barrier to market entry (Santos & Caetano, 2010) and discouraging the participation of public institutions and small companies in plant biotechnology applied research. Early career investigators find a more feasible space in basic research, where genetic engineering tools are used to study gene function or biological processes, but most applied projects aimed at addressing specific agricultural challenges are discontinued before reaching practical implementation. In this way, regulatory systems end up shaping scientific careers and research pathways.

One way for plant biotechnology researchers to actively counter this barrier is by engaging in scientific communication (Arora et al, 2025). They may help demystify complex technologies such as GMOs and gene editing by making their work more visible and accessible to diverse audiences. Furthermore, transparent communication about how these technologies operate and how they may contribute to agricultural sustainability could help mitigate public concerns and polarization, while fostering a more constructive environment for applied research and innovation.

 

Gene editing as a Game Changer in GMOs Regulation

Gene editing is not exempt from the broader controversy surrounding GM crops, and in some jurisdictions, edited crops with site-specific mutations and no foreign DNA remain regulated as GMOs, requiring full environmental and health risk assessments. Grouping distinct genetic techniques under a single category associated with heightened scrutiny can reinforce public perceptions of risk.

However, from a technical standpoint, there is no experimental method capable of determining whether a specific nucleotide change arose spontaneously, through conventional mutagenesis, or via gene editing. When the final genetic alteration is identical, its origin cannot be inferred from molecular analysis alone (Grohmann et al, 2019).

Because some gene-edited modifications are indistinguishable from naturally occurring variations, they challenge the rationale of regulating based primarily on the process rather than the product’s characteristics. In response, several countries have started moving toward a lower regulatory burden for genome-edited products (Schmidt et al, 2020). This shift does not imply deregulation, but rather a reassessment of how risk is evaluated. If adopted more broadly, it could expand plant biotechnology beyond traits traditionally linked to large-scale agriculture to include climate adaptation, resource-use efficiency, improved nutrition, and non-food applications.

Ultimately, the significance of gene editing lies not only in its technical precision but in its capacity to expose tensions within existing regulatory frameworks and to stimulate a reconsideration of how method, product, and risk should be related in global agricultural biotechnology governance.

 

Final Thoughts

Genetic engineering has clear potential to strengthen food and nutritional security under intensifying climate pressures. Yet its adoption, cultivation, and trade remain constrained by fragmented regulatory regimes that limit how quickly and widely these innovations can benefit farmers and consumers. Genome editing has sharpened this tension. When genetic changes are indistinguishable from natural mutations, regulating solely on the basis of process becomes increasingly difficult to justify scientifically. Still, regulation reflects societal values as much as scientific assessment. As global challenges grow, the goal is not to replace governance with science, but to align policy more closely with evidence. If regulatory systems evolve alongside scientific understanding, plant biotechnology can better contribute to resilient and sustainable food systems.

 

Table 1: Regulatory Approaches to Genetically Modified and Gene-Edited Crops Worldwide

The Americas
Country	Main Regulatory Authorities	Regulatory Trigger	Gene Editing (SDN-1 / SDN-2)	Biotech/GM Crops Commercialization	Regulatory Orientation
United States	USDA (APHIS); EPA; FDA	Hybrid (product-focused with process triggers)	Many gene-edited plants exempt if no plant pest risk	Extensive GM cultivation (Soybean, Maize, Cotton, Canola, Sugar beet, Alfalfa, Papaya, Squash, Potato, Apple, Creeping bentgrass (field trials, not broad commercial cultivation), Petunia (ornamental release occurred, but not agricultural commercialization), Tomato)	Innovation-oriented, risk-based
Canada	Canadian Food Inspection Agency (CFIA); Health Canada	Product-based (Plants with Novel Traits)	Regulated only if trait is novel, regardless of method	Extensive GM cultivation (Soybean, Maize, Canola, Sugar beet, Alfalfa, Potato, Apple)	Strongly product-based
Argentina	CONABIA; SENASA	Primarily product-based (case determination first)	Non-transgenic edits may be classified as non-GMO	Extensive GM cultivation (Soybean, Maize, Cotton, Wheat (HB4 wheat approved and cultivated but adoption limited), Alfalfa, Safflower (limited), Potato(limited)	Flexible, innovation-supportive
Brazil	CTNBio; CNBS	Hybrid (biosafety commission review)	SDN-1/2 may be classified as non-GMO (case-by-case)	Extensive GM cultivation (Soybean, Maize, Cotton, Sugarcane, Dry edible beans, Eucalyptus)	Risk-based, structured review
Mexico	CIBIOGEM	Process-triggered (notably for maize)	Generally regulated under GMO framework	Cotton	Biodiversity- and sovereignty-driven precaution
Honduras	National Agricultural Health Service (SENASA Honduras)	GMO framework	Gene editing policy evolving	GM maize cultivated	Adoption-oriented
Costa Rica	National Technical Biosafety Commission	GMO framework	Gene editing evolving	Limited GM cultivation (Cotton, Pineapple)	Regulated adoption
Colombia	Colombian Agricultural Institute (ICA)	Hybrid (case-by-case)	Certain gene-edited crops may be exempt	GM maize, cotton cultivated	Adaptive framework
Chile	Agricultural and Livestock Service (SAG)	Hybrid (presence of foreign DNA decisive)	Case-by-case; foreign DNA central to classification	GM seed production only; no grain cultivation (Soybean, Maize, Canola, Brown Mustard, Wheat, Camelina sativa)	Pragmatic differentiation
Bolivia	Ministry of Rural Development; Biosafety Committee	GMO framework	Policy evolving	Limited GM soy cultivation	Politically debated
Paraguay	National Agricultural and Forestry Biosafety Commission (CONBIO)	Product-oriented with case review	Gene-edited crops assessed case-by-case	Extensive GM soybean cultivation, maize, cotton, wheat	Export-oriented
Peru	SENASA (Peru)	Moratorium-based	Gene editing generally covered under moratorium	GM cultivation banned (extended to 2035)	Biodiversity-centered precaution
Uruguay	National Biosafety System	GMO framework	Policy evolving	GM soybean and maize cultivated	Export-oriented
Ecuador	Ministry of Agriculture; Constitutional framework	Constitutional restriction	NBTs under evolving interpretation	GM cultivation restricted	Food sovereignty orientation
🇪🇺 Europe
Jurisdiction	Main Regulatory Authorities	Regulatory Trigger	Gene Editing (NGT/SDN)	Cultivation Status	Regulatory Orientation
European Union	EFSA; European Commission; Member States	Process-based (Directive 2001/18/EC)	Historically GMO; NGT1/NGT2 reform underway	Very limited cultivation	Moving toward science-based exemptions for NGT1.
Portugal	National Directorate-General for Food and Veterinary Affairs	EU framework	Follows EU NGT policy; Pro-innovation stance on NGT1.	Limited GM maize; acreage stable but historically low (~67,000 ha).	EU precautionary model with a focus on coexistence.
Spain	Ministry of Agriculture; follows EFSA	EU framework	Follows EU NGT policy; Leading advocate for NGT deregulation.	GM maize cultivated; remains EU leader (~79,000 ha in core regions), but in overall decline.	EU precautionary model; highest adoption rate in the EU.
United Kingdom	DEFRA; ACRE; FSA	Product-oriented (Precision Breeding Act 2023)	Fully Integrated: Precision-bred organisms (PBOs) are not regulated as GMOs since Nov 2025.	Farm Trials Active: First commercial-scale trials (wheat/barley) starting Spring 2026.	Post-Brexit Divergence: High-speed pathway for “natural-equivalent” edits.
Asia-Pacific
Country	Main Regulatory Authorities	Regulatory Trigger	Gene Editing (SDN-1 / SDN-2)	Cultivation Status	Regulatory Orientation
India	GEAC; RCGM; IBSC	Process-based GMO framework	SDN-1/2 without foreign DNA exempted (2022 clarification)	Bt cotton widely grown; GM food crops restricted	Science-led adoption
China	Ministry of Agriculture and Rural Affairs (MARA)	Structured GMO framework	Streamlined pathway for low-risk gene-edited plants	Bt cotton widespread; gradual GM expansion; Maize, Soybean, Papaya	Strategic, state-guided
Japan	MAFF; MHLW; MOE	Case-based with SDN distinction	SDN-1 exempt from GMO regulation	Limited (GE tomato/fish); no major GM field crops.	Risk-proportionate adaptation
Australia	Office of the Gene Technology Regulator (OGTR)	Amended Gene Technology Regulations	SDN-1 excluded from GMO definition	Some GM cultivation (Canola, Cotton, Safflower, Indian mustard, Blue Chrysanthemum, Banana)	Science-based refinement
New Zealand	Environmental Protection Authority (EPA) New Unit	Process-based (HSNO Act)	Moving to Australia-style exemptions.	Ban Lifted: Legislation in 2025/2026 to permit field trials.	Innovation-focused
Philippines	Department of Agriculture; Bureau of Plant Industry (DA-BPI)	GMO framework with Plant Breeding Innovation (PBI) clarification	Certain non-transgenic edits exempt	Golden Rice and Bt crops approved, maize, Eggplant	Adaptive but litigious
Bangladesh	Ministry of Agriculture; National Committee on Biosafety	GMO framework	Gene editing under evaluation	Bt brinjal cultivated, cotton	Cautious expansion
Indonesia	Biosafety Commission for Genetically Engineered Products	GMO framework	Policy evolving	GM sugarcane, maize, Potato	Regulated adoption
Vietnam	Ministry of Agriculture and Rural Development	GMO framework	Self-declaration/exemptions for GE plants.	GM maize cultivated	Trade-aligned adaptation
Myanmar	Ministry of Agriculture	GMO framework	Limited clarity	GM cotton cultivated	Emerging adoption
Pakistan	National Biosafety Committee; Ministry of Climate Change	GMO framework	Gene editing policy evolving SDN-1 focus.	New: Bt cotton + GM sugarcane approved (Oct 2025).	Adoption-focused, evolving oversight
Africa
Country	Main Regulatory Authorities	Regulatory Trigger	Gene Editing	Cultivation Status	Regulatory Orientation
South Africa	Department of Agriculture; GMO Executive Council	Process-based GMO Act	Gene editing regulated as GMO	Commercial GM maize, soy, cotton	Structured biosafety oversight
Sudan	National Biosafety Council	GMO framework	Policy evolving	GM cotton cultivated	Emerging adoption
Ethiopia	Environment, Forest and Climate Change Commission	GMO proclamation	Policy evolving	GM cotton approved,TELA maize	Cautious expansion
Ghana	National Biosafety Authority	GMO Act	Policy evolving	GM cowpea approved, maize, soybean	Science-based adoption
Nigeria	National Biosafety Management Agency (NBMA)	GMO Act	Emerging gene editing guidance	GM cowpea, Bt cotton, maize	Expanding biotechnology governance
Kenya	National Biosafety Authority	GMO framework	Case-by-case assessment guidelines.	GM cotton approved	Regulatory reopening
Malawi	Ministry of Agriculture	GMO framework	Limited clarity	GM cotton cultivation	Emerging
Eswatini	Biosafety Advisory Committee	GMO framework	Limited clarity	GM cotton cultivation	Emerging

 

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About the Authors

Sonia Balyan

Sonia is a Scientist at the Indian Biological Data Centre, Faridabad, India, where she leads the development of the Indian Crop Phenome Database, Indian Animal Phenome Database, Indian Array Data Archive, BioNode, and other national-scale FAIR data resources. Her work spans biocuration, computational biology, and plant molecular biology, with contributions to understanding microRNA-mediated stress responses in crops. She is also the founder and host of the Beyond Shodh (www.youtube.com/@beyondshodh24) podcast, serves on the Executive Committee of the International Society for Biocuration (ISB), and is an active member of AgBiodata. Bluesky: @soniabalyan.bsky.social | X: @sonia_balyanBS