BY ABDALLAH EL-KUREBE | The United States has deregulated a genetically modified (GM) African marigold engineered to produce red flowers, while the European Union is advancing regulatory decisions that could accelerate approvals for stacked genetically modified crops.
The developments highlight continuing differences in agricultural biotechnology regulation, with the US taking a decision on a specific genetically engineered ornamental plant and the EU reviewing existing authorisations and considering a more streamlined approach to assessing crops carrying multiple genetic modifications.
The US Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) announced on October 13 that the modified African marigold was no longer subject to its regulations governing the introduction of certain organisms developed through genetic engineering.
APHIS determined that the modified variety was unlikely to pose a greater plant pest risk than its unmodified counterpart, clearing the way for it to fall outside the agency’s applicable regulatory framework.
EU advances GM crop authorisations
In Europe, the European Commission is expected to decide on the renewal of authorisation for genetically modified soybean MON 87769 after EU member states failed to reach a qualified majority for or against the proposal at an Appeal Committee meeting on October 20.
Under the EU decision-making framework, the absence of a qualified majority allows the European Commission to take the final decision.
The anticipated decision comes as the bloc considers changes that could simplify the assessment of genetically modified crops containing multiple genetic events, commonly known as stacked events.
At a September 9 meeting of the Standing Committee on Plants, Animals, Food and Feed, the European Food Safety Authority (EFSA) presented its July 2026 statement on the risk assessment of stacked genetically modified plants.
Drawing on two decades of experience assessing such crops, EFSA concluded that some data requirements might not be necessary in certain cases and that derogations could be considered within the existing legal framework.
The authority clarified questions raised by member states and said the approach would apply to applications submitted after the statement’s publication on July 9, 2026.
Several member states expressed support for the approach, which could reduce the data required for some applications and potentially shorten the authorisation process for stacked GM crops.
However, the approach does not eliminate the need for scientific risk assessment or the EU’s established decision-making procedures.
Two GM maize applications receive positive assessments
EFSA has also issued positive scientific assessments for two genetically modified maize combinations, moving them further along the EU’s authorisation process.
The first concerns maize event Bt11 × MIR162 × MIR604 × GA21 and its subcombinations. The assessment will be followed by a one-month public consultation and the normal decision-making process involving the member states’ Standing and Appeal Committees.
The second concerns maize event Bt11 × MIR162 × MON 89034 × NK603, including its subcombinations.
Following EFSA’s positive scientific opinion, the European Commission opened a public consultation on the application, with comments due by November 15, 2026. The proposal will subsequently proceed through the bloc’s established decision-making procedure.
The assessments represent progress towards possible authorisation, but they do not, by themselves, constitute final approval for the crops.
Indonesia highlights economic impact of GM crops
Beyond regulatory developments in the US and Europe, a seminar in Indonesia has highlighted the socioeconomic implications of agricultural biotechnology for smallholder farmers.
The International Service for the Acquisition of Agri-biotech Applications (ISAAA), Inc., in partnership with CropLife Asia and CropLife Indonesia, organised a hybrid seminar titled Smallholders in the Global Arena: The Socio-Economic Impact of GM Adoption in Indonesia and Beyond on October 14 in Jakarta.
The event attracted more than 40 in-person participants and 2,480 online attendees through Zoom, YouTube and Facebook.
Participants discussed Indonesia’s regulatory pathways, global trends in genetically modified crop adoption and evidence on the socioeconomic effects of GM technology.
The discussions focused on how agricultural biotechnology could influence smallholder livelihoods and family welfare, while examining the regulatory and market conditions shaping adoption in Indonesia and beyond.
Implications for agricultural biotechnology
Taken together, the developments illustrate three important dimensions of the global agricultural biotechnology landscape: regulatory decisions on individual genetically engineered products, efforts to refine risk-assessment procedures, and continued debate over the economic implications of GM crop adoption.
The US marigold decision demonstrates how a product-specific plant-pest risk assessment can determine whether a genetically engineered plant remains subject to a particular regulatory framework. In the EU, EFSA’s approach to stacked events could make some assessments more efficient, although final authorisations remain subject to the bloc’s legal procedures.
Meanwhile, the Indonesian seminar underscores the importance of evaluating biotechnology not only through regulatory and scientific assessments but also through evidence of its effects on farmers and rural households.
For countries considering their own biotechnology policies, the developments offer a reminder that regulatory efficiency, science-based risk assessment and evidence of socioeconomic outcomes are central to decisions about the adoption and governance of agricultural biotechnology.
