Autor/es reacciones

Víctor de Lorenzo

CSIC Research Professor at the National Center of Biotechnology

The European Union's regulatory framework governing the environmental release of genetically modified organisms was established at a time when scientific knowledge of genetics, ecology, and environmental microbiology was far more limited than it is today. In that context, a precautionary approach was both understandable and justified. However, the scientific foundations on which these regulations were built have changed profoundly over the past two decades.

Advances in molecular biology, systems ecology, genomics, and environmental monitoring have greatly improved our ability to understand and predict the behavior of microorganisms in natural ecosystems. At the same time, the emergence of precise gene-editing technologies has blurred the distinction between conventionally bred organisms and those modified in the laboratory. Many modern genetic modifications simply harness natural mechanisms of genetic variation, producing organisms that differ only marginally from variants that could arise through natural evolutionary processes.

Importantly, discussions surrounding genetically modified organisms should distinguish clearly between plants and microorganisms. These are fundamentally different biological systems, developed for different purposes and associated with different patterns of use, risk, and societal benefit. A regulatory framework designed primarily around agricultural crops should not automatically be applied to environmental microorganisms.

Engineered microorganisms are increasingly being developed to address some of society's most pressing challenges. They can reduce dependence on chemical fertilizers by enhancing biological nitrogen fixation, improve crop productivity through beneficial interactions with plant roots, decrease the use of chemical pesticides, and contribute to the remediation of polluted soils, waters, and industrial sites. They have also been proposed as tools for restoring environments damaged by military conflicts and industrial accidents. In these applications, the objective is not private gain alone, but the delivery of measurable public benefits in agriculture, environmental protection, and sustainability.

Yet despite these opportunities, the current European regulatory framework remains a major obstacle to the practical deployment of such technologies. Bringing an engineered microorganism from laboratory development to environmental application often requires seven to ten years of regulatory procedures, imposing costs and uncertainties that discourage investment and significantly slow innovation. As a result, many promising technologies never progress beyond proof-of-concept studies, despite having been developed through substantial public investment.

The ongoing discussions surrounding the European Biotechnology Act II provide a unique opportunity to modernize this framework. Regulation should remain rigorous and science-based, but it should also be proportionate to actual risk and adapted to contemporary scientific knowledge. In particular, procedures for testing and deploying beneficial microorganisms in environmental applications should be streamlined, accelerated, and made more predictable, while maintaining appropriate safeguards and monitoring mechanisms.

Failure to do so would carry significant consequences. Europe risks forfeiting leadership in a strategically important technological field while other regions, notably the United States and China, move rapidly toward implementation. More importantly, it would prevent European citizens from benefiting from innovations that they have already helped finance through national and European research programs.

A modernized regulatory framework is therefore not simply a matter of supporting innovation. It is a matter of ensuring that publicly funded scientific knowledge can be translated into tangible environmental, agricultural, and societal benefits. European taxpayers deserve a system that converts scientific excellence into real-world solutions rather than allowing promising technologies to remain indefinitely confined to the laboratory for others’ benefit.

EN