Setting the scene
Agriculture has been the most important source of sustenance for mankind for thousands of years. However, current farming practices are often singled out as key drivers of climate change. In parallel, as in a vicious circle, agriculture is dramatically impacted by climate change with extreme weather events, like droughts or heavy rainfalls, becoming more and more frequent in all parts of the world. This has obvious economic consequences for farmers, their families and rural communities, whose livelihood largely depends upon healthy crops and good harvests. Besides, this may result in problems of food security, which means shortage and inaccessibility of agri-food products on a larger scale.
In response, the European Union (EU) has taken significant steps to rethink its agri-food systems. With the launch of the European Green Deal and the Farm to Fork Strategy in 2019 and 2020, the focus was placed squarely on sustainability: reducing environmental impact, promoting healthier diets, and ensuring fairer food chains. More recently, however, the EU’s Vision for Agriculture and Food of 2025 has expanded this agenda by placing resilience and competitiveness at its core, emphasizing the need to strengthen the capacity of agricultural systems to absorb shocks, adapt, and transform in the face of climate and economic disruptions. This shift marks an important evolution: from striving for sustainability in principle, to building resilience in practice.
In this context, innovation and scientific research play a key role as they can offer solutions to protect crops and other agri-food products from the negative environmental consequences caused by climate change. TOLERATE – the Horizon Europe project of which the Law Group of Wageningen University & Research (WUR) is also part – pursues precisely this objective. Indeed, the project is investigating ways to increase plants’ resistance to drought by using genetically modified bacteria in the plant substrate, which is also known as ‘rhizosphere’. To this end, the DNA of ancient bacteria that have shown high adaptivity to climate change across millennia is being used and inserted into the genetic material of existing bacteria.
The role of law in TOLERATE
But what is the role that law plays within TOLERATE? Also, and more in general, how can law support the scientific research that is being carried out within the project?
Like in many other countries, in the EU agriculture, food processing, food distribution as well as the scientific research underpinning those activities are often subject to specific requirements set out by law. While such requirements may vary depending on the specific activity or application, they generally have one thing in common: they all strive to ensure the protection of one or more public goods, including public health, plant or animal health or the environment.
Against this background, our role as lawyers within TOLERATE is to identify the relevant legal frameworks for the research and experimental activities that are being conducted by other project partners. In other words, this means identifying the main legal acts that regulate those activities together with the safety precautions that must be taken to ensure there is no risk for public health or the environment, among others.
TOLERATE and Genetically Modified Microorganisms (GMMs)
If one considers the main application that is being developed by TOLERATE – i.e., the implant of the DNA of ancient bacteria into the DNA of existing bacteria – we are dealing with genetically modified microorganisms (GMMs).
In the EU, GMMs are subject to specific legislation, which includes Directive 2009/41/EC and Directive 2001/18/EC. EU law defines GMMs as any microorganism – including bacteria – whose genetic material has been altered in a way that would not normally occur in nature. Direct gene insertion, cell fusion, and recombinant DNA are all examples of techniques that, in accordance with EU law, lead to genetic modifications in microorganisms that are, so to speak, artificially engineered and, as such, not natural.
Now what are the legal implications for those microorganisms that have been genetically modified in the sense described above?
In a similar way to GM food and feed, EU legislation has in place strict requirements for GMMs. These requirements apply to companies researching GMMs and target different R&D activities. These include experiments or studies conducted in dedicated laboratories as well as open field trials where GMMs are released into the environment.
By way of an example, lab facilities willing to conduct experiments with GMMs for the first time are required to notify their national authorities about their plans. In addition, they must provide adequate guarantees in term of safety and containment measures, emergency procedures, and waste management. Then, depending on the level of risk that the experiments to be performed present for public health or the environment, the lab facilities can start their research either immediately or only after having been formally authorised by the national competent authorities.
Likewise, the testing of GMMs in open fields is subject to the issuance of an official permit, which is granted by the relevant national authorities following an EU level consultation with the European Commission and all the other EU countries. The request of that permit must be accompanied by a detailed technical dossier providing information on both the GMM to be tested and the site and including a monitoring plan as well as an environmental risk assessment.
Conclusions
In line with its broader policy direction, the European Commission has increasingly emphasized the importance of innovation, including advanced biotechnologies, precision tools, and digitalisation, as a way to make agri-food systems more sustainable and resilient. TOLERATE embodies this ambition by exploring scientifically promising solutions to climate-induced stress in agriculture. However, the shift from vision to reality is far from seamless.
The current EU legal framework subjects experimental research on GMMs to the fulfilment of relatively stringent safety requirements. This caution is not without reason: it reflects EU’s long-standing public skepticism toward GM techniques. Even so, we should not forget that such requirements are in place to make sure the level of public health and environmental protection in the EU is and remains high.
While these regulatory safeguards are essential, they also mean that the transition toward biotechnological innovation in agriculture is unlikely to happen swiftly under the current rules. For researchers and innovators, this makes early legal assessment key. In any event, when they venture into the GMMs territory, it is advisable that, together with the relevant science, they also consider the regulatory implications of their activities and this as early as possible to ensure that research is carried out in full compliance with the law.
By Mirta Alessandrini & Francesco Montanari