The Spanish Confederation of Scientific Societies (COSCE) has just published a report, submitted to the EU, which proposes and compares different possibilities for reform of the regulatory framework for genome editing techniques.
Genome-edited cherry tomatoes in Japan by Sanatech Seed Co.
New genome editing techniques have been proving their efficiency and potential for plant breeding for years. However, legal obstacles prevent them from becoming a reality in European fields and markets. We need to adjust the regulatory framework to accommodate varieties produced using these techniques if the EU agri-food sector is to be sustainable and competitive.
Genome editing is a technology based on the natural immunity machinery of prokaryotic organisms and allows precise changes to be made to genes of interest.
Through genome editing, new plant varieties can be obtained efficiently, quickly and easily, which today require breeding and selection processes that take years. The resulting plants do not carry foreign DNA, i.e. they are not transgenic, and are indistinguishable from those obtained by traditional breeding.
The many possibilities offered by genome editing
Genome editing makes it possible to develop plants with desirable traits in agriculture: plants that are better able to assimilate nitrogen compounds and therefore need less fertiliser; plants that are resistant to insects and pathogenic micro-organisms, which would reduce the use of pesticides in the fields; and varieties tolerant to salinity, extreme temperatures and drought, which will be better adapted to changing climatic conditions. The nutritional characteristics of some plant-based products, such as bread or oil, and species that serve as fodder for animal feed, can also be improved. All this is already possible. However, since, from a regulatory point of view, edited organisms are not adequately differentiated from transgenic organisms, they remain in a legal limbo that prevents them from being produced and marketed without hindrance.
Since, from a regulatory point of view, edited organisms are not adequately differentiated from GMOs, they remain in a legal limbo that prevents them from being produced and marketed without hindrance.
The origin of this problem lies in the European regulatory framework for gene modification, which dates back to 2001, when genome editing tools did not yet exist. As a result, gene-edited organisms are currently treated by default in the same way as mostly transgenic organisms subject to Directive 2001/18/EC.
In countries such as the US, Argentina and Japan there are regulations approving their use. In Europe, the lack of up-to-date regulation imposes a significant barrier to the application of these technologies to crops of interest.
A very worrying aspect of this situation is that, as many edited varieties do not differ from those improved by traditional methods, Europe will not be able to control their importation from countries where they are approved, placing the EU production sector at a clear competitive disadvantage.
In consultation period with society
Several European governments, including the Spanish government, have made statements in favour of a regulation that would allow the development of gene-edited crops in the EU.
The Court of Justice of the EU has recognised that the legal framework for gene modification has become obsolete, and the European Commission has admitted that this situation is undesirable and deters public and private investment in plant breeding (EC Study, 2021). In autumn 2021, the European Commission undertook a broad consultation process with institutions and stakeholders, which was extended to the general public in 2022.
The proposal for a new regulation is currently in the feedback period. In this way, Europe is trying to move towards a regulation that will unblock the situation and allow the safe and efficient use of these technologies for plant breeding in fields and crops.
The Spanish case
In Spain, the agri-food sector is of great social, economic and territorial balance importance. The country needs to direct its capacity for innovation to meet the challenges set out in the European Strategy "From Field to Fork" (2020): increasing food production, reducing the impact of agriculture and livestock farming on the environment and tackling climate change, which particularly affects the Mediterranean environment.
We will need to use all available resources, including the most advanced breeding techniques, in order not to be left out.
The Spanish Confederation of Scientific Societies (COSCE) has just published a report, submitted to the EU, which proposes and compares different possibilities for reforming the regulatory framework for genome editing techniques, a reform that we consider urgent. We can start with small steps, or we can approach the problem in a holistic way, creating a framework that covers all plant breeding and all varieties obtained by one or other techniques.
In this process, it is essential that society is aware of the scientific principles behind these techniques that will allow the development of healthy and sustainable plants while at the same time taking care of the earth's dwindling natural resources.