BAKGRUNN (fra kommisjonsforslaget)

New genomic techniques (NGTs) provide new opportunities to alter the genetic material of an organism allowing the rapid development of plant varieties with specific characteristics. NGTs constitute a diverse group of techniques, each of which can be used in various ways to achieve different results. In many cases, these new techniques can lead to more targeted and precise modifications to the genome than conventional breeding or established genomic techniques and these modifications could or could not be produced in nature or obtained by conventional breeding techniques.

Targeted mutagenesis and cisgenesis (including intragenesis) are considered NGTs. They are different from established genomic techniques because they have novel features, for example, higher precision and speed in introducing the desired genetic modifications and the insertion of genetic material only from a crossable species. Targeted mutagenesis and cisgenesis do not introduce genetic material from non-crossable species -transgenesis- whereas this is the case with established genomic techniques. In addition, in some cases, products containing or consisting of plants with genetic modifications introduced by NGTs cannot be differentiated from products containing or consisting of plants bred with conventional breeding methods by analytical methods, whereas this is always possible for established genomic techniques.

The scope of this initiative are plants produced by targeted mutagenesis and cisgenesis (including intragenesis), products containing or consisting of these plants and food and feed containing, consisting or produced from these plants. The choice of the scope is based on several reasons. Numerous advanced and early ‘research & development’ applications concern plants, and several plant products are already on or very close to the market. In certain cases, substantially equivalent plants can be obtained with conventional breeding methods and with targeted mutagenesis and cisgenesis. Safety data are mainly available for plants obtained by targeted mutagenesis and cisgenesis, whereas it is at this stage difficult to draw relevant conclusions on other NGTs and applications in animals and micro-organisms.

The European Food Safety Authority (EFSA) concluded that, as regards risks for human and animal health and the environment, there are no specific hazards linked to targeted mutagenesis or cisgenesis6. EFSA also concluded that in targeted mutagenesis, the potential for unintended effects, such as off-target effects, may be significantly reduced compared to transgenesis or conventional breeding. Therefore, due to how these novel techniques work, and compared to transgenesis, a lesser amount of data might be needed for the risk assessment of these plants and products made from them.

There is significant demand in the Union and globally for NGT plants, because of their potential to contribute to addressing current challenges in the agri-food system. Climate change and biodiversity loss have put the focus on long-term resilience of the food chain and the need to transition to more sustainable agriculture and food systems. The European Green Deal’s Farm to Fork Strategy specifically identifies new techniques, including biotechnology, that are safe for consumers and the environment and bring benefits to society as a whole, as a possible tool to increase sustainability of agri-food systems and contribute to guaranteeing food security.