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An interdisciplinary team of researchers has conducted a comprehensive analysis that points to how details in EU legislative texts on genetically modified organisms (GMOs) can or should be updated, in order to make the law more innovation-friendly and predictable. GMO legislation is thirty years old, and as a result of the tremendous development in the field of biotechnology, it is in in urgent need of reform.
In a series of three articles in the journal Trends in Biotechnology, an interdisciplinary international team, with three researchers from the research programme Mistra Biotech at SLU, discusses options for reforming the EU's regulations on genetically modified organisms (GMOs). The purpose is to make risk assessments and decision-making more compatible with scientific principles, and to lay the foundations for international harmonization, which is a prerequisite for the feed and food chain to function globally.
Since 1990, the EU has had special rules that apply to organisms produced by genetic modification. Admittedly, all types of plant and animal breeding change the genetic makeup in some way; but it was the development of the method of transgenesis (gene transfer between species that cannot cross naturally) in the 1980s, that led to the development of the GMO legislative framework.
The legislation requires a comprehensive assessment of the possible risks that GMOs can pose to the environment and human health. It also contains an approval process that allows the European Commission to manage the potential risks that the evaluation might point to. The legislation also requires monitoring, labelling and other measures in order for GMOs and conventional (non-GM) products to coexist.
However, this framework has often been criticized for hindering innovations that would be good for health and environment. In combination with the political deadlock around risk management, the legislation puts a stop to GM technology, although there are no indications that there would be any risks specifically linked to the use of this technology.
There has been a tremendous development of gene technology in 30 years. Recent biotechnological tools enable precise genetic changes in the DNA of organisms without introducing so-called foreign genes. But even these products, the so-called gene edited organisms, are likely to be regulated as GMOs in the EU, following an EU court decision 2018.
Many researchers and other stakeholders are now calling for a reform of the EU GMO legislation. In their three articles, the authors discuss nine details, which are sorted into three main categories: 1) scope and definitions, 2) risk governance (assessment and management), and 3) post-authorization procedures (labelling, co-existence). They believe that the reforms, if implemented, should help to make the EU legislative framework for GMO more predictable and innovation-friendly. The regulatory framework should not discriminate against certain technologies without valid reasons. The reforms would make the regulatory framework dynamic in relation to scientific progress and experience, and take into account the benefits of using these techniques in breeding.
The political reality is also discussed in the articles. The European Commission is currently conducting a study of the legal status of novel genomic technologies and this series of articles will therefore be timely as it provides several scientific input and advice. However, a cautious estimation is that the EU is still not politically ready for a reform that would affect products carrying foreign genes (transgenic products). There are indications that both the public and politicians are more open to the use of new technologies, such as gene editing.
Dr Dennis Eriksson
Department of Plant Breeding, Swedish University of Agricultural Sciences
+46 73 5669522
Eriksson D, Custers R, Edvardsson Björnberg K, Hansson SO, Purnhagen K, Qaim M, Romeis J, Schiemann J, Schleissing S, Tosun J and Visser R. 2020. Options to reform the European Union legislation on GMOs: scope and definitions. Trends in Biotechnology, https://doi.org/10.1016/j.tibtech.2019.12.002
Eriksson D, Custers R, Edvardsson Björnberg K, Hansson SO, Purnhagen K, Qaim M, Romeis J, Schiemann J, Schleissing S, Tosun J and Visser R. 2020. Options to reform the European Union legislation on GMOs: risk governance. Trends in Biotechnology, https://doi.org/10.1016/j.tibtech.2019.12.016
Eriksson D, Custers R, Edvardsson Björnberg K, Hansson SO, Purnhagen K, Qaim M, Romeis J, Schiemann J, Schleissing S, Tosun J and Visser R. 2020. Options to reform the European Union legislation on GMOs: post-authorization and beyond. Trends in Biotechnology, https://doi.org/10.1016/j.tibtech.2019.12.015
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