Regulation of GMO field trials in the EU and new genomic techniques: will the planned reform facilitate experimenting with gene-edited plants?

This study presents the possible consequences of maintaining the current regulatory regime of the experimental release of genetically modified higher plants in the EU for the products of new genomic techniques (NGTs). Currently, the experimental release is a crucial stage before the authorization of a product for the market. By analyzing the data on the performance of field trials in the EU (numbers, sizes, dominating countries) and comparing the present regulatory provisions with those of selected third countries (including new provisions adopted in the UK), this study shows that the current framework of GMO (genetically modified organisms) field trials is ill-fitted for breeding activities. Due to strict limitations placed on the operator of a field trial in the EU, easing the regulatory burdens on the authorization of certain NGT products for the market may not provide researchers (especially, plant breeders) the competitive position they need if the present legal conditions for carrying out GMO field trials with certain NGT products (especially, those that are considered GMOs covered by the EU GMO legislation) are not going to change as well.

New genomic techniques and their European Union reform. Potential policy changes and their implications.

The article discusses amendment options (no significant change, lowering of administrative burdens or exemption of certain products from the legislation) for the European Union (EU) authorization procedures of New Genomic Techniques' (NGT) products and their consequences for the sector and research institutions, particularly in the context of internal functioning, placing products on the market and international trade. A reform of the EU regulatory system requires a change in the procedures for the authorization of NGT products, otherwise EU researchers and investors may still be at a competitive disadvantage (as compared to Argentina, Brazil, Canada, United States or the United Kingdom) due to the inefficiency of the current system and the committee procedure for authorization. New legislation, currently being adopted in the United Kingdom is also presented for comparison.

Legal and practical challenges to authorization of gene edited plants in the EU.

According to a predominant interpretation of the C-528/16 judgment of the Court of Justice of the European Union, mutants resulting from gene editing, even those featuring only single nucleotide variants, should be subject to the authorization procedures designed for organisms developed through genetic modification (i.e. insertion of large DNA fragments). In this article, we illustrate practical problems with the authorization of products of gene editing in the EU. On the basis of these problems, we analyze the influence of the current interpretation of EU legislation and judgment on the practical ability to authorize and detect such products on the EU market. We show that the predominant interpretation of the judgment leads to legally unacceptable consequences, in particular to the violation of the principle of proportionality with regard to individuals who wish to develop and market products of gene editing. As a result of our considerations, we show that the C-528/16 judgment did not need to be interpreted in the dominant way.

Exclusion or exemption from risk regulation?: A comparative analysis of proposals to amend the EU GMO legislation.

The EU Court of Justice's decision that gene-edited plants should be regulated as GMOs triggered various proposal to amend the EU Directive on the release of GMOs in the environment.

The Rapeseed Potential in Poland and Germany in the Context of Production, Legislation, and Intellectual Property Rights.

Rapeseed is an essential crop which is used in many different areas as edible oil, biodiesel, lubricant, and feed. It is one of the most popular oil crops in Europe (63% of oilseeds production in 2017). The current study highlights the potential for further rapeseed development in European Union (EU), with special emphasis on Germany (19% of EU production) and Poland (12% of EU production). The study focused on three factors: cultivation area, volume of production and the numbers of Intellectual Property Rights (IPR), particularly patents granted for rapeseed or rapeseed-related inventions and plant variety rights. Possible further obstacles to development, such as current legal framework, were also taken under consideration. The analyzed statistical data shows that both the cultivation area, as well as the volume of production of rapeseed fluctuated in the last decade in both examined countries, while the numbers for European patent publications and Community Plant Variety Rights showed a rising trend, indicating investments in the Research and Development (R&D) of the crop. The data analysis seems to confirm a hypothesis that there is a potential for the development of rapeseed as a versatile, multi-use crop; however, the current EU GMO policies and a legal uncertainty as to the status of products of certain modern gene editing techniques may hamper making optimal use of this potential.

Certain new plant breeding techniques and their marketability in the context of EU GMO legislation - recent developments.

The comparatively low adoption rate of GMO products in the European Union (EU) market seems to be connected with the strictness of authorization regulations and inefficiency of the authorization process itself. These problems will apply to any product deemed to be a GMO that could potentially be marketable in the EU. Since modern methods of plant breeding involving oligonucleotide-directed mutagenesis (ODMs) or site-directed nucleases (SDNs), including Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), are becoming ever more popular, it is crucial to establish whether the products of such new breeding techniques (NBTs), in particular those which involve precise methods of mutagenesis, are exempted from the EU legislation on GMOs or not. Legal uncertainty as to their status may result in reluctance to invest in such methods and develop them further. Here, developments are presented in the legal classification of certain NBTs products in the context of recent decisions and jurisprudence. The socioeconomic aspects of GMO adoption in both global and European contexts are discussed. The legal and practical landscape of GMO regulation in the EU is presented and how it may pose an obstacle to investment and the development of new products. The latest jurisprudence (e.g., Case C-528/16) [1] on the interpretation of the legal concept of GMOs and the scope of the legislation are analyzed, with the conclusion that the strict regulations will probably also apply to products of the NBTs involving precise methods of mutagenesis. This in turn will probably result in the restriction of their application in the development of new plant varieties in the EU.