Summary
A special regulatory regime applies to products of recombinant nucleic acid modifications. A ruling from the European Court of Justice has interpreted this regulatory regime in a way that it also applies to emerging mutagenesis techniques. Elsewhere regulatory progress is also ongoing. In 2015, Argentina launched a regulatory framework, followed by Chile in 2017 and recently Brazil and Colombia. In March 2018, the USDA announced that it will not regulate genome‐edited plants differently if they could have also been developed through traditional breeding. Canada has an altogether different approach with their Plants with Novel Traits regulations. Australia is currently reviewing its Gene Technology Act. This article illustrates the deviation of the European Union's (EU's) approach from the one of most of the other countries studied here. Whereas the EU does not implement a case‐by‐case approach, this approach is taken by several other jurisdictions. Also, the EU court ruling adheres to a process‐based approach while most other countries have a stronger emphasis on the regulation of the resulting product. It is concluded that, unless a functioning identity preservation system for products of directed mutagenesis can be established, the deviation results in a risk of asynchronous approvals and disruptions in international trade.
New plant breeding technologies (NPBTs), including CRISPR gene editing, are being used widely, and they are driving the development of new crops. They are nevertheless a subject of criticism and discussion. According to a summer 2018 interpretation by the Court of Justice of the European Union (CJEU) applying an absolute interpretation of the precautionary principle, European Union (EU) law makes most NPBTs subject to regulations governing the use of genetically modified organisms (GMOs) in the EU. This contribution summarizes the status of the debate and highlights issues that have thus far not been considered-particularly with regard to the implications of EU regulations for NPBTs for countries outside the EU.
The European Commission's Farm to Fork (F2F) strategy, under the European Green Deal, acknowledges that innovative techniques, including biotechnology, may play a role in increasing sustainability. At the same time, organic farming will be promoted, and at least 25% of the EU's agricultural land shall be under organic farming by 2030. How can both biotechnology and organic farming be developed and promoted simultaneously to contribute to achieving the Sustainable Development Goals (SDGs)? We illustrate that achieving the SDGs benefits from the inclusion of recent innovations in biotechnology in organic farming. This requires a change in the law. Otherwise, the planned increase of organic production in the F2F strategy may result in less sustainable, not more sustainable, food systems.The European Commission (EC) recently launched its Farm to Fork (F2F) strategy. This strategy is a cornerstone of the European Green Deal and is instrumental in working toward the United Nations Sustainable Development Goals (SDGs) [32]. The F2F strategy acknowledges that new innovative techniques, including biotechnology, may play a role in increasing sustainability. At the same time, organic farming will be promoted, and at least 25% of the EU's agricultural land shall be under organic farming by 2030.
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