EU Court of Justice Ruling on Plant Breeding Innovation

On July 25 the European Union (EU) Court of Justice ruled that plants resulting from some of the latest plant breeding innovations, including targeted mutagenesis (i.e. gene editing) such as CRISPR, are considered genetically modified organisms (GMOs). It is important to note that the ruling is an interpretation of existing EU law. It is not a scientific assessment, nor an expression or statement of policy by the EU’s political bodies. This interpretation is at odds with decisions and interpretations made elsewhere in the world, including here in Australia, US, South America and Israel.   Summary  The EU Court of Justice has issued its long-awaited decision on the regulatory status of plants resulting from some of the latest plant breeding innovations. This determines whether they can practically be taken up by researchers, universities, breeders and farmers in the EU. The ruling’s line of argument is based almost entirely on the breeding process (technology involved) and does not differentiate between product categories based on the outcome of these processes. The ruling puts forward a purely process-based approach after an EU specific point in time (2001; the time of adoption of the EU GMO Directive). Organisms obtained by means of mutagenesis which have “conventionally” been used and have a long safety record will continue to be exempt. This exemption would apply to the “classical”, random mutagenesis breeding methods using chemicals or radiation. In Australia, the current review of the Gene Technology Regulations and the National Gene Technology Scheme will provide regulatory clarity on plants and animals derived from the latest breeding methods for Australian industry and public-sector researchers. ABCA’s Statement of Principles on Regulatory Oversight of New Breeding Techniques is available on the ABCA website.   Further information: The Court of Justice of the EU Ruling on Case  C-528/16 and associated Press Release. Media releases from CropLife Australia, EuropaBio and the European Seed Association are also available. Links to some of the media coverage overnight on the EU decision on gene editing techniques: EURACTIV - Industry shocked by EU Court decision to put gene editing technique under GM law: https://www.euractiv.com/section/agriculture-food/news/industry-shocked-by-eu-court-decision-to-put-gene-editing-technique-under-gm-law/ Reuters - GMO rules cover plant gene editing technique: https://www.reuters.com/article/us-eu-court-gmo/eu-top-court-says-mutagenesis-falls-under-eu-gmo-rules-idUSKBN1KF15L Politico - EU’s top court tightens controls over controversial new GMO techniques: https://www.politico.eu/article/mutagenesis-genetically-modified-organisms-eu-court-opens-door-to-certain-contentious-plant-breeding-techniques/ The Guardian - Gene-edited plants and animals are GM foods, EU court rules: https://www.theguardian.com/environment/2018/jul/25/gene-editing-is-gm-europes-highest-court-rules Yahoo - EU court extends GMO rules to new techniques: https://au.news.yahoo.com/eu-court-extends-gmo-rules-techniques-165643988--spt.html Wired – EU ruling could slow Africa’s push for Crispr crops: https://www.wired.com/story/european-ruling-could-slow-africas-push-for-crispr-crops/ Nature - CRISPR plants now subject to tough GM laws in European Union: https://www.nature.com/articles/d41586-018-05814-6 DW - EU risks being left behind after GMO ruling: https://www.dw.com/en/opinion-eu-risks-being-left-behind-after-gmo-ruling/a-44825520 -------------------------------------- Probably unexpected, and does not reflect on the science, but rather a legal interpretation. The media links above would say it all - most if not all are a bit stunned at the decision. No doubt the anti GM urgers will  applaud the decision, but it will have wide implications - or will it?