“Unfortunately, this court ruling, which is inconsistent with the Advocate Generals Opinion published in January, does not provide the necessary regulatory clarity needed by EU researchers,..”
The European Union Court of Justice has ruled that plants created using genome editing methods WILL be classed as genetically modified organisms and therefore have to undergo the same safety checks for their impacts on the environment and human health as existing genetically modified foods (GMOs). Until yesterday this had been a grey area for the industry. The ruling, following ten years of discussion, is seen as a victory for environmentalists but a blow for the bio-economy. Companies that had been working on technologies that change genetic material in plants or animals, had been eagerly awaiting this ruling, which would indicate if they needed to match the EUs rules on genetic modification, which are much stricter than the rules in the USA.
The answer from Brussels is that yes they do. The ruling on Wednesday 25th July (Case C-528/16) from the European Court of Justice said that the organisms created by the new breeding techniques come, in principle, within the scope of the GMO Directive and are subject to the obligations laid down by that directive.
Genome editing is currently being applied in a broad range of projects, including the production of bio-based chemicals to help provide renewable substitutes for many traditional petrochemical building blocks. Other uses include the development of crops to improve yields and reduce food waste and the design of therapeutic tools for recognising specific viral DNA and eradicating HIV proviruses.
Any food developed with the help of gene editing, will now need need to be labelled as GM.
Responding to the rulingEuropaBios(@EuropaBio) Secretary GeneralJohn Brennanhighlighted industrys concerns about the judgement. He warned that in the absence of improved legal clarity in this area, Europe could miss out on significant benefits of certain applications of genome editing.
In addition to providing consumer and environmental benefits, such as enhanced nutrition, improved health or a more circular economy, innovations made possible by genome editing hold enormous promise to keep Europe at the forefront of socio-economic development, continuing to generate jobs and growth in the EU, he said. Unfortunately, this court ruling, which is inconsistent with the Advocate Generals Opinion published in January, does not provide the necessary regulatory clarity needed by EU researchers, academics and innovators.
Speaking further on the day of the announcement, Brennan noted: Public confidence and science-based decision-making are both important for ensuring that genome editing can deliver needed solutions. Looking forward, EuropaBiobelievesthat the next step, for the EU and its Member States, is to engage citizens in an inclusive and fact-based dialogue on what genome editing is, and what it will or will not be used for. It will be important to build knowledge, develop understanding and deliver risk-proportionate policy approaches, allowing innovation, which is already taking place in other parts of the world, to also benefit the EUs society, economy and the environment.
Detlef Weigeldirector of theMax Planck Institute for Developmental Biologyin Tuebingen, Germany, called the ruling in theWashington Post, a sad day for European science.
ForMute Schimpf,food and farming campaigner atFriends of the Earth Europe(@foeeurope)there was a positive reaction to the ruling:
“These new ‘GMO 2.0’ genetic engineering techniques must be fully tested before they are let out in the countryside and into our food. We welcome this landmark ruling which defeats the biotech industry’s latest attempt to push unwanted genetically-modified products onto our fields and plates.”
This story won’t end here, so we will continue to bring you the latest on this important issue. How this will impact on developments in the UK, post-Brexit and outside of the jurisdiction will also remain to be seen.
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