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No Regulatory Exemption for Gene-Edited Products in EU 

The European Court of Justice has decided that organisms made with precision techniques such as CRISPR will be subject to the same rules as transgenic plants or animals.

Jul 25, 2018
Catherine Offord

Crops and other products made using gene-editing techniques should be subject to the same regulatory oversight as organisms developed with other genetic-engineering methods, according to a ruling by the European Court of Justice today (July 25). In a setback for the biotech industry, judges have decided that foods and other products created by tools such as CRISPR must go through safety and labeling checks that were designed for genetically modified organisms (GMOs) created by traditional transgenic approaches.

The decision “would appear to cause all new genome edited organisms to be regulated as if they were derived from classical ‘GM’ or transgenic methods as developed in the 1980s,” Denis Murphy, a professor of biotechnology at the University of South Wales, tells the BBC. He adds that “this will potentially impose highly onerous burdens on the use of genome editing both in agriculture and even in medicine, where the method has recently shown great promise for improving human health and well being.”

See “EU Advisor Recommends Regulatory Exemption for Gene Editing

The debate about whether or not to include gene editing under the EU’s regulatory framework for GMOs was triggered back in 2016, when farmers and environmentalists in France called for clarification on the working definition of genetic modification. Until now, GMOs created by older techniques have been governed by a 2001 directive, but the rules surrounding the products of gene editing have been fuzzy.  

In an opinion published earlier this year, European court advisor Michal Bobek argued that gene-editing tools such as CRISPR, which modify an organism’s DNA directly, are fundamentally different from transgenic techniques, which involve the insertion of foreign genetic material. Products made by gene editing should therefore not be included under the GMO umbrella unless they also contain transgenic material, he wrote.

The proposal met fierce resistance from some researchers and environmentalist groups who argued that gene-editing techniques carry their own risks, and should be subject to the same careful checks as any other genetically engineered organism. 

Those groups responded positively to today’s decision. “Releasing these new GMOs into the environment without proper safety measures is illegal and irresponsible,” Greenpeace EU’s food policy director Franziska Achterberg tells The Guardian, “particularly given that gene editing can lead to unintended side effects. The European commission and European governments must now ensure that all new GMOs are fully tested and labelled, and that any field trials are brought under GMO rules.”

Researchers working in biotechnology have taken a less rosy view. The ruling is “tremendously disappointing,” Nigel Halford, a crop geneticist at the UK’s Rothamsted Research in Harpenden, tells Nature. “It’s a real hit to the head.” He adds that although gene-editing tools will still be used to develop crops, there will be less motivation for European companies to develop the organisms. “They are not going to invest in a technology they see not having any commercial application.” 

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