Organisms created by methods that alter the DNA, including CRISPR gene editing, should be subject to the same聽EU laws as genetically modified organisms, the European Court of Justice ruled today.
The ruling is being hailed as a victory for environmentalists. However, the effect might make it so expensive to launch gene-edited crops that few organisations besides big multinationals will be able to do it. The decision will have global reverberations because the EU is such a huge market.
All new varieties of crops and animals are genetically different to their ancestors in some way. Plant breeders used to wait for beneficial mutations to occur by chance. Then, in the 1950s, they started deliberately inducing random mutations with radiation or toxic chemicals. Much of the food聽we eat today, including some strains of wheat, comes from crops created by such mutagenesis.
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In the 1990s, biologists started genetically modifying organisms by adding extra pieces of DNA, often from entirely different organisms, but they were unable to control where this DNA ended up. In 2003, the EU introduced a directive requiring that organisms created by this form of genetic modification undergo extra safety testing and be labelled, but this directive specifically excluded those created by mutagenesis.
A French farmers鈥� union has been contesting this exemption. It brought a case before the European Court of Justice arguing that organisms created by mutagenesis should be subject to the GM laws. The ECJ essentially agreed: 鈥淥rganisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive,鈥� it ruled today.
However, the ruling continues: 鈥淚t is apparent from the GMO Directive that it does not apply to organisms obtained by means of certain mutagenesis techniques, namely those which have conventionally been used in a number of applications and have a long safety record鈥� It follows that the GMO Directive is also applicable to organisms obtained by mutagenesis techniques that have emerged since its adoption.鈥�
Those techniques include CRISPR genome editing, a new method developed in 2012 that is revolutionising biology.聽Genome editing is arguably the safest of all breeding methods, because it allows us to make precise changes to specific parts of the genome. Conventional breeding, by contrast, can produce thousands of unknown mutations.
There鈥檚 confusion over the ruling鈥檚 significance, though. Some think the EU will definitely follow the ruling, which would be bad news for biologists wanting to create genome-edited products.
Others think the ruling is non-binding advice, and will not necessarily determine EU policy. Ahead of the ruling, 快猫短视频 had asked the European Commission which is correct, but did not receive a direct answer.
鈥淭his year, the expected ruling of the European Court of Justice on the issue should bring important clarification of the scope of the GMO legislation,鈥� is all Anca Paduraru, the EU spokesperson for health and food safety, would say last month.
Johnathan Napier of Rothamsted Research, which is conducting trials of gene-edited plants, said: 鈥淭his is a very disappointing outcome, and one that will hinder European innovation, impact and scientific advance.聽 The classification of genome-edited organisms as falling under the GMO Directive could slam the door shut on this revolutionary technology.聽 This is a backward step, not progress.鈥�
