The European Court of Justice has ruled that organisms obtained by mutagenesis (including gene editing) are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive.
Mutagenesis techniques have made it possible to develop seed varieties which are resistant to selective herbicides, according to the ruling.
Commenting on the ruling, Prof Achim Dobermann, director and chief executive, Rothamsted Research, said: “This is a disappointing judgement by the European Court of Justice. European farmers are already losing out, and now risk falling further behind the rest of the world with this decision.”
Prof Cathie Martin, group leader, John Innes Centre, said: “It is important to point out the wider implications of this ruling (wider than simply its impact on traits engineered using New Breeding Technologies). The important point is that this ruling ignores assessment of the safety of the trait developed, and rules only on the technology used. So introduction of higher yielding crops engineered by mutagenesis (traditional or by NBT) could be blocked by NGOs in the absence of an approved environmental impact evaluation.
“This is going to impact plant breeding in Europe hugely and negatively.”
Prof Denis Murphy, Professor of Biotechnology, University of South Wales, said: “This ruling has potentially important implications for the regulation of the exciting new technique of genome editing both in the EU and elsewhere. Essentially the ruling, which is derived from a case involving plants, 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.
“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.
“It is of course important that, like any new biotechnology, genome editing is properly assessed and regulated according to evidence-based scientific criteria. However, by simply lumping together genome editing with the completely different GM/transgenic biotechnologies, the CJEU has missed a historic opportunity to create a new regulatory framework for this new biotechnology.
“In the rest of the world genome editing will continue to be used for human welfare, whether in curing hitherto intractable genetic diseases or in helping developing countries grow better crops. But sadly much of Europe might miss out on such opportunities if genome editing becomes effectively impossible to use in the EU.”