Europe’s highest court has ruled that gene-edited crops should be subject to the same stringent regulations as genetically modified organisms.

The Court of Justice of the European Union ruled that crops created through processes such as CRISPR are subject to the 2001 directive that legislates deliberate release of GMOs into the environment.

The SMC gathered expert comment on the ruling – feel free to use these comments in your reporting.

Professor Peter Dearden, Director Genomics Aotearoa and University of Otago, comments:

NOTE: Prof Dearden also commented earlier in the year on an FSANZ consultation on how to regulate gene-edited food.

“The EU ruling that gene edited organisms need to be regulated in the same way as GMOs will be a major blow to those in the EU developing novel crops using gene editing techniques. Here in New Zealand, such a determination appears to have been already made, so the EU decision will have little impact here.

“The problem is that we, and the EU, yet again, are trying to regulate technologies rather than outcomes. Gene editing is a far more accurate way to make a mutation than standard mutagenesis techniques. That the more efficient, less damaging and more specific approach is the one vastly more heavily regulated is unfortunate. In the end, the key things to test are the risks and benefits of the organism to be released. Surely this is more important than the way it was made.

“What worries me, and our EU colleagues, is that these determinations will stop innovation in gene editing in NZ or the EU. That loss of capability and capacity will mean we will lose the ability to deploy a technology that, if well used, carefully assessed, and appropriately regulated, could be immensely beneficial to New Zealand in health, agriculture and conservation.

No conflict of interest.

Professor Barry Scott, Massey University and co-chair of the Royal Society Te Apārangi gene editing panel, comments:

“This is hugely disappointing and does not seem to take into account the significant differences in the new gene editing technologies compared to the older technologies. Subjecting the new technologies to the rules and regulations of the older technologies does not appear to take into account the increased scientific knowledge and precision associated with the former. It maintains a process of ‘technology-based’ regulation rather than ‘outcome-based’ regulation which should be the basis of a sound risk management decision making process.

“Such regulation will stifle innovation and development and make it very difficult for the agriculture sector to develop breeding solutions to a rapidly changing environment and therefore enhance the risks of real issues around food security associated with new diseases and the impacts of climate change.”

No conflict of interest.

Dr Kieran Elborough, General Manager Science, New Cultivar Innovation, Plant & Food Research, comments:

“It is important to clarify that this is a court ruling to determine where a technology fits within existing regulations, not a scientific paper detailing the safety or efficacy of these technologies. The decision by the EU court deals specifically with how this technology is regulated in Europe. This is an example of the challenges faced by regulators as potential new solutions to important issues such as food sustainability and security in the face of a growing population and climate change emerge.

“Over time, it will be interesting to see whether new, more detailed regulations develop to restrict or enable this or other new technologies around the world, including in New Zealand.

“Gene editing is a relatively new technology and Plant & Food Research is investigating how we could apply this technology in plants, as proof of concept in containment. It’s important that we understand the potential of this technology and how this could be applied to benefit New Zealand. This will continue to inform any discussion in this country.”

Our colleagues at the UK SMC gathered comment from experts on the ruling.

Prof Maurice Moloney, CEO, Global Institute for Food Security, Canada, said:

“This ruling is surprising given the opinion of Chief Advocate Bobek on this issue just a few months ago. Advocate Bobek used the scientific evidence to reach the logical conclusion that precision breeding technologies like genome editing were indistinguishable in outcome from plants produced through conventional mutagenesis. The court’s ruling is logically absurd in that it asserts that modern techniques with high precision are somehow more risky than random mutagenesis which is replete with unknown changes in the genome. It also rehearses the discredited idea that the method is more important than the product with respect to safety.

“This is a real step backwards for the EU, for innovation and in the wider context for global food security. It will have the consequence of further disrupting world trade in agricultural products at a critical time for world trading policy. I am sure it is also a major blow to biological research throughout the EU.”

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 Wendy Harwood, Crop Transformation Group, Department of Crop Genetics, John Innes Centre, said:

“Every single plant on our planet is here because of mutations occurring during evolution. Human society as we know it, relies on the deliberate selection of mutations to improve food crops.

“The European Court of Justice opinion that organisms obtained by mutagenesis are GMOs and therefore subject to the obligations of the GMO directive is a disappointing setback for the use of valuable new technologies in crop improvement.

“Older mutagenesis techniques that have a long safety record are exempt from this obligation. The same outcomes can be achieved using newer, faster and more precise mutagenesis methods as using the older techniques. Treating the plants derived in different ways is not a logical approach based on the scientific evidence. This decision could have major negative impacts on our ability to respond rapidly to the challenges of providing sufficient, nutritious food under increasingly challenging conditions.”

Prof Ottoline Leyser, Director, The Sainsbury Laboratory, University of Cambridge, said:

“This ruling has arisen because of an action brought to the Court arguing that herbicide-resistant seed varieties pose the same risks to the environment regardless of how they are produced. I agree with this argument. We need a future-proof risk-based regulatory framework based on the traits being introduced, not the way in which they were introduced. It should include all breeding techniques from conventional to whatever the latest approaches might be. The idea that things that could occur ‘naturally’ are distinct and somehow automatically safe for people and for the environment is untenable. The distinction between GMO and not GMO is contrived.”

Dr Sarah Schmidt, Institute for Molecular Physiology, Heinrich-Heine-Universität Düsseldorf, said:

“The ruling of the European Court of Justice to regulate new breeding techniques including gene editing techniques like CRISPR as GMOs is the deathblow for plant biotech in Europe. The costs of fulfilling regulatory science and administration to obtain approval for GMO crops are around $35 million. Only the largest agribusinesses can afford these costs. With today’s court ruling, universities, start-ups and non-for-profits that might produce innovative solutions to tackle world hunger and crop adaption to climate change are excluded from the breeding process. Purely, because they cannot afford the legislative costs for approval of gene-edited crops as a GMO. So, Europe leaves it to big biotech companies to address the biggest humanitarian challenges of our time, hunger and climate change.

“I was shocked to read that the European Court of Justice fears that new breeding techniques could produce DNA changes in crops “at a rate out of all proportion”. New breeding techniques like gene editing enable scientists to make precise, directed changes to the existing crop’s genome. So precise that gene-edited crops could become indistinguishable from naturally occurring crop variants. Yet, the court considers these techniques not as safe, while it considers treatment with a carcinogenic chemical or ionic radiation (conventional breeding techniques) that induce hundreds and thousands of undirected changes in the DNA as safe.”

Prof Huw Jones, Professor of Translational Genomics for Plant Breeding, Aberystwyth University, said:

“I am shocked and saddened that the ECJ has ruled that crops bred using gene editing ARE GMOs and are NOT exempt from the regulations.

“What are the consequences?

“1. This puts the EU at odds with the many countries that have already stated clearly that they do consider crops made using simple gene editing in the same way as other forms of mutagenesis and exclude them from their regulation / labelling requirements for conventional GMOs.

“2. The current expectations of EFSA and the JRC in terms of the information required for a conventional GMO application are impossible to fulfil for most simple gene edited crops where there is no inserted DNA, no new protein, no unique DNA identifier etc.

“3. It blurs the clear biological distinction between small, targeted edits in an organism’s existing genes and the insertion of very large sections of recombinant DNA from a non-sexual compatible species; this ruling means that both will be GMOs and subject to the same regulatory oversight.

“4. It will stifle crop genetic research and innovation in the EU, which will understandably see no route to market for gene edited crops if they are regulated as conventional GMOs. In fact it will encourage more use of older, less targeted mutagenesis methods!

“5. It places importers and port authorities in the impossible position of policing food and feed grown as conventional crops in the countries of origin but that become illegal GMOs when they arrive in EU!”