“New generation” GMO techniques subject to EU regulatory system, rules top court

26 Jul 2018 --- A new generation of food genetic engineering techniques should be subject to EU safety checks and consumer labeling, the European Court of Justice has ruled. The EU's top court has debated whether new genetically modified (GM) seeds and foods – so-called “GMO 2.0” – should be subject to safety checks under EU law. The landmark ruling confirms that the new techniques to modify the genetic material in plant or animal cells must undergo the same safety checks for their impacts on the environment and human health as existing genetically modified foods (GMOs).

The Court of Justice takes the view, first of all, that organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive, in so far as the techniques and methods of mutagenesis alter the genetic material of an organism in a way that does not occur naturally.

“Organisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive. However, organisms obtained by mutagenesis techniques which have conventionally been used in a number of applications and have a long safety record are exempt from those obligations, on the understanding that the Member States are free to subject them, in compliance with EU law,” says a European Court of Justice statement.

Unlike transgenesis, mutagenesis is a set of techniques which make it possible to alter the genome of a living species without the insertion of foreign DNA. Mutagenesis techniques have made it possible to develop seed varieties which are resistant to selective herbicides.

Confédération Paysanne, a French agricultural union which defends the interests of small-scale farming, together with eight other associations, brought an action before the Conseil d’État (Council of State, France) in order to contest the French legislation which exempts organisms obtained by mutagenesis from the obligations imposed by the directive on GMOs.

In particular, that directive provides that GMOs must be authorized following an assessment of the risks which they present for human health and the environment and also makes them subject to traceability, labeling and monitoring obligations.

Confédération Paysanne and the other associations argue that mutagenesis techniques have evolved. Prior to the adoption of the GMO Directive, only conventional or random methods of mutagenesis were applied in vivo to entire plants.  

Subsequently, technical progress has led to the emergence of in vitro mutagenesis techniques which make it possible to target the mutations to obtain an organism resistant to certain herbicides. Confédération Paysanne and the other associations take the view that the use of herbicide-resistant seed varieties carries a risk of significant harm to the environment and human and animal health, in the same way as GMOs obtained by transgenesis.

In the run-up to the European Court of Justice ruling, campaign groups including Friends of the Earth and GM Watch had been raising awareness on the issue, urging politicians across the EU to call for these “new GMOs” to be regulated appropriately.

“I'm delighted that the European Court of Justice has been true to the science and not to the lobbying. It sees the new GM techniques, including new mutagenesis techniques based on genome editing, as processes of genetic modification and thus it says that the products derived from these procedures must be subjected to GMO risk assessment and labeling,” says Dr. Michael Antoniou, a London-based molecular geneticist. 

“It is particularly insightful of the ECJ that it perceives that the risks arising from these new mutagenesis techniques can be as great as those from old-style transgenesis GM methods. Thus it is important that the organisms derived from these new techniques are subject to the GMO regulatory system.”

Mute Schimpf, food and farming campaigner at Friends of the Earth Europe adds: “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.”

It will take some time for the different stakeholders in Europe to determine all the ramifications of today’s ECJ decision and for the regulatory system to decide how it will implement that decision. Legislators could also become involved and draft a new directive to clarify whether to continue to include these newer mutagenesis techniques under existing GMO Directive. While the ECJ decision continues the overall precautionary approach that Europe takes to new biotechnology, one can hope that this ECJ decision will spark for Europe to establish a new regulatory system for gene-editing techniques that is proportionate and risk-based, and that treats those products on their own merit, instead of relegating them to a GMO regulatory system that was not designed for them, and one with a track record that has a lot to be desired.