Originally published in EU Food Law

At the request of the French Council of State, the European Court of Justice (ECJ) may soon clarify the current legal uncertainties about New Breeding Techniques (NBTs), possibly widening opportunities for Small and Medium Enterprises (SMEs) in the agri-food sector, Katia Merten-Lentz of international law firm, Keller & Heckman, writes.

Plant breeding techniques allow, by genome editing, the development of new varieties of plants with high yielding capacities, better resistance to environmental conditions or resistance to specific plant disease.

Such breeding techniques cover a large range of methods from old-established grafting to new sophisticated methods, such as cisgenesis, intragenesis or the brand new ‘DNA scissors’ (CRISPR-Cas 9).

By means of this latter one, specific traits can literally be inserted into plants - for instance resistance to a particular herbicide - allowing the eradication of weeds, but leaving the crops unharmed. These methods - known as trans-genetic modifications -whereby a foreign gene is introduced into a specific target plant, raises questions with regard to ethics, safety and environmental impact. In effect, plants grown using many of the new methods can hardly, if at all, be distinguished from conventionally bred plants, where no foreign DNA has been inserted. In other words, it is almost impossible to tell whether the modification was natural or triggered by a NBT.

Currently, the question at stake is whether the use of NBTs falls within the scope of GMO legislation, with all its related consequences; in particular, the application of the precautionary principle by means of authorisation and labelling requirements of such products.

GMOs are currently defined by Directive 2001/18/EC as organisms “[...] with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”. Thus, unlike the North American product-based approach, EU defines a GMO considering the process rather than the final product.

"The question at stake is whether the use of NBTs falls within the scope of GMO legislation, with all its related consequences."

Annexes to Directive 2001/18/EC set techniques which use leads, or not, to genetic modifications. Recombinant nucleic acid techniques, direct introduction into an organism of heritable material prepared outside the organism and cell fusion are legally considered to generate GMOs whereas in vitro fertilization, natural processes and polyploidy induction do not. In addition, Directive 2001/18/EC expressly excludes mutagenesis and cell fusion of plant cells because of their conventional use in the number of applications and long safety record.

For now, the European Commission has failed to clarify the legal situation of the majority of NBTs. Its working group, specifically dedicated to the topic, reached only one agreement in 2012 on the fact that cisgenesis and intragenesis fall within the scope of Directive 2001/18/EC. But the working group remained divided on other NBTs. EFSA also delivered two scientific opinions in the same year, on cisgenesis, intragenesis and on zinc finger nuclease 3 (ZFN-3). However, it is not in the EFSA’s remits to decide whether plants obtained through NBTs should be considered as a GMO or not. The need is now politic rather than scientific.

All eyes are now on the ECJ, whose decision is eagerly awaited. In effect, companies are already investing in NBTs by modifying existing crops and animals. In case it is decided that NBTs fall under the current GMO legislation, costs would be too high for SMEs to be competitive on the market and to foster innovation in the agri-food business, leaving therefore such R&D projects only to big multinational companies.

Hearing took place on the last 3rd of October and the final Court decision is expected to be delivered not before mid-2018.