This article was originally published in EU Food Law.


Should organisms developed through new plant breeding techniques (NPBTs) be considered GMOs under EU law and be subject to the strict GMO approval process? The European Court of Justice (ECJ) is expected to issue a judgement on this issue, which will indicate if the existing GMO legislation needs to be updated, writes Katia Merten-Lentz of international law firm, Keller and Heckman.

The term NPBTs describes scientific methods for the genetic engineering of plants to enhance desired traits like drought tolerance and pest resistance, by modifying the DNA of the seeds and plant cells. These techniques have significantly evolved over time, allowing faster and more precise results than conventional plant-breeding techniques.

Legislative framework
In the EU, the deliberate release into the environment of GMOs and their placing on the market is regulated by Directive 2001/18/EC (GMO Directive).

Article 2(2) of the GMO Directive defines a genetically modified organism as “an organism, 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”.

For the organisms within its scope, the GMO Directive provides for an authorisation requirement preceded by an environmental risk assessment.
However, according to Article 3 of the GMO Directive, it is not applicable to organisms obtained through certain techniques of genetic modification listed in Annex I B, such as ‘mutagenesis’.

The GMO Directive does not provide a definition of mutagenesis, but it is generally understood as a technique that mimics the natural process of mutations and induces mutations. Mutagenesis does not entail the insertion of foreign DNA into a living organism, however, it involves an alteration of the genome of a living species.
In the context of NPBTs, it is important to note that the GMO Directive attaches great importance to the precautionary principle. For instance, Recital 5 provides that “[t]he protection of human health and the environment requires that due attention be given to controlling risks from the deliberate release into the environment of genetically modified organisms (GMOs)”.

In addition, Article 23 of the GMO Directive contains a safeguard clause allowing Member States to provisionally restrict or prohibit the use of a GMO on their territory where as a result of new or additional information or “reassessment existing information on the basis of new or additional scientific knowledge”, the Member States have detailed grounds for considering that a GMO constitutes a risk to human health or the environment.

Legal proceedings
In France, the Environmental Code excludes organisms obtained through mutagenesis from the GMO regulation by virtue of Article D531-2.

Nevertheless, in December 2014, Confédération paysanne, a French agricultural union representing small-scale farming, together with other associations have challenged the legality of this article and brought an action before the Conseil d’État.

According to Confédération paysanne and associations which supported them, mutagenesis techniques have significantly evolved since the adoption of the GMO Directive. Current methods allow, for instance, to obtain seeds resistance to certain herbicides only, and the use of such products poses risk to the environment and to human and animal health.

To ascertain whether organisms resulting from traditional and new forms of mutagenesis have to be subject to the GMO legislation, the French Conseil d’État made a reference for a preliminary ruling to the European Court of Justice (‘ECJ’).

In October 2017, the ECJ convened a hearing in a grand chamber, which was followed by an Opinion of Advocate General Michal Bobek published on 18 January 2018. The Advocate General concluded that there is no need to update the GMO legislation, noting that organisms obtained by mutagenesis are, in principle, exempted from the obligations under the GMO Directive.

Although the opinion of an Advocate General is not binding, it is rarely ignored by the Court. However, the ECJ’s ruling, which was expected in May, has been delayed.

Current debate
On the one hand, supporters of NPBTs, such as the biggest farmers’ association in the EU, Copa-Cogeca, argue that plants obtained through the NPBTs techniques in question could also be the products of conventional cross-breeding techniques and therefore cannot be considered as genetically modified organisms (GMOs).

In addition, some Member States, such as the Netherlands, believe that the new plant breeding techniques should not come under the GMO legislation as they are as safe as traditional breeding.

On 7 September 2017, the Netherlands made a proposal to improve the exemption mechanism for genetically modified plants under the GMO Directive.
According to the Dutch proposal, the current regulatory framework has a disproportionate impact on costs and creates barriers to the use of innovative technologies. Furthermore, the lack of legal certainty leads to an increased “disharmonisation as regards the application of the GMO Directive to products resulting from the use of NPBTs”.

On the other hand, the organic food sector generally insists that NPBTs should fall within the scope of the GMO legislation. Some of the stakeholders believe that these new biotechnology-driven techniques were developed by the seed industry in response to consumers’ massive rejection of GMOs obtained through long-established techniques.

NGOs like Greenpeace claim that if NPBTs were not regulated under the EU GMO Directive, there is a danger that existing legislation does not cover the risks NPBTs pose to the environment.

The results of the recent research entitled “European consumer healthiness evaluation of ‘Free-from’ labelled food products” conducted by ETH Zurich and European Food Information Council aimed to find out how various free-from labels, including free of GMOs, shape perceptions of foods seem to be particularly relevant in this context.

As stated in the report on the research, which was released in December 2017, French respondents, for instance, were very receptive to GMO-free claims. The debate was intensified when on 28 March, the US Department of Agriculture (USDA) issued a statement regarding the state-of-play on NPBTs. According to the statement, the USDA “does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests”.

Many in the food industry believe EU GMO legislation must apply to the new plant-breeding techniques, as otherwise European consumers, farmers and breeders would not be able to avoid GMOs.

Others warn EU policymakers to take immediate action and encourage innovative new plant breeding techniques following the US decision not to regulate them.

The interpretation of the existing law by ECJ is likely to influence the Commission’s stance on the need for an update of the GMO legislation with regards to the NPBTs. Moreover, some argue that the ruling which puts to the test precautionary principle may have an impact on genetic engineering in general.