On July 25, 2018, the Court of Justice (Court), sitting in a Grand Chamber, issued its judgment in Confédération paysanne and Others, by which it found that (a) organisms obtained by mutagenesis techniques are to be considered genetically modified organisms (GMOs) within the meaning of Directive 2001/181 (Directive), and (b) the express exemption of mutagenesis in Annex 1B of the Directive applies only to organisms obtained by means of techniques of mutagenesis which have conventionally been used in a number of applications and have a long safety record, which may, however, be the subject of national legislation.
I. Legal Context
The scope of the Directive is determined by Article 2, under which a GMO is defined as “an organism, with the exception of human being, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.” The Directive also provides a conditional exemption for organisms obtained through the techniques of genetic modification listed in Annex 1B of the Directive.2 The excluded techniques include mutagenesis and cell fusion. The reason given for the exclusion of these techniques was the “long safety record” and the fact that these have been conventionally used in a number of applications.
The law on the deliberate release of GMOs in the EU, as established by the Directive, was thus always considered to be directed to organisms obtained through so-called transgenesis. Such technique involves a process of inserting a gene into a living organism that normally does not have a copy of that particular gene. In contrast, producing mutations in an organism through mutagenesis occurs through the manipulation of that organism’s genes, without inserting foreign genes. Until the Court’s judgment in case C-528/16, organisms obtained by any mutagenesis technique were generally considered to be exempted from the scope of the Directive as per the express stipulation in Annex 1B.
In December 2015, nine French associations, including the French agricultural union Confédération paysanne, brought an action before the highest French administrative court – Conseil d’Etat (Council of State) – contesting the French legislation for transposing the Directive.3
The applicants argued that since the adoption of the Directive, mutagenesis techniques have evolved, allowing new varieties, and in particular those resistant to herbicides, to be obtained through these techniques. They asserted that the obligations imposed by the Directive, however, do not apply to organisms obtained by mutagenesis despite such organisms presenting risks for the environment and health arising in particular from: (i) allowing weeds with herbicide-resistant genes to develop, produced as a result of the use of increased quantities and varieties of herbicides, and (ii) from unintentional effects such as undesired or off-target mutations on other parts of the genome and accumulation of carcinogenic molecules or endocrine disruptors in cultivated plants intended for human or animal consumption.4
On October 3, 2016, the Council of State asked the Court to determine, in particular, whether organisms obtained by mutagenesis are considered to be GMOs and whether such organisms are subject to the obligations under the Directive.
First, the Court found that organisms obtained by mutagenesis are GMOs within the meaning of the Directive. The Court explained that the mutations brought about by techniques of mutagenesis that result in a production of herbicide-resistant varieties of plant species constitute alterations made to the genetic material of an organism and thus satisfy the definition of a GMO under Article 2(2) of the Directive.5 This conclusion was also supported by the fact that some of the mutagenesis techniques nowadays involve the use of chemical and physical agents, and others involve the use of genetic engineering, altering the genetic material of an organism in a way that does not occur naturally.6 Consequently, the Court noted that mutagenesis was not included in the exhaustive list of techniques not resulting in a genetic modification set out in Annex 1A to the Directive, but rather in the list of techniques set out in Annex 1B that are recognized to result in a genetic modification but are not subject to the provisions of the Directive.7
Second, the Court found that the express exemption of mutagenesis in Annex 1B of the Directive applies only to organisms obtained by means of those techniques of mutagenesis that have conventionally been used in a number of applications and have a long safety record.8 In other words, the Court stated that the Directive applied to organisms obtained by those mutagenesis techniques that had emerged since the adoption of the Directive. By interpreting in conjunction (i) Recital 17, which states that the Directive does not apply to organisms obtained through genetic modification techniques that have a long safety record, (ii) Recital 55, which emphasizes the need to follow closely the development and use of GMOs, and (iii) the statement by the Council of State that the risks linked to the use of new mutagenesis techniques are similar to those which result from the production and release of a GMO through transgenesis, the Court concluded that the Directive cannot be interpreted by simply looking at its literal wording and as such cannot exclude all organisms obtained by means of new mutagenesis techniques, which have appeared or have been mostly developed since the Directive was adopted.9 The Court concluded that excluding organisms obtained by new mutagenesis techniques from the scope of the Directive would compromise the objective pursued by the Directive, which is to protect human health and the environment.10
The Court also concluded that Member States have a discretion under EU law as to whether or not to subject organisms obtained by means of techniques of mutagenesis that have conventionally been used in a number of applications and have a long safety record to obligations laid down by the Directive or to other obligations.11
The Court’s decision subjects modern methods of mutagenesis like the “genetic scissors” CRISPR / Cas-9 technique, to the regulatory regime of the European law on genetically modified organisms. It did so despite the express exemption of mutagenesis from the scope of the regime, pointing to the legislative objective of the Directive of protecting human health and the environment and preventing risks caused by irreversible effects as a result of the release of genetically modified organisms.
The judgment of the Court is a preliminary one, and thus it is now for the French Council of State to apply it and to make a final decision. However, irrespective of the French court’s position, it is expected that the preliminary ruling will result in regulatory changes in the biotech sector. The judgment will have immediate consequences in practice since there are many crop varieties that have been and are being developed by means of new methods of mutagenesis and that may no longer be brought on the market within the EU without the requisite authorization. As concerns the long-term consequences, the judgment has expectedly received much attention, both positive and negative. Almost all the first reactions have seen the judgment as being a clear indication of a political climate in the EU that is skeptical of genetic engineering and honors the precautionary principle.
Legally, it is significant that the Court adopted the approach that the interpretation of the Directive must look beyond the plain wording of the legislation and take full account of its underlying principles. The Court thus took into account factors such as the intention of the EU legislature as well as the subsequent development and use of the subject matter in question. Such an interpretation may not necessarily result in a restrictive approach in all cases. Practice has shown that the competent national authorities tend to stick to a narrow interpretation of the letter of the Directive, whereas some specific modern biotech projects may not be in conflict with the objectives of the Directive.
It therefore remains an open question how politicians, authorities and industry will respond to the judgment, and in particular whether the European legislature starts looking to amend Directive 2001/18 with a view to further developing the regulatory framework for biotechnology so as to improve the consistency and efficiency of that framework, in order to enable and enhance biotech activities that would otherwise be “exported” to other jurisdictions.