Vice-President M L Bay Larsen (Rapporteur),
Presidents of Chambers M A Arabadjiev, A Prechal, M E Regan, L S Rossi,
Judges M Ilešič, S Rodin, N Piçarra, I Jarukaitis, A Kumin, I Ziemele, M Gavalec, Z Csehi, O Spineanu‑Matei
Advocate General M Szpunar
The applicants, a French agricultural trade union and eight environmental protection associations, brought an action to ban the cultivation and marketing of herbicide-tolerant rape varieties obtained by mutagenes and annul the implied decision of the French Government refusing their request to revoke a provision in national legislation purportedly transposing Parliament and Council Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs). That provision excluded certain mutagenesis techniques or methods from the definition of “techniques of genetic modification”, thereby exempting such techniques from the application of the risk assessment procedures laid down in the Directive. The French court referred a number of questions for a preliminary ruling to the Court of Justice of the European Union which ruled, in 2018 ([2019] PTSR 1243), that, under article 3(1), read with point 1 of Annex IB and recital (17) of the Directive, only organisms obtained by techniques or methods of mutagenesis which had conventionally been used in a number of applications and had a long safety record were exempted from the scope of the Directive. The application of that dual criterion thus ensured that, because of age and the variety of uses of a technique of mutagenesis and the information available as to its safety, organisms obtained by that technique could be released into the environment or placed on the market within the European Union, without it being necessary to subject those organisms to the Directive’s procedures and rules. The French court inferred from that judgment that organisms obtained by techniques which appeared after the date that the Directive was adopted, were subject to the obligations imposed by the Directive, including techniques or methods of “in vitro random mutagenesis” (using cloned genetic material). The court accordingly annulled the implied decision and issued a judicial order that the French Government draw up an exhaustive list of techniques or methods of mutagenesis which would come within the excluded category, for the purposes of drafting the French legislation. The French Government drew up a draft decree amending the list of techniques, within which it placed random mutagenesis techniques, with the exception of in vitro random mutagenesis, under the category of techniques for obtaining GMOs which had been traditionally used without harm, therefore excluding them from the scope of the Directive. Following notice of that draft decree, the European Commission issued a detailed opinion stating that there was no justification to distinguish between in vivo random mutagenesis (using whole plants or parts of plants) and in vitro random mutagenesis. Since the draft decree had not yet been adopted, the original applicants brought another case before the French court to obtain a penalty payment intended to ensure the implementation of its earlier decision. In those circumstances the French court stayed the proceedings and referred to the Court of Justice the question, in essence, whether, in order to determine whether a technique of mutagenesis should be treated in the same way as techniques exempted from the scope of the Directive by meeting the dual criterion of conventional use and long safety record, it was sufficient to examine the processes of modification of the genetic material, specifically whether the application in vitro of a technique of mutagenesis initially used in vivo could fall within the exemption.
On the reference—
Held, a technique or method of mutagenesis that included one or more characteristics, distinct from those of a technique that met the dual criterion of conventional use and a long safety record, justified excluding that technique from the exemption provided for in article 3(1) of Directive 2001/18, read in conjunction with point 1 of Annex IB. That exclusion applied only if those distinct characteristics were liable to result in modifications of the genetic material of the organism that differed, by their nature or by the rate at which they occurred, from the modifications resulting from the technique that met the criterion. However, since the referring court in the present case was asked to determine whether the application in vitro of a technique of mutagenesis initially used in vivo could fall within that exemption, it was necessary to ascertain whether the EU legislature considered that the fact that a technique involved in vitro cultures was decisive for determining whether or not such an application fell within the scope of the Directive. In that respect, the EU legislature did not consider that the genetic modifications inherent in the in vitro cultures justified the fact that the organisms affected by such modifications necessarily constituted GMOs subject to the risk assessment procedures in the Directive. It was apparent, from article 2(2)(b) and Part 2 of Annex IA, that in vitro fertilisation was generally not considered to be a technique entailing genetic modification, subject to limited exceptions. Thus, the fact that the application of a technique presupposed an in vitro culture was not regarded by the EU legislature to be an obstacle to its exclusion from the scope of the Directive. Similarly, it followed from article 3(1) and point 2 of Annex IB, that the cell fusion of plant cells of organisms which could exchange genetic material by traditional selection methods fell outside the scope of the Directive even though that cell fusion was necessarily applied in vitro to isolated cells. Accordingly, article 3(1) of Directive 2001/18, read in conjunction with point 1 of Annex IB and recital (17), meant that organisms obtained through the application of a method of mutagenesis based on the same methods which had conventionally been used in a number of applications and had a long safety record, but which differed from those established methods by virtue of other characteristics, were, in principle, not exempted from the Directive’s risk assessment procedures, provided that those characteristics were likely to lead to genetic modifications which differed from those obtained by the established methods of mutagenesis. However, organisms obtained by the in vitro application of a method of mutagenesis which had conventionally been used in a number of in vivo applications and had a long safety record should, in principle, be excluded from the scope of the Directive (judgment, paras 56–58, 63, 64, operative part).
G Tumerelle for the applicants.
M-A de Chillaz and B Le Bret for Fédération française des producteurs d’oléagineux et de protéagineux (the French Federation of oil seed and protein crop producers), intervening.
G Bain and J-L Carré, agents, for the French Government.
F Castilla Contreras, B Eggers, I Galindo Martín and C Valero, agents, for the European Commission.