Case C‑688/21
Confédération paysanne and Others
v
Premier ministre
and
Ministère de l'Agriculture et de l’Alimentation
(Request for a preliminary ruling from the Conseil d’État (France))
Judgment of the Court (Grand Chamber), 7 February 2023
(Reference for a preliminary ruling – Environment – Deliberate release of genetically modified organisms – Directive 2001/18/EC – Article 3(1) – Point 1 of Annex I B – Scope – Exemptions – Techniques/methods of genetic modification which have conventionally been used and have a long safety record – In vitro random mutagenesis)
1. Questions referred for a preliminary ruling – Expedited preliminary ruling procedure – Conditions – Circumstances justifying swift processing – None
(Statute of the Court of Justice, Art. 23a; Rules of Procedure of the Court of Justice, Art. 105(1))
(see paragraphs 26-28)
2. Approximation of laws – Deliberate release of genetically modified organisms – Directive 2001/18 – Scope – Organisms obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and considered as being safe for a long time – Not included – Restrictive interpretation – Organisms obtained by means of a technique/method of mutagenesis based on the same processes of modification of the genetic material as a technique which has conventionally been used and considered as being safe for a long time whilst presenting distinct characteristics – Included – Conditions
(European Parliament and Council Directive 2001/18, recital 17, Art. 3(1), and Annex I B, point 1)
(see paragraphs 47-49, 51-56, 64, operative part)
3. Approximation of laws – Deliberate release of genetically modified organisms – Directive 2001/18 – Scope – Exemption – Organisms obtained by the application in vitro of a technique/method of mutagenesis which has conventionally been used in a number of applications in vivo and considered as being safe for a long time – Effects inherent in in vitro cultures – No effect on the exclusion of the exemption of those organisms
(European Parliament and Council Directive 2001/18, recital 17, Art. 3(1), and Annex I B, point 1)
(see paragraphs 58-60, 63, 64, operative part)
Résumé
In 2015, the Confédération paysanne, a French agricultural union, and eight associations whose purpose is the protection of the environment and the dissemination of information concerning the hazards posed by genetically modified organisms (GMOs) brought an action before the Conseil d’État (Council of State, France) concerning the exclusion of certain techniques or methods of mutagenesis (1) from the scope of the French legislation intended to transpose Directive 2001/18 (2) on the deliberate release into the environment of GMOs. In that context, the Conseil d’État (Council of State) had submitted to the Court of Justice a request for a preliminary ruling, which gave rise to the judgment in Confédération paysanne and Others (C‑528/16), delivered in 2018. (3)
The present case follows on from that judgment, in which the Court ruled that the scope of the Directive 2001/18 excludes only organisms obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record. The Conseil d’État (Council of State) took the view that it follows from that judgment that the organisms obtained by means of techniques/methods which appeared or were mainly developed after the date of the adoption of that directive, namely by virtue of techniques of ‘in vitro random mutagenesis’ (4) must be included in the scope of Directive 2001/18. Accordingly, the Conseil d’État (Council of State) issued an order and, to ensure its implementation, the French Government, in particular, drew up a draft decree relating to the modification of the list of techniques for obtaining GMOs which have been traditionally used without proven harm for public health or the environment. That draft decree provided that random mutagenesis, with the exception of in vitro random mutagenesis, had to be regarded as falling within such use.
Following notification of that draft decree, (5) the European Commission issued a detailed opinion, in which it stated that it was not justified, in the light of EU law and in the light of scientific advances, to draw a distinction between in vivo random mutagenesis and in vitro random mutagenesis. Since the draft decree was not adopted by the French authorities, the Confédération paysanne and the group of environmental protection associations again referred the matter to the Conseil d’État (Council of State) seeking enforcement of the order which had been declared.
The supreme administrative court considered that it needed clarification as to the scope of the judgment in Confédération paysanne and Others, in order to determine whether, in the light of the characteristics and uses of in vitro random mutagenesis, that technique/method should be regarded as falling within the scope of Directive 2001/18. It therefore referred the question to the Court of Justice for a preliminary ruling.
By its judgment, delivered by the Grand Chamber, the Court specifies the conditions under which organisms obtained through the application of a technique/method of mutagenesis which is based on the same processes of modification, by the mutagenic agent, of genetic material as a technique/method of mutagenesis which has conventionally been used in a number of applications and has a long safety record, but which differs from that second technique/method of mutagenesis by other characteristics, are, in principle, excluded from the exemption provided for by Directive 2001/18. (6)
Findings of the Court
First of all, the Court states that the limitation of the scope of the exemption provided for by Directive 2001/18 as regards the applicability of that exemption to techniques/methods of mutagenesis, by reference to the dual criterion of, first, conventional use in a number of applications, and, second, having a long safety record, (7) is closely linked to the very objective of that directive, (8) namely to protect human health and the environment, in accordance with the precautionary principle. The application of that dual criterion thus makes it possible to ensure that, on account of the age and variety of uses of a technique/method of mutagenesis and the information available as to its safety, organisms obtained through that technique/method may be released into the environment or placed on the market within the European Union, without it being necessary, in order to avoid adverse effects on human health and the environment, to subject those organisms to risk assessment procedures. (9)
In that context, the Court finds that a general extension of the benefit of the exemption from the scope of Directive 2001/18 to organisms obtained through the application of a technique/method of mutagenesis which is based on the same processes of modification, by the mutagenic agent, of the genetic material of the organism concerned as a technique/method of mutagenesis which has been conventionally used in a number of applications and which has a long safety record, but which combines those processes with other characteristics, distinct from those of that second technique/method of mutagenesis, would not respect the intention of the EU legislature.
The release into the environment or the placing on the market, without having carried out a risk assessment procedure, of organisms obtained by means of such a technique/method of mutagenesis is capable, in certain cases, of entailing negative effects, which may be irreversible and affecting several Member States, on human health and the environment, even where those characteristics do not relate to the processes of modification, by the mutagenic agent, of the genetic material of the organism concerned.
However, to consider that organisms obtained through the application of a technique/method of mutagenesis which has conventionally been used in a number of applications and with a long safety record necessarily fall within the scope of Directive 2001/18 where that technique/method has undergone any modification would be liable to render largely redundant the exemption provided for by that directive. Such an interpretation could make all forms of adaptation of techniques/methods of mutagenesis excessively difficult, even though that interpretation is not necessary to achieve the objective of protecting the environment and human health pursued by that directive, in accordance with the precautionary principle.
Therefore, the Court considers that the fact that a technique/method of mutagenesis includes one or more characteristics distinct from those of a technique/method of mutagenesis conventionally used in a number of applications and which has a long safety record justifies the exclusion of the exemption provided for by the directive only in so far as it is established that those characteristics are liable to result in modifications of the genetic material of the organism concerned that differ, by their nature or by the rate at which they occur, from those obtained by the application of that second technique/method of mutagenesis.
That being said, in the final part of its analysis, the Court examines the distinction between in vivo and in vitro mutagenesis techniques at the heart of the dispute in the main proceedings. It notes in that regard, following an analysis of the scheme laid down in Directive 2001/18 on techniques/methods involving in vitro cultures, that to hold that, because of the effects inherent in in vitro cultures, an organism obtained through the in vitro application of a technique/method of mutagenesis initially used in vivo is excluded from the exemption provided for by Directive 2001/18 would fail to have regard to the fact that the EU legislature did not consider that those inherent effects were relevant for the purpose of defining the scope of that directive. In particular, the Court states that Directive 2001/18 provides for the exclusion of several techniques of genetic modification involving the use of in vitro cultures from the GMO control scheme provided for by that directive.