Organisms obtained by the in vitro application of a mutagenesis technique, which has traditionally been used for various in vivo applications and whose safety has long been proven, are excluded from the scope of the GMO Directive (2001/18), the Court of Justice of the European Union ruled on Tuesday 7 February (Case C-688/21).
Random mutagenesis, which consists of increasing the frequency of spontaneous genetic mutations in living organisms, can be applied in vitro (mutagens are used on plant cells and the whole plant is then artificially reconstituted) or in vivo (mutagens are used on the whole plant or parts of plants).
In a judgment delivered in July 2018, the Court ruled that only organisms obtained by means of a technique of mutagenesis which has conventionally been used for various applications and with a long safety record benefit from the exemption of the prudential assessment and monitoring requirements of the GMO Directive (2001/18) (see EUROPE 12070/6).
In France, the farmers’ union La Confédération paysanne and eight environmental protection associations are asking the Council of State (‘Conseil d'État’) to apply a 2020 decision that organisms obtained by means of techniques or methods that emerged or mainly developed after the adoption of the directive, in particular by means of in vitro random mutagenesis techniques, are subject to the obligations of the GMO directive.
Based on the opinion of the Advocate General (see EUROPE 13053/24), the Court is of the opinion that the effects inherent from in vitro cultivation do not justify excluding from the exemption provided for in the GMO Directive organisms obtained by the in vitro application of a mutagenesis technique traditionally used for various in vivo applications and whose safety has long been proven. According to the Court, the fact that a technique involves in vitro cultures is not in itself decisive in determining whether it falls within the scope of EU law.
However, the European Court notes that the limitation (dual criteria of traditional use for various applications and proven safety) of the scope of the Directive’s exemption is closely linked to the EU legislator’s objective of protecting human health and the environment.
The Court considers that 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 a technique of mutagenesis with characteristics distinct from those of a technique of mutagenesis which has been conventionally used in a number of applications and has a long safety record could have negative effects on human health and the environment, affecting several Member States in a sometimes irreversible manner.
Therefore, a technique of mutagenesis which includes one or more characteristics distinct from those of a mutagenesis traditionally used for various applications and whose safety has been proven for a long time may be subject to the GMO Directive when it is established that these characteristics are likely to lead to changes in the genetic material of the organism concerned which are different (in nature or in the rate at which they occur) from those resulting from the application of the second technique of mutagenesis.
See the judgment: https://aeur.eu/f/590 (Original version in French by Mathieu Bion)