Niveau juridique : Union européenne
Texte de la question :
« The Epibreed procedure involves activating naturally-occurring retrotransposons – mobile genes responsible for gene regulation – by means of two mutagenic chemicals. One of these comes from the tuber leaf mushroom, the other is a synthetic molecule that is incorporated into the DNA if, for example, seeds are soaked in an aqueous solution. One causes inhibition of gene transcription, the other inhibition of DNA methylation.
The chemicals ensure that the retrotransposons multiply vigorously and become mobile, i.e. they are released from a chromosome and randomly incorporated into the genome at new locations. The aim is for them to activate the genes in the new neighbourhood. This is only the case when there is a particular stimulus, e.g. cold or heat. The change cannot be controlled with any degree of precision but occurs randomly.
Does the Commission consider this procedure to be a genetic one, governed by Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms?
What is the Commission’s assessment of this procedure in comparison to conventional mutagenesis procedures, which are not governed by the obligations set out in the GMO Directive? »
Réponse donnée par Mme Kyriakides au nom de la Commission, le 9 septembre 2020 :
« The Commission can provide the Honourable Member with a general response to the question, as a specific one could only be given following an in-depth regulatory analysis of a specific application.
The Commission would like to refer to the judgment of the Court of Justice of the EU on mutagenesis in Case C 528/16(1).
Taking into account in particular paragraph 27 to 30 of the judgment, the Commission considers that the Epibreed technique alters the genetic material of an organism in a way that does not occur naturally.
In paragraph 51 of the judgment, the Court further clarifies that ‘Article 3(1) of Directive 2001/18(2), read in conjunction with point 1 of Annex I B to that directive, cannot be interpreted as excluding, from the scope of the directive, organisms obtained by means of new techniques/methods of mutagenesis which have appeared or have been mostly developed since Directive 2001/18 was adopted. Such an interpretation would fail to have regard to the intention of the EU legislature reflected in Recital 17 of the directive to exclude from the scope of the directive only organisms obtained by means of techniques/methods which have conventionally been used in a number of applications and have a long safety record’.
Based on the information available, the Epibreed technique yields organisms that are to be considered genetically modified within the meaning of Article 2(2) of Directive 2001/18/EC and that are subject to the provisions of that directive, as it had not already been conventionally used in a number of applications with a long safety record at the time of adoption Directive 2001/18/EC. »
Texte de la question disponible ICI.