Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt (C-528/16)

Judgment of 25 Jul 2018

law://eu/cjeu/2016/c-528-16/para_25@2026-11-13

25In those circumstances, the Conseil d’État (Council of State, France) decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling:(1) Do organisms obtained by mutagenesis constitute [GMOs] within the meaning of Article 2 of Directive 2001/18, although they are exempt under Article 3 of and Annex I B to the directive from the obligations laid down for release and placing on the market of [GMOs]? In particular, may mutagenesis techniques, in particular new directed mutagenesis techniques implementing genetic engineering processes, be regarded as techniques listed in Annex I A, to which Article 2 refers? Consequently, must Articles 2 and 3 of and Annexes I A and I B to Directive [2001/18] be interpreted as meaning that they exempt from precautionary, impact-assessment and traceability measures all organisms and seeds obtained by mutagenesis, or only organisms obtained by conventional random mutagenesis methods by ionising radiation or exposure to mutagenic chemical agents existing before those measures were adopted?(2) Do varieties obtained by mutagenesis constitute genetically modified varieties within the meaning of Article 4 of Directive [2002/53] which would not be exempt from the obligations laid down in that directive? Or, on the contrary, is the scope of that directive the same as that under Articles 2 and 3 of and Annex I B to [Directive 2001/18], and does it also exempt varieties obtained by mutagenesis from the obligations laid down for the inclusion of genetically modified varieties in the common catalogue of agricultural plant species by [Directive 2002/53]?(3) Do Articles 2 and 3 of and Annex I B to Directive [2001/18] on the deliberate release into the environment of [GMOs] constitute, in so far as they exclude mutagenesis from the scope of the obligations laid down in the directive, a full harmonisation measure prohibiting Member States from subjecting organisms obtained by mutagenesis to all or some of the obligations laid down in the directive or to any other obligation, or do the Member States, when transposing those provisions, have a discretion to define the regime to be applied to organisms obtained by mutagenesis?(4) May the validity of Articles 2 and 3 of and Annexes I A and I B to Directive [2001/18] with regard to the precautionary principle guaranteed by Article 191(2) [TFEU], in that those provisions do not subject [GMOs] obtained by mutagenesis to precautionary, impact-assessment and traceability measures, be called into question, taking account of the development of genetic engineering processes, the appearance of new plant varieties obtained by means of those techniques and the current scientific uncertainty as to their impacts and the potential risks they represent for the environment and human and animal health?’

Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt (C-528/16)

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