AG Opinion: Organisms obtained by mutagenesis are GMOs exempt from the provisions of the GMO Directive

09.02.2018

Advocate General Bobek’s opinion in a reference from the Conseil d’État to the CJEU[1] for a preliminary ruling concerning regulation of the release into the environment of genetically modified organisms (GMOs) obtained by mutagenesis was delivered on 18 January 2018. AG Bobek’s opinion considers that while organisms obtained by mutagenesis are GMOs, they are not subject to the regulations set out in the GMO Directive[2]. GMOs that are regulated under the GMO Directive can only be authorised following an environmental risk assessment and are subject to traceability, labelling and monitoring requirements.

Mutagenesis describes processes involving modification of the genome of an individual. Mutagenesis can occur naturally or following exposure to a mutagen and, unlike transgenesis, it does not involve insertion of foreign DNA into a living organism. Early techniques for mutagenesis, including those involving in vivo exposure to mutagenic agents (such as ionising radiation or chemical agents) were in common usage at the time of the introduction of the GMO Directive. However, these techniques did not permit targeted mutagenesis. New techniques have since appeared, such as oligonucleotide-directed mutagenesis and directed nuclease mutagenesis, which do permit precise mutations in a gene and have opened up the possibility of producing seed varieties which are resistant to selected herbicides.

At present, it remains the case that no organism which is the product of directed mutagenesis has been included in the common catalogue of varieties of agricultural plant species[3]. The only herbicide-resistant seeds in the common catalogue, of which there are 52, are the result of in vitro random mutagenesis. Confédération Paysanne, which protects the interests of small scale farmers in France, and other public interest groups were concerned about the release of herbicide-resistant seed varieties into the environment, citing a risk of accumulation of carcinogenic molecules or endocrine disruptors in the environment. A challenge was therefore launched in respect of certain provisions in the GMO Directive that exempt varieties which are the product of mutagenesis from the obligations laid down therein in relation to the release and placing on the market of GMOs. The applicants also argued that Directive 2002/53/EC does not permit inclusion of such modified organisms in the common catalogue.

AG Bobek recommends that products of mutagenesis be included within the definition of a GMO provided that they meet the substantive criteria set out in the GMO Directive. AG Bobek explained that it would not have been necessary to create an exemption from the obligations under the GMO Directive for organisms obtained by mutagenesis if those organisms were already excluded from the definition of a GMO. He also found that there did not appear to be sufficiently substantiated grounds on which to require the legislation to be updated in light of the relevant technological advances. Varieties which are the product of mutagenesis should therefore remain, according to the Advocate General, exempted from the obligations set out in the GMO Directive notwithstanding his view that they are GMOs.

Maintaining a consistent interpretation of the GMO Directive and the Directive on the common catalogue[4] also required such varieties to be exempted from the specific obligations in relation to genetically modified agricultural plant species set out in Directive 2002/53/EC too, not least because genetically modified products are only touched on incidentally in that Directive. Finally, it was noted that the exemption indicates that the release of products obtained by mutagenesis is not regulated at EU level. Therefore, subject to compliance with the overarching principles of EU law, Member States are not precluded from legislating in relation to products obtained by mutagenesis.

It now falls to the judges of the CJEU to consider the case and the Advocate General’s opinion.
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[1] Case C-528/16
[2] Directive 2001/18/EC
[3] The common catalogue lists the varieties which can be marketed in the EU
[4] Directive 2002/53/EC