EU’s Highest Court Rules on the Regulatory Framework Applicable to GMOs Developed Through New Mutagenesis Techniques

The case was brought by Confédération paysanne and other associations (NGOs) before the Supreme Administrative Court in France (Conseil d’État) as they challenged French legislation exempting all organisms obtained by mutagenesis from GMO-related pre-approval procedures and obligations.

Under the EU’s 2001 GMO Directive, all GMOs, i.e., all organisms in which the genetic material has been altered in a way that does not occur naturally by mating or natural recombination, are subject to regulation (risk assessment including field testing, traceability, labelling and monitoring obligations), except organisms created using certain mutagenesis techniques.

According to the NGOs, the mutagenesis exception in the GMO Directive should cover only pre-existing mutagenesis techniques (applying chemical agents or ionizing radiation to generate random gene mutations in vivo to entire plants or parts thereof). In the NGOs’ view, the exception could not cover in vitro or “directed” mutagenesis techniques developed largely after 2001. Such new techniques would include oligonucleotide-directed mutagenesis, i.e., the introduction into cells of a short DNA sequence causing a mutation in the cell (ODM), and directed nuclease mutagenesis using different types of proteins (e.g., zinc finger nucleases, TALEN, CRISPR/Cas9) capable of cutting or editing the DNA (SDN1)². According to the NGOs, herbicide-resistant plants bred using such new mutagenesis techniques create, at least in theory, risks such as the spread of herbicide-resistant weeds, increased pollution caused by having to fight such weeds, and unintended gene mutations.

The Conseil d’État asked the CJEU whether the GMO Directive covered organisms developed using the above-mentioned new mutagenesis techniques.

In his opinion of January 18, 2018, Advocate-General Bobek advised³ that there is no basis for limiting the mutagenesis exception to techniques that already existed in 2001. He noted the European Commission’s clarification during the hearing that the EU legislature “had no intention to regulate mutagenesis techniques” at all.

In its judgment of July 25, 2018, surprisingly, the CJEU reached a different conclusion, which puts this judgment at odds with the position of the European Commission and all Member States that intervened in this case (Austria, France, Greece, the Netherlands, Sweden and the United Kingdom).

At the outset, the CJEU clarified that all organisms obtained through mutagenesis fall within the definition of GMOs. That is because such organisms are considered a product of genetic modification and because under EU law, exemptions should generally be interpreted strictly.

The CJEU then found that new oligonucleotide-directed mutagenesis or directed nuclease mutagenesis techniques should not be exempted from the scope of the GMO Directive. In the CJEU’s view, the term “mutagenesis” should be read as “mutagenesis, which [has] conventionally been used in a number of applications and [has] a long safety record.” The Court’s finding was based primarily on the purpose of the GMO Directive, as shown by two of its recitals.

First, the CJEU quoted Recital 17, which states in general that the Directive “should not apply to techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record.” Interestingly, the CJEU did not address the point raised by Advocate-General Bobek in his opinion, that Recital 17 was a general statement that could not be used to interpret the mutagenesis exemption.

Second, the CJEU quoted Recital 8, which states that “the precautionary principle was taken into account in the drafting of the directive and must also be taken into account in its implementation,” to justify a narrow reading of the exemption. The CJEU did not address a point raised by the Advocate-General, that the precautionary principle cannot be used to change the wording of EU legislation.

Importantly, the CJEU also clarified the margin of discretion left to Member States with respect to organisms that are exempt from the GMO Directive. In this regard, the Court stated that Member States were free to define the applicable legal regime for such organisms. As long as they comply with overarching principles of EU law, and in particular rules on the free movement of goods, Member States may thus subject organisms exempted under EU law to regulatory scrutiny, including risk assessment, traceability, labelling and monitoring obligations that would be applicable to non-exempted organisms under EU law.

This makes the review of both EU level and national level regulations compulsory for any company active in this sector. Innovative companies dealing with gene editing techniques and GMOs are advised to take note of the ruling and investigate whether their products may or may not be exempt from regulatory scrutiny.

¹ Directive 2001/18/EC of the European Parliament and of the Council of March 12, 2001, on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ 2001 L 106, p. 1).

² These terms are not used by the CJEU itself, but they are mentioned in the referral judgment of the Conseil d’État and in the opinion of Advocate-General Bobek.

³ Opinion of January 18, 2018, Case C-529/16, ECLI:EU:C:2018:20. Advocate-General opinions do not bind the CJEU, but they are followed in the majority of cases.