ECJ ruling – Intentional release of genetically modified organisms into the environment (mutagenesis)

In its judgment of July 25, 2018 – Case C-528/16 – the ECJ issued a new landmark ruling on GMOs (genetically modified organisms). This ruling addressed questions of interpretation of Directives 2001/18/EC on the deliberate release into the environment of genetically modified organisms and 2002/53/EC on a common catalogue of varieties of agricultural plant species.

The subject of the preliminary ruling proceedings before the ECJ was the French Prime Minister's refusal to repeal a national provision that, in principle, did not describe organisms obtained through mutagenesis as genetic modification within the meaning of a GMO. Mutagenesis is used as a method in medical and biological research to elucidate specific gene functions. In classical mutagenesis, the spontaneous mutation rate in the genome of living organisms is increased by exposing them to genetically altering (mutagenic) substances or radiation. The parties also disputed the issue of prohibiting the cultivation and marketing of herbicide-tolerant rapeseed varieties obtained through mutagenesis.

The ECJ ruled that organisms obtained by mutagenesis techniques/methods are GMOs within the meaning of Article 2(2) of Directive 2001/18/EC. Article 3(1) of the directive is to be interpreted as meaning that only those organisms obtained by mutagenesis techniques/methods that are traditionally used in a range of applications and have long been considered safe are excluded from the scope of the directive. Article 4(4) of Directive 2002/53/EC is to be interpreted in the same way. This directive applies to the acceptance of certain agricultural species in a common catalogue of varieties of agricultural plant species whose seed or plant material may be marketed commercially.
However, organisms resulting from mutagenesis processes/methods that have only emerged since the directive was adopted, or that have primarily evolved since, are covered by the scope of both directives. The ECJ ruled that the risks to the environment and human health in these cases cannot yet be determined with certainty. This particularly applies to the new breeding techniques Crispr/Cas9. These gene scissors are capable of docking at specific sites in DNA to make targeted genetic changes there. While agriculture benefits from this practice, its application in human DNA is highly controversial due to the uncertainty of the techniques.

Furthermore, the ECJ clarified with regard to Article 3(1) of Directive 2001/18/EC that this article does not deprive Member States of the power to subject the aforementioned entities excluded from the scope of the directive to its scope. In this respect, Member States are granted discretion, since the EU legislature has excluded these entities from the scope of both directives but has not provided any further specific provisions for them. However, other EU law – in particular the fundamental freedom under Article 36 TFEU on the free movement of goods – must be observed.

Please also compare AGCT-Genetic Engineering.report 7-8/2018 and AGCT-Genetic Engineering.report 11/2018

Statement from the BDP

In an interview with Top Agrar, Stephanie Franck of the BDP (Federal Association of German Plant Breeders) criticized the ECJ ruling on the new breeding technologies (Crispr/Cas9). She argued that the classification as GMOs jeopardizes breeding progress. Europe is losing innovation. Access to these breeding methods is particularly difficult for medium-sized breeders due to the strict regulations of genetic engineering law. This puts European breeders at a disadvantage compared to others outside the EU. There is also a risk of innovative companies moving outside of Europe, which could jeopardize the future progress of European medium-sized companies, which are still considered leaders in the field of breeding technologies. Distortions of competition between agricultural regions are to be expected.

Overall, plant breeders believe that new breeding methods must be separated from traditional genetic engineering. The former develops organisms that are indistinguishable from those obtained through natural crossing and selection. According to plant breeders, these should then be treated equally. The BDP now intends to discuss options for action, but particularly sees the need for new genetic engineering legislation. The role of breeding in society must be widely discussed. A societal understanding of breeding technology is needed.

Statement from the ZKBS

From the ZKBS's perspective, the ECJ ruling fails to take into account the current state of scientific knowledge by ignoring previous assessments by recognized institutions. The ZKBS believes that the newer genome editing techniques addressed in the ECJ ruling are not entirely GMOs. The ZKBS considers the classification of minimal genome modifications—so-called oligonucleotide-directed mutagenesis—as GMOs to be questionable, as their end products are indistinguishable from a natural organism or one created by conventional mutagenesis. These would be subject to the strict regulations and procedures of genetic engineering law in the future, even though complex, multi-year approval procedures already exist for them.

The new methods are indispensable for plant breeding and agriculture, as they enable more efficient and faster breeding progress through targeted modification of the genomes of the target organism. Such a so-called process-based risk assessment in Europe would contradict the product-based risk assessment commonly used by major agricultural countries. This could lead to disadvantages in international trade and problems with controls by the relevant European customs authorities.

The ZKBS therefore strongly calls for European genetic engineering law to be adapted to the current state of scientific knowledge, which is still based on the state of knowledge from 1990.