What’s it all about?
Progress is underway: the EU is introducing a legal framework for new genomic techniques. The new molecular biology method CRISPR/Cas9 (colloquially known as “gene scissors”) makes it possible to change DNA building blocks in almost all living cells and organisms more easily and precisely than was previously possible. This process promises development not only in human medicine, but also in the breeding of plants and animals. Instead of years of breeding and selection, targeted manipulation of the genetic make-up of crops can achieve benefits in agricultural use more quickly. However, the European Court of Justice already put a damper on the use of this method in the European Union in 2018 when it held in a preliminary ruling (JUDGMENT OF THE COURT (Grand Chamber), 25 July 2018, In Case C-528/16) that organisms obtained with the help of this new biotechnological method were also “genetically modified organisms” within the meaning of EC Directive 2001/18/EC on the deliberate release of genetically modified organisms (“GMO Directive”) (Directive (EC) 2011/18).
What does the previous EU regulatory framework for genetically modified organisms (GMOs) from 2001 regulate?
Art. 2 No. 2 of the GMO Directive defines a GMO as an “organism, other than a human being, whose genetic material has been modified in a way that cannot occur naturally by mating and/or natural recombination”. However, according to Art. 3 (1) of the GMO Directive in conjunction with Annex I B, certain methods of genetic modification are excluded from the scope of application, which according to No. 1 of the Annex also includes mutagenesis.
Following Recital 17 of the GMO Directive, the CJEU ruled that the application exemption should cover genetic modification techniques which have been traditionally used in a variety of applications and have long been considered safe. In contrast, the CJEU classified the techniques associated with the use of genetic engineering that have emerged since the adoption of the GMO Directive and whose risks to the environment and human health cannot yet be determined with certainty. The CJEU explicitly stated that the legal framework for GMOs is also applicable to techniques that have arisen since then.
What does the classification as GMO mean and how do plants edited with the CRISPR/Cas9 method differ from conventional GMOs?
Throughout the EU, GMOs may only be placed on the field as seed or on the market as food or feed if they have been authorised for this purpose. In practice, classification as a GMO is tantamount to a ban on cultivation and use.
The current legal framework for GMOs is based on certain biotechnology techniques as applied since the late 1990s. While “genetic technology” is traditionally understood as the introduction of a foreign gene into the organism concerned, the new breeding methods allow the precise and time-saving mutagenesis of the genetic material of cultivated plants, for which the term “genome editing” has become established(Joint statement “Towards a scientifically based, differentiated regulation of genome-edited plants in the EU” by the German National Academy of Sciences Leopoldina, the German Research Foundation and the Union of the German Academies of Sciences and Humanities; page 9). Molecular biologists Emmanuelle Charpentier and Jennifer Doudna received the Nobel Prize in Chemistry in 2020 for their development of a method for genome editing CRISPR/Cas9.
Apart from scientific objections according to which the new procedures of genome editing are not to be equated with “genetic technology”; in practice there is also a lack of detection procedures; to detect and control the use of the new procedures, for example when importing seeds and plants.
What does the EU Commission Study say?
In light of the CJEU decision C-528/16, the Council of the European Union in November 2019 requested the Commission to undertake an enquiry into the status of novel genomic techniques under Union law and, if appropriate in light of the findings of the enquiry, to submit a proposal. (COUNCIL DECISION (EU) 2019/1904 of 8 November 2019 L 293/103)
In April 2021, the EU Commission subsequently published its study on the status of new genetic engineering techniques under Union law, in particular in the light of the Court of Justice’s judgment in Case C-528/16. (Study report SWD (2021) 92)
The study coins the term “new genomic techniques” (NGT) and makes it clear that organisms obtained through new genomic techniques are covered by GMO regulations. However, the study recognises that developments in biotechnology, combined with the lack of definitions on the meaning of key terms, still lead to ambiguities in the interpretation of some concepts and thus to legal uncertainty. The study defines NGTs as “techniques capable of modifying the genetic material of an organism that have emerged or been developed since 2001”, i.e. after the existing EU legislation on genetically modified organisms was adopted. The study points to the status and use of NGTs in plants, animals and microorganisms for agricultural food, industrial and pharmaceutical applications. The law is struggling to keep pace with the rapidly evolving field of new genomic techniques and the procedures currently enshrined in the legislation are difficult to adapt to scientific progress.
Furthermore, the current authorisation process for GMOs is not geared towards promoting sustainability in the agri-food sector.
What does the EU Commission intend to do?
The EU Commission is planning new legislation for plants and organisms obtained using certain NGTs.
In September 2021, the EU Commission published a roadmap on the initiative to establish a new regulatory framework for plants derived from targeted mutagenesis and cisgenesis. Feedback could be submitted up until 22 October 2021 and is also published on the EU Commission’s website. In the second quarter of 2022, the EU Commission plans a public consultation. The adoption of a concrete proposal for an EU regulation by the Commission is planned for the second quarter of 2023.
The aim is to enable innovation in the agri-food system while maintaining a high level of protection for health and the environment, and to contribute to achieving the objectives of the European Green Deal and the Farm-to-Fork Strategy.
Outlook
It will however be years before the Commission’s proposal passes the EU legislative process and a corresponding regulation can be applied. Let us hope that the new legislative initiative can take effect before the EU loses out in the area of new genome editing methods.
