At the time of writing, the regulatory situation in the European Union (EU), vis-à-vis genome editing, is in a state of flux for reasons which will become apparent. This may be resolved in the current weeks and months. In any event, it will be inevitable to come back to this discussion in more detail at a later stage. This chapter considers current Union law in the context of current discussions in the EU related to genome editing and current and upcoming developments.

According to the European Commission the current EU legal framework related to GMOs aims to: ^[1]

• ‘Protect human and animal health and the environment by introducing a safety assessment of the highest possible standards at EU level before any GMO is placed on the market.
• Put in place harmonised procedures for risk assessment and authorisation of GMOs that are efficient, time-limited and transparent.
• Ensure clear labelling of GMOs placed on the market in order to enable consumers as well as professionals (e.g. farmers, and food feed chain operators) to make an informed choice.
• Ensure the traceability of GMOs placed on the market.’

The Commission also identifies the following building blocks of GMO legislation:

• Directive 2001/18/EC on the deliberate release of GMOs into the environment (European Union, Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC – Commission Declaration (EUR-Lex – 32001L0018, 2001),
• Regulation (EC) 1829/2003 on genetically modified food and feed (European Union, Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (Text with EEA relevance) (EUR-Lex – 32003R1829 – EN – EUR-Lex), 2003),
• Directive (EU) 2015/412 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory (European Union, Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their, 2015),
• Regulation (EC) 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms (European Union, Genetically modified organisms — traceability and labelling (EUR-Lex – l21170 – EN – EUR-Lex), 2003), and
• Directive 2009/41/EC on contained use of genetically modified micro-organisms. Regulation (EC) 1946/2003 on transboundary movements of GMOs (European Union, Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance) (EUR-Lex – 32009L0041 – EN – EUR-Lex), 2009).

It also notes that ‘these main pieces of legislation are supplemented by a number of implementing rules or by recommendations and guidelines on more specific aspects which we will not consider at this stage. ^[1]

In 2018, the question as to whether genome editing is covered by EU GMO law came before the Court of Justice of the European Union (CJEU), which is the ultimate judicial authority for dispute resolution and, as in this example, to interpret EU legislation. This case was raised through a request for clarification by the French Conseil d’État, which had previously received a plea at national level (Friedrichs, et al., Meeting report of the OECD conference on “Genome Editing: Applications in Agriculture—Implications for Health, Environment and Regulation”, 2019). In July 2018, the CJEU delivered its ruling, which is described below (Case C-528/16) (CJEU, July 2018).

In November 2018, the European Commission’s Scientific Advice Mechanism (SAM) Group of Chief Scientific Advisors published ‘A scientific perspective on the regulatory status of products derived from gene editing, and the implications for the GMO Directive’ (European Commission Group of Chief Scientific Advisors, 2018), in which they recommend ‘revising the existing GMO Directive to reflect current knowledge and scientific evidence, in particular on gene editing and established techniques of genetic modification. This should be done with reference to other legislation relevant to food safety and environmental protection.’

The Commission’s reaction to the CJEU’s judgment is evident from their website: ‘In July 2018, the Court of Justice of the European Union (CJEU) clarified that organisms from new mutagenesis techniques fall within the scope of the EU GMO legislation. The Commission is now working with EU countries and stakeholders to implement the Court’s ruling.’

In November 2019, the European Council requested ‘the Commission to submit a study in light of the Court of Justice’s judgment in Case C-528/16 regarding the status of novel genomic techniques under Union law, and a proposal, if appropriate in view of the outcomes of the study’ (European Council, 2019). It is worth emphasising that the request to the Commission referred not only to Directive 2001/18/EC, on which there has been much commentary, but also to the other legal instruments noted in Commission’s building blocks described above (European Union, Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC – Commission Declaration (EUR-Lex – 32001L0018, 2001). The Commission’s study is expected to be released at the end of April 2021. When it is published, it is certain to stimulate a major debate on the path forward in the EU.

In the meantime, there have been numerous responses both formal and informal to the CJEU judgment. It would be an onerous task to summarise this body of information. It would probably be more confusing rather than clarifying and clarity is more helpful at that this stage.

However, three documents are worthy of note. First, a report by the All European Academies (ALLEA) reviews the latest scientific evidence with respect to applications of genome editing in agriculture (ALLEA, 2020). The report was based on a two-day symposium that was organised jointly by ALLEA and the Royal Flemish Academy of Belgium (KVAB) in November 2019, that aimed to establish a dialogue between scientists and other relevant stakeholders. The resulting report presents the state of the art of scientific evidence in the field and explores what genome editing can deliver for agriculture. In addition, it explores the ethical and societal considerations related to agricultural applications of genome editing, traceability and intellectual property issues, and possible paths to harmonise EU regulation and legislation with recent scientific developments.

Second, the European Group on Ethics in Science and New Technologies (EGE) published an opinion on the Ethics of Genome Editing in March 2021 (EGE, 2021). The report addresses genome editing across a range of sectors including human health, animal livestock breeding and gene drives. It has a chapter dedicated to genome editing in plants. It identifies and discusses a range of ethical questions raised across all sectors in which genome editing is expected to have an impact.

Finally, an article entitled ‘Status Under EU Law of Organisms Developed Through Novel Genomic Techniques’ (van der Meer, et al., 2021) is a comprehensive analysis which contributes to the discussion on the legal status of organisms developed through novel genomic techniques. It achieves this by considering the history of EU GMO Directives as well as the technical context of some of the terms in the Directive. It also goes on to consider the judgment of the CJEU in Case C-528/16 (CJEU, July 2018).

[1] Website: European Union: GMO Legislation (accessed: 20^th March 2023)