EU to consult on new regulatory framework for new genomic techniques

Following the UK government’s public consultation on reducing regulation in England for gene edited organisms, the European Commission has now published results from its study of new genomic techniques (NGTs). NGTs are genomic techniques that have emerged or been developed since 2001 when the current EU legislation on genetically modified organisms was adopted. The EU study was published on 29 April 2021 and will be followed by an EU-wide public consultation.

Announcing publication of this new study, EU Commissioner for Health and Food Safety, Stella Kyriakides, said: “The study we publish today concludes that New Genomic Techniques can promote the sustainability of agricultural production, in line with the objectives of our Farm to Fork Strategy. With the safety of consumers and the environment as the guiding principle, now is the moment to have an open dialogue with citizens, Member States and the European Parliament to jointly decide the way forward for the use of these biotechnologies in the EU.”

These comments represent a significant shift away from the current EU position and towards acknowledging real benefits of the use of NGTs in sustainable agriculture, potentially paving the way for a significant update to EU regulation of gene editing in plants.

Interestingly, the study highlighted in particular that NGTs and their products have developed rapidly and that despite considerable interest in NGT research within the EU, most development work is taking place outside of the EU. The Court of Justice of the European Union (CJEU) ruled in 2018 that organisms obtained by mutagenesis are GMOs, and since then, there have been reports of negative impacts on research involving new genomic techniques within the EU due to the current regulatory framework, which is seen to be amongst the most restrictive in the world.  The study clearly identified a desire for a change in EU regulations amongst public and private researchers within the EU.

The findings of the study also clearly identify potential benefits that could be derived from use of NGTs in agriculture. The report highlights that NGTs have the potential to contribute to the objectives of the EU’s Green Deal and in particular to the ‘farm to fork’ and biodiversity strategies and the United Nations’ sustainable development goals (SDGs) for a more resilient and sustainable agri-food system. Specific examples of potential benefits are recognised within the report, such as plants more resistant to diseases and environmental conditions or climate change effects in general, improved agronomic or nutritional traits, reduced use of agricultural inputs (including plant protection products) and faster plant breeding.

It seems that the study has concluded both that there is a desire for regulatory change as well as a significant potential benefit.

As part of the study, the EC requested the European Food Safety Authority (EFSA) to provide an overview of the potential risk associated with plants developed through new NGTs: taking into account its previous scientific opinions, its ongoing work on the topic as well as opinions published by competent authorities and national institutions since 2012 . Of course, any relevant risk or safety considerations will depend on the particular technique and the way in which that technique is used in a particular organism. Significantly, the report notes that for certain NGTs (specifically, site-directed nuclease type 1 and type 2 (SDN-1, SDN-2), ODM and cisgenesis), the EFSA has not identified new hazards compared to either conventional breeding or established genomic techniques (EGTs).

The EFSA also pointed out that random changes to the genome, such as insertions, deletions or rearrangements of genetic sequences, arise in conventional breeding as well as in genome editing, cisgenesis, intragenesis and transgenesis. The authors of the EC report state that: EFSA has concluded that off-target mutations potentially induced by site-directed nuclease (SDN) techniques are of the same type as, and fewer than, those mutations in conventional breeding. Therefore, in certain cases, targeted mutagenesis and cisgenesis carry the same level of risk as conventional breeding techniques.

The EC study also encompassed a review of ethical considerations and the report highlights that although the use of NGTs may raise ethical concerns, so does missing opportunities as a result of not using them.

The study was discussed by EU ministers at the Agriculture and Fisheries Council on 26-27 May 2021 and the European Parliament will also be consulted. A recently published summary of the main results of the Agriculture and Fisheries Council meeting notes that ministers held a debate on the conclusions of the EC study on NGTs and explored possible future policy actions, commenting that: in general, they agreed with the findings of the study, notably the need to address legal uncertainty and to adapt the existing legislation to take into account scientific and technological progress.

The EU Commission has indicated that a public consultation will be carried out over the coming months with the aim of: maintaining a high level of protection of human and animal health and the environment whilst gathering benefits from innovation.

It remains to be seen how the different approaches of the individual EU member states will influence the outcome of the consultation and how that outcome will differ from the UK government’s conclusions following its consultation earlier this year, but the results of the EC study clearly pave the way for an update to EU regulations. The results of the UK consultation are due to be published by the end of June 2021.