Possible EU futures for CRISPR-edited plants: Little margin for optimism?

Abstract

This article addresses the scenarios that may be encountered by the first application for pre-market approval of a CRISPR-edited plant in the EU. Two alternative scenarios are considered in the short and medium term. One of these possible EU futures depends on the final drafting and approval of EU legislation on certain New Genomic Techniques, which was started in 2021 and is due to be quite advanced before the next European Parliament elections in 2024. Since the proposed legislation excludes plants with foreign DNA, two different approval processes for CRISPR-edited plants will coexist if the legislation enters into force: one for plants whose genome has been altered, resulting in mutagenesis, cisgenesis and intragenesis; and the second for plants whose alterations result in transgenesis in general. In the event that this legislative process does not succeed, CRISPR-edited plants in the EU could face a regulatory scenario whose foundations were laid in the 1990s: the regulatory framework that applies to GM crops, food and feed. In this review, an ad hoc analytical framework has been built that considers in depth the two possible futures for CRISPR-edited plants in the EU. This framework emphasises the way in which the European Union and the Member States (MS), with their respective national interests, have historically shaped the regulatory framework for plant breeding in the EU. On the basis of the analyses carried out on the two possible futures for CRISPR-edited plants and of their potential with respect to plant breeding, the main conclusions are the following. Firstly, that the regulatory review that started in 2021 is not in itself “good enough” for plant breeding and CRISPR-edited plants. Secondly, that compared to its alternative, the regulatory review currently underway contains at least some promising improvements in the short term. Hence, thirdly, in addition to adopting the current regulation, the MS need to continue to work towards a substantial improvement in the legal status of plant breeding in the EU in the medium term.

Processes for regulating genetically modified and gene edited plants

“… 203 , 204 However, there is a chance of new legislation being proposed to provide CRISPR-edited plants with a regulatory framework, but it is considered that the proposed legislation will not be the best possible, even if it is passed due to the constraining influence of the current GM regulatory framework. 64 And there are other views that propose that for genome editing applications, the level of robustness in the evidence currently required for the Environmental Risk Assessment of GMOs needs to be maintained. 205 …”

Modern Plant Biotechnology: An Antidote against Global Food Insecurity

“…However, in recent times, there have been calls for a review of the current regulations in Europe to differentiate between genome-edited crops and transgenic GMOs, considering the precise and targeted nature of the former. This is now being debated in the EU scientific community [193][194][195][196][197].…”

CRISPR in Agricultural Food Crops: Exploring the Significant Contribution of this Beneficial Gene Editing Technique in Food Crops for Yield Improvement

“…Past experiences with GMOs have shown that public opposition can significantly hinder the adoption of these technologies, regardless of their potential benefits. While early surveys suggest that the public may be more accepting of gene editing compared to GMOs, especially if the modifications could be achieved via conventional breeding, there is still significant public concern and a lack of understanding about these technologies (Escajedo San-Epifanio et al, 2023).…”