Possible EU futures for CRISPR-edited plants : Little margin for optimism?
Escajedo San-Epifanio, Leire (Universidad del País Vasco. Departamento de Derecho Público, Ciencias Histórico-Jurídicas e Historia del Pensamiento Político)
Filibi, Igor (Universidad del País Vasco. Departamento de Derecho Público, Ciencias Histórico-Jurídicas e Historia del Pensamiento Político)
Lasa López, Ainhoa (Universidad del País Vasco. Departamento de Derecho Público, Ciencias Histórico-Jurídicas e Historia del Pensamiento Político)
Puigdomènech, Pere 1948- (Centre de Recerca en Agrigenòmica)
Uncetabarrenechea Larrabe, Javier (Universidad del País Vasco. Departamento de Derecho Público, Ciencias Histórico-Jurídicas e Historia del Pensamiento Político)

Date:	2023
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.
Grants:	Agencia Estatal de Investigación PID2021-123796OB-C21
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	European integration ; EU regulatory framework for plant breeding ; EU legislation on new genomic techniques ; Premarket approval of CRISPR-edited plants ; EU status of CRISPR-edited plants
Published in:	Frontiers in plant science, Vol. 14 (March 2023) , art. 1141455, ISSN 1664-462X

DOI: 10.3389/fpls.2023.1141455
PMID: 37008488

13 p, 551.6 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Experimental sciences > CRAG (Centre for Research in Agricultural Genomics)
Articles > Research articles
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