Abstract

Ten years ago, biotechnologies experienced a technological breakthrough with the new genome-editing techniques (particularly CRISPR/Cas). This technological revolution not only opens up new fields of investigation with more powerful genetic engineering tools for human, animal and plant health, but also changes the regulatory criteria applied to genetic transformations and the legislation in many countries. Considering this new international background, the European Union was obliged to review Community regulations regarding these new genomic techniques (NGTs). The regulatory review process is long and complex. Begun in 2019, where are we in 2023? What genetic transformations are involved? Is the response up to the challenges? This article proposes some answers to these questions.

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