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In the gene-editing race, the EU lags behind other Western powers

More than 350 scientists and agricultural entrepreneurs filled the Biotech Forum during the 1st Congress organized by Biovegen, the platform that promotes biotechnology in this sector, held during the recent edition of Fruit Attraction, in Madrid.

One of the main topics addressed was the European Commission's proposed regulation on New Genomic Techniques (NGT) and the developments achieved in plant breeding by these methods, approved by the Parliament on February 7. Diego Orzáez, a CSIC researcher at the IBMCP (Institute of Molecular and Cellular Biology of Plants, Valencia), highlighted how these techniques have developed in recent years to become "faster, more efficient and more accurate."

In the race towards gene editing, the EU, which has not yet finished debating the regulations that will govern it, is lagging behind other Western powers.



The researcher explained how progress has been made from CRISPR-Cas 9-directed mutagenesis ("editing" parts of a molecule without inserting foreign material) towards analogous techniques, but with additional functionalities that, in turn, can be combined.

Leire Escajedo, professor at the University of the Basque Country, discussed the latest European legislation on plant breeding. She also mentioned how current legislation is based on genetics from the 1990s, and that the EU Court of Justice ruled in 2018 that it was necessary to revise it and adapt it to the NTGs, to which the restrictions in force for GMOs still apply today.

She also analyzed the text proposed by the EC as a result of this ruling, which was backed, with some amendments, by the EP in February. Escajedo considered it a "step forward" that the proposal includes a "differentiated legal status" for GMOs. She clarified that the text being debated today divides plants obtained through these techniques into two: NGT-1, whose genetic modifications could well have been obtained by traditional methods (with successive crosses and selection) by investing a lot of time and working through many generations (these plants would be exempt from the GMO directive), and NGT-2, whose modifications would continue to be regulated by the directive, although with a risk assessment that would take other considerations into account. The difference would lie in the number of genetic changes in the genome. Those with up to 20 would fall into the first group, and those with more would fall into the second. But this criterion is not very clear, so "we will have to watch for the small print of the final text," she added.

The situation of the European regulation of biostimulants is quite different. Estefanía Hinarejos, director of Regulatory Affairs at Alga-Energy, analyzed the prospects of the entry into force of EU Regulation 2019/1009 in July 2022. Hinarejos welcomed the approval of this regulation, which forces manufacturers to prove the products' effectiveness through tests. However, the expert lamented how, for now, the regulation only acknowledges 4 types of microorganisms, meaning that it still suffers from "shortcomings that, for the time being, have been canceled out through partial harmonization." She also called for development to be guided by "proportionality," and for "realistic" requirements for the certification of new products.

For more information:
Biovegen
Tel.: +34 661208696
https://biovegen.org

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