A proposal from the Netherlands Ministry of Infrastructure and the Environment points the way out of the GM regulatory impasse for most CRISPR crops in Europe. Rather than trying to clarify ambiguous definitions, the EU could simply amend Annex B1, that is the list of technologies that are excluded from regulation by the directive on GMOs (2001/18/EC).
“Not all products resulting from the use of New Breeding Techniques would be exempted; instead, exemption would be based on the dual condition that: (i) the resulting organism does not contain recombinant nucleic acids; and (ii) no genetic material other than what could be exchanged through traditional breeding methods is introduced”, writes a group of academic researchers in the November issue of Trends in Biotechnology.
Dennis Eriksson and colleagues present examples of publicly funded research resulting in applications that may be affected by the Dutch proposal if it were to be adopted into EU legislation. After considering research programs under way in Austria, France, the Netherlands, Sweden, England, and Wales, they argue that many of those crops would not be regulated as GMOs, because they have only point mutations or deletions in endogenous genes, or the addition of genetic material from crossable species.
Some stakeholders are reluctant to open up the EU GMOs legislation for amendments, but Eriksson et al. think that the proposed change is compatible with the original intentions for GMOs regulation in the EU and would successfully update the regulatory framework responding to technical progress.