Which organisms and technologies fall under the mutagenesis exemption of the European GMO-Directive?

Abstract

The European GMO-Directive’s (2001/18/EC) mutagenesis exemption may exempt organisms produced by genome editing from the legal obligations of the Directive, according to the recently published opinion of the Advocate General of the Court of Justice of the European Union (CJEU). We analyse his opinion and assess that the caveat in Art. 3(1) i.c.w. Annex 1B does not allow the use of nucleic acid vector constructs and CRISPR’s sgRNA. This represents an obstacle for genome editing in plants and animals, since most current setups use vectors. However, alternatives are under way.