In his Opinion on Case C-528/16, Advocate General of the European Court of
Justice Michal Bobek said that organisms obtained by mutagenesis are, in
principle, exempted from the obligations in the Genetically Modified
Organisms Directive of the European Parliament (GMO Directive). The GMO
Directive regulates the deliberate release into the environment of
genetically modified organisms (GMOs) and their placing on the market within
the EU.

The Opinion Case said that the Directive does not, however, apply to
organisms obtained through certain techniques of genetic modification, such
as mutagenesis ('the mutagenesis exemption'). Unlike transgenesis,
mutagenesis does not, in principle, entail the insertion of foreign DNA into
a living organism.

The Advocate General first considers that an organism obtained by
mutagenesis can be a GMO if it fulfills the substantive criteria laid down
in the GMO Directive. He observes that the Directive does not require the
insertion of foreign DNA in an organism in order for the latter to be
considered as a GMO, but merely says that the genetic material has been
altered in such a way that does not occur naturally. The Opinion Case also
indicated that Member States can legislate with regard to organisms obtained
by mutagenesis.

The first reaction to the Opinion Case came from the European Plant Science
Organisation (EPSO), which states that it welcomes the Advocate General's
opinion, and that it is an important step in clarifying the European
Directive concerning organisms modified by recent mutagenesis techniques
that appeared after 2001.

[curia.europa.eu].
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