We previously published a Correspondence in the June issue of Nature Biotechnology discussing the potential implications of the Court of Justice of the European Union (CJEU) Advocate General's interpretation of how products generated by new plant breeding techniques (NBPTs) would be subject to regulation under European Union (EU; Brussels) law. At that time, it appeared possible that the EU's decision to exempt 'mutagenesis' from Directive 2001/18/EC might also apply to all future mutagenic technology, regardless of the use of novel techniques.
After the final ruling of the Grand Chamber of the CJEU on 25 July 2018 (ref. 3), it is now clear that that view is wrong. Europe is now on a course to take a much more sweeping and precautionary view of the NBPT products that fall under the remit of the directive than was first suggested by the Advocate General; indeed, only a very narrow set of products generated by conventional mutagenesis are now exempt from EU regulatory oversight. In a sense, the CJEU decision now puts the ball back squarely in the court of European legislators, who must decide whether they want to do nothing—except appease some environmentalists and other lobbyists—or change a European regulatory system that currently regulates mutagenized plant products that are completely indistinguishable from nonregulated mutagenized products. (...)