European Court issues opinion exempting some genetic engineering techniques from GMO laws
The European Court of Justice Advocate General Michal Bobek has issued an opinion that “organisms obtained by mutagenesis” (or genetic engineering techniques such as CRISPR) are exempt from European regulations controlling GMOs.
The European Court of Justice Advocate General Michal Bobek has issued an opinion that “organisms obtained by mutagenesis” (or genetic engineering techniques such as CRISPR) are exempt from European regulations controlling GMOs.
The European Parliament’s Directive 2001/18/EC regulates the deliberate release into the environment of GMOs and their placing on the market within the European Union (EU). The Directive does not, however, apply to organisms obtained through certain techniques of genetic modification, such as mutagenesis. Unlike transgenesis, mutagenesis does not, in principle, entail the insertion of foreign DNA into a living organism. It does, however, involve an alteration of the genome of a living species.
In making his decision, Bobek first considered that an organism obtained by mutagenesis can be a GMO if it fulfills the criteria in the GMO Directive. 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 that the genetic material has been altered in such a way that does not occur naturally.
The opinion was issued after France asked for clarification on the scope of the GMO Directive. Bobek determined that the only relevant distinction that should be made in order to clarify the scope of the mutagenesis exemption is the caveat set out in Annex I B of the GMO Directive, namely whether the technique “involves the use of recombinant nucleic acid molecules or GMOs other than those produced by mutagenesis or cell fusion of plant cells of organisms which can exchange genetic material through traditional breeding methods.” Therefore, mutagenesis techniques are exempt from the obligations of the GMO Directive provided that they do not involve the use of recombinant nucleic acid molecules or GMOs other than those produced by one or more of the methods listed in Annex I B.
The Opinion does not negate member states from adopting measures regulating such organisms, as long as they respect the overarching principles of EU law. It should be noted that the Advocate General’s Opinion is not binding on the Court of Justice. It is the role of the Advocates General to propose to the Court, in complete independence, a legal solution to the cases for which they are responsible. The Judges of the Court are now beginning their deliberations in this case. Judgment will be given at a later date.