16 I EUROPEAN SEED I EUROPEAN-SEED.COM I n December 2014, nine NGOs chal- lenged the transposition of the EU Directive 2001/18/EC – on the deliber- ate release of GMOs into the environment – by the French government as regards the exemption of varieties obtained from mutagenesis. Focusing on herbicide tolerant varieties in rapeseed and sun- flower, and considering those products as ‘hidden GMOs’, they claimed no assess- ment was carried out prior to market- ing. Consequently, they asked the Prime Minister to repeal the corresponding part of the French law and to adopt a morato- rium on sales and cultivation whilst eval- uating the risks as legally required by the said Directive. In March 2015, as no answer was given, the same NGOs brought the matter before the Conseil d’Etat which called the Ministry of Agriculture to testify – a rather rare procedure in this Court. In September 2016, in her public reading, the rapporteur demonstrated the French transposition of Directive 2001/18/EC was not to be questioned. Bridging historical mutagenesis and those of ‘New Plant Breeding Techniques’ which lead to mutations, she raised awareness of the Council that those techniques were not in the scope of the legislator when the directive was adopted. She also focused on the similarity of risks that are usually attributed to GMOs: use of herbicides (‘main objective of in vitro mutagen- esis in field crops’), gene flow and unin- tended effects. In that respect, NPBTs ‘dim differences between mutagenesis and transgenesis’, the precautionary principle could be endangered, as being adopted by the Treaty on the Functioning of the EU after the said Directive entered into implementation. PRELIMINARY QUESTIONS As a consequence of those recommenda- tions and citing ‘a serious difficulty in interpreting European Union law’, the Conseil d’Etat referred four interlocutory questions to the Court of Justice of the European Union (ECJ) on 3 October 2016: 1. Are organisms obtained from mutagenesis all exempted from the scope of Directive 2001/18/CE, including those which proceed from genetic engineering? Consequently, are the latter exempted from precautionary measures, impact assessment and traceability? 2. Is the definition of GMO consistent between Directive 2002/53/CE – on the common catalogue of varieties of agri- cultural plant species – and Directive 2001/18/CE? In that sense, are scopes of both directives similar and are varieties obtained by mutagenesis exempted from requirements for acceptance of GM vari- eties in the catalogue? 3. Is the exemption of mutagenesis from the scope of Directive 2001/18/CE to be considered as a full harmonization measure between EU Member-States or do Member States retain a degree of discretion to determine the provisions applicable to products obtained from mutagenesis? 4. Are the exemption provisions of Directive 2001/18/CE still valid as regards the precautionary principle taking into account the evolution of genetic engineer- ing processes, the existence of varieties obtained from those techniques and the scientific uncertainty of impacts for envi- ronment and human and animal health? PROCEDURE Requests to the ECJ for preliminary rulings are a common instrument regu- larly used by national courts that have to interpret or assess the transposition of national laws. Here, the responsible Court asks advice from the ECJ on how to interpret the basic act (the EU Directive 2001/18/EC) in order to properly assess and rule on the French transposition. In this case, this is not a classical adversarial procedure with the two par- ties pleading. Only the parties to the underlying national procedure (in casu the 9 anti-GM NGOs and the French gov- ernment) as well as any Member State and EU institutions were allowed to submit written observations to the ECJ; as did Austria, Greece, the Netherlands, Sweden and the UK, together with the EU Council, Parliament and Commission. The ECJ decided to listen to the par- ties and contributing states and institu- tions during a hearing in early October 2017. The advocate general made his opinion public on Jan. 18, 2018: 1. He stated that organ isms obtained by mutagenesis are, in princi- ple, exempted from the obligations in the Directive provided that they do not involve the use of recombinant nucleic acid molecules or GMOs. The mutagene- sis exemption applies to all mutagenesis techniques, both to those known at the time of adoption of the Directive (2001) and those considered new in 2018. 2. Directive 2002/53/EC on the common catalogue of varieties of agricul- tural plant species is to be interpreted as exempting varieties obtained by mutagen- esis from the specific obligations laid down therein for the inclusion of genet- ically modified varieties in the common catalogue of agricultural plant species. 3. Member States are free to adopt measures regulating such organisms provided they respect overarching prin- ciples of EU law. 4. The provisions of Directive 2001/18/CE for exempting specific tech- niques from its scope are still valid. This opinion is only advisory and does not bind the Court in its final deci- sion. However, it is an important step on the way to a ruling and advocates’ opinions are generally followed by the Court. Experience shows that such cases generally take between 15 to 24 months before the ECJ renders its decision. It will be then addressed to the national court that referred the questions. In casu, the Conseil d’Etat will then provide its national decision on the basis of this input. Nevertheless, it is very clear that the case goes far beyond the national borders: the ECJ ruling will give guid- ance to the EU Commission for inter- pretation of Directive 2001/18/EC as regards the latest plant breeding meth- ods. Importantly, the ECJ often takes its liberty to either solely address the con- crete addressed questions or approach the subject in a way that allows for a more general interpretation beyond those. It is therefore unclear whether the ECJ in the end will provide conclusive guidance that may be used to clarify the regulatory status of the latest breeding methods. Editor’s Note: Emmanuel Lesprit is Director of Regulation & Innovation Affairs at the French Seed Union (Union Française des Semenciers - UFS). A CLOSE-UP OF THE FRENCH CONSEIL D’ETAT REQUEST FOR A PRELIMINARY RULING OF THE ECJ ON MUTAGENESIS. BY: EMMANUEL LESPRIT TO EXEMPT OR NOT TO EXEMPT, THAT’S THE QUESTION EMMANUEL LESPRIT