Case C-528/16 on Mutagenesis Opinion of Advocate General Bobek Dr. Astrid Brandt, Steering Committee Meeting 16.05.2018

Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz Background Nine French agricultural associations brought an action before the French Council of State in order to contest the French regulation transposing the GMO Directive 2001/18/EC European Court of Justice was invited by the French Council of State to clarify the exact scope of the GMO Directive On January 18, 2018, Advocate General Bobek delivered his opinion on the four questions referred to the Court Date of delivery of the judgment by the Court still to be determined

Questions referred to the Court Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz Questions referred to the Court Do organisms obtained by mutagenesis constitute GMOs within the scope of the Directive? May new directed mutagenesis techniques be regarded as techniques of genetic modification in Annex I A? Consequently, does the Directive exempt from precautionary impact assessment all organisms obtained by mutagenesis or only those obtained by conventional mutagenesis? Does the exemption of mutagenesis constitute a full harmonisation measure prohibiting Member States from subjecting organisms obtained by mutagenesis to the obligations of the Directive? May the validity of the mutagenesis exemption be called into question, taking into account the development of genetic engineering techniques?

Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz Opinion on Question 1: a) Do organisms obtained by mutagenesis constitute GMOs within the scope of the Directive? b) May new directed mutagenesis techniques be regarded as techniques of genetic modification in Annex I A? c) Consequently, does the Directive exempt from precautionary impact assessment all organisms obtained by mutagenesis or only those obtained by conventional mutagenesis? Yes, they can be GMOs: An exemption would be illogical if they could not be characterised als GMOs in the first place. What is excluded does not need to be exempted. Case-by-case analysis is required! There is only one relevant distinction: the caveat set out in Annex I B. No further distinction should – or even could – be made judicially. Intentional decision not to distinguish between techniques. Narrowing down the caveat in Annex I B in 2001 was considered to sufficiently take into account technological developments. This does not mean an unqualified exemption for any and all mutagenesis techniques!

Annex I B of the Directive 2001/18/EC Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz Annex I B of the Directive 2001/18/EC “TECHNIQUES REFERRED TO IN ARTICLE 3 Techniques/methods of genetic modification yielding organisms to be excluded from the Directive, on the condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those produced by one or more of the techniques/methods listed below are: mutagenesis, (2) cell fusion (including protoplast fusion) of plant cells of organisms which can exchange genetic material through traditional breeding methods.”  The range of techniques was narrowed down in 2001 by the prohibition on the use of recombinant nucleic acid molecules. Old: no use of GMOs.

Recital 17: Exemption for safe techniques only? Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz Recital 17: Exemption for safe techniques only? Are only those mutagenesis techniques exempted that have „conventionally been used in a number of applications and have a long safety record“? Neither text nor historical context support that proposition: Neither article 3 nor Annex I B refer in any way to recital 17, such as mirroring its wording or using its categories. Recital 17 was inserted by the Commission before the mutagenesis exemption was discussed in subsequent stages of the legislative process. Mutagenesis exemption was inserted later and independently of recital 17.

Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz Opinion on Question 2: Does the exemption of mutagenesis constitute a full harmonisation measure prohibiting Member States from subjecting organisms obtained by mutagenesis to the obligations of the Directive? If the EU legislator had excluded mutagenesis because of its assumed general safety, he would logically have precluded Member States from making national regulations on that same issue. This assumption ist not supported by the Advocate General. It is rather assumed that the EU legislator simply did not wish to regulate that matter at EU level: - no legislator could wish to state now and forever that something is so safe it does not need any regulation at all; - same trend as adoption of Opt out; seems to indicate a certain renationalisation of competences in the field of GMOs. Measures regulating mutagenesis by Member States are not precluded, provided that they respect overall EU law obligations.

Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz Opinion on Question 3: May the validity of the mutagenesis exemption be called into question, taking into account the development of genetic engineering techniques? The mutagenesis exemption has been changed in 2001. Thus, it cannot be argued the EU legislature failed to update relevant legislation. As far as the triggering of the precautionary principle is concerned, there appears to be rather limited knowledge of the concrete risks for health and evironment. According to the Court‘s case-law, „risk uncertainty“ does not mean mere general doubts. Concrete risks must be identified supported by serious and independent scientific research. A fear of a risk, or risk of a risk, is not enough. No factor of such a kind has been disclosed as to affect the validity of the mutagenesis exemption.

Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz Outlook Date of delivery of the judgment by the Court still to be determined Press release of the Network commenting on the judgment? If Court does not follow the opinion of the Advocate General: Welcome the decision and, if applicable, emphasize open questions? If Court follows the opinion of the Advocate General: - Reject the decision without going into details OR - Emphasize positive aspects - „same standards for old and new mutagenesis techniques“, „new techniques not generally exempted“ - and point out open questions, e.g.  Definition of „recombinant nucleic acid molecules“  Definition of the term „to involve“

Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz Open Questions „recombinant nucleic acid molecules“ Does „recombining” mean the joining of any two pieces of DNA or RNA from the same species, or do they have to be from different species? „to involve“ Does „involve” mean that a „recombinant nucleic acid molecule” has been used at any step in the mutagenesis process, or only that the molecule is in the final product? If followed by the Court, the Advocate General’s Opinion clarifies the scope of the GMO Directive. The key question of how that applies to the new techniques, however, remains unanswered.

Possible National Measures? Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz Possible National Measures? If Court follows the present opinion: Examine national scope to adopt measures regulating directed mutagenesis? Patchwork of national rules undermines European Single Market and uniform risk assessment. If organisms resulting from directed mutagenesis are exempted from the GMO Directive and therefore have a non-GMO-status: Is Opt out applicable?