EU Court of Justice Rules that Gene-Edited Organisms Are GMOs and Subject to GMO Regulations

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Dear Friends and Colleagues

EU Court of Justice Rules that Gene-Edited Organisms Are GMOs and Subject to GMO Regulations

In its judgment published on 25 July 2018, the Court of Justice of the European Union (EU) has clarified that gene-edited organisms are genetically modified organisms (GMOs) and are subject to EU GMO regulations.

The Court of Justice was requested by the Conseil d’État (Council of State, France) to determine whether organisms obtained by mutagenesis are GMOs and whether they are subject to the obligations laid down by the EU GMO Directive, after French national organisations filed a case at national level. Unlike transgenesis, mutagenesis is a set of techniques which make it possible to alter the genome of a living species without the insertion of foreign DNA. There has been intense biotech industry lobbying to try to exclude organisms produced by the new generation of genetic engineering technologies of gene editing from existing EU regulations on GMOs.

The Court ruled that organisms obtained by mutagenesis are GMOs within the meaning of the EU GMO Directive, in so far as the techniques and methods of mutagenesis alter the genetic material of an organism in a way that does not occur naturally, and such organisms are subject to the obligations laid down by that directive. The Court also determined that the GMO Directive is applicable to organisms obtained by mutagenesis techniques that have emerged since its adoption. It clarified that only the old mutagenesis techniques that were already exempted, are to be excluded from the scope of the law.

With best wishes,

ECJ ruling on gene editing products: Victory for consumers, farmers, environment

https://corporateeurope.org/pressreleases/2018/07/ecj-ruling-gene-editing-products-victory-consumers-farmers-environment

July 25th 2018 Food and agriculture

The European Court of Justice (ECJ) today published its ruling on the legal statusof food and feed crops derived from certain new genetic modification techniques. It gave clear confirmation that organisms from these new gene editing techniques are covered by existing EU GMO regulation.

Reacting to the decision, which corroborates the January 2018 opinion of one of the court’s Advocates General, Corporate Europe Observatory’s agribusiness campaigner Nina Holland said:

“This is a big victory for the environment, farmers and consumers. It clarifies that EU decision makers have to ensure that products from these new techniques are assessed for potential food safety and environmental risks, and that they are properly labelled as GMOs.

“Big agribusiness corporations will continue their lobbying in Brussels to escape EU safety rules for the new GMOs, but today’s ruling leaves no doubt: Products from gene editing are covered by the existing EU GMO rules.

“This ruling also means that the secret, unregulated field trial currently run in Belgium is illegal. The CRISPR-technique does in no way have a “history of safe use”, and the plants used in this trial are undoubtedly GMOs. Belgian authorities should act accordingly and halt this trial.”

Contact:

Nina Holland, +32 466 294420

nina.holland@corporateeurope.org

Notes to editors:

The ECJ ruling:The ECJ has concluded that products from new gene editing (GE) techniques are to be considered genetically modified organisms (GMOs) and as such are covered by existing EU GMO regulation. Importantly, the court clarifies that only the old mutagenesis techniques that were already exempted, are to be excluded from the scope of the law.

The case was referred to the EU court by the French Conseil d’État after French organisations had filed it at the national level.

Biotech industry lobbying and stakes: The biotech industry has been making an audacious bid to have products of the new generation of genetic engineering techniques exempted from existing EU regulation for genetically modified organisms (GMOs). With dozens of patents for new GM techniques already filed, the patent holders including big agrochemical corporations like Bayer/Monsanto, BASF, and Dow Agrosciences have great financial stakes in keeping the regulation fo their techniques as minimal as possible. As Testbiotech reports, DowDuPont has filed around 50 international patent applications for gene editing and plants, followed by Bayer-Monsanto with around 30 applications.

EU adherence to the UN Cartagena Protocol on Biosafety: The EU is Party to the UN Cartagena Protocol on Biosafety, which obliges it to respect other countries’ rights to refuse certain GMOs. If a Party to the treaty, in this case the EU, were to not monitor and label certain GMO varieties it exports,  this Party will be unable to respect its obligations under the Cartagena Protocol.

The techniques in question: The new generation of genetic manipulation techniques refers to different types of gene editing techniques, including oligonucleotide-directed mutagenesis , agroinfiltration and zinc finger nuclease technology. These techniques involve the cutting of DNA strands at specific locations to create tailor-made genetic changes which are different from the change patterns resulting from previous GM techniques.

Citizen, academic and NGO voices on the issue: Scientists, consumer groups, famers and NGOs have called for products from gene editing and other new GM techniques to be regulated under existing GMO rules, as any new approach to producing food and feed crops should be fully tested and its products labelled to ensure their safety for the public and the environment.

Belgian CRISPR field trial illegal? A secret and unregulated field trial with CRISPR maize by the Flemish Institute for Biotechnology (VIB) was held in 2017 and 2018. The plants tested in the field have been produced from a plant that was clearly categorised as a GMO. In this case the EU GMO law should have been applied, and the field trial should have been registered as a GM trial including biosafety measures

Item 2

COURT OF JUSTICE OF THE EUROPEAN UNION
PRESS RELEASE NO 111/18
Judgment in Case C-528/16
Confédération paysanne and Others v Premier minister and Ministre de
l’Agriculture, de l’Agroalimentaire et de la Forêt

Luxembourg, 25 July 2018
https://curia.europa.eu/jcms/upload/docs/application/pdf/2018-07/cp180111en.pdf

Organisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive

However, organisms obtained by mutagenesis techniques which have conventionally been used in a number of applications and have a long safety record are exempt from those obligations, on the understanding that the Member States are free to subject them, in compliance with EU law, to the obligations laid down by the directive or to other obligations

Unlike transgenesis, mutagenesis is a set of techniques which make it possible to alter the genome of a living species without the insertion of foreign DNA. Mutagenesis techniques have made it possible to develop seed varieties which are resistant to selective herbicides.

Confédération paysanne is a French agricultural union which defends the interests of small-scale farming. Together with eight other associations, it has brought an action before the Conseil d’État (Council of State, France) in order to contest the French legislation which exempts organisms obtained by mutagenesis from the obligations imposed by the directive on genetically modified organisms (GMOs).¹

In particular, that directive provides that GMOs must be authorised following an assessment of the risks which they present for human health and the environment and also makes them subject to traceability, labelling and monitoring obligations.

Confédération paysanne and the other associations argue that mutagenesis techniques have evolved over time. Prior to the adoption of the GMO Directive, only conventional or random methods of mutagenesis were applied in vivo to entire plants. Subsequently, technical progress has led to the emergence of in vitro mutagenesis techniques which make it possible to target the mutations in order to obtain an organism resistant to certain herbicides. Confédération paysanne and the other associations take the view that the use of herbicide-resistant seed varieties carries a risk of significant harm to the environment and to human and animal health, in the same way as GMOs obtained by transgenesis.

It is in this context that the Court of Justice has been requested by the Conseil d’État to determine, in essence, whether organisms obtained by mutagenesis are GMOs and whether they are subject to the obligations laid down by the GMO Directive.

In today’s judgment, the Court of Justice takes the view, first of all, that organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive, in so far as the techniques and methods of mutagenesis alter the genetic material of an organism in a way that does not occur naturally. It follows that those organisms come, in principle, within the scope of the GMO Directive and are subject to the obligations laid down by that directive.

The Court states, however, that it is apparent from the GMO Directive that it does not apply to organisms obtained by means of certain mutagenesis techniques, namely those which have conventionally been used in a number of applications and have a long safety record. The Court nevertheless specifies that the Member States are free to subject such organisms, in compliance with EU law (in particular the rules on the free movement of goods), to the obligations laid down by the GMO Directive or to other obligations. The fact that those organisms are excluded from the scope of the directive does not mean that the persons concerned may proceed freely with their deliberate release into the environment or with their placement on the market within the EU. The Member States are thus free to legislate in this area in compliance with EU law, in particular with the rules on the free movement of goods.

With regard to the question whether the GMO Directive may also be applicable to organisms obtained by mutagenesis techniques that have emerged since its adoption, the Court considers that the risks linked to the use of these new mutagenesis techniques might prove to be similar to those that result from the production and release of a GMO through transgenesis, since the direct modification of the genetic material of an organism through mutagenesis makes it possible to obtain the same effects as the introduction of a foreign gene into the organism (transgenesis) and those new techniques make it possible to produce genetically modified varieties at a rate out of all proportion to those resulting from the application of conventional methods of mutagenesis. In view of these shared risks, excluding organisms obtained by new mutagenesis techniques from the scope of the GMO Directive would compromise the objective pursued by that directive, which is to avoid adverse effects on human health and the environment, and would fail to respect the precautionary principle which that directive seeks to implement. It follows that the GMO Directive is also applicable to organisms obtained by mutagenesis techniques that have emerged since its adoption.

Finally, the Court examines the question whether genetically modified varieties obtained by mutagenesis must fulfil a condition laid down by another EU directive²,according to which a genetically modified variety may be accepted for inclusion in the common catalogue of varieties of agricultural plant species the seed of which may be marketed only if all appropriate measures have been taken to avoid risks to human health and the environment. The Court considers that the concept of ‘genetically modified variety’ must be construed as referring to the concept of a GMO in the GMO Directive, with the result that varieties obtained by mutagenesis which come under that directive must fulfil the condition mentioned above. By contrast, varieties obtained by means of mutagenesis techniques which have conventionally been used in a number of applications and have a long safety record are exempt from that obligation.

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NOTE: A reference for a preliminary ruling allows the courts and tribunals of the Member States, in disputes which have been brought before them, to refer questions to the Court of Justice about the interpretation of EU law or the validity of a European Union act. The Court of Justice does not decide the dispute itself. It is for the national court or tribunal to dispose of the case in accordance with the Court’s decision, which is similarly binding on other national courts or tribunals before which a similar issue is raised.

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Endnotes

1. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ 2001 L106, p.1).
2. Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (OJ2002 L193, p.1), as amended by Regulation (EC) No 1 829/2003 of the European Parliament and of the Council of 22 September 2003 (OJ 2003 L268, p.1).