European Union – New tech products, GMOs or not ? The European Commission will decide alone

Co-published with Inf'OGM

Crispr/Cas9, oligodirected mutagenesis, zinc finger nuclease… Those names are a few of a longer list of new techniques of biotechnologies (NTB) for which the European Union is still to decide whether their products are falling under the scope of the EU GMO legislation or not. After having consulted with scientists experts, legal services and some member states, the European Commission has promised it will release a document before the end of 2015. If any were expecting this document to be discussed with the European Parliament and all the Member states, they had it wrong as the European Commission will not contact them, contrarily to what was announced in the first place...

2015 started with many news on the issue of the new techniques of biotechnology, those new “GMOs” that might end up being not legally considered as GMOs. In january, an open letter from associations and unions to the European Commission stated that all the new techniques of biotechnology should be considered as giving rise to GMOs falling under the scope of the EU legislation (1). In April 2015, a german decision revealed Cibus' strategy which, for years, has been requesting some member states to consider nationally that oligodirected mutagenesis is not giving rise to GMOs (2). Still in April, the High Council of Biotechnology in France started a work on the NTB (3). Finally, the industries have been active for long to obtain that those biotechnologies are out of the legal frame on GMOs as shown by a document written in 2014 (4).

The European Commission provide a vague answer to Jose Bove
As the civil society, the member of the European Parliament from the Greens, Jose Bove, considers that the “new biotechnology techniques must be considered to be techniques which produce GMOs”. In February 2015, he asked the European Commission about its intentions towards those NTB. In April 2015, the European Commission answer was quite vague: it said it was working to “clarify whether new biotechnology techniques, applicable to plant breeding, are falling under the scope of Directive 2001/18/EC”. And the EC adds that “The decision to include or exclude a technique from the scope of Directive 2001/18/EC depends on the interpretation of the definition of Genetically Modified Organisms and of the conditions for exemption provided for in the directive. This analysis is currently ongoing and results cannot be anticipated yet” (5). Such an analysis has been going on since 2007…

The European Commission will decide alone on the status of NTB
In may 2012, Eric Poudelet from the European Commission, explained “[classifying the new techniques of biotchnology as GMO or not] is a tough issue that do worries a lot the Commission but scientists do not always agree […] It will be up to member states to take this decision” (6). Since this statement, it turns out that the EC changed its mind: following a request from Corporate Europe Observatory in June 2015, the EC was more precise regarding the process it intends to follow. According to the information received by CEO, the EC will finalise its document before the end of 2015. This document, which aims at clarifying how the EC interprets the definition of a GMO according to EC/2001/18 directive and therefore which will clarify which techniques give rise to GMOs or not, might be a Communication or a Commission notice according to the EC. It will therefore not be a legal proposal which would have implied talks and votes of the European Parliament and the European Council. No vote will be required but a presentation to Member States is foreseen.

If the EC expects Member States to follow its interpretation, it does not exclude differences of opinion (just for the oligodirected mutagenesis, Czech Republik considers it to give rise to GMOs contrarily to some other member states (7)). The EC then warns that in such cases, the European Union Court of Justice (EUCJ) will have the final word in this debate in the course of a legal challenge. Such a decision would be the end of the debate, the EUCJ's decision applying to all.

Up to now, the European Commission might generate legal uncertainties. If the 28 member states and the European Commission agree that the products obtained through NTB fall under the scope of the EU GMO legislation, the industries would be the only ones to be willing to challenge this decision. But until then, dealing with those products would be clear: a mandatory authorisation would be required following a risk assessment, a labelling, a post-marketing environmental monitoring... But, if the EC was to consider some products as not falling under the scope of the EU GMO legislation, in contradiction with opinion of some member states (or the opposite), a considerable uncertainty will exist: which opinion will prevail? What about the products? Would they be commercialised without authorisation, leaving the member states willing to consider them as GMOs in the position to take restrictive measures? And the industries? And the citizens willing to know what they are cropping, eating, using? All those questions will lead to the legal challenges at the EUCJ the EC is referring to.
Unless... Unless the Transatlantic Trade and Investment Partnership (TTIP) agreement under negotiation was to impose a decision. A reasonable assumption considering the talks that EU representatives had with US representatives and seed industries on this issue (8).

5, Parliamentary question « New biotechnology techniques » from Jose Bove, 27 february 2015, EC's reply on 15 april 2015
8, Article to be published soon

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