Victory for environmental consumer and sustainable small-scale agricultural campaigners. Genetically Modified Organisms (GMOs) made using certain mutagenesis techniques with the same effects as transgenesis that appeared after 2001 are covered by obligations listed in the GMO directive said the European Court of Justice in a highly awaited case on Wednesday 25 July (Case C-528/16, see EUROPE 12068).
The GMO directive (2001/18/EC) on the voluntary dissemination of GMOs in the environment governs authorisation to market GMOs, which are subject to obligations to assess their risks, along with labelling and traceability requirements.
Following the conclusions of Advocate General Michal Bobek (see EUROPE 11942), the European Court of Justice confirmed that an exemption from the directive does not apply to GMOs obtained using mutagenesis techniques that have traditionally been used for a range of applications and which have long proved to be safe. It states, however, that the member states are free to decide whether to apply the directive’s obligations or other obligations to such GMOs.
The Advocate General concluded that GMOs obtained using mutagenesis are in principle exempt from the obligations of the GMO directive, but the ECJ says that some GMOs obtained using mutagenesis are in fact subject to the directive’s obligations.
On the question of whether the GMO directive applies to genetically-modified organisms made using mutagenesis techniques that arose after 2001 (i.e. after adoption of the directive), the Court of Justice says that the risks connected with using these new mutagenesis techniques could prove similar to those connected with the manufacture and dissemination of GMOs using transgenesis.
This is for two reasons. Firstly, the direct modification of an organisms’ genes using mutagenesis makes it possible to produce the same effects as introducing foreign genes into that organism. Secondly, the new technique make it possible to produce varieties of GMO at extraordinary speed and volumes, way above those made using traditional mutagenesis.
Hence the ECJ feels that excluding from the directive’s scope of application GMOs obtained using new mutagenesis techniques would compromise the directive’s aim of avoiding the negative impact of GMOs on human health and the environment and would misunderstand the precautionary principle.
The ECJ therefore agreed with Confédération Paysanne and the other associations that filed the complaint in France.
Satisfaction among environmentalists, disappointment for industry
The ruling has been hailed as a victory by environmental campaigners, consumer activists and promoters of some kinds of agriculture, and as a defeat for agri-food businesses criticised by the NGOs, such as Corporate Europe Observatory (CEO) for carrying out intense lobbying to wriggle out of assessment and labelling requirements.
This ruling clarifies the fact that the EU decision-makers must ensure that products made using these new techniques shall be subject to an assessment of their potential risks for food safety and the environment and be properly labelled as GMOs, said Nina Holland of CEO.
In the opinion of the Greens/EFA: 'Today's ruling is a victory for food safety and the environment. Just because the industry has come up with new ways to modify organisms does not mean that these techniques should be exempt front existing EU standards on GMOs,’ said Belgium’s Bart Staes.
‘The Court made it crystal clear that plants and animals derived from gene editing are subject to the same safety and labelling requirements as other GMOs. These requirements exist to prevent harm and inform consumers about the food they eat,’ said Franziska Achterberg, food policy export for Greenpeace.
On the other hand, the European biotech industry expressed the sector’s concerns that Europe was depriving itself of significant benefits in terms of innovating in genetic engineering and its potential job creation and growth prospects.
In a press release, EuropaBio’s Secretary General John Brennan highlighted industry’s concerns about the judgement. He warned that in the absence of improved legal clarity in this area, Europe could miss out on significant benefits of certain applications of genome editing. (Original version in French by Aminata Niang)