Forthcoming Gene-editing Proposal by the European Commission
The European Commission is expected to publish its legislative proposal for New Genomic Techniques (NGTs – gene edited crops) on July 5. Under existing rules, the EU treats NGTs such as plants obtained by targeted mutagenesis, cisgenesis and intragenesis as GMOs and the objective of the forthcoming Commission proposal is to create a ‘lighter’ regulatory regime for gene edited crops. A leaked version of this draft proposal (dated June 7, attached) shows the complex nature of this new Regulation and reveals two notable concessions from the European Commission to environmental NGOs and organics sector: herbicide-tolerant NGTs will continue to fall under existing GMO rules and NGTs are essentially banned from use in organic farming.
The proposal also contains two categories of NGT crops, each with their own authorization procedure. The two categories are:
Category 1 NGT plants for notification: Gene-edited crops will be allowed on the EU market without approval process if they are considered “conventional-like,” meaning they could also occur naturally or by conventional breeding, based the criteria of Annex I of the proposal. These crops must be notified to the European Commission, which will decide whether they are “conventional-like”. Plant reproductive material, including for breeding and scientific purposes, that contains or consists of category 1 NGT plants, have to be labeled indicating the words “new genomic technique category 1”.
Category 2 NGT plants for authorization: Gene-edited crops that are not considered “conventional-like” will have to undergo an EU authorization process that is similar to that for existing GMO legislation and procedures. The amount of information necessary for the risk assessment will vary on a case-by-case basis depending on their risk profiles. Existing traceability and labeling requirements for GMOs will apply, but other requirements, such as the submission of an event-specific detection test or a monitoring plan may be waived. Regulatory incentives should be offered to (potential) applicants for category 2 NGT plants containing traits with the potential to contribute to a sustainable agri-food system or benefit small businesses. Interestingly, and in contrast with GMOs, EU member states will not be able to ban the cultivation of these crops – a big difference with GMOs.
Both environmental NGOs and plant breeding organizations (like Euroseeds) have criticized the proposal. Euroseeds welcomed the intent of the new legislation but criticized its complexity and inconsistency, saying it ignored the reality of farming.The group expressed “serious doubts” about the notification process in the draft, which it called “overly complex and lengthy.” It said the process risked “politicizing” what should be an administrative decision based on “clear scientific criteria,” putting the EU at odds with approaches taken in other jurisdictions such as the UK and placing a “major burden” on developers. Euroseeds also criticized the ban on the use of NGTs in organic farming, calling it “illogical and discriminatory,” and questioned the legal basis for effectively banning herbicide-tolerant NGT crops by treating them as conventional GMOs.